Description

Pemetrexed Disodium Ketone Impurity is a high-purity chemical reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for the quality control and method development of Pemetrexed Disodium, a key chemotherapeutic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for impurity profiling, method validation, and ensuring drug safety and efficacy. The availability of a well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements and maintaining robust quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the ketone impurity in Pemetrexed Disodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific degradation product under various stress conditions.
• Quality Control & Batch Release: Serves as a system suitability standard and for routine quality control testing to ensure impurity levels in commercial batches are within specified limits.
• Research & Development: Used in R&D to understand the degradation pathways of Pemetrexed Disodium and to develop robust synthetic processes that minimize impurity formation.

Basic Information

Product Name	Pemetrexed Disodium Ketone Impurity
CAS No.	1644287-27-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pemetrexed Disodium Related Compound K; Pemetrexed Ketone Impurity; Pemetrexed Disodium Degradant; 4-[2-[2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt ketone impurity; ALIMTA® Impurity; 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 ketone form; LY231514 Disodium Ketone Impurity
EINECS	Contact for details

Quality Control

Our Pemetrexed Disodium Ketone Impurity is manufactured under strict quality systems to ensure the highest standards of purity and consistency, suitable for use as a pharmaceutical reference standard. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity, purity, and potency. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the rigorous demands of cGMP and ICH guidelines for impurity standards.

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 (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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