Finished Product - Test Procedure

VERITAS PHARMACEUTICALS LIMITED,
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas
STANDARD TEST PROCEDURE
Asmatab 10 Tablet
Product Name:
(Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
Document No.: TP/ BD 001/00 Effective Date'. 12Feb2014

Version No,: 00 Superseded doc, No.: Nil Review Date '. 11 Feb 2017
Label Claim : Asmatab 10 Tablet

(Each tablet contains Montelukast'10 mg as Montelukast Sodium INN)
Storage Condition: Store in a dry & cool place (below 25"C),

Ref, Method : INN
Protected from liqht.
Shelf Life : 36 months Paekino ' Rliqter /Ahr-Ahr iY10'q\
Approval of Current Version of the Document
Name Job Title Signature & Date
Prepared by Md. Monjur Rahman Executive Quality Control

,*%2,o
Checked by Md. Tarikul lslam Bossunia Asst. Manager Quality Control
Approved by Md. Moniruzzaman Quality Assurance Manager ryr,,a6fs /aZ /ly
This document is Effective from the Date of the Approval.
WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER DELEGATE, COPY OF THIS
DOCUMENT IS STRICTLY PROHIBITED
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 1 of 13
ffieritas It/uradpur, Vannara, Mouchak, Gazipur, Bangladesh

Asmatab 10 Tablet
Product Name:
Doc. No,: TP/ BD 001/00 Version: 00 Prepared By, Approved By:

Yffi[,o
A,METHOD OF ANALYSIS OF GRANULES
A.1 Description
Procedure:
Take about 1 gm of sample in a watch glass and observe for its physical appearance, color, etc. using a white
background.
Limit: A white to Off-white colored, granules
A.2 ldentification
ln HPLC assay, the chromatogram obtained from the sample solution, shows a principal peak with the same retention
time as the principal peak in the chromatogram obtained with the standard solution.
b, The UV absorption spectrum of the solution for assay preparation gives maxima at 220 nmt2nm, which corresponds
to that of the Montelukast Sodium WS.
A.3 Moisture Content
Dry a weighing crucible !n an oven at 105'C for 30 minutes. Place it in desiccators, allow cooling and weighing it.
Accurately weigh about 1.0 g of sample in the bottle and dry the stopper bottle in an oven at'100-105"C forone hour.
Remove the crucible from oven and allow cooling in desiccators and reweigh. Calculate the percentage of loss on
drying using the following formula:
Calculation:
M1-W2)x100
(w1-c)
= % loss
Where, C = Weight of the crucible in g
W1 = Weight of the crucible and sample before drying in g.
W2 = Weight of the crucible and the sample after drying in g.
Limit: Not More Than 3.5 %
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 2 of 13
ffiritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

Asmatab 10 Tablet
Product Name:
Doc. No.: TP/ BD 001/00 Version: 00 Prepared By,

W_ltq Approved ay:=fu[ity
A.4 Assay
Method-|, (Bv HPLC)

Chromatoqraphic Svstem:
Apparatus Perkin Elmer Flexure HPLC with PDA Detector
Column Cre, 150mmx4.6mm, 5p or equivalent
Mobile Phase Weigh accurately 1.99 of ammonium acetate, transfer into 500m1 of
beaker, add 500m1 of water and dissolve properly. Adjust the pH
3.5t0.05 with Glacial Acetic acid : Methanol(15:85)
Diluting solution Water: Methanol (30 : 70 )
Temperature Ambient (30'C)
Flow rate 1.5 ml/min

Monitoring wavelength 254nm
Load 10 pl
Retention Time 4-6
Standard preparation:
Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean dry 100m1
standard volumetric flask. Add about 60ml diluting solution, Shake well and Sonicate for 5 minutes. Make volume with
same diluting solution and mix well. Call this solution A. Filter it through 0.45 micron PTFE- membrane disk filter.
Sample preparation:
Weigh and powder 20 tablets. Transfer powdered sample equivalent to 10.0 mg of Montelukast into a clean 100m1
standard volumetric flask. Add 60ml diluting solution. Shake mechanically and sonicate for 5 minutes. Make volume
with the same diluting solution and mix well. Call this solution B, Filter it through 0.45 micron PTFE- membrane disk
filter.
Svstem suitabilitv test:

Parameter : Acceptance criteria
lnjection six replicate of standard solution RSD Not more than 2.0%
Place vials containing diluting solution as blank, standard preparation A and sample preparation B into the tray of the
auto sampler of Perkin Elmer Flexure HPLC . Run the instrument and record the chromatogram, Calculate the quantity
of Montelukast Sodium in sample using the following equation:
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 3 of 13
ffieritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

Asmatab 10 Tablet
Product Name:
Doc. No.: TP/ BD 001/00 Version: 00 Prepared rt, Approved By:

ffit,
YW,,
Calculation:
Montelukast content, mg/tablet
Peak area of sample X Wt. of standard (mg) X Y X Theoretical Avg. wt. of tablet
Peak area of standard X Wt. of sample (mg) x 1.037X 100
Where,
Y = Strength of Montelukast Sodium (Working standard) on as it is basis

'1.037is the conversion factor from Montelukast Sodium to Montelukast
Hence calculate the amount in % of labeled amount by following formula:
Content (mg/tab)
Assay, %= -----..--- x 100
Label claim (mg/tab)
Limit: 9.0 mg- 11.0 mg (90.0 %- 110.0 % ofthe label claim)
Method-ll:
By UV-Vis spectrophotometer
Preparation of Standard:
Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean & dry 100 ml
volumetric flask. Dissolved and Volume up to the mark with 0.5% SLS (Sodium Lauryl sulfate) solution, sonicate for 05
minutes and shake to mix well. Call the solution A.
Transfer 5 ml of this solution A into a clean & dry 50 ml standard volumetric flask and volume up to the mark with same
solvent and shake to mix well. Call the solution B.
Preparation of Sample:
Weigh and powder 20 tablets. Transfer powder equivalent to 10.0 mg of Montelukast into a 100 ml standard flask.
Volume up to the mark with 0.5% SLS (Sodium Lauryl sulfate) solution, sonicate for 05 minutes and shake to mix well.
Filter this through WHATMAN filter paper. Call the filtrate solution C.
Transfer 5 ml of this solution C into a clean & dry 50 ml standard volumetric flask and volume up to the mark with same
solvent and shake to mix well. Call the solution D.
Measure the absorption of solution B & D in a 1cm cell at the wavelength of maximum absorbance at about 280 nm with
suitable Spectrophotometer using 0.5% SLS solution as a blank
IF THE DOCUMENT IS SIGNED BY BLUE INK, TT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 4 of 13

Asmatab 10 Tablet
Product Name:
Doc. No.:TP/ BD 001/00 Version: 00 prepared By:

W,o Approved av'
ffi{. r"
Calculation:
Absorbance of sample X Wt. of standard (mg) X Y X Theoretical Avg. wt. of tablet
Absorbance of standard X Wt. of sample (mg) x 1 .037X 100
Where,
1.037 is the conversion factor from Montelukast Sodium to Montelukast
Content (mg/tab)
Assay, %= ---------- x 100

Labelclaim (mg/tab)
Limit: 9.0 mg - 11.0 mg (90.0 %- 110.0 % ofthe label claim)
B,METHOD OF ANALYSIS CORETABLET

B.l Description
Procedure:
Take about core tablets. in a watch glass and observe for its physical appearance, color, etc. using a white background.
Limit: A white to off-white colored, round shaped tablet with "V" engraved on one side and break line on other side.
B.2 ldentification
Follow the Method Step A 2
8.3 Thickness
Measure the Thickness of tablets with slide calipers and confirm the result.
Limit: 2.90 mm - 3.25 mm (3.10 mm t 5%)
IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 5 of 13

Asmatab 10 Tablet
Product Name:
(Each tablet contains Montelukast 10 mo as Montelukast Sodium INN)
Doc. No.: TP/ BD 001/00 Version: 00 Prepared By: $4.,q..,

l^/Ae-.1 t /.
Approved ev,
fr1ftv
8.4 Average Tablet Weight
Weigh 20 Tablets, selected at random, singly and calculate the average weight.
Total weight of 20 Tablets ( mg)
Avg. Weight =
20
Limit: 90.0 mg - 100.0 mg (95.0 mg t 5%)
8.5 Uniformity of Weight
Determine the weight of each tablet and calculate the percentage variation from the average weight"
Let,
Average Weight of 20 Tablets = X
Minimum weight of the Tablet = X1

Maximum Weight of the Tablet = X2
Wherexl <x<x2
Then, (X1-X)x100
Then percentage variation from minimum weight =
X
(X2-X)x100
And percentage variation from highest weight =
X
Limit: Out of 20 Tablets, maximum 2 tablets shall deviate t7.5o/o of average weight and none shall deviate x 15% of
average weight.
8.6 Friability Loss .
Dedust the tablets. Take Weight of 20 tablets selected at random. Place the tablets in the friability tester. Run the machine
as per SOP VPL-QC-004-00
Let,
Weight of 20 Tablets before rotation= W1 g
IF THE DOCUMENT IS SIGNED BY BLUE IN& IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 6 of 13
Seritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

Asmatab 10 Tablet
Product Name:
(Each tablet contains Montetukast 10 mg as Montelukast Sodium INN)
rt,
Doc. No.: TP/ BD 001/00 Version: 00 Prepared
Yffij,. Approvedey:
ffirv
Weight of 20 Tablets after rotation = W2 g
(W1-W2)x 100
So, Friability loss =
W,1
Limit: Not more than 1%
B.7 Hardness
Place the tablet between the jaws. For each measurement, orient the tablet in the same way with respect to the direction
of application of the force. Carry out the measurement on 10 tablets and confirm the result against the specification.
Determine the hardness of 10 core tablets in Kp using Suitable Hardness Tester, conversion factor of unit (Kg) to Kp.
1KP=9.76n
Limit: Not less than 3.5 Kp
B,8 Moisture Content
Collect approximately 5 g of sample. Crush the sample with mortar and pastel. Follow the HllJtnoO Step A.3
Limit: Not more than 3.5%
8.9 Disintegration Time

Determine the disintegration time of six tablets.
Place 700 mlwaterin the vessels, raise the temperature upto 37't1"C. lntroduce one tablet in each tube, add a disc, to
each tube, follow SOP VPL-QC-002-00. Record the time to disintegrate all the six tablets.
Limit: Not more than 15 minutes
8.10 Assay
Take the Assay % from the result of granules and calculate the content from the following formula:
Assay% from Granules x average weight of 20 tablets
Assay % = -------
Theoretical average weig ht
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 7 of 13

Asmatab 10 Tablet
Product Name:
(Each tablet contains Montelukast 10 mg as Monterukast sodium rNN)
Doc. No.: TP/ BD 001/00 Version: 00 Prepared By: *|ffilr, Approved ev'
.kfftv
Hence calculate the amount in mg/tablet of labeled amount by following formula:
Assay, %
Content (mg/tab) = - x Label claim (mg/tab)
100
Limit: 9.0 mg - 11.0 mg (90.0 %- 110.0 % ofthe tabet ctaim)
C,METHOD OF ANALYSIS OF COATED TABLET
C.1 Description
Procedure:
Take about coated tablets in a watch glass and observe for its physical appearance, color, etc. using a white background.
Limit:A white to Off white colored, round shaped film coated tablet with "V" engraved on one side and otherside break
line
C.2 Identification
Follow the Method Step A.2
C.3 Thickness
Measure the Thickness of tablets with slide calipers and confirm the result against the Specification.
Limit: 3.0 mm - 3.33 mm (3.17 mm t 5%)

C.4 Average Tablet Weight
Follow the Method Step B.4
Limit: 92.0 mg - 102.0 mg (97.0 mg t 5 %)
C.5 Uniformity of Weight
Limit: Out of 20 Tablets, maximum 2 Tablets shall deviate t 7.5 of average weight and none shall deviate r1S o/o
of
average weight
C.6 Hardness
Limit: Not less than 4 Kp
IF THE DOCUMENT IS SIGNED BY BLUE INI( IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page B of 13
Seritas
Product Name: (Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Doc. No.: TP/ BD 001/00 Version:00 Prepared By:

\'ff;i, Approved Bv:
ftffirv
C.7 Moisture Content
Step A. 3
Collect approximately 5 g of sample. Crush the sample with mortar and pastel. Follow the Method
Limit: Not more than 3.5%
C.8 Disintegration Time
Follow the Method SteP B.9
Limit: Not more than 30 minutes
C.9 Dissolution
Method-1,(By HPLC)
Chromatoqraphic Svstem:
Apparatus Perkin Elmer Flexure HPLC with PDA Detector
Column Cra, 150mmx4.6mm, 5;r or equivalent
Mobile Phase Weigh accurately 1.9 g of ammonium acetatelransfer into 500m1 of

beaker, add 500m1 of water and dissolve properly. Adjust the pH
3.5t0.05 with GlacialAcetic acid : Methanol(15:85)
Diluting solution 0.025M Tri-sodium o(hophosPhate
Temperature Ambient (30'C)
Flow rate 1.5 ml/min
Monitoring wavelength 254nm
Load 10 pl
Retention Time 4-6
Dissolution Svstem:
Dissolution medium : 0.025M Tri-sodium orthophosphate, 1000m1
Apparatus : 2 (Paddle)
Stirring speed : 100 rpm
Temperature :37t0.5"C
Time :45 min
rF THE DOCUMENT rS STGNED By BLUE rN& rT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WOR( -
Page 9 of 13
ffieritas
Asmatab 10 Tablet
Product Name: (Each tablet contains Montelukast 10 mq as Montelukast Sodium INN)
By: Approved By:

Doc. No.:TP/ BD 001/00 Version: 00 Prepared
Y{Xil,
Weigh and transfer accurately about 10.0 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard
volumetric flask, Add about 60ml diluting solution. Shake well and Sonicate for
5 minutes, Make volume with same
diluting solution and mix well. Call this solution A. Filter it through 0.45 micron PTFE- membrane disk filter.
Callthis solution A. Transfer 10 mlof this solution to l00mlvolumetric flask & dilute with dissolution medium to volume.
Filter this solution through 0.2p disk filter. Call this solution B.
Sample preparation:
Place 1000 ml of dissolution media into each vessel, and assemble the apparatus. Allow the medium to equilibrate to a
temperature of 37t0.5"C. Place 1 tablet into each bucket, cover it and operate the apparatus at the specified rate. After
45min withdraw a definite volume of sample and filter it with filter paper. Again filter the filtrate through 0.2p disk filter. Call
this solution C.
Procedure:
Place vials containing standard preparation B and sample preparation C into the tray of auto sampler of Perkin Elmer
Flexure HPLC. Run the instrument and record the chromatogram. Calculate the quantitles of Montelukast present in
sample preparation using the following equation.
Calculation:
Percent release of Montelukast,
Peak area of sample C x Weight of standard (mg) x Y

Peak area of standard B x 10 x1.037
Where, Y = Potency of Montelukast Sodium. (Working standard, as it is)
1.037= Conversion Ratio of Montelukast Sodium to Montelukast.
lnterpretation : Unless otherwise specified in the individual monograph, the requirements are met if the quantities of
active ingredient dissolvbd from the units tested conform to the accompanying acceptance table. Continue testing through
the three stages unless the results conform at either 51 or 52 . The quantity, Q, is the amount of dissolved active
ingredient specified in the individual monograph, expressed as a percentage of the labeled content; the 5%, 15% and 250/o
values in the Acceptance Table are percentages of the labeled content so that these values and Q are in the same terms.
Stage Number Tested Acceptance criteria
Sr Each unit is not less than Q + 5%

:
Sz 6 Average of '12 units (Sr + Sz ) is equal to or greater than Q, and no unit is less
than Q - 15o/o
S: 12 Average of 24 units (Sr + Sz + Se) is equal to or greater than Q, not more than
2 units are less than Q - 15%, and no unit is less than
Q-25o/o
Limit: Not less than 70% within 30 minutes.
Page 10 of 13
Seritas
Asmatab 10 Tablet
Doc. No.: TP/ BD 001/00 Version:00 prepared av, tfff$1a Approved By:
ftTil"2,"
Method-ll:
By UV-Vis spectrophotometer
Preparation of 0.025M Tri Sodium Orthophosphate:
Weight and dissolved 9.5 g TriSodium Orthophosphate in 1000 mlwater.
Dissolution Svstem:
Dissolution medium :0.025MTri-sodiumorthophosphate,l000ml
Apparatus : 2 (Paddle)
Stirring speed : 100 rpm
Temperature :37t0.5'C
Time :45 min
Weigh and transfer accurately about 10.4 mg of working standard of Montelukast Sodium into a clean dry 100m1 standard
volumetric flask. Add about 60ml 0.025M Tri Sodium Orthophosphate. Shake well and Sonicate for
5 minutes. Make
volume with same diluting solution and mix well. Call this solution A. . Transfer 10 ml of this solution to 100m1 volumetric
flask & dilute with 0.025M Tri Sodium Orthophosphate to volume. Filter this solution through 0.2p disk filter. Call this
solution B.
Sample preparation:
Place 1000 ml of dissolution media into each vessel, and assemble the apparatus. Allow the medium to equililirate to a
temperature of 37t0.5'C. Place 1 tablet into each bucket, cover it and operate the apparatus at the specified rate. After
45min withdraw a definite volume of sample and filter it with filter paper, Call this solution C.
Take the absorbance of both B & C solution al344t2 nm in a UV Vis spectrophotometer, using 0.025M Tri Sodium
Orlhophosphate buffer as blank.
Galculation:
Absorbance of sample X Wt. of standard (mg) X Y
Absorbance of standard X 10 x 1=0T t" 6 )7

Where, Y = Potency of Montelukast Sodium. (Working standard, as it is)
1.037= Conversion Ratio of Montelukast Sodium to Montelukast .
IF THE DOCUMENT IS SIGNED BY BLUE INr(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 11 of 13
ffieritas
Asmatab 10 Tablet
Product Name:
(Each tablet contains Montelukast 10 mg as Montelukast Sodium INN)
Doc. No.: TP/ BD 001/00 Version: 00 Prepared By: )(ff^Lr,, Approved ay:ffi"tv
lnterpretation : Unless othenivise specified in the individual monograph, the requirements are met if the quantities of
active ingredient dissolved from the units tested conform to the accompanying acceptance table. Continue testing through
the three stages unless the results conform at either 51 or 52 . The quantity, Q, is the amount of dissolved active
ingredient specified in the individual monograph, expressed as a percentage of the labeled content; the 5%, 15o/o and 25o/o
values in the Acceptance Table are percentages of the labeled content so that these values and Q are in the same terms.
Stage Number Tested Acceptance criteria
Sr 6 Each unit is not less than Q + 5%
Sz 6 Average of 12 units (Sr + Sz ) is equal to or greater than Q, and no unit is less

than Q - 15%
Se 12 Average of 24 units (Sr + Sz + Sr) is equal to or greater than Q, not more than
2 units are less than Q - 150/0, and no unit is less than
Q-25%
Limit: Not less than 70% within 30 minutes.
C.10 Assay
Crush coated tablets and follow Step No. A.4
Limit: 9.0 mg - 11.0 mg (90.0 % - 110 0 % of the label claim)
C. 11 Content Uniformity
Follow Step 44 for chromatographic condition, standard preparation and system suitability.
Sample Preparation:
Transfer one tablet into a clean 100m1 standard volumetric flask. Add 60ml diluting solution. Shake mechanically and
sonicate for 5 minutes. Make volume with the same diluting solution and mix well. Call this solution Br. Filter it through
0.45 micron PTFE- membrane disk filter.
Carry out the above procedure with other nine tablets. Call these solutions Bz, Bs , B+ ------Bro.
Place vials containing diluting solution as blank, standard preparation A and sample preparation B* ( Br , Bz , --------Bro)
into the tray of the auto sampler of Perkin Elmer Flexure HPLC. Run the instrument and record the chromatogram.
Calculate the quantity of Montelukast Sodium in sample using the following equation:
Page 12 of 13
Seritas
Asmatab 10 Tablet
Doc. No,:TP/ BD 001/00 Version: 00 Prepared tr YiE)l-'.

Approved By: Siffi1 y
Calculation:
Montelukast content, %
Peak area of sample X Wt. of standard (mg) X Y X 100
Peak area of standard X Wt. of sample (mg) x 1 .037X 100
Where,
1.037is the conversion factor from Montelukast Sodium to Montelukast
Content (mg/tab)
Assay, %= ------ x 100

Labelclaim (mg/tab)
Limit: lndividual content is in 85.0 % - 1 15^0 % of the average content
D.Finished Produ ct T est Meth od
D.1 Take results of coated tablets for all the parameters of finished products.
D.2 Check the strips and inner cartoon of the finished product and verify the below information:
a. Batch No.
b. Mfg. Date
c. Exp. Date
d. MRP
e. No. of tablets /strip
f. No. of strips per inner ca(oon.

Revision History .
Document No, Version No Date Reason
TPi BD 001/00 00 Feb-2014 lnitial Test procedure of Asmatab '10 Tablet
IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
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VERITAS PHARMACEUTICALS LIMITED,

Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

Document No.: TP/ BD 001/00 Effective Date'. 12Feb2014

Label Claim : Asmatab 10 Tablet

Storage Condition: Store in a dry & cool place (below 25"C),

Approval of Current Version of the Document

Name Job Title Signature & Date

Prepared by Md. Monjur Rahman Executive Quality Control

Approved by Md. Moniruzzaman Quality Assurance Manager ryr,,a6fs /aZ /ly

This document is Effective from the Date of the Approval.

STANDARD TEST PROCEDURE

Doc. No,: TP/ BD 001/00 Version: 00 Prepared By, Approved By:

Limit: A white to Off-white colored, granules

A.3 Moisture Content

Where, C = Weight of the crucible in g

W1 = Weight of the crucible and sample before drying in g.

W2 = Weight of the crucible and the sample after drying in g.

Limit: Not More Than 3.5 %

ffiritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

STANDARD TEST PROCEDURE

Doc. No.: TP/ BD 001/00 Version: 00 Prepared By,

Method-|, (Bv HPLC)

Apparatus Perkin Elmer Flexure HPLC with PDA Detector

Column Cre, 150mmx4.6mm, 5p or equivalent

Diluting solution Water: Methanol (30 : 70 )

Temperature Ambient (30'C)

Flow rate 1.5 ml/min

Retention Time 4-6

Svstem suitabilitv test:

STANDARD TEST PROCEDURE

Doc. No.: TP/ BD 001/00 Version: 00 Prepared rt, Approved By:

Peak area of standard X Wt. of sample (mg) x 1.037X 100

Y = Strength of Montelukast Sodium (Working standard) on as it is basis

Hence calculate the amount in % of labeled amount by following formula:

Assay, %= -----..--- x 100

Label claim (mg/tab)

Limit: 9.0 mg- 11.0 mg (90.0 %- 110.0 % ofthe label claim)

STANDARD TEST PROCEDURE

Doc. No.:TP/ BD 001/00 Version: 00 prepared By:

Absorbance of sample X Wt. of standard (mg) X Y X Theoretical Avg. wt. of tablet

Absorbance of standard X Wt. of sample (mg) x 1 .037X 100

Y = Strength of Montelukast Sodium (Working standard) on as it is basis

1.037 is the conversion factor from Montelukast Sodium to Montelukast

Hence calculate the amount in % of labeled amount by following formula:

Assay, %= ---------- x 100

Limit: 9.0 mg - 11.0 mg (90.0 %- 110.0 % ofthe label claim)

B,METHOD OF ANALYSIS CORETABLET

Follow the Method Step A 2

Limit: 2.90 mm - 3.25 mm (3.10 mm t 5%)

STANDARD TEST PROCEDURE

Doc. No.: TP/ BD 001/00 Version: 00 Prepared By: $4.,q..,

Total weight of 20 Tablets ( mg)

Limit: 90.0 mg - 100.0 mg (95.0 mg t 5%)

8.5 Uniformity of Weight

Average Weight of 20 Tablets = X

Minimum weight of the Tablet = X1

Then percentage variation from minimum weight =

8.6 Friability Loss .

Weight of 20 Tablets before rotation= W1 g

STANDARD TEST PROCEDURE

Limit: Not more than 1%

B,8 Moisture Content

Limit: Not more than 3.5%

8.9 Disintegration Time