PHR1533

Cholesterol

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Cholesterol, 3β-Hydroxy-5-cholestene, 5-Cholesten-3β-ol
• Empirical Formula (Hill Notation): C₂₇H₄₆O
• CAS Number: 57-88-5
• Molecular Weight: 386.65
• Beilstein: 1915888
• EC Number: 200-353-2
• MDL number: MFCD00003646
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823445
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. C2155000; traceable to USP 1131960
• API family: cholesterol
• form: powder
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• bp: 360 °C (lit.)
• mp: 147-149 °C (lit.)
• solubility: water: soluble 0.00003 g/L at 20 °C
• density: 1.067 g/mL at 25 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C
• SMILES string: CC(C)CCC[C@@H](C)[C@H]1CC[C@H]2[C@@H]3CC=C4C[C@@H](O)CC[C@]4(C)[C@H]3CC[C@]12C
• InChI: 1S/C27H46O/c1-18(2)7-6-8-19(3)23-11-12-24-22-10-9-20-17-21(28)13-15-26(20,4)25(22)14-16-27(23,24)5/h9,18-19,21-25,28H,6-8,10-17H2,1-5H3/t19-,21+,22+,23-,24+,25+,26+,27-/m1/s1
• InChI key: HVYWMOMLDIMFJA-DPAQBDIFSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Cholesterol is a waxy material that belongs to the class of sterol-lipids found naturally in foods from animal sources, such as egg yolks, meat, and cheese.[1] It serves as a precursor for the biosynthesis of steroid hormones, bile acid and vitamin D.[2]

Application

Cholesterol may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and food products by gas chromatography,[3] or by high performance liquid chromatography.[4]

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Major component of all biological membranes; ~25% of total brain lipid is cholesterol.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0249 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable