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Merck

PHR1237

Colecalciferolo

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

(+)-Vitamina D3, 7-deidrocolesterolo attivato, Calciol

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Informazioni su questo articolo

Formula empirica (notazione di Hill):
C27H44O
Numero CAS:
Peso molecolare:
384.64
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
200-673-2
Beilstein/REAXYS Number:
2339331
MDL number:

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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

Quality Level

Gene Information

human ... VDR(7421)

mp

83-86 °C (lit.)

application(s)

food and beverages

format

neat

storage temp.

-10 to -25°C

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Questo articolo
C2100000C97745.00936
Cholecalciferol European Pharmacopoeia (EP) Reference Standard

C2100000

Cholecalciferol

Cholecalciferol analytical standard

Sigma-Aldrich

C9774

Cholecalciferol

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

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

technique(s)

-

technique(s)

-

application(s)

food and beverages

application(s)

pharmaceutical (small molecule)

application(s)

-

application(s)

liquid formulation
pharmaceutical

format

neat

format

neat

format

-

format

-

form

solid

form

solid

form

crystalline

form

solid

Quality Level

300

Quality Level

-

Quality Level

200

Quality Level

500

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

analytical standard

grade

-

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.[1]

Application

Cholecalciferol (Vitamin D3) may be used as a pharmaceutical reference standard for the determination of the analyte in food, feeds,[2] serum samples[3] and pharmaceutical formulations[4][2][3] 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 agisce attraverso un recettore che modula la proliferazione e la differenziazione delle cellule sia normali, sia tumorali.
La vitamina D agisce attraverso un recettore che è un membro della superfamiglia dei fattori di trascrizione ligando-dipendenti. Modula la proliferazione e la differenziazione sia delle cellule normali che tumorali. Ha effetti antiproliferativi e antimetastatici sulle cellule del cancro della mammella, del colon e della prostata. I recettori della vitamina D attivati nell'intestino e nelle ossa sono responsabili della regolazione dell'assorbimento e dell'omeostasi del calcio.

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

signalword

Danger

Hazard Classifications

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

Classe di stoccaggio

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


Certificati d'analisi (COA)

Cerca il Certificati d'analisi (COA) digitando il numero di lotto/batch corrispondente. I numeri di lotto o di batch sono stampati sull'etichetta dei prodotti dopo la parola ‘Lotto’ o ‘Batch’.

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I documenti relativi ai prodotti acquistati recentemente sono disponibili nell’Archivio dei documenti.

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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)
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)
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)
Bich Tran et al.
The American journal of clinical nutrition, 99(1), 156-161 (2013-10-11)
Observational data suggested that supplementation with vitamin D could reduce risk of infection, but trial data are inconsistent. We aimed to examine the effect of oral vitamin D supplementation on antibiotic use. We conducted a post hoc analysis of data

Articoli

Simultaneous LC-MS/MS determination of vitamins D₂ and D₃ in infant milk powder meeting GB 5009.296-2023 criteria for accuracy and sensitivity.

Protocolli

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

Ascentis Express C18 is suitable for routine analysis of fat-soluble vitamins D2 and D3, providing optimized chromatograms.

Separation of (±)-α-Tocopherol, analytical standard; Menadione (K3), analytical standard; (+)-γ-Tocopherol, analytical standard; Cholecalciferol (D3), analytical standard

Domande

1–4 di 4 domande  
  1. How much IU/mg having PHR1237 Supelco Cholecalciferol (Vitamin D3)?

    1 risposta
    1. The potency of this product has not been determined.

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  2. How can I determine the shelf life / expiration / retest date of this product?

    1 risposta
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

      Utile?

  3. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 risposta
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

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  4. I assume the material will be shipped with dry ice. So up to how many days/time the material will remain stable in this shipping condition ?

    1 risposta
    1. This product is stable for relatively short periods of time. The item is shipped at ambient temperature. A transit time of up to 2 weeks will not impact the quality of this material. Upon delivery, this product should be stored at -20°C.

      Utile?

Recensioni

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