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PHR1405

Capecitabine

Name: Capecitabine
Brand: SIAL

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:

154361-50-9

Molecular Weight:

359.35

NACRES:

NA.24

PubChem Substance ID:

329823378

UNSPSC Code:

41116107

MDL number:

MFCD00930626

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Properties

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

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

SMILES string

O[C@H]1[C@@H](O)[C@H](N2C(N=C(NC(OCCCCC)=O)C(F)=C2)=O)O[C@@H]1C

InChI

1S/C15H22FN3O6/c1-3-4-5-6-24-15(23)18-12-9(16)7-19(14(22)17-12)13-11(21)10(20)8(2)25-13/h7-8,10-11,13,20-21H,3-6H2,1-2H3,(H,17,18,22,23)/t8-,10-,11-,13-/m1/s1

InChI key

GAGWJHPBXLXJQN-UORFTKCHSA-N

Gene Information

human ... TYMS(7298)

Description

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.

Application

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

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 and EP 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.

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.

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pictograms

GHS08

signalword

Danger

hcodes

H341,H350,H360FD

pcodes

P201 - P308 + P313

Hazard Classifications

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

Storage Class

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