Description

Pemetrexed Ep Impurity E is a critical pharmaceutical reference standard used in the quality control and analytical development of the anticancer drug Pemetrexed. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a known benchmark for impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Pemetrexed drug substance and drug product.
• Analytical Method Development & Validation (HPLC/LC-MS): Crucial for developing, validating, and calibrating chromatographic methods to detect and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure drug product specifications are met.
• Stability Studies: Employed to track the formation of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Compliance & Filings: Necessary for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development (R&D): Used in studies to understand the degradation pathways and chemistry of Pemetrexed.

Basic Information

Product Name	Pemetrexed Ep Impurity E
CAS No.	182009-04-7
Molecular Formula	C20H21N5O6
Molecular Weight	427.41 g/mol
Synonyms	L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-; Pemetrexed Impurity E; Pemetrexed Related Compound E; (2S)-2-[[4-[2-(2-Amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioic acid; Pemetrexed Acid Impurity; ALIMTA Impurity E; Pemetrexed Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Pemetrexed Ep Impurity E is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.