Description

Pemetrexed Ep Impurity C is a specified impurity of the antineoplastic agent Pemetrexed, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Pemetrexed drug substances and products. It is primarily required by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Pemetrexed.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor and control impurities.
• Quality Control (QC) Testing: Employed in routine QC laboratories to confirm the identity and level of this specific impurity in Pemetrexed active pharmaceutical ingredient (API) and finished drug products.
• Stability Studies: Used to track the formation of degradation products under various stress conditions to establish product shelf life.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Pharmacopoeial Testing: Aids in compliance testing against pharmacopoeial monographs such as USP, EP, or JP that specify impurity limits.

Basic Information

Item	Detail
Product Name	Pemetrexed Ep Impurity C
CAS No.	1802552-16-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pemetrexed Impurity C; Pemetrexed Related Compound C; Pemetrexed EP Impurity C; (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); Alimta Impurity C; LY231514 Impurity C; N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid impurity
EINECS	Contact for details

Quality Control

Our Pemetrexed Ep Impurity C is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (NMR, MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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