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Merck

PHR1237

Colecalciferol

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

(+)-Vitamina D3, 7-deshidrocolesterol activado, Activado, 7-deshidrocolesterol, Calciol

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Fórmula empírica (notación de Hill):
C27H44O
Número CAS:
67-97-0
Peso molecular:
384.64
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823242
EC Number:
200-673-2
Beilstein/REAXYS Number:
2339331
MDL number:
MFCD00078131

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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

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

grade

certified reference material, pharmaceutical secondary standard

agency

USP 1131009, traceable to Ph. Eur. C2100000

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

Quality Level

300

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

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

La Vitamina D actúa a través de un receptor que forma parte de la superfamilia del factor de transcripción dependiente del ligando. Modula la proliferación y diferenciación de las células normales y cancerosas. Tiene efectos contrarios a la proliferación y desarrollo de metástasis en células de cáncer de mama, colon y próstata. Receptores activados de vitamina D en el intestino y los huesos mantienen la absorción de calcio y la homeostasis.
La vitamina D actúa a través de un receptor que modula la proliferación y la diferenciación tanto de las células sanas como de las cancerosas.

Analysis Note

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

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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 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
GHS06,GHS08

signalword

Danger

Hazard Classifications

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

Clase de almacenamiento

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

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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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)
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)
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)
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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