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Key Documents

Y0000664

Methotrexate impurity E

European Pharmacopoeia (EP) Reference Standard

Synonyme(s) :

4-{[(2,4-Diaminopteridin-6-yl)methyl]methylamino}benzoic acid

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About This Item

Formule empirique (notation de Hill):
C15H14N7O2
Numéro CAS:
Poids moléculaire :
324.32
Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

pharmaceutical primary standard

Famille d'API

methotrexate

Fabricant/nom de marque

EDQM

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-8°C

InChI

1S/C15H15N7O2/c1-22(10-4-2-8(3-5-10)14(23)24)7-9-6-18-13-11(19-9)12(16)20-15(17)21-13/h2-6H,7H2,1H3,(H,23,24)(H4,16,17,18,20,21)

Clé InChI

LWCXZSDKANNOAR-UHFFFAOYSA-N

Description générale

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the Issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Methotrexate impurity E EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

Conditionnement

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Autres remarques

Sales restrictions may apply.

Pictogrammes

Skull and crossbonesHealth hazard

Mention d'avertissement

Danger

Mentions de danger

Classification des risques

Acute Tox. 3 Oral - Eye Irrit. 2 - Muta. 2 - Repr. 1B - Skin Irrit. 2

Code de la classe de stockage

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

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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D A Cairnes et al.
Therapeutic drug monitoring, 5(3), 363-366 (1983-01-01)
Simple and convenient preparations of two metabolites of the antineoplastic drug methotrexate (MTX) are described. MTX is incubated in a Tris-HCl rabbit liver homogenate to produce 7-hydroxymethotrexate. Filtration, lyophilization, and recrystallization from water gives a chromatographically pure product. Analytical amounts
Masanobu Uchiyama et al.
Biomedical chromatography : BMC, 26(1), 76-80 (2011-03-26)
A simple and sensitive HPLC method has been developed for the determination of methotrexate (MTX) and its major metabolites, 7-hydroxymethotrexate (7-OH-MTX) and 2,4-diamino-N(10-) methylpteroic acid (DAMPA), in human plasma. After deproteinization of the plasma with 5% aqueous acetonitrile solution containing
Rapid quantitation of methotrexate and its metabolites in human serum, urine and bile, using solid-phase extraction and high-performance liquid chromatography.
B Nuernberg et al.
Journal of chromatography, 487(2), 476-482 (1989-02-24)
B C Widemann et al.
The Journal of pharmacology and experimental therapeutics, 294(3), 894-901 (2000-08-17)
The novel methotrexate (MTX) rescue agent carboxypeptidase-G(2) (CPDG(2)) converts >98% of plasma MTX to 2, 4-diamino-N(10)-methylpteroic acid (DAMPA) and glutamate in patients with MTX-induced renal failure and delayed MTX excretion. DAMPA is eliminated more rapidly than MTX in these patients
C Wolfrom et al.
European journal of clinical pharmacology, 39(4), 377-383 (1990-01-01)
The pharmacokinetics of methotrexate (MTX), 7-hydroxymethotrexate (7-OHMTX), 2,4-diaminomethylpteroic acid (APA), folinic acid, and 5-methyltetrahydrofolate (5-MTHF) have been studied during 21 high-dose MTX (HDMTX) infusions (5 g.m-2 in 24 h) with leucovorin (LCV) rescue, a component of the therapy of 5

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