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Key Documents

C2150000

Cholecalciferol for system suitability

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

Cholecalciferol, (+)-Vitamin D3, 7-Dehydrocholesterol activated, Activated 7-dehydrocholesterol, Calciol

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About This Item

Empirical Formula (Hill Notation):
C27H44O
CAS Number:
Molecular Weight:
384.64
Beilstein:
2339331
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

biological source

synthetic

grade

pharmaceutical primary standard

Agency

EP

API family

cholecalciferol

form

solid

manufacturer/tradename

EDQM

technique(s)

gas chromatography (GC): suitable
liquid chromatography (LC): suitable

mp

83-86 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

−20°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)

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the Issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.
Cholecalciferol, also referred to as vitamin D3, promotes the absorption of calcium and phosphorus in the body to regulate bone growth. It is most commonly found in humans and animals and is produced in our skin when exposed to sunlight. It is used to treat and prevent bone disorders (such as rickets, osteomalacia).

Application

Cholecalciferol for system suitability may be used as an analytical reference standard for the determination of the analyte in pharmaceutical formulations by liquid chromatography.

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.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

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(C)

Not applicable


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Cholecalciferol
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 246(6), 2058-2059 (2013)
Vitamin D is not directly necessary for bone growth and mineralization
Underwood JL and DeLuca HF
American Journal of Physiology. Endocrinology and Metabolism, 246(6), E493-E498 (1984)
Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial
Trivedi DP, et al.
BMJ (Clinical Research ed.), 326(7387), 469-469 (2003)
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
Sara S Oberhelman et al.
Mayo Clinic proceedings, 88(12), 1378-1387 (2013-12-03)
To determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants. Forty mothers with exclusively breast-fed infants were randomized to receive oral

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