Mineral Oil and Lanolin Alcohols

Basic Information

Name: Mineral Oil and Lanolin Alcohols

CAS No: Mineral oil [8012-95-1], Lanolin alcohols [8027-33-6]

Functional Categories

Emollient Emulsifying agent Plasticizer

1. Nonproprietary Names

None Adopted

2. Synonyms

Amerchol L-101; liquid paraffin and lanolin alcohols; Protalan M16; Protalan M-26.

3. Chemical Name & CAS Registry

Mineral oil [8012-95-1], Lanolin alcohols [8027-33-6]

4. Empirical Formula & Molecular Weight

A mixture of mineral oil and lanolin alcohols.

5. Structural Formula

See Section 4.

6. Applications

Mineral oil and lanolin alcohols is an oily liquid used in topical pharmaceutical formulations and cosmetics as an emulsifying agent with emollient properties; see Table I. It is used as a primary emulsifier in the preparation of water-in-oil creams and lotions and as an auxiliary emulsifier and stabilizing agent in oil-in-water creams and lotions.

7. Description

A pale yellow-colored, oily liquid with a faint characteristic sterol odor.

8. Pharmacopeial Specifications

Lanolin alcohols and mineral oil are listed as separate monographs in BP, JP, PhEur and USP–NF but the combination is not listed; see Lanolin Alcohols and Mineral Oil.

9. Typical Properties

d value 41 Arsenic 42 ppm Ash 40.2% Heavy metals 420 ppm HLB value 8 Hydroxyl value 10–15 Iodine number 412 Microbiological count The total bacterial count, when packaged, is less than 10 per gram of sample. Moisture content 40.2% Saponification value 42 Solubility Soluble 1 in 2 parts of chloroform, 1 in 4 parts of castor oil, and 1 in 4 parts of corn oil. Practically insoluble in ethanol (95%) and water. Precipitation occurs in hexane. Specific gravity 0.840–0.860 at 258C

10. Stability & Storage

Mineral oil and lanolin alcohols is stable and should be stored in a well-closed container in a cool, dry place.

11. Incompatibilities

Lanolin alcohols is incompatible with coal tar, ichthammol, phenol, and resorcinol.

12. Method of Manufacture

Lanolin alcohols is dissolved in mineral oil.

13. Safety

Mineral oil and lanolin alcohols is generally regarded as an essentially nontoxic and nonirritant material. However, lanolin alcohols may be irritant to the skin and causes hypersensitivity in some individuals.(1

14. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled

15. Regulatory Status

Accepted for use in topical pharmaceutical formulations and cosmetics. Included in the Canadian List of Acceptable Nonmedicinal Ingredients.

16. Related Substances

Lanolin alcohols; mineral oil; petrolatum and lanolin alcohols.

17. Comments

See Lanolin Alcohols and Mineral Oil for further information