Methotrexate Sodium is a high-potency pharmaceutical Active Pharmaceutical Ingredient (API) and the disodium salt of methotrexate. It belongs to the antimetabolite and antifolate class of pharmaceutical compounds and acts primarily by inhibiting dihydrofolate reductase, thereby interfering with folate-dependent nucleotide synthesis. MEDIOCON INC supplies quality-focused Methotrexate Sodium API for pharmaceutical formulation, analytical development and bulk API requirements.
Methotrexate Sodium is also known as Methotrexate Disodium, Disodium Methotrexate, Sodium Methotrexate, Methotrexate Sodium Salt and Methotrexate Disodium Salt. Its CAS number is 7413-34-5, molecular formula is C₂₀H₂₀N₈Na₂O₅, and molecular weight is approximately 498.4 g/mol. FDA's Global Substance Registration System identifies Methotrexate Sodium with UNII 3IG1E710ZN.
Methotrexate Sodium is a yellow, brownish or orange crystalline hygroscopic powder and is freely soluble in water. The material is sensitive to light and moisture and therefore requires appropriate pharmaceutical storage and handling conditions.
Methotrexate Sodium is used in pharmaceutical products for a range of therapeutic applications, including certain malignancies, rheumatoid arthritis, psoriasis and other immune-mediated conditions, depending on the approved dosage form, indication and regulatory jurisdiction. Methotrexate acts as an antifolate antimetabolite and inhibits DNA synthesis and cellular proliferation.
USP pharmaceutical standards provide analytical requirements for methotrexate-based drug substances and products. For injectable methotrexate sodium, USP specifications include chromatographic impurity controls and a pH range of 7.0–9.0 for the constituted preparation.
MEDIOCON INC supplies Methotrexate Sodium for pharmaceutical API requirements, formulation development, analytical research and commercial pharmaceutical applications. Supporting documentation such as Certificate of Analysis (COA), MSDS/SDS and applicable technical documentation can be provided according to product specification and customer requirements.
Methotrexate Sodium should be handled using appropriate pharmaceutical safety procedures because methotrexate is a potent cytotoxic/antimetabolite pharmaceutical substance. Appropriate protective measures, controlled handling and regulatory requirements should be followed during manufacturing and processing.
MEDIOCON INC focuses on quality-oriented supply of Methotrexate Sodium API for domestic and international pharmaceutical customers.
| Parameter | Specification |
|---|---|
| Appearance | USP / Pharmaceutical Grade |
| Identification | IR, UV & HPLC Compliant |
| Assay (HPLC) | 97.0% – 102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 7.0 – 9.0 |
| Individual Impurity | NMT 0.20% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 5.0% |
| Specific Rotation | +19.0° to +24.0° |
| Solubility | Freely Soluble in Water |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Methotrexate Sodium API Manufacturer & Supplier in India | MEDIOCON INC (CAS 7413-34-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Methotrexate Sodium API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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