Description

Pemetrexed Disodium Heptahydrate is a high-purity pharmaceutical active ingredient, a multi-targeted antifolate agent essential for modern chemotherapy regimens. Its primary value lies in its critical role as the active pharmaceutical ingredient (API) in the manufacture of injectable oncology drugs. This compound is specifically required by pharmaceutical manufacturers and research institutions developing and producing treatments for various cancers, including non-small cell lung cancer and malignant pleural mesothelioma.

Application

• Pharmaceutical API Manufacturing: Primary use as the active ingredient in the formulation of injectable pemetrexed-based chemotherapy drugs.
• Oncology Drug Development: Serves as a key reference standard and raw material in R&D for new anticancer therapies and combination treatments.
• Generic Drug Production: Essential for manufacturers producing generic versions of pemetrexed disodium injectable solutions after patent expiry.
• Clinical Research Material: Used in preclinical and clinical studies to evaluate efficacy, safety, and new therapeutic indications.
• Analytical Reference Standard: Employed in quality control laboratories for HPLC, UV, and other analytical method development and validation.
• Finished Dosage Formulation: Integral component in the final lyophilized powder or solution for injection, requiring strict adherence to cGMP guidelines.

Basic Information

Product Name	Pemetrexed Disodium Heptahydrate
CAS No.	357166-29-1
Molecular Formula	C20H19N5Na2O6 • 7H2O
Molecular Weight	597.49 g/mol (Anhydrous basis: 471.37 g/mol)
Synonyms	Pemetrexed Disodium Heptahydrate; LY231514 Disodium Heptahydrate; N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt Heptahydrate; Alimta® API; Pemetrexed Disodium Salt Heptahydrate; Multitargeted Antifolate Disodium Salt Heptahydrate; MTA Disodium Heptahydrate
EINECS	Contact for details

Quality Control

Our Pemetrexed Disodium Heptahydrate is manufactured under strict quality systems designed for pharmaceutical active ingredients. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, potency, and related substances. We provide full traceability and support regulatory filings with comprehensive documentation, including detailed Certificates of Analysis (COA). Production adheres to cGMP principles, and the material is suitable for use in the manufacture of injectable drug products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), or as specified on the label. The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions. Keep the container sealed when not in use to prevent moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	18.0% - 22.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 1.0 EU/mg (or as per grade requirement)
Sterility	Sterile (for sterile grade, upon request)
pH (1% Solution)	7.5 - 9.5

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