Description

Methotrexate USP

Methotrexate USP is a high-purity, antimetabolite and antifolate active pharmaceutical ingredient (API) used in pharmaceutical formulations for the treatment of various cancers, autoimmune disorders, and inflammatory diseases. As a folic acid analog, Methotrexate inhibits dihydrofolate reductase (DHFR), leading to suppression of DNA synthesis, cell proliferation, and immune activation.

• USP-compliant folate antagonist for antineoplastic and immunosuppressive therapy
• Used in oral and parenteral formulations for oncology and rheumatology indications
• Inhibits DNA synthesis by targeting dihydrofolate reductase
• Effective in cancer, psoriasis, rheumatoid arthritis, and ectopic pregnancy management
• Manufactured under Good Manufacturing Practice (GMP) certified conditions
• Supplied with full regulatory documentation including Certificate of Analysis (CoA), DMF, and supporting technical data

Chemically designated as N-[4-[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-L-glutamic acid, Methotrexate USP appears as a yellow to orange crystalline powder with low water solubility. It is active against rapidly dividing cells and is considered a cornerstone agent in low-dose autoimmune protocols and high-dose oncology regimens.

In pharmaceutical applications, Methotrexate USP is used in:

• Oral tablets and parenteral injectables for leukemia, lymphoma, osteosarcoma, and breast cancer
• Low-dose weekly therapy for rheumatoid arthritis and psoriatic arthritis
• Intramuscular or systemic administration for ectopic pregnancy treatment
• Topical or intralesional use in dermatological or oncologic contexts
• Pediatric and adult treatment regimens where immune modulation or cytotoxicity is required

Methotrexate requires careful dose management due to its narrow therapeutic index. Leucovorin (folinic acid) rescue is often used in high-dose protocols to minimize toxicity to healthy cells.

CarboMer supplies Methotrexate USP with stringent control over assay, particle size, heavy metals, residual solvents, and microbial contamination. Each lot complies with United States Pharmacopeia (USP) monograph specifications and is suitable for regulated pharmaceutical use in sterile and non-sterile applications.

Material is packaged in sealed, light-protective, tamper-evident containers. Available in R&D, clinical, and commercial-scale quantities. Minimum order quantities (MOQ), lead times, and documentation—including CoA, SDS, and Drug Master File (DMF) access—are available upon request.

Each batch is tested for identity (UV, IR), assay (anhydrous basis), related substances, heavy metals, loss on drying, and microbial purity. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.

As with all CarboMer oncology and immunomodulating APIs, Methotrexate USP is supported by expert regulatory guidance, formulation support, and a reliable global supply chain to ensure safe and consistent access to this essential therapy.