Description

Pemetrexed Ep Impurity D is a high-purity chemical reference standard, specifically identified as a known impurity of the antineoplastic agent Pemetrexed. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is an essential material for research and development scientists, quality assurance laboratories, and regulatory affairs professionals working in the pharmaceutical and fine chemical sectors to ensure drug purity and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Pemetrexed Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Pemetrexed.

Basic Information

Product Name	Pemetrexed Ep Impurity D
CAS No.	144051-68-3
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 D; Pemetrexed Related Compound D; (2S)-2-[[4-[2-(2-Amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioic acid; Pemetrexed EP Impurity D; Alimta Impurity D
EINECS	Contact for details

Quality Control

Our Pemetrexed Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Certificates are available upon request.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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