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Y0002040

Calcifediol for impurity D identification

European Pharmacopoeia (EP) Reference Standard

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Synonym(s):
25-Hydroxycholecalciferol, 25-Hydroxyvitamin D3
Empirical Formula (Hill Notation):
C27H44O2
CAS Number:
19356-17-3
Molecular Weight:
400.64
MDL number:
MFCD00867077
UNSPSC Code:
41116107
NACRES:
NA.24

biological source

synthetic

grade

pharmaceutical primary standard

Agency

EP

API family

calcifediol

form

solid

manufacturer/tradename

EDQM

technique(s)

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

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

C[C@H](CCCC(C)(C)O)[C@H]1CC[C@H]2\C(CCC[C@]12C)=C\C=C3\C[C@@H](O)CCC3=C

InChI

1S/C27H44O2/c1-19-10-13-23(28)18-22(19)12-11-21-9-7-17-27(5)24(14-15-25(21)27)20(2)8-6-16-26(3,4)29/h11-12,20,23-25,28-29H,1,6-10,13-18H2,2-5H3/b21-11+,22-12-/t20-,23+,24-,25+,27-/m1/s1

InChI key

JWUBBDSIWDLEOM-DTOXIADCSA-N

Gene Information

human ... VDR(7421)

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General description

Calcifediol is a metabolite of vitamin D3, which is responsible for maintaining appropriate amounts of calcium and phosphorus for strong as well as healthy teeth and bones.
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.

Application

Calcifediol for impurity D identification may be used as an EP reference standard for the determination of the analyte in pharmaceutical formulations by liquid chromatography.

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
GHS06,GHS08

Signal Word

Danger

Hazard Statements

H301 + H311,H330,H372

Hazard Classifications

Acute Tox. 2 Inhalation - Acute Tox. 3 Dermal - Acute Tox. 3 Oral - STOT RE 1 Oral

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Calcifediol for impurity D identification
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 118, 6045-6066 (2019)
Calcifediol-loaded liposomes for local treatment of pulmonary bacterial infections
Castoldi A, et al.
European Journal of Pharmaceutics and Biopharmaceutics, 118, 62-67 (2017)

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