Description

Methotrexate Hydrate is a potent antimetabolite and antifolate agent, widely recognized for its critical role in chemotherapy and immunosuppressive therapy. Its primary value lies in its ability to inhibit dihydrofolate reductase, effectively disrupting DNA synthesis and cellular replication. This makes it an essential active pharmaceutical ingredient (API) for manufacturers in the pharmaceutical and biotechnology sectors, particularly for producing treatments for cancer, autoimmune diseases like rheumatoid arthritis, and psoriasis.

Application

• Oncological Therapeutics: A key chemotherapeutic agent in the formulation of injectable and oral medications for various cancers, including leukemia, lymphoma, breast cancer, and lung cancer.
• Autoimmune Disease Treatment: Used in the production of drugs for managing autoimmune conditions such as rheumatoid arthritis, psoriasis, and Crohn's disease, often at lower doses than for oncology.
• Pharmaceutical Research & Development: Serves as a critical reference standard and biochemical tool in pharmacological studies, drug discovery, and mechanism of action research.
• Generic Drug Manufacturing: An essential API for companies producing generic versions of methotrexate-based medications, ensuring cost-effective treatment options.
• Hospital & Compounding Pharmacy Use: Utilized in sterile compounding for preparing patient-specific doses in clinical settings.

Basic Information

Product Name	Methotrexate Hydrate
CAS No.	19590-50-2
Molecular Formula	C₂₀H₂₂N₈O₅ • xH₂O
Molecular Weight	454.44 g/mol (Anhydrous basis)
Synonyms	Methotrexate; 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]-; Rheumatrex; Trexall
EINECS	243-204-2

Quality Control

Our Methotrexate Hydrate is manufactured and tested under strict quality management systems. We ensure compliance with major pharmacopoeial standards, including USP, EP, and JP, for use as a pharmaceutical active ingredient. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, confirming it meets the stringent requirements for pharmaceutical formulation.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment away from direct light exposure to maintain stability and potency.

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 Content (KF)	≤ 12.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP for non-sterile substances

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