Description

Pemetrexed Disodium CAS NO 150399-23-8 is a high-purity, non-sterile active pharmaceutical ingredient (API) primarily used as an antineoplastic agent. This compound is a critical component in the formulation of chemotherapeutic drugs targeting specific cancers. It is essential for pharmaceutical manufacturers, research institutions, and compounding facilities engaged in oncology drug development and production. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final medicinal product.

Application

• Oncology Pharmaceutical Manufacturing: Primary active ingredient in the synthesis of injectable chemotherapeutic formulations.
• Antifolate Chemotherapy: Used in drugs that inhibit key enzymes (thymidylate synthase, dihydrofolate reductase) involved in folate metabolism for cancer cell proliferation.
• Treatment of Malignant Pleural Mesothelioma: A key component in first-line combination therapy regimens.
• Treatment of Non-Small Cell Lung Cancer (NSCLC): Used as a single agent or in combination with other chemotherapeutics for non-squamous NSCLC.
• Pharmaceutical Research & Development (R&D): Serves as a reference standard and raw material for new drug discovery, pharmacokinetic studies, and formulation development.
• Analytical Testing & Quality Control: Used as a certified reference material (CRM) in HPLC and other analytical methods for assay and impurity profiling.

Basic Information

Product Name	Pemetrexed Disodium
CAS No.	150399-23-8
Molecular Formula	C20H19N5Na2O6 • xH2O
Molecular Weight	Anhydrous: 471.37 g/mol
Synonyms	Pemetrexed Disodium Heptahydrate; LY231514 Disodium; 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; Alimta® (Brand Name API); MTA Disodium; Pemetrexed Disodium Salt; Antifolate LY231514 Disodium
EINECS	Contact for details

Quality Control

Our Pemetrexed Disodium is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. We provide full traceability and support regulatory submissions. Certificates of Analysis (COA) documenting compliance with in-house specifications are available for every lot. The product is suitable for use under cGMP (current Good Manufacturing Practice) conditions for API manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere packaging.

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)	≤ 20.0% (for heptahydrate form)
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 1.0 EU/mg (for injectable grade)
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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