Description

7-Hydroxy Methotrexate is a key metabolite and impurity of the important chemotherapeutic agent Methotrexate. Its precise analysis and control are critical for ensuring the safety, efficacy, and quality of pharmaceutical products. This compound is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and metabolic studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Methotrexate and its related substances in drug products and biological matrices.
• Impurity Profiling: Critical for monitoring and controlling the levels of 7-Hydroxy Methotrexate as a specified impurity in Methotrexate Active Pharmaceutical Ingredient (API) and finished dosage forms, per ICH guidelines.
• Metabolic Research: Used in preclinical and clinical studies to investigate the pharmacokinetics, metabolism, and excretion pathways of Methotrexate.
• Analytical Method Development: Essential for developing, validating, and calibrating high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS/MS) methods.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine QC testing within pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with regulatory specifications.
• Biochemical Research: Used as a tool to study dihydrofolate reductase (DHFR) inhibition and folate metabolism in various experimental models.

Basic Information

Product Name	7-Hydroxy Methotrexate
CAS No.	5939-37-7
Molecular Formula	C20H22N8O5
Molecular Weight	454.44 g/mol
Synonyms	7-Hydroxymethotrexate; 4-Amino-10-methyl-7-hydroxyfolic acid; 4-Amino-10-methyl-7-hydroxypteroylglutamic acid; 7-OH-MTX; NSC-139490; L-Glutamic acid, N-[4-[[(2,4-diamino-7-hydroxy-6-pteridinyl)methyl]methylamino]benzoyl]-; Methotrexate metabolite
EINECS	Contact for details

Quality Control

Our 7-Hydroxy Methotrexate is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by IR and HPLC, and residual solvent analysis, to ensure it meets high-purity standards suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

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 should be kept under anhydrous conditions. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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