Description

Pemetrexed Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the oncology drug Pemetrexed disodium by serving as a key marker in impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and regulatory compliance in the global pharmaceutical supply chain.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pemetrexed Impurity 18 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Pemetrexed.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring drug product consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Supports synthetic chemistry research, degradation pathway studies, and the development of robust purification processes for Pemetrexed.

Basic Information

Product Name	Pemetrexed Impurity 18
CAS No.	1265908-60-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pemetrexed Related Compound 18; Pemetrexed EP Impurity G; Pemetrexed USP Impurity; L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-; Alimta Impurity 18; LY231514 Impurity 18; Pemetrexed Degradant; Pemetrexed Process Impurity
EINECS	Contact for details

Quality Control

Our Pemetrexed Impurity 18 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (NMR, MS, IR), and residual solvent analysis, to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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 Q3C guidelines

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