.

~ntr&uction requtrements Some chapters such as Drmension d Hard

Cellulos~Capst~leShells, Hard Gelatin Capsule Sheilr;,
The Eighth edition of the Indian Pharmacopoeia (IP2018) 1s Taste and 0dour. Granules, Approximate pH of SOIULIU~S,
~ u b l i s h e d the
b ~ Indian Pharmaco~oelaCommission (IPC) in Uonocyte actlvatlon test, Mtcrobto[ogical assay of vltamtn
accordance with a designed plan by lfle Screntific Body 6,: actlvlly, Mlcrobiologlca[ assay of calcium pantothenatc.
IPC, in fulfilment of the requirements of the Dmgs and restfor biological reactivity, "ivoas well as jn vitr.0,
Cosmetics Act I940 and Rules thenunder and completed ~ ~~~~~~~t and
t Viral ~safety evaluation
~ of~biotechnology
~ ~ i
though the untiring efforts Its members. Secretanat and denbed from cell lines ofHutnan or Animal origin are
Laboratory over a period of about two years. It newly included as per the technologtcal requirements.
the IP 2014 edrtlon but any monograph of the earlier edltton
that does not figure m thrs ed~ttonconttnues to be official as Format
stipulated m the Second Schedule of the Drugs andCosmetics
Act, 1940 [n an effort to make the pharmacopoera more user-friendly, the
design of the tests of the monographs and test methods ale
Presentation kept same Cross-referencing has been avoided to make each
-monograph <omplete 111 rtself, thus makmg ~t convenient to
The Indtan Pharmacopoeia 201 8 1s presented m four volumes the user
volume I contarns the Not~ces.Preface, the Structure
of the IPC, Acknowledgements lntrdductton. G e ~ ~ c l a lPharrnacopoeial Requirements
and Index 'Ohme I' AS ~nthe this cotnpendlum provtdes a publrcly avarl?ble
General Monographs on dosage folnls. on dmg statement conce1nlng the quaflty of a product that can be
substances, dosage ffolllls and ~hamaceuticaiaids (A to M) 2,pzcted alld demonstrated at any time throughout the
Volume 111 contatns Monographs 011drug substances. dosage accepred of drrIcle. ~h~ standards laid down
fomls and phamaceutlca' to 1' follo"ed b> and represent the lnlnlmum ltlt]l which the must comply
distingished by colour codes, Monomphs on \'acc~ncsand and is for the manufacturer to ensure that the article
hmunosera for human use, Herbs and herbal products.%lood manufactured accordance \vith (jood ManuficturLng
and blood-related products, BiOtechnOlOg~pmtices (GMPs) It 1s that su@ciently stringent
Derived products, *llergen products and llllllt~are app\led at the time of release of a batch of drug
R a d l o - ~ h a m a c ~ u ~preparations,
~c~l Volume IV substance or drug product so that the pharnlacopoelal
Veter~narymonographs and Index standards are met until its explry when stored under the storage
The scope of the Indian Pharmacopocla has been extended to condit~onsspectRed
include products of blotechnolo~,herbs and hehalprducn, It mu$ be noted that a vaIrd interpretation ofany requlrernent
veterinary vaccmes and addttional antiretroviral dmgs and ofthe lndian Phannacopoela should be done In the context of
formulations, 1~cluSlveof commonly used fixed-dose the monogaph as a whole, the relevant general monographs,
combinations. Standards for new d r ~and s drugs used under where appropriate, the specified tests and methods of analysis
National Health Programmes and included in National List of includlllg any reference to the General Notices.
Essential Medicines are added and the drugs as well as their ~ ~ ~ i with l i the
~ Genera\
~ i t sotlces
~ will facilitate the correct
formulations currently not used are omitted from this edition. application ofthe requirements.
The number of monographs of Dmgs substances, Dosage
forms, Excipients, Vaccines and Immunosera for Human use, Changes 8

Ilcrbs and Herbal Products, Blood and Blood related products

ICccping in mew the esscntlal requlretnent under the Dmgs
and Biotechnology Derived Therapeutic products have been
and Cosmetics Act. 1940and Rules thereunder, the tnfomation
increased in this edition Monographs of Vaccines and
on the category of a drug, and available usual strengths of
Immunosera for Human use are also upgraded in view of the
dosage fonns has been kept in this edition.
latest development ofthe technology in the field. Many general
chapters such as Tablets, Capsules, Volumetric Glassware and General chemical tests b r tdenhfication of an article have been
Maintenance, Identification, PreseNatio more Specific infiaredt ultraviolet
Mtcroorganism have been revtsed. The ic and HPLC tests have been given
General Chapters such as Visintegr?tion, ccpt of relyins on published tnhred specm
upgraded to harmonise wrth prevarli nt~ficai~on has been contillued

I
 Tile use of chromatographic methods has been greatly pertainingto thequalityrequircmcntsofmedicinalsubstances.
extended to cope up with the need for thc specificity in assays It also includes reference data such as reference spectra,
'. i
'and in particular. in assessing the pature and extent o f - typical chromatograms etc. The test metbods reflect the y.
impurities in drus substances and drug products. Most ~f the sophisticationofanalytical me tho do lo^ and instrumentation.
existing assays and related substances tests have been
Analytical methods in general are in harmony with those
~~pgraded to liquid chromatography method In vlew to have
adopted intemtionclily fur rnoniioring the quality uf d1ug.s.
the specificity and td harmonise with other International
The steps taken for harmonization have been initiated by the
Pharmacopoeias to theextcnt necessary. The up-gradation 111
need to cope with the increasing demand for drugs
this edi~ioncovels ali the amendments and crrata rclcascd
manufactured in the country to meet globally accepted
after publication ofAddendutn 3_0 16 to 1P-20 14.
standards.
In most of the parentera1 preparation and other monographs,
Accordingly 10 new chaptkrs have been introduced based on
the test for pyrogens Involving the use of anlrnals has been
almost cl~in~nated and replaced with Bacter~alEndotoi~ntest current technologies used by the stakeholders and harmonized
In some blood and blood related monographs, the Bacterial with other international pharrnacopoieas; like Dimensions of
Endotoxtn test has been incorporated. The test for B~ologrcal Hard Cellulose Capsule Shells, Monocyte '4ctivation Test,
React~v~ty, in L'ILO. Test for Biological reactivity, trz vltro
Granules and Odour and Taste etc.
Microbiological Assay of Vitamin B I Z activity and The trend towards controlling the microbial quality of all
itficrobiological Assay of Calcium Pantothenate has peen medicinal products has been rkcognized and the requirement
added. regarding limits ofmicrobial contamination, even of products
r\/lore essential oils nlonographs, crude herbal drugs an3 for oral administration and topical application, so that
extracts ha\-? been'incol.porated and also s o z e existing adegiiate controls are exercised by the manufacturers by the
monographs-have been revised under the seclioi~Herbs a r ~ ~ ladoption 6r GMPS has h e n continued
Herbal Products in volume III. GeneraiChapter on Maintenance, identification, preservation
Three nlonographs on radiophar~naceuticalpreparations. and disposal of micro-organisms has been revised and a
10 n~onographson Blood ar~dBluud lelated products, general chapter on Viral safety evaluation of biotechnology
06 monographs on Biotechnology Der~vedTherapeutic products derived from cell lines of Human or Animal origin
products, 01 nex monograph on Vaccines and lmmunosera has been included for the first time.
for Hurnan use and 15 monographs on Hcrbs and The Herbs and Herbal products section has been tevised by
Herbal products have been added in Volume [I1of this edition. inclusion of Botanical Extract.
A separate volume for veterinaq monographs as Volume 1V of
this edition of Indian Pharmacopoeia has be'en designed to Monographs
provide comprehensive informadon to those concerned
The General Monographs for dosage forms of active
with- the quality control of veterinary medicines. I4 new
pharmaceutical ingredients (APIs) are grouped together at
veterinary monographs have been added in this..-- volume.
the beginning of Volume 11. They are followed by the .
Several monograpfs on chemicals along with a number of
monographs for the APIs, phannaceutical aids and individual
mono,oraphs mterinary-vaccines. diagnostic; irnmunosera
dosage forms, all in alphabetical order upto Volume 111.
and sursical materials have been given place in this volume.
Monographs for other articles of special nature such as
Many monographs just on the basis of'usual strengths and
vaccines and immunosera for human use, hertis and herbal
doses have been mendoned in this vblurne while complete
products, blood and blood related products, biotechnology
monographs are mentioned in other volumes of IP. 'derived therapeutic products and radiopharmaceuticals
The monograph OH Brz~cellamelite,ai~(Strain Rev I) Vaccine, preparations are given in sep-gate sections in Volume 1x1.
L~ve;Canine Adenovirus Viccine, Ina~tivated;C>nlne Special emphasis has been given to monographs
adenovirus vaccine, Live; Canine Contagious Hepatitis adding new ones and updating the existing monographs in
Vaccine, LIV?;Old Adjuvant Vaccine Against ~asturellosisin volullle N
-
sheep and Goats & Rinderpest Vaccine, Live have been -
omitted. Any necessary corrections have been incorporated A list of 220 new monographs included in the 20 18edition of
the Indian Pharmacopoeia, is given below:
in this edition. , .
-'GeneralChapters
'volume I is devoted mainlyto test methods . .
mail [hc drticles cf the phzmacopoeia and g logical Reactivity! !~r? 3.w
 2.2.24. Test for Biological Reactivity, Cmustine Elzrrlapril Maleate and
In Kvn Camustine Injectior~ HydrnchlorothiazideTablets .
2.2.25. Monocytc Activation Test CeMinb - .. Esci~loprarnUxaiate and Clulla~epiila
Tablets
2.226. Microbiological Assay of Cefdinir Oral Suspension .
Calcium Pantothenate Esmolol Injection
Cefixirne Dispersible Tablets
CefuroximcAxetil
2.2.27. h~icrobiolo~ca1~sayofViMmin md Potassiurrl Gtodolac Prnlrlnged-release Tablee
U,,hchvity Clavulanlate 'Tablets Folic Acid and Methylcubalarnin
Tablets
2.2.28. Safety Eva'uati0n af Chn(ecaIcifiro[ Concentrate (Powder
.Biotechnology produck dciivd F ~ . ~ ~ ) Ganciclovir
from cell lines of Human or Ganciklovir Injection
Animal origin Cihdipine
Ganciclovir Oral Suspension
CilnidipineTablets
2.4.45. Odour and Taste Glibenclarnide and Metformin Tablets
Cinacalcet Hydrochloride
2.4.46.. Approximate pH of Solutions . Glycopyrrolate
Clindamycin Palmitate ~~drochloride
5.8.2. Dimensions of Hard Cellulose . Glycopyrrolate Injection
Cansule
. .
Shells Clindamycin Palmitate Hydrochloride
Oral Suspension GLycopyrrolate Tablets
Granules (General Monographs for Hydroxyurea
Dosage Fonns j Clonidine Hydrochloride
and.Chlorthalidone Tablets Hydroxyurea Capsules
Monographs on drugsubstanc%'dosage -Cyclobenzaprine ~ ~ d ~ ~ & ~ ~ ~and iEaracetan~ol
Ibrrprofen d ~ Tablets
- forms and pharmaceutical aids
Cyclobenzaprine Tablets Ibuprofen and Pseudoephedrine
Abiraterone Acetate Tablets . Hydrochloride Tablets
Dacarbazine
Aluminium, Magnesium and Isoflurane
Simethicone Chewable Tablets Dacarbazine Injection
Isotretinoin Gel
Aluminium, Magnesium and Daclatasvir Dihydrochloride Latanoprost Eye Drops
Sirnethicone Oral Suspension Dapoxetine Tablets
Latanoprost and ~imololOphthalmic
Ambrisentan S-Dapoxetine Hydrochloride Solution
Ambrisenbn Tablets S-Dapoxetine Tablets Letrozole
Arnilonde and Hydrochlorothiazide Dapsone
Letrozole Tablets
- -- .- .-
Tahletq
Darifenacin Hydrobromide Levetiracetam Tablets
Arnlodipine and Benazepril
Hydrochloride Capsules Darifenacin Prolonged-release Tablets Levodopa and Carbidopa Prolonged-
.-

Aprepi tant Darunavir Ethanoyate release Tablets

Aprepitant Capsules Damriavir Tablets Levofloxacin Oral Solution
Armodafmil Diclofenac Diethylamine Lignocaine
Artesunate Injection - Lignocaine and Pnlocaine Cream -
Diclofenac Sodium and Paracetarnol
Atenolol and Chlorthalidone'lablets Tablets T,ignocaine Hydrochloride Topical
Atorvastatin-and Fenofibrate Tablets Solution -
~iciofenacGel
Azelnidipine . Tablets
.
Lignocaine OralTopical Solution
Diethylene Glycol Monoethyl Ether "
Bisoprolol Pumarate Lorcaserin Hydrochloride Hemihydrate
Dinoprostone
Bisoprolol Fumarate and Lorcaserin Tablets
Hydrochlorothiazide Table@ Dinoprostone Oral Solution Magaldrate and Simethicone Chewable
Bosentan Monohydrate Diphenoxylate Hydrochloride and Tablets
Atropine Sulphate Tabfets Magaldrate and SimethiconeOral
Bosentan Tablets
Calcium and Vitamin D3Tablets Suspension
~ a p t o ~ rand
i l Hydrochlorothiazide Mefenamic Acid and Dicyclomine
'ibicrs Hydrochloride Tablets
 INTRODUCTION
hfcmautinu Hydrochloride
h~lemantineTablets
Mcsna
..
Metadoxine .
Metformin Hydrochloride Prolonged-
release atd Glimepiride'kiblets
~eth~fco&larnin .
Methyldopa and Hydrochlorothiazide
Tablets
Metoprolo1Succinate Prolonged-
release and Amlodipine Besilate
Tablets .
Metoprolol Tartrate and
Hydrochlorothiazide Tablets
Montelukast Granules
Montelukast Sodium a ~ d
Levocetirizine HydrochlorideTablets
Mycophenolate Mofetil Oral
Suspension
- Mycophenolate Mofetil Tablets
Nadifloxacin
Nadifloxacin Cream-
Nadifloxacin Gel
Nitroglycerin Injection
Norethisterorie and Ethinyl Estradiol
Tablets .
Norgestimate
Norsestirnate and Ethinyl Oestradiol
Tablets
Ofloxacin and OmidazoleTablets
Olanzapine and ~luoxetine~ablets
Olmesartan Medoxomil and
.Hydrochlorothiazide Tablets
Omeprazole and Domperidone
Capsules
Olopatadine Hydrochloride
Olopatadine Ophthalmic Solution
Olopatadine Tablets . .. -
Oxaliplatin Injection
Oxybutynin Hydrochloride
O x ~ l b u ~ nProlonged-release
in Tzblets
Oxyrnetaoline HydrochlorideNasal Telmisartan and Hydmchlorothiaxide
Solution Tablets
Oxymetazoline Hydrochloride . . Terbinafine Hydrochloride
Terbinafine Cream
Paliperidone
Pantoprazole Gastro-resistant and Terbinafine Tablets
Dompendone Prolonged-release Thioguanine
Capsules Thioguanine Tablets
Paracctrunol and Caffeine Tablets Ticagrelor
Pnroxetine Hydrochloride Hemihydrate Tobramycin and Fluorometholorte
Phenylephrine Eye Drops Acetate Ophthalmic Suspension
Phenylephrine Hydrochloride and . Tobramycin Inhalation Solution
~hlor~heniramine Maleate Drops Trimetazidine Tablets
Phenylepkine Hydrochloride and Trospium Chloride Tablets
Chlorphenirainine Maleate Syrup
Vonconazole Injection
Phytomenadione Xylornetazoline Hydrochloride and
Phytomenadione Injection
.,.. Sorbitol Nasal Drops :.,z:
Piperacilljn artd Tazobactarn Injection
Piroxicam Tablets Tablets -
Zolpidem Tartrate Prolonged-release
Zonisamide Capsuies
.. .
Pregabalin and Methylcobalamin
Capsules
Antibiotics
Prilocaine
Ger~tar~ucui
C~eail
Procarbazine Hydl-ochlorideCapsules
Gentarnicin Ointment
Propylene Glycol Monocaprylate
Quinapril Hydrochloride Radiopharmaceuticals
Quinapnl and Hydrochlorothiazide Galliuln (68 Ga) Cl~loridesolut~on
for
Tablets Radiolabelling
Repaglinide and Metfo~minTablets Sodium Iodide (Iz3 1) Injection
(From '14 Xe)
Risedronate Sodium Tablets
Sodium Iodide (I2' I) Solution for
Ropivacaine Hydrochloride
RadiolabellGig
Ropivacaine Injection
R6suvastatin Calcium and ~ z e t i i i b e Herbals
Tablets Amarbel
Rosuvastatin and Fenofibrate Tablets Anise Oil
Sertaconazole
. . Nitrate - Belladona Dry Extract Tablets
..SertaconazoleNitrate and Citronella Oil (Gwniol type)
Beclornethasone Dipropionate Cream
Citronella Oil (Javatype) .
Sndium Aler~dronateTrihydrate
Green Co&c Bcail Extract
Sucralfate Horse Chestnut Dry ~xtract
~ucralfate$blets Juniper Oil
Tarnsulosin Hydrochloride Prolonged-
Mandarin Oil
.
Milk Thistle
Milk Thistle Dry Exlract
 IP 2018
Schisandra Dry Extract
y Schisandra Fruit
sweet Orange Oil - bphalexin Veteriosy Oral Powder
Tvak . Enrofloxacin Injection
vaccines and Immunosera for Btiman
Use
pneumococcal Polysaccharide
Conjugate Vaccine (Adsorbed)
Scorpion Venom Antiserum
Biotechnology Derilred Therapeutic Injection
Products
~ollicieStimulatingHormone
Concentrated Solution
Follicle Stimulating Hormone LnJection 2.1.6. Volumerric Glassware
Follicle StimulatingHormone
Lntcrferon p-ldnjection - 2.2.15. Host Cell Protcins and Host
Tenparatide
Teriparatlde ir~jection
Blood and B b d Reiated ~roducts
Anti-D (IgM) monoclonal blood
grouping reagent
Blood Grouping Reagent Anti-Fy",
Anti-Fyb
Blood Grouping Reagent Antl-W,
Anti-skb
Blood Grouping Reagent Anti-K,
Anti-k
Blood Groupinixgent Anti-M,
Anti-N
Blood Grouping Reagents Anti Pl
Blood Grouping Reagents Anti-Lea,
Anti-Leb
Blood Grouping Reagents hti-S,
Anti-s - ~ o n o ~ r a pondrug
Blood ~~~~~i~~ leCtinSh t i - ~
Blood Grouping LectinsAnti-A1
Veterinary Non-biological
~lbendazole~etain&~r;tipdwder
hoxyciitin Tabtets
, - ,
h p r o l i u m oral b k d e r
Buparvaquone
auparvaquone In!ec:io~:
Cekoxime intmmamaq in%ion Penussis and Inactivated
Poliomyelitis Vaccine
._
Cephalexin lntrautenne Powder far
Suspension Adsorbed Diphtheria, T e h a ~ ~ s .
perrtlqsis, Snactivated ~oiiomyektis
Vaccine
. -. and Haernophilus ~ f i j ~ ~ s ~ u ~
Type b Conjugate Vaccine
Malboflonacin lnjstlOn Adsorbed Dipl~thcria,Tetanus.
myo-lnosito\ . Pertussis and (Acellular Component)
Oxytetracycline Hydrochloride ~ ~ l i ~ ~ ~(Inactivated)
e l i t i s Vaccine.
Injection , Adsorbed Diphtheria, Tetanus.
Sodium Acid ~hospiateInjection pertussis, oliom myelitis (Inactivated)
Timethoprlm and ~ul~hamethoxazole and Haemopbilus infl~ienifleType b
Conjugate Vaccine
A{\opurinolTablets
'Upgradation Aluminium Hydroxide Gel
General Chapters upgraded:
moxycilhn Capsules
Amoxyci\lin D~spersibleTablets
2.2.3. Bacterial Endotoxins moxycillin lnjectlon
Aill~xycillrnOralsuspension
Cell DNA
- 2.2.20. Maintenance, Identification, Amoxycillin Sqdium
Preservation and Disposal of AmoxycilllnTrihydrate~y&ate
Microorganisms Ampicillirt Capsules
--
2 3 . 9 . Alurnrniunl in Adsorbed
Vaccines
Amp~cillinInjectron
Ampicillin Oral Suspension
2.3.30. h'itrogen
Ampicillin Sodium
2.4.9. Conductivity ~n~picilhn Trihydrate
2 5.1 Disintegration Test
Ampiclllln Vstennary Oral Powder
2.5.2 Dissolution Test
58.1, Dimensions of Hard Gelatin AmprOliumHydrOchlO*de
Capsule Shells Anthrax spore Vaccine, Live
Herbs and Herbal Products hti-D.(Rho) lmmun.~globulin
Vaccines: Geneial Requirements ArjunaDry Extract
Veterinary Diagnostics . Atmcurium Besylate Injection
Veterinary lmmunosera - avian infectious Bronchitis Vaccine,
- Vetennary Vaccines: Gene61 inactivated
Requirements Avian lnfecGous Bronchitis %Wine,
hs subsbnas, dosage Live
for"" and harmaceutical aids Avian bfectious L ~ v ~
be& have been up@aded: Vaccine, Live
Abiraterone Acetate Avian Mycoplasma Antigen
Acepromazine Maleate .- Azathioprine Tablets
ANproma&e - ' Ba&US ca~ette-~u&nVzccine
Aciclovir (Freeze-Dried)
, , *. *
.
Bacitracin Zinc
Ban1buterol3ydroch!oride
 Bambuterol Tablets
Batamethasone Cream
BCG for Irnrnunotherapy
Bendamustine Injection
Bemathine Penicillin
Benzathine Penicillin Injection
Benzhexol Tablets .
Benzyl Alcohol
Benzyl Benzoate
Betamethasone Valerate Cream -
Bhibhitaki
Bifonazole Cream
Biphasic insulin Lispro Injection
Blackquarter Vaccine
Brirnonidine Tartrate Eye Draps
Brucella Abortus (straid 19 Vaccine)
Vaccine, Live
i3umetarnidc Itijcctinn
Butylparaben
. Calcitonin (Saimon) Injection
Calciurn Folirrale (Leucovorin Ca)
Calcium Magnesium Borogluconate
Injection
Calcium Stearate
Canine Adenovirus Vaccine, Live
Canine Coronavirus Vaccine,
Inactivated
1 Canine Distemper Vaccine, Live
Canine Infectious Contagious
Hepatitis Vaccine,
- Inactivated
Canine Parainfluenza Virus Vaccine, . Diloxanide Furoate
Live
Canine Parvovirus ~accine,'~nactivated
Canine Parvovirus vaccine, Live
Caprofen
- Carboxymethy lcellulose Sodium
Carnauba Wax
Cefopenzone Injection
Cefoperazone Sodium
~ ~ ~ o P~~~~W ~ ~ Q QType~b Conjugate
Suspension
Cefotaxime Sodium Injectiqn
CctirizincHydrochloride
Cefpodoxime Tablets
C e h i d e Cream Diphtheria, Tetanus, Pertussis (Whole
Cetrimide Emulsitjling Ointment dell), Hepatitis B (rDNA) and
Haernophilzrs ii?fiuenzaeType b
Ohtorthalidone
Conjugate Vaccine (Adsorbed)
Cholecalciferol Dipyl iclnukull:
Cholera Vaccine (Innctivatcd,Oral) Disopyramide Phosphate Capsales
ClarithromycinTablets
.. Disopyramide Phosphate Prolonged-
release Capsules
Classical Swine Fever Vaccine, Live
Diilalproex Prolonged-releaseTablets
Clobazam Tablets
Divalproex Sodium
Clobetasone Cream
D O C ~ ~ Anhydrous
~ X ~ I
Clomifene Cibate
Doxofjrlline
ClotrimazoleCream
Doxorubicin Injection
~iotrimazolePessaries
Duloxetine Gastro-resistant Tablets
Clonidine Tablets
Egg Drop SyndromeY76(Adenovirus)
Closantel Sodium Dihydrate Vaccine, 1nactiliated
Crospovidone . Enrofloxacin -
Crotaminton . Enterotoxaemia Vaccine, Inactivated
Cyclosporinc Ergotamine lnject~on
Daruharidra Roots Esmolol Hydrochlorid
Decoquinate Ethacrynic Acid
Ethanolamine
Dcsferrioxarnine Itijection
Etoposide
Dexamethasone Sodium Phosphate
fibrin Sealant Kit
Dexametl~asoneTablets
Filgrastin concentrated solution
Dexlansoprazole Fenspiride Hydrochloride
Diazoxide Finasteride
Diclazuril Finasteride Tablets
Dichlorophen Tablets Foot and Mouth Disease Vaccine,
Diclofenac Prolonged-release Tablets Inactivated
Dicloxacillin Sodium Flucloxacillin Oral Solution -
Fortified Benzathine-PenicillinInjection
Folic Acid
Diluted Pentaerythritol Tetranitrate
Fortified Procaine Penicillin Injection
Dimethicone
Fosinopril Sodium
Dinitolamide
Fowl Cholera vaccine, Inactivated
Diphtheria Vaccine (Absorbed) Fowl Poxvaccine, Live
Diphtheria, Tetanus and Pertussis F~~~~~~ injection
Vaccine (Adsorhed)
Frusemide Tablets
Diphtheria, Tetanus, Pertussis (Whole -Furazo,idone .
Cell) and Haemophilus infuenzae
S ~ Vaccine~ - Gabapcntin Capsules
(Adsorbed) Gemcitabine Hydrochloride
Ginkgo ~ r j~fx i i c t
, ,
Ginkgo ~ a b l e t s
Glibenci,mide Tablets
Gliclazide Insulin Glargine Methy lprednisotone
GlictazideTablets InsulinGlargine Injection - Metolazone Tablets
e - - Metoprolol Succinate
GlucOsamine Sulphate Sodium Ivermectin lnjection ..

Chlonde Ivermectin Oral Paste Metoprolo1Succinate Prolonged-

Goat Pox Vaccine, Live Ivermectin Pour on release Tablets
Guggulipid Japanese Encephalitis Live Vaccine . MetO~rolo'
G~~lipidTablets (Human) Metronidazole Benzoate Oral
Japanese Encephalitis Vaccine Suspension ..
Guggul Resin
(Human) Metronidazole Injection
Haemonhagic SepticaenliaVaccine, I

~nactivated Japanese Encephalitis Vaccine Mon~etasoneCrea~n

Heparin Injection
Heparin Sodium
Hepatitis A (Inactivated) and Hepatitis
3 (rDNA) Vacc~ne(Adsorbed)
Human Albumin
Human Normal Immunoglobulin
Human Normal Immunoglobulinfor
Intiavenous use
Human Plasma Protein Fraetion
Hydrochlorothiazlde
Hydrochlorothiaude Tablets
Hydroxychloroquine Tablets
HydroxypropylmethylCellulose
Hyoscine Butylbromide
Hyoscine Butylbromide Inject1011
Hyosc~neButylbrorntde Tablets
Hyoscine Hydrobrom~de
Hyoscyamine Sulphate
Ifosfanlide Inject~on
Lmipenem
Inactivated Hepatitis Ascdirie
(Adsorbed)
Inactivated Hepatitis B Vaccine
Inactivated InfluenzaVaccine
(SplitVrrion) .
Inactivated I~fluenzaVaccine
(Surface $tigen)
Inactivated (Adsorbed, Human) hilometasone ointment
Ketorolac Trornetharnine Moxidectin
Labetalol hjection isti tic Acid
Lactic Acid Nifedipine ~rologed-selea~eTabiet?
Latanoprost Nitroxynil Injection . .
Levamisole [~iject~on Ofloxacin
Levetiracetam .. Otloxacin
- Oral Suspension
LevocetirizineTabieE OfloxacinTablets .
Levodropropizine C)lmesartahhledosomil
Lcvofloxacin Inhsion Ondansetron Hydrochloride
Levofloxaci~lInjection Ondansetron Orally 1)esinrzgrarin~
Levonorgestrel and Ethinyloestradiol Tablets
Tablets Oral Rehydralion Salts
Levosalbutamol Sulphate . Orphcnadrine Citrate
Liquid Maltitol Orphenadrinz Hydrochloride
Marek's Diseasc Vaccine, Live Oxytetracyciine Hydrochloride
Measles and Rubella Vaccinc (Lil'e) Injection
~ e a s i e Vaccine
s (Live) O~~tetracyclineDihydrate I~ijection
Measles, Mumps and Rubella Vaccine Oxytocin
(Live) . Oxytocin Injection
Mebendazole paracetarnol Infusion
Mcbcndazole Tablets Paroxetine ~ ~ d r o c h l o r i d e
Medroxyprogesterone Injection Pegfilgrastim
Menotropin for Injection . ~emetrexedInjection
Meropenem penicillamine Tablets
Mesalazine Pentobarbito~1cSodium
Mesalazine Prolonged-release Tablets Pertussis Vaccine. , .

Inactivated Influenza Vaccine Mctformin Hydroclrloridt Peste Dcs Pctits Rurni[tants Vaccine,
(Whole Virion) Metformin Tablets Live
Isoprenaline - Methi . Pethidine Injection -
Isoprenaline Injection Methocarbamol Phenindione
Isopropyl Palmitate ~ethotrexate ~henindioneTablets
lsosorbide Dinitrate Tablets
Isoxsuprine Hydrochloride
Isoxsupr~nelnjection
 INTRODUCTION

Piperacillin Tacmlimus Capsules Changed Titles of Monographs

Piperazine Citrate TamsuIosin Hydrochloride Prolonged- From Benzoyl Peroxide to Hydrous
~ o l i o m ~ ~ i t i s V a c c(Inactivated)
ine release Capsules Benzoyl Peroxide
Polion~yelitisVaccine, Live (Oral) Teicoplanin From - Fasterodine Fumarate to
Tetanus Veterinary Vaccine Fesoterodine Fumarate
Procaine Hydrochloride
Theileriosis Vaccine, Live From Gugulipid Table& to Gugglipid
Progesterone
PromazineTablets . . Theophylline Injection Tablets -
Thiopentone Injection From 'Gugulipid' to 'Guggulipid'
Promethazine Syrup From 'Labetalol' to 'Labetalol Injection'
Thiopentone Sodium
Quinine Sulphate From 'Sulphadimidine Tablets' to
Thymol
Rabeprazole Injection 'Sulphadimidine Bolus Tablets'
Tick-borne Encephalitis vaccine
Rabies Vaccine: Human i
(Inactivated). Monographs shifted from Chemical to

iI
Ranitidine Injection Biotechnology Derived Therapeutic
Tolazamide Tablets
Ranitidine Oral Solution Products
Triamcinolone Acetonide Injection
Ritodnne Injection Calcitonin (Salmon)
Triamcinolone Tablets
Ritocavir Triethyl Citrate Calcitonin (Salmon) Injection -
Ronidazolz Tribasic Calciilm Phosphate Human Insulin -.
Ronidazole Veterinary Oral Powder TriflupronlazineHydrochloride Injection - Insulin Injection '
' /

Rotavirus Vaccine (Live.Attenuated, Trospium Chloride Insulin Aspart I

. Insulin Aspart Injection !

Tylosin
- Roxithromycin Tybsin Injection Insulin Lispro
Rubella Vaccine (Live) Insulin Lispro Injection . .
Tylasin Tablets
Saccharin Sodium Biphasic Insulin Aspart Injection
Typhoid (Strain Ty ?La) Vaccine, Li\:e
Salmonella Pullorurn Coloured Antign (oral) Bipbasic Insulin Lispro Injection . -+
Salmonella Vaccine, Inactivated Typhoid Vaccine (Freeze Dried) Biphasic Isophane Insulin Injection
Somatropin . Typhoid Vaccine isophane Insulin ~njection
Somatropin Concentrated Solution Typhoid Vi Conjugate Vaccine Insulin Glargine
Somatropin for Injection Typhus Vaccine Insulin Glargine Injection
Senna Dry Extract Valproic Acid
Senna Leaf Vancomycin Hydrochloride for
Omissions
Senna Pods Intravenous Inhsion General Monographs (Veterinary)
Senna Tablets Vancomycin Hydrochloride Dip Concentrate
sheep POX Vaccine, Live Attenuated Varicella Vaccine, Live Premixes
Sildenafil Cifrate Vecuronium Bromide Veterinary Aerosols
Sitagliptin Phosphate - Vinblastin Sulphate -- Teat Dips
Teat Sprays .
Sodium Acetate Water for Injections in Bulk '

Udder Washes -
Sodium Phosphate Zidovudine
z i i c oxide and Salicylic Acid Paste Brucella melitensis (Strain Rev. I )
Sodium Valproate
Vaccine, Live
Sorbitan Oleate Zolmitriptan Nasal Spray
CanineAdcno\~irusVaccine, Inactivated . .
Spectinomyc.inHydrochloride Zolmitriptan Tablets
Canine Adenovirus Vaccine, Live
Spectinomycin Injection Canine Contagious Hepatitis Vaccine, -
Changed Titles i
Spirarrijsia . Live -Y
Sterile Diluent for Live Vaccine Changed Titles of General Chapters . Old Adjuvant Vaccine Against
Pasturellosis in Sheep and Goats
. Rinderpest Vaccine, Live
' Stcrile Diluent for L.iveVaccines
 INDIAN
PHARMACOPOEIA
2018-- -

Volume I
 INDIAN PHA COPOEIA 2018
CONTENTS

Notices
Preface
-
Indian Pharmacopoeia Commission
Acknowledgements

. General Chapters

VOLUME I1
General Notices
General Monographs on Dosage Forms
Monographs on Drug substances, Dosage forms and
Pharmaceutical aids Monographs A to M .... 1123

VOLUME 111
GeneralNotices
Monographs on Drug substances, Dosage f o m and
Pharmaceutical aids Monographs N to Z
Monographs on Vaccines and Inmunosera for Human Use
Monographs on Herbs and Herbal Products
Monographs on Blood and Blood-related Products
Monographs on Bioteclinology Derived TherapeuticProducts
Monographs on Allergen Products
Monogriphs on RadiopharmaceuticalPreparation

VOLUME IV
GeneralNotices
Notice
Monographs on Drug subs
Biologicals, Diagnostic .... 4161
. .

Lndex .... 1-103.

 CONTENTS

Notices
Preface
. IndianPharmacopoeiaCommission
Acknowledgements
Introduction
1 I<!-.
1 .
I

1. General Notices
2. Test Methods
2.1. Apparatus
2.2. Biological Methods
2.3. ' ~ h e k i c aMethods
l
2.4. Physical and Physicochemical Methods
2.5. ~hannaceu&calMethods.
2.6. .Herbal Products
2.7. Vaccines
'

2.8. Bbod and Blood-related Products

Reference Data
Reagents and Solutions .

General Tests
Primary Packages for Pharmaceuticals
Tables
 IM)W PHARMACOPOES. 2@?8 GENERAL NOT1CES

GENERAL NOTICES

General Statements .... 11

Name
Official and O@cialArticles
OfficialStandards
Added Substances
AlternativeMethods
Meanings of Terms .... 12
- ProvisionsApplicable to Monographs and Test Methods .... 12
Expression ofcontents .... 12
Expression of Concentrations ..., -12
~bbrevizedS d k m n l '
- .... 13
Weights and Measures -
Motlographs
General Monographs
Production

i
1
Manufacture of Dntg Products
Excipients
IndividualMonographs
Ties .

- Chemical Formulae
Atomic and MolecularWeights

Statement of Csntent
Category
Dose
 i
6
GENERAL NOTICES INDIAN PHAR~~ACOPUWA
2018

Tests.audAssays .-.. 15 . .
..
Tests. .... 15 ,I -
:!
.-.
. ,

Otlier Tests .... 15 s

.:j
Limit., .... 15 4
:. .

Z.?

Quantities .-.. 15 jtI

:i
Appambr; . .... 15 .i
1

I
Reagents and Solutions .... 15 !iI
I r;
i Indicators .... 15 . .::

I Reference Substances .... 15

. ..

1 TestsAnimais .... 16
. :

1
$
:.

li.
Calculation of Results .... . 16

I.
I
Storage
. . -,
-
StorageContainers
- ....
....
-
- 16
*-16
.9
...
?!
>.
i
it
'i
1
9 1
i
Labelling .... 16
I
.i
I
 IP 2018 GENERAL NOTICES

General Notices use but not necessarily to articles that may be sold under the
sane name for other purposes.
Ar. zrticle is not ofPhamacopoeial quality unless it complies
General Stabhents
Gih all the requirements stated in the monograph. This does
The General Notices provide the basic guidelines for the not imply that pihrmance of all the tests in a monograph is
iotemretation and application of des&&&, tests, arrays, necessarily a prerequisite for a mZnlIfacturer in assessing
and other specifications of the Indian Pharmacopoeia (IP),as compiiancewith the pharmacopoeiabefore.r e f. w eofa product.
as to the made in the and Phannacopoeial requirements for articles used in veterinary
texts of the Pharmacopoeia. medicine are established on the.same basis as those used in .
A mooograph to be constructed in accordance with any human medicine. It should be noted that no re-quirementin the
..
genera] monograph or notice or any appendix, note or other pharmacopoeia can be taken in isolation.Avalid interpretation
explanatory material that is contained in this Pharmacopoeia of any particular requirement depends upon it being read in
and that is applicable to that monograph. All statements context of the monograph as a whole, the specifkdme&md of
contained in the monograph, except where a specific general analysis, the relevantGeneral Notices and where appropriate .
notice indicates otherwise and with the exceptions given the General Monographs.
hereafter, constitutestandards forthe officiaIarlictes.An article Where a preparation hatis the subject of a monograph in the
is not ofphamacopoeialquality unless it complies with all of Indian Phamacopoeia is supplied .for use in veterinary
. the requirements stated. medicine, the standards of Indian ~ha@ampoeiaapply unless . .
~xce~tio;; to the General Notices do exist, and whereS'theL othenvise justijied and authorized.
do, the wording the individual monograph or an appendix ,tive pllamac~uticai ingredieits (drug substances),
takes precedence and specifically indicates directions excipients(phamaceuti;al a;ds), pharmaceutical preparations
. . or the intent. Thus, the specific wording of standards, tests,
(dosage fornls) and articles described in the monographs .
assays and other specifications is binding wherever are illtended for human and veterinary use (unless
deviations from the General Notices exist. Likewise, where reslricred to one of these uses). It be notedhowever,
thereis no specificmention tothecontrary, theGeneralNotices that in the event of doubt of interpretation in any text of
apply- Veterinary monographs of IP, Indian Pharmacopoeia
Name. The full name or title of this book, including addenda Commission (IPC) should be consulted.
thereto, is Indian ~hamacopoeia2018, abbreviated to IP 0 1 . The given in the monographs are not framed to
In the texts, the tern "Pharmacopoeia" or "IP" without provide against all possible impurities, or
qualification means thelndian 2018 and any adulterants; they provide appropriate limitation of potential
amendments and thereto. impurities only.
Official and Official Articles. The word 'official' wherever A must with the requiremen& specified,
used in this Pharmacopoeia, or with reference theretoThToughout its shelf-lifeassigned to it by the manufacturer.
is sPonYmous with -' . P... ~ ~ ~ ~ 'IP'~ and ~ with
P ~ F~~~opened
~ ~or broached
~ ' ,containen, the lnaximum of
'cornpendial'. The designation IP in conjunction with the validity for use will be as may be stated in the individual
official title on the label of an article is an indication that the
article purports to comply with IP standards. .
monograph. Nevenheless,the for assigningme
period of validity shall be with the manufacturer. -
The following terms are used where the articles for which
Added Stlbstances. An official substance, as distinguished
monographs are-provided are tb be distinguished.
from an official preparation, contains no added substances
An official substance is a single d ~ u gor-tiadrug entity or a except whenspeclficallype~ttedktheiii&vidualmonograph-
phanaceutical aid f~ which the monograph title includes no - Unless othewise specified in the individual monograph, or
indication of the nature of a dosage form. elsewhere in the General Notices, suitable substances may be
-
An official preparation is a drugpr&t(dosage form) and is added to an oacial preparation to enhance its stability,
the finished or p&ally finishedpreparation or product of one PreSeme its propemes, usefulness or elegance, or to facilitate
or more official subsmCes formulated"foruseon fhe patient. its preparation. Suchaaxiliarysubstances shall be hamless in
the amounts used, shall not exceed the minimum quantity
An article is an item for which a mon e their intended effect, shall not impair the
whether an oEcial substance or an offi or the bioavailabiiity or safety of the
Official S t a n d a r d s The requiremen hall not interfere with any of the tests and
monog~aphsapply to articles that are inten for dr,termimngconpiiance with the official
 GENERAL NOTICES IP 2018
-
I
standards. Particular care should be @kento ensure that such . Soiution. Where the name of the solvent is not stated,
I substances are free from harmht organisms. The freedom to "solutionmimplies a solutionin water. The water used complies
the manufacturers to add auxiliary substances imposes on with the requiremen&of the monogcagh on Purified Water.
I
them the responsibilit!i of satisfying the licensing authorities The used without qualification
on the purpose of the addition and the innocuity of such indicates the use of the Celsius scale.
substances. No substanceshall be added to conceal any defect
or damage or deficiency in the substance or formulation. Water. Ifthe term is used without quatification it meansPurified
Water of the Pharmacopoeia. The term 'distilled water'
Alternative Methods. The tests and assays describedarethe indicates Purified Water prepared by
official methods upon which the standards of the
disalation.
Pharmacopoeia are based. Alternative methods of analysis Water-bath. A bath of boiling water unless water at another
. may be used for control purposes, provided that the methods
temperature is indicated. Other methods of heating may be
used are shown to give results of accuracy and provided !he required lemperahlre is a ~ ~ r O x i m a t e l ~
enable an unequivocal decision to be made as to whether maintained but not exceeded.
compliance with the standards of the monographs would be
J achieved if the official methods were used. Automated Provisions Applicable To Monographs and Test Methods
I procedures, ut~lisingthe same basic chemistry as the test Expression of Contents. Where thecontent ofasubstance is
procedures given in the monograph may also be used to defined, the expression "per cent" is used according to
determine compliance. Such alternative or automated circumstances with one oftwo meanings:
procedures must be validated and are subject to appro?'ai by - pe;cent w/w @ercentage, weight in weight) expressing
the authority competent to author~sedmanufacturer of the numberofgrams ofsubstance m 100 grams of final
substance or product . product,
In the event of doubt or dispute, the methods of analysis of - per cent v/v (percentage, volume in volume)expressing
'

.the Pharmacopoeia are alone authoritative and only the result the number of mil[llitresof substance in 100mil!ilitres of
obtained by the procedure given in this Pharmacopoeia is final product.
conclusive.
The expression "parts per million" refers to the weight in
Meanings of Terms weight, unless otherwise stated.
~ l ~ ~h~ ~ termh ~ l wihout means Where the content ofa substanceis expressed in terms of the
ethanol (9j per cent). Other dilutions of ethanol are indicated ~ h ~ m l cf~llnula
al forthat substance limit exceeding
o ~ by a statement of 100 per cent may be stated. Such an upper limit applies to the
by the tern "ethanol*'o r c c a ~ C o hfollowed
the percentage by volume of ethanol (C2H60)required result of the assay calculated in terms ofthe equivalent content
! Desiccator. A tightly-closed container of suitable size and
of the specified chemical formula. For example, the statement
not less than 99.0 per cent and not more than
design that maintains an atmosphere of low motsture content .O per cent of C:w2 implies the result ofthe assay is
I .
by means of
suitable desiccant.
gel Or phosphorus pentoside Or other llot less than 99.0 per cent and not more than 101.0per cent,

I Drying and ignition to constant weight. Two consecutive

weighings after the drying or igniting operations do not d~ffer
by more than 0.5 mg, the second weighing following an
calculated in terms of the equivalent content of C7&02.
Where the result of an assay or test is required to be calculated
with reference to the dried, anhydrous, ignited substance, or
the substance free from solvent, the determination of loss on
additional period of drying or of ignition respectively
drying, water content, loss on ignition, content of the specified
appropriate to the nature and quantity of the residue.
solvent, respectively is carried out by the method prescribed
Ethanol. The term "ethanol" without qualification means in the relevant test in the monograph
anhydrous ethanol or absolute alcohol ?
..

Expression of Concentrations. The following expressions in

Filtration. Unless otherwise stated, filtration is the passing of addition to the ones given under Expression of Content are
a liquid through a suitable filter paper or equivalent device also used:
until the filtrate is clear.
- per cent wlv (percentage, weight in volume) expressing -
Freshly pcepared. Made not more than 24 hours &fore it is of of substance in 100 millili~esof
used.
Label. Any printed packing material, inciud (percentage, volume in weight) expressing
that provide information on the article. of millilitres of substance in 100 grams of
NegligibIe. A quantity not exceeding 0.50

- Q
q
,
2
, .; - ". ,- r
.
I
 Usually, the strength of solutions of solids in liquids is l# It is for the licensing authority to
an independent analyst.
@
expressed as percentage weight in volume, of liquids in liquids verifj that the instructions have been foliowed.
as percentage volume in volume, ofsolids in semi-solid
,. bases I
(e.g. creams) and of gases in liquids as percentage we~ghtin
weight.
a
The absence of a section on Production does not jmplp that
attention to featur s such as those given above is not required.
An article d e s c r i h in a monograph of tile Pharmacopoeis is
When the c o n c e n ~ i o nof a solution is expressed as parts of to be manufacturb in accordance with the principles of good
dissolved substance in parts of solution, it means pam by manufacturinpfpractice and in accordance with the.
weight(g)aiasolid in parts t~yvolurne(ml)oftl~e fi*al solutio~l; requirements oQthe ~ r u g and s Coslnetics Rules. 1945.
as parts by weight (g) of a gas in pa- by weight [s)of the The general pridcipks applicable to the manufacture and
final solution. quality assuranceof4 dnlgs and preparations meant for human
- When the concentration of a solution is expressed in lrlolarity use apply equallid to veterinary products as well.
I
designated by the symbol M preceded by a number. it denotcs Manufacture of Drug ~ r h d u c t s .The opening decnitive
the number of moles ofthe stated solutecontained in sufficient statement in cefi&n monographsfor dwg products is given in
Purified Water (unless otherwise stated) to produce I litre of terms of the actije ingredient(s) only Any ingrediends) othei
solution. than those inclujed in the statement, must comply with the
$
Abbre&ted stateme& incolnpletesentences are senera/ noti~e~n:Exci~ienG and the product to
in parts of the monqgaphs for directness and brivity (for the ~harmaco~ogial requirements.
&
example, IodineVaIue Not more than ..... .; Relative Density. dfiicial
pre s are preiared O I ~ ~from Y ingredients that
.:.....to ........) Where the tcsts are abbreviated,. it is to be -comply e q u i r e k n t s of the pbrmacopoeiai .-
understood that the test method referred to in backets nlonograp se indi\lidual ingredients fol which .
provides the method to be folltiwed and' that .the values monogfip
specified are the applicable limits;
e-added in preparing an official
Weights and Measures. The mctric system of weights and us, shall have no adverse influence
measures is employed in the Pharmacopoeia.All measures are f the active ingredients and shall
required to be graduated at 25" and ail measurements in tests nd assays of the Pharmacopoeia.
knd'assa~s,unless otherwise stated, are to be made a t that ure that such substances are free
temperature. Graduated glass apparatus used in analytical
0,peratioris shall comply with the requirements stated in
Chapter 2.1.6

the subject ofan individual monograph

Monographs mply with the tests glven in the general
-
General Monographs r a drug substance is the International
(INN) approved by the World Health
General monographs on dosage forms includc requrrements
names and synonyms have also been
of gencral application and apply to all preparations within the
here included, they have the same
scope of the introduction section of the general monograph,
except where a preamble limits the application.
The requirements are not necessarily c ducts are the Ones commor;ly
given specific preparation; additional onYm5 drawn fmn the hi\
sometimes be given in the individual mo tive ingredient or mgredients
ho\vever. a groduct contains '
Production. Statements given under the heading Production
Its of an active molecule, the
relate to particular aspects of the manufactur~ng-processand
arne of the active ingredient.
are not necessarily comprehensive. However, they are
hateTablets and Chloroquine
mandatory instructions" to mlmufacturc?rs. Th~ymay pelate,
for example, tosource materials, to them
and its validation and con,trgl .When the chemical structure~fano%cial
is to be carried out by the or gi&rally ~&epted,$he g ~ h and k
either on selected batches &en at ?he beginning ofthe
All this cannot beverified on a sample of information. This informatian refers to the