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Merck

PHR1405

Supelco

Capecitabine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Capecitabine, CAP, 5′-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine, Ro-9-1978

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About This Item

Empirical Formula (Hill Notation):
C15H22FN3O6
CAS Number:
Molecular Weight:
359.35
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

Pricing and availability is not currently available.

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0001642
traceable to USP 1090706

API family

capecitabine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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1 of 4

This Item
HPA003140HPA007426HPA007927
biological source

rabbit

biological source

rabbit

biological source

rabbit

biological source

rabbit

antibody form

affinity isolated antibody

antibody form

affinity isolated antibody

antibody form

affinity isolated antibody

antibody form

affinity isolated antibody

product line

Prestige Antibodies® Powered by Atlas Antibodies

product line

Prestige Antibodies® Powered by Atlas Antibodies

product line

Prestige Antibodies® Powered by Atlas Antibodies

product line

Prestige Antibodies® Powered by Atlas Antibodies

form

buffered aqueous glycerol solution

form

buffered aqueous glycerol solution

form

buffered aqueous glycerol solution

form

buffered aqueous glycerol solution

UniProt accession no.

O60635

UniProt accession no.

P41732

UniProt accession no.

O95857

UniProt accession no.

Q13813

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.
Capecitabine is an orally administered drug belonging to the class of fluoropyrimidine carbamates. It converts into 5-fluorouracil (5-FU) at the tumor tissues by exploiting the high intratumoral concentrations of thymidine phosphorylase.[1]

Application

Capecitabine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography[2] and spectrophotometric[3] 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

Capecitabine is an anti-cancer drug, a prodrug of doxifluridine, metabolized to 5-fluorouracil at the tumor site. The activation of capecitabine follows a pathway with three enzymatic steps and two intermediary metabolites, 5′-Deoxy-5-fluorocytidine (5′-DFCR) and 5′-Deoxy-5-fluorouridine (5′-DFUR), to form 5-fluorouracil.

Analysis Note

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

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA2199 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Precautionary Statements

Hazard Classifications

Carc. 1B - Muta. 2 - Repr. 1B

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Spectrophotometric determination of capecitabine in pharmaceutical formulations
Kishore M, et al.
International Journal of ChemTech Research, 1(10), 238-241 (2010)
First-in-human phase II trial of the botanical formulation PHY906 with capecitabine as second-line therapy in patients with advanced pancreatic cancer
Saif MW, et al.
Cancer Chemotherapy and Pharmacology, 73(2), 373-380 (2014)
RP-HPLC method development and validation for estimation of capecitabine in capsules
Kumar KR, et al.
International Journal of ChemTech Research, 2(1), 307-311 (2010)
Bahar Javdan et al.
Cell, 181(7), 1661-1679 (2020-06-12)
The human gut microbiome harbors hundreds of bacterial species with diverse biochemical capabilities. Dozens of drugs have been shown to be metabolized by single isolates from the gut microbiome, but the extent of this phenomenon is rarely explored in the

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