Description

Methotrexate Impurity 39 is a characterized impurity of the pharmaceutical compound Methotrexate, a critical antimetabolite and antifolate agent. This impurity is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Methotrexate drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Methotrexate Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Stability Studies & Degradation Pathway Analysis: Employed to study the degradation behavior of Methotrexate under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release Testing: Integral for routine quality control testing to ensure batches of Methotrexate meet stringent pharmacopeial specifications (USP, EP, JP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity identification and qualification data.
• Research on Impurity Synthesis & Characterization: Serves as a starting material or intermediate for research into the synthesis, isolation, and structural elucidation of related process impurities.

Basic Information

Product Name	Methotrexate Impurity 39
CAS No.	65148-64-3
Molecular Formula	C₂₀H₂₂N₈O₅
Molecular Weight	454.44 g/mol
Synonyms	N-[4-[[(2,4-Diamino-6-pteridinyl)methyl]methylamino]benzoyl]-L-glutamic Acid; L-Glutamic Acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-; Methotrexate Impurity F; Methotrexate Related Compound F; 4-Amino-10-methylpteroic acid derivative; MTX Impurity 39
EINECS	Contact for details

Quality Control

Our Methotrexate Impurity 39 is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, MS, and NMR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, related substances, and residual solvents, ensuring compliance with the standards required for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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