Description

Pemetrexed Impurity D CAS NO 1265908-59-5 is a critical pharmaceutical reference standard used in the quality control and analytical development of the anticancer drug Pemetrexed. 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 pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard for the identification and quantification of Pemetrexed-related impurities.
• Analytical Method Development and Validation in HPLC, UPLC, and LC-MS systems.
• Quality Control (QC) and Quality Assurance (QA) testing of Pemetrexed Active Pharmaceutical Ingredient (API) and finished drug products.
• Stability Studies and forced degradation studies to monitor impurity profiles.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development (R&D) of Pemetrexed synthesis pathways and impurity formation mechanisms.

Basic Information

Product Name	Pemetrexed Impurity D
CAS No.	1265908-59-5
Molecular Formula	C20H21N5O6
Molecular Weight	427.41 g/mol
Synonyms	Pemetrexed Related Compound D; L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-; Pemetrexed EP Impurity D; Pemetrexed USP Impurity D; Pemetrexed Impurity 4; ALIMTA Impurity D; LY231514 Impurity D
EINECS	Contact for details

Quality Control

Our Pemetrexed Impurity D is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency, suitable for use as a certified reference material. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic analyses. We adhere to relevant ICH guidelines and can supply material compliant with USP/EP monograph requirements for impurity standards.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.