Description

Pemetrexed Ep Impurity B is a high-purity reference standard specifically identified as a process-related impurity of the antineoplastic agent Pemetrexed. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and quality assurance laboratories in the pharmaceutical and biotechnology sectors, particularly those involved in oncology drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Pemetrexed-related impurities.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing in API and finished drug product QC labs.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation over time.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the Pemetrexed manufacturing process.

Basic Information

Product Name	Pemetrexed Ep Impurity B
CAS No.	1802552-04-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pemetrexed Impurity B; Pemetrexed Related Compound B; Pemetrexed EP Impurity B; Alimta Impurity B; (2S)-2-[[4-[2-(2-Amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioic acid (related to Pemetrexed); LY231514 Impurity B; N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid impurity; Pemetrexed Disodium Impurity B
EINECS	Contact for details

Quality Control

Every batch of Pemetrexed Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulatory filings.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.