Indian Standard Specification Laid Down for Sampling and Testing of Baby Care Products and Skin Care Products is as per BIS.

1. INDIAN STANDARD SPECIFICATION
LAID DOWN FOR
SAMPLING AND TESTING OF BABY
CARE PRODUCTS AND
SKIN CARE PRODUCTS
Submitted to: Prof. (Dr.) Gita Chawla
Submitted by: Md Huzaifa Khan
M Pharm (P. Analysis)
2023-528-004

2. CONTENTS
1. General requirements of sampling
2. Baby care products
3. Skin powder for Infants
4. Baby toilet soap
5. Skin care product
6. Face packs
7. Skin powder
8. Skin cream
9. References

4. BABY CARE PRODUCT
Skin powder for Infants Types of skin powders for
infants
• Type 1: with talc as base
ingredient (90 percent,
Minimum)
• Type 2: with starch as base
ingredient (90 percent,
Minimum)
• Type 3: with talc and starch as
base ingredients, in any
combination (total 90 percent,
Minimum)
• *this classification is absent in IS 5339 : 2004
Baby care products are defined as the
pediatric cosmetics which usually
contain harmless ingredients that
make no or therapeutic value and is
used more or less to prevent rather
than cure undesirable skin problems.
• Non-irritant substances
• Allergen free
• pH- skin friendly
• Addition of anti-oxidants,
chelating agents, skin barrier
protective ingredients.

5. •Requirements:
1. Skin powder for infants shall consist principally of a finely-powdered free flowing absorbent innocuous material
such as natural talc and/or starch and may contain mild perfume, as well as other ingredients consistent with the
accepted practice in the cosmetic industry.
2. The powder shall essentially be free from colouring matter. It may be buffered to control pH. It shall be free from
boric acid when tested by the method prescribed in Annex A.
3. Unless specified otherwise, all the raw materials used in the manufacture of skin powder for infants shall
conform to the requirements prescribed in the relevant Indian Standards where these exist.
4. The ingredients used, if any, shall comply with the provisions of IS 4707 (Part 2) and latest International
Fragrance Association (IFRA) standards for safe use of fragrance materials.
5. For safety evaluation of novel ingredients used in the formation of a skin powder for infants, the skin powder for
infants shall comply to IS 4011. (Methods of Test for Safety Evaluation of Cosmetics ( Third Revision ), 2018)
6. Skin powder for infants shall also comply with the requirements given in Table 1 when tested as prescribed in
col 6 of the Table 1.

6. Requirements table from
IS 5339 : 2021
•Contains specification to
which skin powder for
infants must comply in
terms of qnt. and
methodology.

7. •Specific Requirements:
1. Product shall be dermatologically safe when tested as per IS 4011.
2. Heavy metals calculated as lead (Pb) and arsenic (as As2O3 ) shall not exceed 20 and 2 ppm, respectively
when tested by the respective method prescribed in Indian Standards.
•Sampling:
• Representative samples of the material shall be drawn as prescribed in IS 3958. (methods of sampling cosmetics)
• Tests for all the characteristics shall be carried out on the composite sample as per methods referred under col 6 of
Table 1.
• The material shall be taken to have conformed to the standard if the composite samples passes all the tests.
• Test Methods:
1. TEST FOR FREEDOM FROM BORIC ACID (ANNEX A)
Reagents: Concentrated sulphuric acid and Rectified spirit.

8.  Procedure:
Weigh about 1 g of the
material in a porcelain or
China dish.
Add about 2 ml of
concentrated sulphuric acid
and stir thoroughly with a
glass rod.
Then add about 5 ml of
rectified spirit and again stir
thoroughly.
Ignite and observe the
appearance of the flame.
Acceptance/rejection criteria:
The material shall be considered to be free from boric
acid if the flame does not have a green outer edge.
2. DETERMINATION OF MATTER INSOLUBLE IN BOILING
WATER (ANNEX B)
 Reagents: Rectified spirit
 Procedure:
1. Weigh accurately about 1g of the material and transfer to
a 500 ml beaker.
2. If necessary, wet the material with a little rectified spirit
& Add to the beaker about 200 ml of water and boil.
3. Allow to settle and filter the supernatant liquid through a
Gooch crucible & Wash the residue in the beaker with
water and transfer completely to the f ilter.
4. Dry the residue in the crucible at 105 ± 2 °C to constant
mass.
Calculation:
Matter insoluble in boiling water, percent by mass =
100×𝑀1
𝑀
Where,
M1= mass in g of the residue, and
M = mass in g of the material taken for the test.

9. 3. DETERMINATION OF FINENESS (ANNEX C)
Reagent: Denatured Spirit — Filtered.
For Type 1
1. Place about 10 g of the material,
accurately weighed, in the specified IS
Sieve and wash by means of a slow
stream of running tap water and finally
with fine stream from a wash bottle
until as much material as would pass
through the sieve has passed.
2. In case the material is not easily wetted
by water, the washing could be started
with a slow stream of filtered
denatured spirit.
3. Let the water drain from the sieve and
then dry the sieve containing the
residue on a steam bath or oven.
4. Transfer the residue onto a tared watch
glass carefully and dry it to constant
mass at 105 ± 2 °C.
For Type 2 and Type 3
1. Place about 10 g of the material, in the specified IS
Sieve & After complete transferring of weighed
quantity of material on sieve initially gently shake
sieve in horizontal direction.
2. Try to pass maximum possible quantity of the
weighed material through sieve by shaking sieve in
horizontal direction. Now use clean dry camel hair
soft brush to remove any clogging of sieve or
break of lump due to material.
3. With the help of brush try to pass material through
sieve by applying gentle pressure on material.
After confirming that no more material is passing
through the sieve then residue left on the sieve
shall be transfer on tarred weighed butter paper.
4. Note the weight of residue of material left on
sieve.
Calculation:
Material retained on the specified sieve, percent by mass =
100×𝑀1
𝑀
Where, M1= mass in g of the residue retained on the specified sieve
M = mass in g of the material taken for the test.

10. 4. DETERMINATION OF MOISTURE AND VOLATILE MATTER (ANNEX D)
Procedure:
1. Weigh accurately about 5 g of the material in a porcelain or glass dish, about and about 6 to 8 cm in
diameter and about 2 to 4 cm in depth.
2. Dry in an air oven at a temperature of 105 ± 2 °C to constant mass (within ± 5 mg)
Calculation:
Moisture and volatile matter, percent by mass =
100×𝑀1
𝑀
Where,
M1 = loss in mass in g on drying
M = mass in g of the material taken for the test

11. 5. DETERMINATION OF pH OF AQUEOUS SUSPENS1ON (ANNEX E)
 Procedure:
1. Take 10 g of the material in a 150 ml beaker and add 90 ml of freshly boiled and cooled water or
purified water.
2. Stir well to make a thorough suspension.
3. Determine the pH of the suspension at a temperature of 25 ± 1 °C, using a pH meter within 5 min of
making the suspension.
4. In case of a material which does not wet, the pH shall be determined on the filtrate.

12. 6. TEST FOR HEAVY METALS (ANNEX F)
Reagents: Dilute Hydrochloric Acid (Approximately 5 N),
Dilute Acetic Acid (Approximately 1 N), Dilute
Ammonium Hydroxide (Approximately 5 N)
Apparatus: Nessler Cylinders - 50 ml capacity.
Standard Lead Solution:
1. Dissolve 1.600 g of lead nitrate in water and make up the
solution to 1 000 ml. Pipette out 10 ml of the solution and
dilute again to 1 000 ml with water.
2. One millilitre of this solution contain 0.01 mg of lead (as Pb).
The colour produced with hydrogen sulphide solution is
matched against that obtained with standard lead solution.
Acceptance/rejection criteria:
The sample may be taken to have passed the test, if the colour
developed in the sample solution is less than that of standard solution.
Weigh about 2.000 g of material in a
crucible and heat on a hot plate and
then in a muffle furnace to ignite it at
600 °C to constant mass.
Add 3 ml of dilute hydrochloric acid,
warm (wait till no more dissolution
occurs) and make up the volume to
100 ml. Filter the solution.
Transfer 25 ml of the filtrate into a
Nessler’s cylinder. In the second
Nessler’s cylinder, add 2 ml of dilute
acetic acid, 1.0 ml of standard lead
solution and make up the volume
with water to 25 m1.
Add 10 ml of hydrogen sulphide
solution to each Nessler cylinder and
make up the volume with water to 50
ml. Mix and allow to stand for 10
min.
Compare the colour produced in the
two Nessler’s cylinders. Blank
determination without samples are
recommended to avoid errors arising
out of reagents.
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13. 8. DETERMINATION OF ARSENIC (ANNEX G )
Arsenic present in a solution of the material is reduced to arsine, which is made to react
with mercuric bromide paper. The stain produced is compared with a standard stain.
Reagents: Mixed Acid- Dilute one volume of concentrated sulphuric
acid with four volumes of water. Add 10 g of sodium chloride for each 100
ml of the solution.
Ferric Ammonium Sulphate Solution, Concentrated Hydrochloric Acid ,
Stannous Chloride Solution
Procedure:
1. Carry out the test as prescribed in IS 2088, adding into
the Gutzeit bottle, 2 ml of Ferric ammonium sulphate
solution, 0.5 ml of stannous chloride solution and 25 ml
of sample solution as prepared in F-4.
2. For comparison, prepare a stain using 0.001 mg of
arsenic trioxide.
9. DETERMINATION OF LOSS ON IGNITION (ANNEX H)
 Procedure:
1. Weigh accurately about 4 g of the material in a
tared crucible and ignite at red heat to constant
mass. Cool in a desiccator and weigh.
Calculation:
Loss on ignition, percent by mass =
100×(𝑀−𝑚)
𝑀
Where,
m= mass in g, of the ignited material.
M = mass in g, of the material taken for the test.

14.  BABY TOILET SOAP (IS 10523 : 2014/2016/2019)
•Requirements:
•Description: Baby toilet soap shall be a high grade,
thoroughly saponified, milled soap or homogenized
soap or both, white or coloured, mildly perfumed or
unperfumed, and compressed in firm smooth cakes. It
shall possess good cleaning and lathering properties. It
shall be free from rancidity.
•Ingredients: Baby toilet soaps shall contain only the
following: a) Colouring matter, perfume, preservatives
and super fatting agents; b) All other ingredients
except moisture shall be declared on the label; and c)
All these materials shall be non-injurious to skin in
use with soap.
•Baby toilet soap shall also comply with the
requirements given in Table 1.

15. Sampling:
1. Number of test:
Tests for the determination of total fatty matter and free caustic alkali shall be conducted on each of the
individual samples separately.
Tests for determination of all the remaining characteristics shall be conducted on the composite sample.
2. Criteria for Conformity:
For Individual Sample- For each of the characteristics which has been determined on the individual samples the mean (x)
and the range ( R ) of the test results shall be calculated as follows:
Mean (x) = (𝑠𝑢𝑚 𝑛𝑜𝑓 𝑡ℎ𝑒 𝑡𝑒𝑠𝑡 𝑟𝑒𝑠𝑢𝑙𝑡)/(𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑡𝑒𝑠𝑡 𝑟𝑒𝑠𝑢𝑙𝑡)
Range (R) = The difference between the maximum and the minimum values of the test result

16.  TEST METHODS:
1. TEST FOR FREEDOM FROM GRIT (ANNEX A)
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Hold a bar of soap in running tap water and rub between
both hands for about 3 minutes.
No gritty or rough feel should be perceived while rubbing
the soap surface.
Examine the surface of the bar which shall not be rough and
shall feel smooth when the fingers are moved across the
surface.
Set the bar on and let it dry for 24 hours at room
temperature and examine its surface.
The soap shall be taken to have passed the test if there is no
gritty or rough feel on the surface.
Outline of the Method :
Soap is rubbed with water between the hands
for a specified time and examined for its
gravity or rough feel, if any.

17.  DETERMINATION OF NICKEL (ANNEX C)
Outline of the Method
The method is based on the isolation of metal from the soap and reaction between nickel in the oxidized
form with dimethyl glyoxime forming a red color.
Reagents
Sodium Hydroxide, Concentrated Hydrochloric Acid, Dimethyl Glyoxime Solution, Saturated Bromine
water, Liquor Ammonia
 Procedure:
1. Isolation of Metals from Soap :
• Weigh 50g of soap in a beaker and dissolve in
hot water.
• Add to this soap solution 40ml of concentrated
hydrochloric acid, stir and keep on steam bath
until fatty acid layer separates.
• Add 20 g of paraffin wax, stir at intervals and
allow it to settle until phases are clear.
• Cool to room temperature.
• Remove wax cake with rod, rinse with water and add
rinsings to aqueous phase.
• Evaporate aqueous phase to about 60 ml by gentle
boiling.
• Add 100 ml of water and filter through paper washed
previously with hydrochloric acid.
• Evaporate filtrate and washings to about 60 ml, Cool and
transfer to volumetric flask.
• Make up the volume to 100 ml, Take aliquot portions for
metal estimation.

18. 2. DETERMINATION OF NICKEL CONTENT:
The sample shall be considered to have passed the test if no pink colour develops.
Add 10 ml of dimethyl glyoxime solution, followed by 15- 20 ml of 95 percent ethyl alcohol. Mix
thoroughly and make up the volume and again mix thoroughly. Allow the solution to stand for 5
minutes to permit fun development of colour.
Then add 5 ml of liquor ammonia in excess, if precipitation occurs, filter the solution and wash the
precipitate with distilled water; combine the filtrate and the washings and concentrate to a volume of a
few millilitres and transfer to a 50ml volumetric flask.
Add liquor ammonia dropwise until excess bromine is destroyed as indicated by the disappearance of
brown colour.
Add to the flask 3ml of saturated bromine water and allow to stand for one minute.
Transfer the solution to a 50ml glass stoppered volumetric flask using a small quantity of water for
rinsing the solution from the beaker into the volumetric flask.
Take 50 ml aliquot of the aqueous solution from the test solution in a 250ml beaker. - Evaporate the
solution to about 15ml by heating.

19.  DETERMINATION OF IRON (ANNEX D)
Outline of the Method
The method is based on the isolation of metal from the soap by dissolving in hot water. The aqueous extract is treated with citric acid
to sequester aluminium and then thioglycolic acid in ammoniacal solution is added and colour measured spectrophotometrically.
Reagents:
Liquor ammonia, Sulphuric acid, Citric acid, Thioglycolic acid, standard iron solution, Methyl red indicator
 Procedure:
1. Isolation of Metals from Soap :
• Same as in Nickle
2. Determination of Iron Content:
• Take 5 ml aliquot of the aqueous solution from the test solution in a 25ml volumetric flask.
• To this add 4 ml citric acid solution and 0·02ml methyl red indicator and liquor ammonia till the colour of the
solution turns yellow.
• Then add 3 ml liquor ammonia in excess. - Cool the solution and add 3ml thioglycolic acid.
• Make up the volume to 25 ml and mix the solution thoroughly.
• Filter the solution through acid washed and dried filter paper. - Measure absorbance of the clear solution at 540 nm
in the spectrophotometer using water as reference.
• Prepare a calibration curve with standard iron solution and determine the iron content of the soap sample from it.
 Apparatus: Spectrophotometer

20.  DETERMINATION OF COPPER (ANNEX E)
Outline of the Method
The method is based on the isolation of metal from the soap and to make a copper complex using zinc dibenzyl
dithiocarbamate in carbon tetrachloride solution and measure the colour of the solution spectrophotometrically.
Reagents:
Zinc Dibenzyl Dithiocarbamate Solution, Standard Copper Solution.
 Procedure:
1. Isolation of Metals from Soap :
• Same as in Nickle
2. Determination of Copper Content:
• Take 20ml aliquot of the aqueous solution and to it add 10 ml of zinc dibenzyl dithiocarbamate solution followed by
25ml sulphuric acid in a separating funnel.
• Shake the solution for one minute and allow it to settle.
• Wash the aqueous layer with carbon tetrachloride and transfer to volumetric flask.
• Makeup the volume and mix well.
• Measure absorption of the clear solution at 435 nm in the spectrophotometer.
• Prepare a calibration curve with standard copper solution and determine the copper content of the soap sample from
the curve.
 Apparatus: Spectrophotometer

21. SKIN CARE PRODUCT
1. Face packs: IS 15153 : 2002 (Reaffirmed Year : 2022 )
Requirements:
•Description: Face packs shall be a smooth paste or fluid or dry powder free from any gritty particles. It may
be colored for aesthetics and may contain natural or synthetic scrubbing materials.
•Ingredients: Unless specified otherwise, all the raw materials used in the manufacture of face pack shall
conform to the requirements prescribed in the relevant Indian Standards wherever exist.
•The dyes/colors used in the manufacture of face pack shall comply with the provisions of IS 4707 (Part 1).
•Ingredients other than dyes/colors shall comply with the provisions of IS 4707 (Part 2)

22. SAMPLING:
•Representative samples of the material shall be drawn as prescribed in IS 3958.
•Test for all characteristics shall be carried out on the composite sample.
•The material shall be taken to have conformed to this standard if the composite sample passes
all the tests.

23. METHODS OF TEST
1. DETERMINATION OF pH:
 Procedure
1. A standard single or double electrode pH
meter may be used.
2. Instrument shall be initially calibrated at
pH 7 and 9.2 with appropriate buffer
solution.
3. The test sample consisting of 10 percent
(m/v) dispersion of the product of either
type of face pack in previously boiled and
cooled water shall be poured into a glass
beaker and pH determined directly
without any dilution within 5-10 minutes.
1. DETERMINATION OF STABILITY:
Apparatus: Incubator (Maintained at 45 + 10C) 25ml
Cylindrical Glass Bottles with proper plug and cap
 Procedure
1. Taking a glass bottle and fill to the three-fourth of
its capacity with the product and close it with plug
and cap tightly.
2. Keep the bottle in an oven at 45 + 10C for 48hr.
3. Periodically examine the contents.
4. The emulsion should not split leaving separate
layers & neither the suspended pigments should
settle.

24. 3. Determination of Residue on Evaporation and Loss on Drying
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Heat the clean petri dish in hot air oven for
15-20 minutes.
Place it in a desiccator for 20 minutes.
Weigh the petri dish accurately.
Weigh into the petri dish approximately
about 2-3 g of sample.
Spread the product by rotating the petri
dish or using dry and clean spatula to form
a layer.
Then weigh the petri dish accurately and
keep it in an oven at 105 + 2°C for 3 hours.
Cool in desiccator and weigh.
 Apparatus: Glass Petri Dish, Oven, Desiccator.
Calculation:
Residue on evaporation, percent by mass =
100×𝑀1
𝑀
Where, M1= mass in g of the residue.
M = mass in g of the material taken for the test.

25. 4. ASH CONTENT:
Procedure:
1. Take 1 g sample in dried crucible.
2. Ignite it on oxidizing flame till the
sample gets completely charred.
3. Transfer the crucible in furnace at
8000C for 1 hour.
4. Take out the crucible, cool and weigh.
Calculation:
Percentage Ash = "Mass of residue x 100" /(𝑀𝑎𝑠𝑠 𝑜𝑓 𝑠𝑎𝑚𝑝𝑙𝑒)

26. 2. Skin Powders: (IS 3959 : 2023)
TYPES Skin powders shall be classified into three types as follows:
a) Body powders — shall include talcum powders, toilet powders, deodorant powders and dusting powders. These shall
consist principally of a finely powdered free flowing absorbent innocuous material such as natural talc (hydrous silicate of
magnesium with the formula Mg3Si4O10H2O) and may contain small amounts of perfume and colouring matter, as well as
other ingredients consistent with the accepted practice in the cosmetic industry. The latter may include materials having
anti-perspirant and deodorant properties;
b) Face powders — shall essentially be similar to body power described under (a) except that it shall be of finer particle size
and free from grit; and
c) Cool/Cooling body powders — shall also be similar to body powder described under (a) in addition containing permitted
levels

27. Requirements:
Body Powders and Face Powder Shall meet the description requirement given in 3. The dyes, colours (pigments,
lakes etc) if used shall comply with the latest version of IS 4707 (Part 1). These shall not be more than sparingly
soluble either in water or in oil when tested by the method prescribed in Annex B.
Ingredients :
• Unless specified otherwise, all the
raw materials used in the
manufacture of skin powders shall
confirm to the requirements
prescribed in the relevant Indian
Standards where these exist. Other
ingredients shall comply with the
provisions of IS 4707 (Part 2).
• For safety evaluation of novel
ingredients used in formulation of a
skin powder, the skin powder shall
comply to IS 4011.
• The material shall also comply with
the requirements given in Table 1
when tested as prescribed in col (6)
and col (7) of the Table 1.

28. METHODS OF TEST
1. TEST FOR SOLUBILITY OF COLOURS:
 Procedure :
1. Take 1 g of the material add 50 ml of water,
boil for 15 min and filter. The filtrate shall
be colourless or faintly coloured
2. Take 10 g of the material and add 50 ml of
rectified spirit. Boil under reflux for 15 min
and filter. The filtrate shall be colourless or
faintly coloured.
(ANNEX B)
 Other tests: (same as the baby-powder)
1. Determination of matter insoluble in boiling
water
2. Determination of fineness
3. Determination of moisture and volatile matter
4. Determination of pH of aqueous suspension
5. Test for heavy metals
6. Determination of arsenic
7. Determination of menthol and camphor by
gas chromatography
8. Determination of borates (as boric acid)

29. 3. SKIN CREAM IS 6608 : 2004 (REAFFIRMED 2019)
Requirements:
•Description: Face packs shall be a smooth paste or fluid or dry powder free from any gritty particles. It may
be colored for aesthetics and may contain natural or synthetic scrubbing materials.
•Ingredients: Unless specified otherwise, all the raw materials used in the manufacture of skin creams shall conform to
the requirements prescribed in the relevant Indian Standards where such standards exist.
•The dyes, colors (pigments, lakes etc.) if used in
the manufacture of skin creams shall comply
with 1S 4707 (Part 1) subject to the provision of
schedule Q of Drugs and Cosmetic Act, issued
by the Government of India.
•Other ingredients shall comply with the
provisions of IS 4707 (Part 2).

30. METHODS OF TEST
1. Test for thermal stability :
 Apparatus: A humidity chamber/incubator
controlled at 60 to 70 % RHand 45 +- 10C.
Clear glass bottles of around 30 ml capacity
with plug and screw on cap for proper closure.
 Procedure
1. With the help of spatula, insert the cream into
glass bottle and tap it to settle to the bottom.
2. Fill up to two-third capacity of bottle and insert
plug and tighten the cap. • Keep the filled bottle
erect in side the incubator at 45 + 10C for 48 h.
3. The sample shall be taken to have passed the test,
if on removal from the incubator shows no oil
separation or any other phase separation
(ANNEX A)
1. Determination of residue :
 Apparatus: Incubator (Maintained at 45 + 10C) 25ml
Cylindrical Glass Bottles with proper plug and cap
 Procedure
1. Weigh accurately about 5 g of the material in a clean
and dry weighing bottle and dry to constant mass at
105 + 10C.
2. Cool in a desiccator and weigh.
Calculation:
Residue percent by mass =
100×𝑀1
𝑀2
Where,
M1= mass in g of the residue, and
M2 = mass in g of the material taken for the test.
(ANNEX D)

31. 3. DETERMINATION OF PH: (ANNEX B)
Apparatus: A pH meter, preferably equipped with a glass electrode.
Procedure:
i. For Oil-in-Water Emulsion Creams
•Weigh accurately 5+0.01 g of the cream in a 100 ml beaker.
•Add 45 ml of water and disperse the cream in it.
•Determine the pH of the suspension at 27°C using the pH meter.
ii. For Water-in-Oil Emulsion Creams
•Weigh 10 g of the cream to the nearest 0.1 g.
•Add 90 ml of rectified spirit previously adjusted to pH 6.5 to 7.0.
•Warm, if necessary to 45°C and stir thoroughly for 15 min.
•Filter the alcoholic layer through a filter paper and measure the pH of the filtrate at 27°C using the pH
meter

32. 4. DETERMINATION OF TOTAL FATTY SUBSTANCE CONTENT: (ANNEX C)
Principle of the method: The emulsion is broken with dilute mineral acid and the fatty matter is extracted with petroleum
ether. It is weighed after removal of the solvent.
Reagents: Dilute Hydrochloric Acid, Petroleum Ether, Methyl Orange Indicator Solution, Sodium Sulphate
Procedure:
1. Weigh accurately about 2 g of the material into a conical flask, add 25 ml of dilute hydrochloric acid
2. Fit a reflux condenser into the flask, and boil the contents until the solution is perfectly clear.
3. Pour the contents of the flask into a 300 ml separating funnel and allow it to cool to room temperature.
4. Rinse the conical flask with 50 ml of petroleum ether in portions of 10 ml.
5. Pour the petroleum ether rinsing into the separating funnel, shake the separating funnel well and leave until the layers separate.
6. Separate out aqueous phase and shake it out with 50 ml portions of petroleum ether twice.
7. Combine all the ether extracts and wash them with water until free of acid.
8. Filter the petroleum ether extracts through a filter paper containing sodium sulphate into a conical flask, previously dried at a
temperature of 90 + 2°C and then weighed.
9. Wash the sodium sulphate on the filter with petroleum ether and combine the washings with filtrate.
10. Distill off the petroleum ether and dry the material remaining in the flask at a temperature 90 + 2°C of to constant mass.

33. Calculation:
Total fatty substance, percent by mass =
100×𝑀1
𝑀
Where, M1= mass in g of the residue.
M = mass in g of the material taken for the test.

34. 4. SKIN GEL (IS 18429 : 2023)
Requirements:
•Description: Skin gels are jelly semisolid preparations. It could be in aqueous or non-aqueous base.
•Unless specified otherwise, all the raw materials used in the manufacture of skin gel shall conform to the requirements
prescribed in the relevant Indian Standards where these exist.
•All ingredients of skin gel shall comply with the provisions of IS 4707 (Part 1) and IS 4707 (Part 2) subject to the provisions
of the Drugs and Cosmetics Act, 1940 and rules framed there under.
•For safety evaluation of novel ingredients used in the formation of skin gel, it shall comply to IS 4011.
•The cosmetic product shall also comply with the requirements given in Table 1 when tested as prescribed in col (4) of table 1.
• Sampling:
• Representative samples of the product shall be drawn as
prescribed in IS 3958.
• Test for all characteristics shall be carried out on the
composite sample.
• The product shall be taken to have confined to the
specification if the composite sample passes all the tests.

35. Methods of Tests:
1. ANNEX A : DETERMINATION OF pH
2. ANNEX B : TEST FOR HEAVY METALS
3. ANNEX C : DETERMINATION OF ARSENIC
All as previously discussed

36. REFERENCE
1. IS 5339 : 2021
2. IS 10523 : 2014/2016/2019
3. IS 15153 : 2002 (Reaffirmed Year : 2022 )
4. IS 3959 : 2023
5. IS 6608 : 2004 (Reaffirmed : 2019)
6. IS 18429 : 2023