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Key Documents

Y0000664

Methotrexate impurity E

European Pharmacopoeia (EP) Reference Standard

Sinónimos:

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

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About This Item

Fórmula empírica (notación de Hill):
C15H14N7O2
Número de CAS:
Peso molecular:
324.32
UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

methotrexate

manufacturer/tradename

EDQM

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

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)

InChI key

LWCXZSDKANNOAR-UHFFFAOYSA-N

General description

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.

Packaging

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

Other Notes

Sales restrictions may apply.

pictograms

Skull and crossbonesHealth hazard

signalword

Danger

Hazard Classifications

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

Storage Class

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

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificados de análisis (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
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
H N Alkaysi et al.
Therapeutic drug monitoring, 12(2), 191-194 (1990-03-01)
A procedure for the determination of methotrexate in human plasma is reported. The analysis involved extraction of methotrexate as an ion pair in ethyl acetate. Reconstituted residue was analyzed using reverse phase C-18 column and a mobile phase consisting of

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