Description

Pemetrexed Impurity 17 is a designated impurity of the antineoplastic agent Pemetrexed disodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily required by quality control laboratories, regulatory affairs departments, and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Pemetrexed drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pemetrexed Impurity 17 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles in Pemetrexed batches.
• Quality Control & Assurance: Employed in routine QC testing to ensure drug substance and product compliance with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Pemetrexed formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Pemetrexed, enabling process optimization for impurity minimization.

Basic Information

Product Name	Pemetrexed Impurity 17
CAS No.	1265908-61-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pemetrexed Related Compound 17; Alimta Impurity 17; 4-[2-[4-[(3S)-3-[[4,7-Bis(2-hydroxyethyl)-1,3-thiazolo[5,4-d]pyrimidin-2-yl]sulfanyl]butanoyl]piperazin-1-yl]-2-oxoethyl]benzoic acid; LY231514 Impurity 17; Pemetrexed Disodium Impurity 17
EINECS	Contact for details

Quality Control

Our Pemetrexed Impurity 17 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. Our quality system is designed to support pharmaceutical development and is aligned with current industry standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
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.