Description

Methotrexate Sodium is the sodium salt form of methotrexate, a well-established folic acid antagonist and antimetabolite. This compound is a critical active pharmaceutical ingredient (API) valued for its potent therapeutic effects. It is essential for manufacturers in the pharmaceutical industry, particularly those producing oncology and rheumatology medications, as well as for research institutions conducting biochemical studies.

Application

• Oncological Therapeutics: Primary API for the formulation of injectable and oral chemotherapeutic agents used to treat various cancers, including leukemia, lymphoma, and breast cancer.
• Rheumatoid Arthritis Treatment: Key component in disease-modifying antirheumatic drugs (DMARDs) for managing autoimmune conditions like rheumatoid arthritis and psoriasis.
• Pharmaceutical Intermediates: Serves as a crucial starting material or intermediate in the synthesis of more complex pharmaceutical compounds and prodrugs.
• Biochemical Research: Used in laboratory research as a dihydrofolate reductase (DHFR) inhibitor to study cell proliferation, folate metabolism, and mechanisms of antineoplastic action.
• GMP Manufacturing: Supplied as a raw material for Good Manufacturing Practice (GMP) compliant production of finished dosage forms.

Basic Information

Product Name	Methotrexate Sodium
CAS No.	15475-56-6
Molecular Formula	C₂₀H₂₁N₈NaO₅
Molecular Weight	476.42 g/mol
Synonyms	Methotrexate Disodium; Sodium Methotrexate; Amethopterin Sodium; MTX Sodium; 4-Amino-10-methylfolic acid sodium salt; 4-Amino-N10-methylpteroylglutamate sodium salt; L-Glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-, sodium salt (1:2)
EINECS	239-472-7

Quality Control

Our Methotrexate Sodium is manufactured and tested under a strict quality management system. It is produced to meet exacting standards, with specifications typically aligned with major pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia). Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure compliance with your specific application requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, consider storage under inert conditions.

Specification

Item	Specification
Appearance	Yellow or yellow-orange crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 12.0 %
pH (1% Solution)	7.5 - 9.0
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 1.0 EU/mg (if for injectable use)
Sterility (if required)	Sterile

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