Description

Methotrexate CAS NO 59-05-2 is a potent antimetabolite and antifolate agent that plays a critical role in inhibiting key enzymes involved in folic acid metabolism. This compound is essential for its therapeutic efficacy in targeted medical treatments and as a key reference standard in pharmaceutical research and development. It is primarily required by pharmaceutical manufacturers, clinical research organizations, and analytical laboratories for the production of oncology and autoimmune disease therapeutics, as well as for quality control and method validation.

Application

• Oncological Therapeutics: A cornerstone chemotherapeutic agent used in the treatment of various cancers, including leukemia, lymphoma, and osteosarcoma.
• Autoimmune Disease Management: Employed as a disease-modifying antirheumatic drug (DMARD) for conditions such as rheumatoid arthritis and psoriasis.
• Pharmaceutical Reference Standard: Serves as a high-purity certified reference material (CRM) for assay calibration, impurity profiling, and pharmacopeial testing (e.g., USP, EP).
• Active Pharmaceutical Ingredient (API): Used in the formulation and manufacturing of injectable and oral dosage forms.
• Biochemical Research: Utilized in life science research to study folate metabolism, cell proliferation, and mechanisms of drug action and resistance.
• Veterinary Medicine: Applied in veterinary oncology for the treatment of certain cancers in animals.

Basic Information

Product Name	Methotrexate
CAS No.	59-05-2
Molecular Formula	C₂₀H₂₂N₈O₅
Molecular Weight	454.44 g/mol
Synonyms	Amethopterin; MTX; 4-Amino-10-methylfolic acid; 4-Amino-10-methylpteroylglutamic acid; L-Glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-; NSC-740; Rheumatrex; Trexall; CL-14377; WR-19039
EINECS	200-413-8

Quality Control

Our Methotrexate is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopeial standards such as USP and EP. A detailed Certificate of Analysis (COA), including results for assay, related substances, residual solvents, and microbiological tests, is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C (59-77°F) or as specified on the label. The product is light-sensitive (store away from light). Keep the container in a dry, cool, and well-ventilated area, away from incompatible materials.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (Karl Fischer)	≤ 12.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Complies with USP <61>

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