Description

Methotrexate Related Compound E (50 Mg) (4-{[(2,4-Diaminopteridin-6-Yl)Methyl](Methyl)Amino}Benzoic Acid, Hemihydrochloride) is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research. This compound, with CAS number 70844-48-3, is essential for ensuring the purity, safety, and efficacy of methotrexate-based drug products and analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in oncology drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of methotrexate in drug substances and finished products via HPLC, LC-MS, and other analytical techniques.
• Impurity Control in API Manufacturing: Serves as a specified impurity marker in the quality control of methotrexate active pharmaceutical ingredient (API) batches to ensure compliance with ICH Q3A/B guidelines.
• Method Development and Validation: Critical for developing, validating, and transferring analytical methods in regulatory submissions (e.g., ANDA, NDA) for methotrexate formulations.
• Stability Studies: Employed to monitor the formation of degradation products in methotrexate drug products during forced degradation and long-term stability testing.
• Pharmacological and Toxicological Research: Used in metabolic and pharmacokinetic studies to understand the pathways and effects of methotrexate and its related substances.
• Calibration and System Suitability: Essential for calibrating analytical instruments and establishing system suitability parameters in compendial testing (USP, EP).

Basic Information

Product Name	Methotrexate Related Compound E (50 Mg)
CAS No.	70844-48-3
Molecular Formula	C₂₀H₂₂N₈O₂ • ½HCl
Molecular Weight	407.89 g/mol (free base)
Synonyms	4-{[(2,4-Diaminopteridin-6-yl)methyl](methyl)amino}benzoic acid hemihydrochloride; Methotrexate Impurity E; Methotrexate Related Substance E; 4-[[(2,4-Diamino-6-pteridinyl)methyl]methylamino]benzoic acid hemihydrochloride; MTX Related Compound E; N-[4-[[(2,4-Diamino-6-pteridinyl)methyl]methylamino]benzoyl]glutamic acid related compound E; Amethopterin Related Compound E
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, NMR, and mass spectrometry to ensure structural identity and high purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, chromatographic data, and confirming suitability for use as an analytical reference standard. Our quality processes are designed to support compliance with cGMP, ICH, and relevant pharmacopoeial guidelines (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.