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Cholesterol

CAS No.: 57-88-5
Molecular Weight: 386.65 g/mol
Chemical Formula C27H46O

Cholesterol is a waxy, fat-like substance that your body needs for good health, but in the right amounts. Unhealthy levels of cholesterol can lead to a condition called high blood cholesterol.

General Properties and Specifications of Cholesterol:
Appearance: White crystalline compound.
Odor: Odorless.
Solubility of 10% solution in Diethylether: Almost clear colorless.
Solubility of 10% solution in Chloroform: Clear colorless.
Assay (GC): 99% minimum as total steroid.
Loss on drying: 0.1% maximum.
Sulphated Ash: 0.1% maximum.
Homogeneity by TLC: Passes test.
Suitability for Cell Culture: Passes.
Bacterial Endotoxin Test (BET) (EU/mg = IU/mg): <0.05 EU/mg.
Relative Density: about 1.07
Melting Point: 147C to 150C.
Boiling Point: 360C decomposes.
Solubility: Negligible solubility in water. Moderately soluble in hot alcohol. Soluble in benzene, oils, fats.
Storage: 0C to 4C (Refrigerate).


Cholesterol USP NF Grade Specifications:
C27H46O --- 386.65
Cholest-5-en-3-ol, (3β)-;
Cholest-5-en-3β-ol CAS 57-88-5
UNII: 97C5T2UQ7J

DEFINITION
Cholesterol is a steroid alcohol containing NLT 95.0% and NMT 102.0% of cholest-5-en-3β-ol (C27H46O), calculated on the dried basis. It may contain suitable stabilizers.

IDENTIFICATION
A. Infrared Absorption.
B. It meets the requirements of the test for Optical Rotation, Specific Rotation.
C. It meets the requirements of the test for Melting Range or Temperature.
Residue on Ignition: NMT 0.1%
Limit of Related Sterols and Other Organic Impurities: To pass the test.
Total impurities including related sterols NMT 5%.
Melting Range or Temperature: 147C to 150C.
Optical Rotation Specific Rotation:
Sample solution: 20 mg/mL, undried, in dioxane.
Acceptance criteria: −34° to −38°
Acidity: To pass the test.
Loss on Drying: Dry under vacuum at 60C for 4 h. Acceptance criteria: NMT 0.3%
Solubility in Alcohol: Dissolve the 500 mg Sample in 50 mL of warm alcohol in a stoppered flask or cylinder, and allow to stand at room temperature for 2 h. No deposit or turbidity is formed.


Cholesterol BP Ph Eur Grade Specifications:
C27H46O --- 386.7 CAS 57-88-5
Action and use: Excipient.

DEFINITION
Cholest-5-en-3β-ol.
Content:
- cholesterol: minimum 95.0 per cent (dried substance);
- total sterols: 97.0 per cent to 103.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Practically insoluble in water, sparingly soluble in acetone and in ethanol (96 per cent).
It is sensitive to light.

IDENTIFICATION
A. Melting point: 147C to 150C.
B. Thin-layer chromatography.
C. Dissolve about 5 mg in 2 mL of methylene chloride. Add 1 mL of acetic anhydride, 0.01 mL of sulfuric acid and shake. A pink colour is produced which rapidly changes to red, then to blue and finally to brilliant green.

TESTS
Solubility in ethanol (96 per cent): In a stoppered flask, dissolve 0.5 g in 50 mL of ethanol (96 per cent) at 50C. Allow to stand for 2 h. No deposit or turbidity is formed.
Acidity: To pass the test.
Loss on drying: Maximum 0.3 per cent, determined on 1.000 g by drying in vacuo at 60C for 4 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.