Methotrexate EP Impurity B

SZ CAT No:	SZ-M019026
CAS No	54-62-6
Mol.F.	C19H20N8O5
Mol.Wt.	440.4
Inv. Status	In Stock
Rel. CAS No	1217459-90-9 (hydrate)

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Chemical Name: (2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl]amino]benzoyl]amino]pentanedioic acid (as per EP) ; (S)-2-{4-[(2,4-diaminopteridin-6-yl)methylamino]benzamido}pentanedioic acid (as per USP)

Synonym: Methotrexate USP Related Compound B ; (4-Aminofolic acid, Aminopterin (EP))

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: NC1=NC(N)=C2C(N=CC(CNC3=CC=C(C(N[C@]([H])(C(O)=O)CCC(O)=O)=O)C=C3)=N2)=N1

Identification and Quantitation of Impurities in Methotrexate
dulal c. chatterji, altice g. frazier, and joseph f. gallell
Journal of Pharmaceutical Sciences Volume 67, Issue 5, May 1978, Pages 622-624

determination of methotrexate and its major metabolite, 7_hydroxymethotrexate, using capillary zone electrophoresis and laser-induced fluorescence detection
mark c. roach, philippe gozel and richard n. zare
Journal of Chromatography, 426 (1988) 129-140

Analytical methodologies for determination of methotrexate and its metabolites in pharmaceutical, biological and environmental samples
Forough Karami , Sara Ranjbar , Younes Ghasemi , Manica Negahdaripour
Journal of Pharmaceutical Analysis 9 (2019) 373-391

Perspectives of Methotrexate-Based Radioagents for Application in Nuclear Medicine
Paweł Krzysztof Halik,* Przemysław Kozmin ́ ski, and Ewa Gniazdowska
Mol. Pharmaceutics 2021, 18, 1, 33–43

Methotrexate EP Impurity B is chemically (2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl]amino]benzoyl]amino]pentanedioic acid (as per EP) ; (S)-2-{4-[(2,4-diaminopteridin-6-yl)methylamino]benzamido}pentanedioic acid (as per USP). It is also known as Methotrexate USP Related Compound B ; (4-Aminofolic acid, Aminopterin (EP)). Methotrexate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Methotrexate EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Methotrexate.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.

Methotrexate EP Impurity B

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