Methotrexate Impurities

General Information

Methotrexate Impurities and Methotrexate

For evaluating the purity and safety of Methotrexate, an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Methotrexate impurity standards. These impurity standards include crucial compounds such as (4-(Methylamino)benzoyl)-D-glutamic acid, Methotrexate Impurity A, Methotrexate Impurity B, Methotrexate Impurity D, and more. Additionally, Daicel Pharma provides worldwide delivery options for Methotrexate impurity standards.

Methotrexate [CAS: 59-05-2] is an antimetabolite and antifolate agent known for its antineoplastic and immunosuppressant properties. It treats acute lymphoblastic leukemia, relapsed or refractory non-Hodgkin lymphoma, psoriasis, and rheumatoid arthritis.

Methotrexate: Use and Commercial Availability  

Methotrexate, a potent folic acid antagonist, is an FDA-approved drug that treats rheumatoid arthritis, including juvenile idiopathic arthritis. Methotrexate exhibits anti-inflammatory and immunomodulatory properties. It combines with anti-TNF agents and has demonstrated effectiveness in managing ulcerative colitis, non-Hodgkin’s lymphoma, breast carcinoma, small-cell carcinoma of the lung, head and neck epidermal tumors, and ovarian carcinoma. Methotrexate is available under brand names such as Jylamvo, Otrexup, Otrexup PFS, Rasuvo, and Reditrex.

Methotrexate Structure and Mechanism of Action

The chemical name of Methotrexate is N-[4-[[(2,4-Diamino-6-pteridinyl)methyl]methylamino]benzoyl]-L-glutamic acid. Its chemical formula is C₂₀H₂₂N₈O_5, and its molecular weight is approximately 454.4 g/mol.

Methotrexate blocks dihydrofolic acid reductase. It interferes with DNA synthesis, cellular replication, and DNA repair.

Methotrexate Impurities and Synthesis

Methotrexate¹ an antimetabolite and antifolate agent, can potentially contain impurities that may affect its quality and performance. They can include related substances, residual solvents, and degradation products. It is crucial to ensure strict quality control measures during the manufacturing and storage of Methotrexate to minimize impurity levels and maintain its efficacy and safety. Monitoring and controlling impurities in Methotrexate are essential to ensure its therapeutic benefits.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for preparing Methotrexate impurity standards, which include (4-(Methylamino)benzoyl)-D-glutamic acid, Methotrexate Impurity A, Methotrexate Impurity B, Methotrexate Impurity D, and more. In addition, we offer deuterium-labeled Methotrexate standard, Methotrexate-d3, which is essential for conducting bioanalytical research and BA/BE studies. Our Methotrexate impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Methotrexate impurity standards, degradation products, and labeled compounds to evaluate the effectiveness of generic Methotrexate. Each delivery has a comprehensive characterization report.