All Photos(1)

PHR1237

Supelco

Cholecalciferol (Vitamin D3)

Pharmaceutical Secondary Standard; Certified Reference Material

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

Quality Level

grade

certified reference material
pharmaceutical secondary standard

form

neat
solid

CofA

current certificate can be downloaded

application(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

83-86 °C (lit.)

Featured Industry

Food and Beverages

format

neat

pharmacopeia traceability

traceable to BP 787
traceable to PhEur C2100000
traceable to USP 1131009

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)

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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

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.
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.

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.

Pictograms

Skull and crossbonesHealth hazard

Signal Word

Danger

Hazard Statements

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

Certificate of Analysis

Certificate of Origin

Simultaneous microemulsion liquid chromatographic analysis of fat-soluble vitamins in pharmaceutical formulations: optimization using genetic algorithm
Momenbeik F, et al.
Journal of Chromatography A, 1217(24), 3770-3773 (2010)
Is supercritical fluid chromatography hyphenated to mass spectrometry suitable for the quality control of vitamin D3 oily formulations?
Andri B, et al.
Journal of Chromatography A, 1515(5-6), 209-217 (2017)
High-performance liquid chromatographic determination of vitamin D in foods, feeds and pharmaceuticals by successive use of reversed-phase and straight-phase columns
TAKEUCHI A, et al.
Journal of nutritional science and vitaminology, 30(1), 11-25 (1984)
Determination of vitamins A, D, E, and K in human and bovine serum, and ?-carotene and vitamin A palmitate in cosmetic and pharmaceutical products, by isocratic HPLC
Wang LH and Huang SH
Chromatographia, 55(5-6), 289-296 (2002)
Sina Gallo et al.
JAMA, 309(17), 1785-1792 (2013-05-02)
Vitamin D supplementation in infancy is required to support healthy bone mineral accretion. A supplement of 400 IU of vitamin D per day is thought to support plasma 25-hydroxyvitamin D (25[OH]D) concentrations between 40 and 50 nmol/L; some advocate 75...

Protocols

HPLC Analysis of Vitamin D2 and D3 on Ascentis® Express C18

This application demonstrates the suitability of the Ascentis Express C18, 5 μm, for the routine analysis of the fat-soluble vitamins D2 and D3 . Structures along with the optimized chromatogram obtained on the Ascentis Express C18, 5 μm are presented.

AOAC Method 2011.11: UHPLC/MS/MS Analysis of Vitamin D2 and Vitamin D3 on Titan™ C18

Separation of Ergocalciferol (D2), analytical standard; Cholecalciferol (D3), analytical standard

HPLC Analysis of Vitamin D2 and Vitamin D3 on Ascentis® C18

Separation of Ergocalciferol (D2), analytical standard; Cholecalciferol (D3), analytical standard

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