Description

Pemetrexed Ep Impurity A CAS NO 869791-42-4 is a critical pharmaceutical reference standard used in the quality control of Pemetrexed, a key chemotherapeutic agent. This impurity is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and biotechnology industries for method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Pemetrexed Ep Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Pemetrexed analysis.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity profiles and ensure batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, MAA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Pemetrexed to improve formulation stability.

Basic Information

Product Name	Pemetrexed Ep Impurity A
CAS No.	869791-42-4
Molecular Formula	C20H21N5O6
Molecular Weight	427.41 g/mol
Synonyms	Pemetrexed Impurity A; Pemetrexed Related Compound A; L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-; (2S)-2-[[4-[2-(2-Amino-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioic acid; Pemetrexed Degradation Product A; Pemetrexed EP Impurity A; Alimta Impurity A
EINECS	Contact for details

Quality Control

Our Pemetrexed Ep Impurity A is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is rigorously tested using validated analytical methods, including HPLC for assay and related substances, to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, identity, and chromatographic data. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
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.