Description

Pemetrexed Disodium Hemipentahydrate is a key pharmaceutical intermediate and active pharmaceutical ingredient (API) used in the synthesis of modern chemotherapeutic agents. This compound matters for its critical role in ensuring the efficacy and safety of final drug formulations, requiring stringent quality control. It is primarily needed by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug development and production.

Application

• Primary active pharmaceutical ingredient (API) in the manufacture of pemetrexed-based injectable chemotherapy drugs.
• Critical intermediate for pharmaceutical research and development of novel antifolate agents.
• Reference standard for analytical method development and validation in quality control laboratories.
• Used in preclinical and clinical studies to investigate new therapeutic applications.
• Essential component for formulation development of lyophilized (freeze-dried) powder for injection.
• Starting material for the synthesis of related pharmaceutical compounds and metabolites for testing.

Basic Information

Product Name	Pemetrexed Disodium Hemipentahydrate
CAS No.	357166-30-4
Molecular Formula	C20H19N5Na2O6 · 2.5H2O
Molecular Weight	516.41 g/mol (anhydrous basis)
Synonyms	Pemetrexed Disodium Salt Hemipentahydrate; LY231514 Disodium Hemipentahydrate; 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 Hemipentahydrate; Alimta® Intermediate; Pemetrexed Disodium 2.5-Hydrate; Multitargeted Antifolate Disodium Salt
EINECS	Contact for details

Quality Control

Our Pemetrexed Disodium Hemipentahydrate is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure compliance with pharmaceutical-grade standards, including identity, purity, and impurity profile verification. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with each batch to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Due to its hygroscopic nature, the container must be kept in a dry environment with minimal exposure to humidity. For long-term storage, consider desiccants or a nitrogen atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	8.0% - 12.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
pH (1% solution)	7.5 - 9.5
Specific Rotation	Contact for details

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