PHR1237

Cholecalciferol (Vitamin D3)

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Cholecalciferol, (+)-Vitamin D₃, 7-Dehydrocholesterol activated, Activated 7-dehydrocholesterol, Calciol
• Empirical Formula (Hill Notation): C₂₇H₄₄O
• CAS Number: 67-97-0
• Molecular Weight: 384.64
• Beilstein: 2339331
• EC Number: 200-673-2
• MDL number: MFCD00078131
• PubChem Substance ID: 329823242
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 787; traceable to Ph. Eur. C2100000; traceable to USP 1131009
• API family: cholecalciferol
• form: solid
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 83-86 °C (lit.)
• application(s): food and beverages
• format: neat
• storage temp.: -10 to -25°C
• SMILES string: CC(C)CCC[C@@H](C)[C@@]1([H])CC[C@@]([C@]1(C)CCC/2)([H])C2=C\C=C(C[C@@H](O)CC3)/C3=C
• InChI: 1S/C27H44O/c1-19(2)8-6-9-21(4)25-15-16-26-22(10-7-17-27(25,26)5)12-13-23-18-24(28)14-11-20(23)3/h12-13,19,21,24-26,28H,3,6-11,14-18H2,1-2,4-5H3/b22-12+,23-13-/t21-,24+,25-,26+,27-/m1/s1
• InChI key: QYSXJUFSXHHAJI-YRZJJWOYSA-N
• Gene Information: human ... VDR(7421)

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.
Cholecalciferol (vitamin D3) is a fat-soluble vitamin that manifests skeletal and extra-skeletal effects. The skeletal effects augment the bone health whereas the extra-skeletal effects concern the immune system, the cognition, the cardiovascular system, etc.

Application

Cholecalciferol (Vitamin D3) may be used as a pharmaceutical reference standard for the determination of the analyte in food, feeds, serum samples and pharmaceutical formulations by various chromatography techniques.

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

Vitamin D acts through a receptor that is a member of the ligand-dependent transcription factor superfamily. Modulates the proliferation and differentiation of both normal and cancer cells. Has antiproliferative and antimetastatic effects on breast, colon, and prostate cancer cells. Activated vitamin D receptors in intestine and bone maintain calcium absorbance and homeostasis.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAC0270 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS06,GHS08
• Signal Word: Danger
• Hazard Statements: H300 + H310 + H330 - H372
• Precautionary Statements: P260 - P262 - P280 - P302 + P352 + P310 - P304 + P340 + P310 - P314
• Hazard Classifications: Acute Tox. 2 Dermal - Acute Tox. 2 Inhalation - Acute Tox. 2 Oral - STOT RE 1 Oral
• Storage Class Code: 6.1A - Combustible, acute toxic Cat. 1 and 2 / very toxic hazardous materials
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable