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Documentos Principais

PHR1596

Supelco

Pemetrexed

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Pemetrexed disodium heptahydrate

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About This Item

Fórmula empírica (Notação de Hill):
C20H19N5Na2O6 · 7H2O
Número CAS:
Peso molecular:
597.48
Código UNSPSC:
41116107
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to Ph. Eur. Y0001539

família API

pemetrexed

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 500 mg

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

Formato

neat

temperatura de armazenamento

2-8°C

cadeia de caracteres SMILES

[Na+].[Na+].[nH]1c2[nH]cc(c2[c](nc1N)=O)CCc3ccc(cc3)C(=O)N[C@@H](CCC(=O)[O-])C(=O)[O-].O.O.O.O.O.O.O

InChI

1S/C20H21N5O6.2Na.7H2O/c21-20-24-16-15(18(29)25-20)12(9-22-16)6-3-10-1-4-11(5-2-10)17(28)23-13(19(30)31)7-8-14(26)27;;;;;;;;;/h1-2,4-5,9,13H,3,6-8H2,(H,23,28)(H,26,27)(H,30,31)(H4,21,22,24,25,29);;;7*1H2/q;2*+1;;;;;;;/p-2/t13-;;;;;;;;;/m0........./s1

chave InChI

QJVSMHJWAOSBMD-MYXYZBIASA-L

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Descrição geral

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.
Pemetrexed is an anionic anticancer drug with a narrow therapeutic index. As a folate anti metabolite, it acts as an inhibitor of thymidylate synthase. It can act effectively against a broad-spectrum of solid tumors such as non-small-cell lung and breast cancers in clinical trials. It is also effective against both dihydrofolate reductase and glycinamide ribonucleotide formyl transferase.

Aplicação

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.

Nota de análise

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

Outras notas

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.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAA4712 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictogramas

Health hazardExclamation mark

Palavra indicadora

Danger

Frases de perigo

Classificações de perigo

Muta. 2 - Repr. 1A - Skin Irrit. 2 - STOT RE 1

Órgãos-alvo

Blood,Immune system,Testes

Código de classe de armazenamento

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

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Certificados de análise (COA)

Lot/Batch Number

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Metotrexato meets USP testing specifications

Sigma-Aldrich

M9929

Metotrexato

5-Fluorouracil ≥99% (HPLC), powder

Sigma-Aldrich

F6627

5-Fluorouracil

Metotrexato ≥98% (HPLC), powder

Sigma-Aldrich

A6770

Metotrexato

Utility of Schiff?s base Formation Reactions for the Spectrophotometric Determination of Pemetrexed Disodium in bulk and in its Pharmaceutical Formulations.
Khan PS, et al.
Asian Journal of Research in Chemistry, 7(3), 323-326 (2014)
Maria M Posada et al.
Drug metabolism and disposition: the biological fate of chemicals, 43(3), 325-334 (2014-12-17)
Pemetrexed, an anionic anticancer drug with a narrow therapeutic index, is eliminated mainly by active renal tubular secretion. The in vitro to in vivo extrapolation approach used in this work was developed to predict possible drug-drug interactions (DDIs) that may

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