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Merck

PHR1238

Ergocalciferol (Vitamin D2)

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Ergocalciferol, Calciferol, Ercalciol, Ergosterol irradiated, Irradiated ergosterol, Vitamin D2

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About This Item

Empirical Formula (Hill Notation):
C28H44O
CAS Number:
50-14-6
Molecular Weight:
396.65
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823243
EC Number:
200-014-9
Beilstein/REAXYS Number:
1916682
MDL number:
MFCD00166988

Key Documents

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SMILES string

CC(C)[C@@H](C)/C=C/[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 key

MECHNRXZTMCUDQ-RKHKHRCZSA-N

InChI

1S/C28H44O/c1-19(2)20(3)9-10-22(5)26-15-16-27-23(8-7-17-28(26,27)6)12-13-24-18-25(29)14-11-21(24)4/h9-10,12-13,19-20,22,25-27,29H,4,7-8,11,14-18H2,1-3,5-6H3/b10-9+,23-12+,24-13-/t20-,22+,25-,26+,27-,28+/m0/s1

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. E0900000, traceable to USP 1239005

API family

ergocalciferol

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

114-118 °C (lit.)

application(s)

clinical testing

format

neat

storage temp.

-10 to -25°C

Quality Level

300

Gene Information

human ... VDR(7421)

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Analysis Note

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

Application

Ergocalciferol (Vitamin D2) may be used as a pharmaceutical reference standard for the determination of the analyte in serum samples, cosmetics 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.

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.

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.
To see an example of a Certificate of Analysis for this material enter LRAB7854 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Skull and crossbonesHealth hazard
GHS06,GHS08

signalword

Danger

Hazard Classifications

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

Storage Class

6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials

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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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(7), 209-217 (2017)
A RAPID METHOD FOR DETERMINATION OF VITAMINS D2 AND D3 IN PHARMACEUTICAL PREPARATIONS BY HPLC
Sarioglu K, et al.
Journal of Liquid Chromatography and Related Technologies, 24(7), 973-982 (2001)
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)
R Jorde et al.
European journal of endocrinology, 152(1), 39-45 (2005-03-15)
Smoking is associated with reduced bone density and calcium absorption, and reduced serum levels of vitamin D. A compensatory increase in serum parathyroid hormone (PTH) would therefore be expected as a result of an altered calcium balance. However, reports on
H A Bischoff-Ferrari et al.
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 19(2), 265-269 (2004-02-19)
Intracellular 1,25-dihydroxyvitamin D receptor (VDR) is expressed in human skeletal muscle tissue. However, it is unknown whether VDR expression in vivo is related to age or vitamin D status, or whether VDR expression differs between skeletal muscle groups. We investigated
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