Rationale

Nothing is more memorable than a smell as people often quoted. It is said that the
smell is a reflection of what a person is. The use of cologne let others know that a person
cares about his appearance and practices good hygiene.
Many companies added fragrances to their products such as soap, cigarettes, washing
powders and etc. It is generally marketed as having the ability to enhance sexual
attractiveness. Although cologne can make a person good,it may also trigger health problems
like allergic reactions, asthma-like symptoms and chronic headaches, nevertheless, it depends
on the chemical used in the product.
Perfume types reflect the concentration of aromatic compounds in a solvent, which in
fine fragrance is typically ethanol or a mix of water and ethanol. Various sources differ
considerably in the definitions of perfume types. The intensity and longevity of a perfume is
based on the concentration, intensity and longevity of the aromatic compounds, or perfume
oils, used. As the percentage of aromatic compounds increases, so does the intensity and
longevity of the scent.
It used to give the human body, animals, food, objects and living spaces a pleasant
sceant. As people often says, when someone smells nice, it automatically makes them more
attractive.

Unit Dose Formulation

Batch Size
Ethanol --------------------------------------- 60%

60/100 x X/500 = 300

Distilled Water ------------------------------ 36%

36/100 x X/500 = 180

Sorbitol --------------------------------------- 2%

2/100 x X/500 = 10

Fragrance ------------------------------------- 2%

2/100 x X/100 = 10

Procedure
1. Mix the perfume oil and sorbitol.
2. Slowly this mixture to the water and add alcohol.
3. Stir until a clear product results.

Technical Specifications of Raw Materials

Purified Water
Purified water is water obtained by a suitable process. It is prepapred from water
complying with the U.S. Environmental Portection Agnecy National Primary Drinking Water
Regulations of the European Union or Japan. It contains no added substance.
NOTE Purified water is intended fro use as an ingredient of official preparations and in
tests and assays unless otherwise specified. Where used for sterile dosage forms, other than
for parenteral administration, process the article to meet requirements under Sterility Tests, or
firsr render the Puirfied Water sterile and thereafter protect it fro microbial contamination. Do
not use Purified Water in preparations intended for parenteral administration. For such
purposes use Water for Injection, Bacteriostatic Water for injection. The tests for Total
organic carbon and Conductivity apply to Purified water produced on site for use.
Purified Water packaged in bulk for commercial use elsewhere meets the requirements of
all the tests under Sterile Purified Water, except Labeling and Sterility as an ingredient of
official preparations and in tests and assays.

USP Reference Standards USP 1,4-Benzoquinone RS.USP Sucorose RS

Total organic carbon: it meets the requirements
Water conductivity: it meets the requirements

Alcohol
Alcohol contains not less than 92.3 percent and not more than 93.8 percent, by weight,
corresponding to not less than 94.9 percent and not more than 96.0 percent, by volume, at
15.56, oc C2H5OH.
Packaging and Storage Preserve in tight containers, remote from fire
IdentificationA: Mix 5 drops in a small beaker with 1 mL of potassium permanganate solution (1 in
100) and 5 drops of 2 N sulfuric acid, and cover the beaker immediately with a filter paper
moistened with a solution recently prepared by dissolving 0.1 g of sodium nitroferricyanide
and 0.25 g of piperazine in 5 mL of water: an intense blue color is produced on the filter
paper, the color becoming paler after few minutes.
B: To 5 mL of a solution (1 in 10) add 1 mL of 1.0 N sodium hydroxide, then slowly (over
a period of 3 minutes) add 2 mL of 0.1 N iodine: the odor of iodoform develops, and a yellow
precipitate is formed within 3 minutes.
Specific gravity: between 0.812 and 0.816 at 15.56, indicating between 92.3% and 93.8%,
by weight, or between 94.9% and 96.0%, by volume, of C2H5OH.
Acidity - To 50 mL, in a glass-stoppered flask, add 50 mL of recently boiled water. Add
phenolpthalein TS, and titrate with 0.020 N sodium hydroxide to a pink color that persists for
30 seconds: not more than 0.90 mL of 0.020 N sodium hydroxide is required for
neutralization.
Limit of nonvolatile residue Evaporate 40 mL in a tared dish on a water bath, and dry at
105 for 1 hour: the weight of the residue does not exceed 1 mg.
Water-insoluble substances Dilute it with an equal volume of water: the mixture is clear
and remains clear after 30 minutes after cooling to 10.
Aldehydes and other foreign organic substances place 20 mL in a glass-stoppered
cylinder that has been thoroughly cleaned with hydrochloric acid, the rinsed with water and
finally with the Alcohol to be tested. Coll the contents to approximately 15, and add, by
means of a carefully cleaned pipet, 0.10 mL of 0.10 N potassium permanganate, noting
accurately the time of addition. Mix at once by inverting the stoppered cylinder, and allow it
to stand at 15 for 5 minutes: the pink color does not entirely disappear.
Amyl alcohol and nonvolatile, carbonizable susbstances allow 25 mL to evaporate
spontaneously from a porcelain dish, carefully protected from dust, until the surface of the
dish is barely moist: no red brown color is produced immediately upon the addition of a few
drops of sulfuric acid.
Limit of acetone and isopropyl alcohol To 1.0 mL add 1.0 mL of water, 1.0 mL of a
saturated solution of dibasic sodium phosphate, and 3.0 mL of a saturated solution of

potassium permanganate. Warm the mixture to 45 to 50, and allow to stand until the
permanganate color is discharged. Add 3.0 mL of 2.5 N sodium hydroxide, and filter without
washing, through a sintered-glass filter. Prepare a control by mixing 1.0 mL of the saturated
solution of dibasic sodium phosphate, 3.0 mL of 2.5 N sodium hyrdroxide, 80 ug of acetone,
and 5.0 mL of water. To each solution add 1 mL of furfural (1 in 100), allow to stand for 10
minutes, then to 1.0 mL of each solution add 3 mL of hydrochloric acid: any pink color
produced in the test solution is not more intense than that in the control.
Methanol to 1 drop of water, 1 drop of dilute phosphoric acid (1 in 20), and 1 drop of
potassium permanganate solution (1 in 20). Mix, allow to stand for 1 minute, and add sodium
metabisulfite solution (1 in 20), dropwise, until the permanganate color is discharged. If a
brown color remains, add 1 drop of the dilute phosphoric acid. To the colorless solution add 5
mL of freshly prepared chromotropic acid TS, and heat on a water bath at 60 for 10 minutes:
any violet color should not exceed that produced by 0.04 mg of methanol in 1 mL of water,
treated in the same way as the sample.

Sorbitol
Sorbitol contains not less than 91.0 percent and not more than 100.5 percent of
C6H14O6,calculated on the anhydrous basis. The amounts of other polyhydric alcohols, and
any hexitol anhydrides, if detected, are not included in the requirements, nor the calculated
amount under Other Impurities.
Package and storage Preserve in tight containers.
USP Reference standards USP Sorbitol RS.
IdentificationA: Dissolve 1 g of Sorbitol in 75 mL of water. Transfer 3 mL of this solution to a 15-cm
test tube, add 3 mL of freshly prepared catechol solution (1 in 10), and mix. Add 6 mL of
sulfuric acid, mix again, then gently heat the tube in a flame for about 30 seconds: a deep
pink or wine red color appears.
B: The retention time of the major peak in the chromatogram of the Assay preparation
corresponds to that in the chromatogram of the Standard preparation as obtained in the
Assay.
Water, Method: not more than 1.0%%
Residue on ignition: not more than 0.1%
Chloride: A 1.5-g portion shows no more chloride than corresponds to 0.10 mL of 0.020 N
hydrochloric acid (0.0050%).
Sulfate: A 1.0-g portion shows no more sulfate than corresponds to 0.10 mL of 0.020 N
sulfuric acid (0.010%).
Arsenic, Method II: 3 ppm
Heavy metlas Dissolve 2.0 g in 25 mL of water: the limit is 0.001%.
Organic volatile impurities, Method IV: meets the requirements.
AssayMobile phase use degassed water.
Resolution solution Dissolve mannitol and USP Sorbitol RS in water to obtain a
solution having concentrations of about 4.8 mg per mL of each.
Standard preparation Dissolve an accurately weighed quantity of USP Sorbitol RS in
water, and dilute quantitatively with water to obtain a solution having a known concentration
of about 4.8 mg per mL.

Assay preparation Transfer about 0.24 g of Sorbitol, accurately weighed, to a 50-mL

volumetric flask, dissolve in 10 mL of water, dilute with water to volume, and mix.

Rose Oil
Rose oil is volatile oil distilled with steam from the fresh flowers of Rosa gallica Linne,
Rosa damascena Miller, Rosa alba Linne, Rosa centifolia Linne, and varieties og these
species (Fam. Rosaceae).
Packaging and storage Preserve in well-filled, tight containers.
Solubility test One mL is miscible with 1 mL of chloroform withut turbidity. Add 20 mL of
90 percent alcohol to this mixture: the resulting liquid is neutral or acid to moistened litmus
paper and, upon standing at 20, deposits crystals within 5 minutes.
Specific gravity: between 0.848 and 0.863 at 30 compared with water at 15.
Angular rotation: between -1 and -4.
Refractive index: between 1.457 and 1.463 at 30.

Formulation
Ethanol
Water
Sorbitol
Fragrance

%v/v in 50ml
60% (30ml)
36% (18ml)
2% (1ml)
2% (1ml)

Technical Specification of Finished Product

Parameter

Specification

1.Organoletpic Evaluation
1.1 Color and Appearance
1.2 Form
1.3 Odor

Colorless to faint yellow

liquid
Bergamot-rose-lemon scent

2. Physical Properties
2.1 pH
2.2 Specific Gravity
2.3 Viscosity
2.4 Deliverable Weight

6
0.936
N/A
60ml

3. Microbiological Testing
3.1 Standard Plate Count
3.2 Coliform Count
3.3 Salmonella
3.4 Molds and Yeasts Count

Not more than 100 cfu

0 cfu
0 cfu
Not more than 10 cfu

Name of the Product: Bubbles Cologne

Batch/Lot no.: AIP 002130
Date manufactured: 03/08/16
Expiration date: 02/08/18
Packaging
Immediate: Spray bottles
Secondary: Tighly closed with label
Conclusion: Based on the study conducted the product is stable for two years prior to the
manufacturing date.

Certificate of Analysis
Parameter

Specification

Actual Result

1.Organoletpic Evaluation
Color and Appearance
1.2 Form
1.3 Odor

Colorless to faint yellow

liquid
Bergamot-rose-lemon scent

Colorless
Liquid
Rose scent

2. Physical Properties
2.1 pH
2.2 Specific Gravity
2.3 Viscosity
2.4 Deliverable Weight

6
0.936
N/A
60ml

6
0.936
N/A
60mL

3. Microbiological Testing
3.1 Standard Plate Count
3.2 Coliform Count
3.3 Salmonella
3.4 Molds and Yeasts Count

Not more than 100 cfu

0 cfu
0 cfu
Not more than 10 cfu

0
0
0
0

Facility and Equipment Used in Compounding

Facility
-

University of Southern Philippines-Foundation Laboratory

Equipment

Analytical balance
Graduated cylinder
Beaker
Sieve
Mortar and pestle
Funnel