( Reaffirmed 1995 )

IS :!5349 -1981

Indian

Standard

SPECIFICATION FOR LANOLIN, ANHYDROUS, FOR COSMETIC INDUSTRY

(First

Revision)
PCDC 19
Refmsenting Directorate General New Delhi of Health Services,

Cosmetics Sectional Committee,

Chairman DR S. S. GOTHOSKAR Members

SHRIN. C. CHA~TERJEE

SHRI V. G. DESHPANDE DR S. S. KARMARKAR SHRIW. M. FERNANDES

National Test House, Calcutta Ciba-Geigy of India Ltd, Bombay

(

Alternate)

SHRI GURMUKH SINGH

& Drug Administration, Maharashtra State, Bombay Bengal Chemical & Pharmaceutical Works Ltd, Calcutta

Food

SHRIPROBIRROY( Alternate) Johnson &Johnson Ltd, Bombay DRS.N.IYER SHRIMATI USHA R.Josm ( AZternate) Drugs Control Administration, Government of SHRIR. C. MEHTA
Gujarat, Ahmadabad DR M. A. PATEL (Alternate ) DR K. S. NARAYAN DR A. T. KAJI (AZternatc ) SHRI N. A. NIMBALKAR SHRI F.F. PATANWALA SHRIN.K.SANYAL (Alternate) SHRI S. RAMASWAMY SHRI K.S. Hindustan Lever Ltd, Bombay Fragrance & Flavour Association, MIS I%.S. Patanwala, Bombay Bombay

Directorate General of Technical Development, New Delhi

Swastik Household and Industrial Products \ Pvt Ltd, Bombay SHRI C. R. KRISHNAMOORTHYAlternate ) ( Lakmi: Limited, Bombay SHRID. J. RIBEIRO SHRI B. S. BARVE ( Alternate ) Central Drugs Laboratory, Calcutta DR S. K. ROY DR P. C. BOSE( Altmate ) Indian Soap and Toiletries Makers Association, SHRI S. N. SEN Bombay ( Continued on page 2 )

SHRIS.N. AGARWAL ( Alternate ) RAO

reproduction

in whole or in part by any means except with written permission of the of copyright under the said Act.

publisher shall be deemed to be an infringement

IS : 5340.- 1981
( Continuedfrom page 1 ) Members SHRI V. SITARAM Representing Basic Chemicals, Pharmaceuticals and Cosmetics Export Promotion Council, Bombay

SHRI I. SUND~ESH ( Alternate) SHRIMATI USHA SUKTHANKAR Consumers Guidance Society, Bombay SHRIMATI USHA KAMERKAR( Alternate j bodrej Soaps Ltd, Bombay SHRI M. S. THAKUR SHRI N. G. IYER ( Alternate ) Director General, IS1 ( Ex-08cio Member ) SHRI M. S. SAXENA, Director ( P & C-) SHRI ASHOK KUMAR Deputy Director ( P &.C ), ISI

Raw Materials and Grass List Subcommittee,

Convener SHRI D. J. RIBEIRO Members SHRI B. S. BARVE (Alternate tu Shri D. J. Ribeiro ) AWSTANT COMMISSIONER ( COSMETICS ) Lakm6 Limited, Bombay

PCDC 19 : 1

Food

SENIOR SCIENTIFIC OFFICER ( CHEMICALS ) SHRIV( .~G~%%;ANDE . DR S. N. IYER SHRIMATI USHA R. JOSHI ( Ahrnate SHRI R. C. MEHTA DR K.S. NARAYAN DR A. T. KAJI ( Altrmate ) SHRI K. S. RAO

and Drug Administration, State, Bombay

Maharashtra

Ciba-Geigy of India Ltd, Bombay Johnson &Johnson Ltd, Bombay ) Drugs Control Administration Ahmadabad Hindustan Lever Ltd, Bombay ( Gujarat ),

Swastik Household and Industrial Products Pvt Ltd. BombavI SHRI C. R. KRISHNAMURTHY Alternatc ) ( Sudarshan Chemical Industries Ltd, Pune SHRI K. L. RATHI SHRI U. N. LIMAYE ( Alternuts ) Central Drugs Laboratory, Calcutta DR S. K. ROY DR P. C. BOSE( Alternate) Geoffrey Manners & Co Ltd, Bombay DR N. D. SHAH DR M. M. DOSHI ( Alternate) Devarsons Pvt Ltd, Ahmadabad SHRI NAV~NCHANDRA SHAH R. SHRI VINODCH~NDRA MEHTA ( Alternate ) K. Godrej Soaps Ltd, Bombay SHRI M. S. THAKUR SHRI N. G. IYER ( Alternute)

IS:!wo-1981

Indian

Standard

SPECIFICATION FOR LANOLIN, ANHYDROUS, FOR COSMETIC INDUSTRY

(First
0.
0.1 This Standards Cosmetics Coal and

Revision)

FOREWORD

Indian Standard ( First Revision ) was adopted by the Indian Institution on 6 May 1981, after the draft finalized by the Sectional Committee had been approved by the Petroleum, Related Products Division Council.

0.2 This standard was originally issued in 1969. Initially while reviewing this standard the Sectional Committee had agreed to indicate separately the essential and optional requirements. Subsequently, this was found nonimplementable for certification and, therefore, a single set of requirements only was decided to be stipulated. In this revision, the requirements of alkalinity, water-soluble acids and alkalis, ammonia and glycerine have been dropped. Changes have also been made in the melting range and saponification value of the material. All other changes considered necessary to align the standard with other Indian Standards on raw materials for cosmetics, have also been included in this revision. 0.3 Anhydrous lanolin is a purified fat-like substance obtained from the wool of sheep. It is a water-in-oil emulsifier. It is commonly used in skin foods, lubricating creams, hand creams, baby preparations, hair preparations, etc, for its emollient properties. 0.4 For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS : 2-1960*. The number of significant places retained in the rounded ofI value should be the same as that of the specified value in this standard. 1. SCOPE 1.1 This standard prescribes the requirements and the methods of sampling and test for anhydrous lanolin for cosmetic industry.
*Rules for rounding off numerical values ( revised ) .

ISt5340-1981 2. REQUIREMENTS 2.1 Description - The material

tenacious, odour. unctuous shall be in the form of a pale yellow, mass, almost odourless or having a slight characteristic

2.2 Solubility - The material shall be sparingly soluble in 95 percent ethyl alcohol and freely soluble in ethyl ether and chloroform. Further, it shall mix, without any separation of layers, with twice its mass of water. 2.3 The material shall comply with the requirements given in Table 1 when tested according to the methods prescribed in IS : 548 ( Part I )-1964* and Appendix A. Reference to relevant clauses of Appendix A and IS : 548 ( Part I ) - 1964* is given in co1 4 and 5 of the table.
TABLE

1 REQUIREMENTS

FOR

LANOLIN, INDUSTRY

ANHYDROUS,

FOR

COSMETIC

&.
(1) i)

CHAIIACTERISTIC

REQUIREMENT 7-

METHOD OF TEST, REP TO

Melting

range, C

(2)

36 ,d 45 0.5 2.0 18 to 32 92 to 106 To pass the test As agreed to between the purchaser and the supplier (see Note) 0.15 To pass the test To pass the test

Cl No. in Appendix A (4) -

Cl No. in IS : 548 (Part I) - 1964* 951 5. 1 7 14 15 13 -

ii) Loss on drying, percent by mass, Max iii) Acid value, Max iv) Iodine value v) Saponification vi) Petrolatum vii) Colour value

A-2 -

viii)

Sulphated ash, percent by mass, Max

A-3 A-4 A-5

ix) Chlorides x) Water soluble oxidizable substances

NOTE - Generally it has been found that the colour of the material on Lovibond Tintometer in & Cell is 12 Y+3 R Max. The choice regarding the colour of the material to suit the colour in the final product has been left to the discretion of the user. *Methods of sampling and test for oils and fats and chemical tests ( revised ) .

: Part I Methods of sampling, physical

*Methods of sampling and test for oils and fats: Part I Methods and chemical tests ( revised ) .

of sampling, physical

IS:5340-1981 3. PACKING 3.1 Packing AND MARKING

- The material shall be packed in mild steel drums lacquered from inside or as agreed to between the purchaser and the supplier.
3.2 Marking - Each container following information : a) Name b) Name of the material; of the manufacturer and/or his recognized trade-mark, if any; to enable the date of manufacture shall be suitably marked to give the

c) Batch number in code or otherwise, to be traced back from records; d) Net mass ; and e) Name 3.2.1 Mark. and content containers of preservative(s), may

if added. with the IS1 Certification

The

also be marked

NOTE -The use of the IS1 Certification Mark is governed by the provisions of the Indian Standards Institution ( Certification Marks ) Act and the Rules and Regulations made thereunder. The IS1 Mark on products covered by an Indian Standard conveys the assurance that they have been produced to comply with the requirements of that standard under a well-defined system of inspection, testing and quality control which is devised and supervised by IS1 and operated by the producer. IS1 marked products are also continuously checked by IS1 for conformity to that standard as a further safeguard. Details of conditions under which a licence for the use of the IS1 Certification Mark may be granted to manufacturers or processors, may be obtained from the Indian Standards Institution.

4. SAMPLING 4.1 The method for preparing

and the criteria for conformity representative test samples of the material shall be as prescribed in Appendix B.

5. TEST

METHODS
to methods prescribed A of this standard. in IS : 548

5.1 Tests shall be carried out according

( Part I ) - 1964* and in Appendix

*Methods of sampling and test for oils and fats: Part I Methods of sampling, and chemical tests ( raised ).

physical

IS : 5340 - 1981

APPENDIX A (Clauses 2.3 and 5.1)

METHODS OF TEST FOR LANOLIN, FOR COSMETIC A-l. A-l.1 QUALITY OF REAGENTS
and distilled water

ANHYDROUS,

INDUSTRY

Unless specified otherwise, pure chemicals (see IS : 1070-1977*) shall be used in tests.

NOTE- Pure chemicals shall mean chemicals that do not contain impurities which affect the results of analysis.

A-2. A-2.1

TEST

FOR PETROLATUM

Reagent Rectified Spirit Boil 1 g of the material with 80 ml of rectified spirit. the solution.

A-2.1.1 A-2.2
Observe

Procedure

A-2.2.1 The material shall be taken to have passed the test, if the solution is clear or not more than opalescent. A-3. A-3.1 DETERMINATION OF SULPHATED ASH

Reagent Concentrated Su&huric Acid

A-3.1.1 A-3.2

Procedure - Weigh accurately about 5 g of the material in a tared crucible. Ignite ( see Note ), gently at first until thoroughly charred, then cool and moisten the residue with 1 ml of concentrated sulphuric acid. Ignite gently until the carbon is completely consumed, then heat strongly. When the carbon has completely disappeared, cool the crucible in a desiccator and weigh.
NOTE- Conduct the ignition in a place protected from air currents and use as low a temperature as possible to effect the combustion of carbon.

A-3.3

Calcula~on
Sulphated where m=mass M=mass ash, percent

by mass =M

mx 100

in g of the residue obtained, and in g of the material taken for the test.
).

*Specification for water for general laboratory use ( secondr&n 6

IS : 5346 - 1981 A-4. TEST FOR CHLORIDES

A-4.0 Outline of the Method - Chlorides are isolated by refluxing the material with alcohol. The turbidity produced with silver nitrate is compared with that produced by a control standard. A-4.1 Apparatus Nessler Cylinders50 ml

A-4.1.1 A-4.2

capacity

(see IS : 4161-1967*).

Reagents
Rectijed S@it Dilute Nitric Acid 4 N. 2 percent. Silver Nitrate Solution -

A-4.2.1
A-4.2.2 A-4.2.3

A-4.2.4

Standard Hydrochloric Acid -

exactly 0 *0 1 N.

2 *000 g of the material with 20 ml of rectified A-4.3 Procedure -Boil spirit under a reflux condenser, cool and filter. Take the filtrate in a Nessler cylinder, add 1 ml of dilute nitric acid and 1 ml of silver nitrate solution and dilute to the mark with water. Carry out a control test in another Nessler cylinder using 1.0 ml of standard hydrochloric acid and the same quantities of other reagents as used with the sample. Allow the cylinders to stand for 3 minutes protected from direct sunlight and compare the turbidity. A-4.3.1 The material shall be taken to have passed the test, if the turbidity produced with the material is not greater than that in the control test. A-5. A-5.1 TEST ROR WATER SOLUBLE OXIDIZABLE SUBSTANCES

Reagent
Potassium Permanganate Solution O-01 N.

A-5.1.1
A-5.2

Procedure - Warm IO- 0 g of the material with 50 ml of water on a steam-bath with constant stirring until it is melted. The fat separates completely on cooling, leaving the water layer nearly clear. Separate the water layer, filter it and preserve the filtrate. Take a 10 ml portion of this filtrate and warm it with 0.5 ml of potassium permanganate solution. A-5.2.1 The material shall be taken to have passed the test, if it is does not completely decolourize the potassium permanganate solution within 10 minutes.
*Specification for Nessler cylinders.

IS:5340-1981

APPENDIX B ( Clause 4.1 )

SAMPLING OF LANOLIN, ANHYDROUS, FOR COSMETIC INDUSTRY B-l. El.0 GENERAL REQUIREMENTS OF SAMPLING
samples, the following

In drawing, preparing, storing and handling precautions and directions shall be observed.

B-l. 1 Samples shall be taken in a protected

dust or soot.

place not exposed to damp air, the material being for samples from

El. 2 Precautions shall be taken to protect the samples, sampled, the sampling instrument and the containers adventitious contamination. B-l.3

The samples shall be placed in clean and dry glass containers. The sample containers shall be of such size that they are almost completely filled by the sample.

B-l .4 Each container shall be sealed air-tight after filling and marked with full details of sampling, date of sampling, batch or code number, name of the manufacturer and other important particulars of the consignment. B-l.5
B-2. Samples shall be stored in such a manner that the temperature the material does not vary unduly from the normal temperature. of

SAMPLING INSTRUMENT

B-2.1 Closed Type Sampling Tube, Undivided - Shown in Fig. 1. The length of the instrument should be such as to enable it to reach the bottom of the container being sampled. It consists of two concentric metallic tubes closely fitting into each other throughout their entire length, so that one tube may be rotated within the other. Longitudinal openings of about one-third the circumference are cut in both tubes. In one position, the the sampling tube is open in this openings in the two tubes coincide; position and admits the material. By turning the inner tube through an The inner tube may have a angle of 180, it becomes a sealed container. diameter of 20 to 40 mm and is undivided along its length to serve as a single container. The two concentric tubes are provided with ports at their bottom-ends, so placed that it becomes possible to drain the material contained in the instrument through them, when the longitudinal openings coincide.

IS:!i340-1981
CLOSED

OPE N e

SECTION

XX

PORTS

OPEN

CLOSED

BOTTOM

VIEWS

FIG. 1 CLOSED TYPE SAMPLING TUBE, UNDIVIDED 9

Is : 5349 - 1981
B-2.1.1 The instrument is inserted closed, the material opening it, and finally, it is closed and withdrawn. B-3. SCALE OF SAMPLING the material a lot. If the manufacture, containers in conformity is admitted by

B-3.1 Lot - All the containers in a single consignment of drawn from a single batch of manufacture shall constitute consignment is declared to consist of different batches of the batches shall be marked separately and the groups of each batch shall constitute separate lots. B-3.2 Samples of the material shall be tested from each lot for ascertaining to the requirements of the specification.

B-3.3 The number of containers ( n ) to be chosen from the lot shall depend on the size of the lot N and shall be as given in Table 2.
TABLE 2 NUMBER
LOT

OF CONTAINERS

TO BE SELECTED FOR SAMPLING

SIZE s[; to

No. OF CONTAINERS BE SELECTEI) TO (2nJ 3 4 5 6 7 8

up 51 201 401 651 1 001

50 200 ,, 400 ,, 650 9, 1 000 iid above

B-3.4 The containers to be selected for sampling shall be chosen at random. In order to ensure the randomness of selection, random number tables shall be used. For guidance and use of random number tables IS : 49051968* may be referred. In the absence of random number tables, the following procedure may be adopted: Starting from any container in the lot, count them as 1, 2, 3, . . . . . ., up to r and so on in one order, where r is the integral part of N/n, N being the lot size and ta the sample size. Every rth container thus counted shall be drawn from the lot so as to constitute the required sample size. B-4. B-4.1 TEST The SAMPLES material AND REFEREE

SAMPLE
to sampling, if already not so.

shall be melted, ,prior

*Methods for random sampling.

IS:5340-1981 B-4.2 Lower the sampling tube ( B-2 ) slowly to a required depth and draw the sample by operating the sampling tube as described in B-2.1.1 from each container selected. The total quantity of the material drawn from each container shall be about 200 ml. B-4.3 Thoroughly mix all portion of the material drawn from the same container. Out of these portions, equal quantities shall be taken out from each selected container and shall be well mixed up together so as to form a composite sample measuring not less than 600 ml. B-4.4 The composite sample shall be divided into three equal parts, one for the purchaser, another for the supplier and the third for the referee. These parts shall be transferred to sample containers which shall then be sealed air-tight with stoppers and labelled with all the particulars of sample given under B-l .4. B-4.5 Referee Sample - The referee sample, bearing the seals of the purchaser and the supplier, shall be used in case of a dispute between the two. It shall be kept at a place agreed to between the purchaser and the supplier. Bd5. NUMBER OF TESTS given in 2 shall be carried out on

B-5.1 Tests for all the characteristics the composite sample. B-6. CRITERIA FOR CONFORMITY

B-6.1 The material shall be taken to have conformed to this specification, if the composite sample satisfies all the requirements given in 2.

11

INDIAN ON COSMETIC IS : 263-1977 918-1968 1462-1977 1463-1977 1767-1980 2519-1977 2520-1977 2521-1977 2528-1977 2529-1977 2850-1977 2851-1978 3986-1973 3987-1977 4828-1977 4236-1977 4652-1980 4653-1977 4887-1980 5340-1981 5356-1977 6333-1977 6334-1980 7101-1973 7299-1974 9601-1980 9681-1981

STANDARDS RAW MATERIALS

Boric acid ( third revision ) Calcium carbonate, precipitated for cosmetic industry (first revision ) Talc for cosmetic industry ( second revision) Kaolin for cosmetic industry ( second revision) Dicalcium phosphate for dentifrice ( second revisiore ) Calcium stearate for cosmetic industry (jirst revision ) Zinc stearate for cosmetic industry (jirst revision ) Magnesium stearate for cosmetic industry (Ji7St revision ) Magnesium carbonate for cosmetic industry (first revision ) Magnesium oxide for cosmetic industry (first revision ) Zinc oxide for cosmetic industry (first revision ) Titanium dioxide for cosmetic industry (j%st revision ) Sodium lauryl sulphate for cosmetic industry (,f;rsS revision ) Sorbitol solution ( 70 percent ) (first revision ) Beeswax, bleached, for cosmetic industry (first revision ) Glyceryl monostearate for cosmetic industry (&t rcutin ) Ethyl p-hydroxybenzoate for cosmetic industry (firsr revision ) Methyl p-hydroxybenaoate for cosmetic industry (Jirst revision ) Petroleum jelly for cosmetic industry (jkt revision ) Lanolin, anhydrous, for cosmetic industry (Jirst revtiion ) iso-propyl myristate for cosmetic industry (jrst revision ) Propyl p-hydroxybenzoate for cosmetic industry (firsb revbsion) Butyl p-hydroxybenzoate for cosmetic industry (first revdsioon ) Coconut diethanolamide Mineral oil for cosmetic industry Sodium silicate for cosmetic industry Stearic acid for cosmetic industry

AMENDMENT NO. 1 MARCH 1996 TO IS 5340 : 1981 SPECIFICATION FOR LANOLIN, ANHYDROUS FOR COSMETIC INDUSTRY
(First Revision) ( Pffge 7, clause A-4.3 ) A-4.3 PROCEDURE Weigh accurately about 2.0 g sample and ignite the material in a crucible. Extract ash in about lo-15 ml of rectified spirit. Take the extract in a Nessler cylinder, add 1 ml of dilute nitric acid and 1 ml of silver nitrate solution and dilute to the mark with water. Carry out a control test in another Nessler cylinder using 1.0 ml of standard hydrochloric acid and the same quantities of other reagents as used with the sample. Allow the cylinders to stand for 3 minutes protected from direct sunlight and compare the turbidity. Substitute the following for the existing:

(PCD19)
Reprography Unit, BIS, New Delhi, India