Description

Pemetrexed Impurity 19 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, stability studies, and regulatory compliance. It is essential for quality control laboratories and manufacturers involved in the production and validation of Pemetrexed drug substances and products to ensure patient safety and product efficacy.

Application

• Primary use as a certified reference standard for the identification and quantification of Pemetrexed Impurity 19 in active pharmaceutical ingredients (APIs) and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for conducting stability studies and forced degradation studies to understand the degradation pathways of Pemetrexed.
• Used in pharmaceutical quality control and release testing to ensure batches meet stringent impurity limits set by pharmacopeial standards (e.g., USP, EP).
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Valuable for research and development of Pemetrexed generics and biosimilars.

Basic Information

Product Name	Pemetrexed Impurity 19
CAS No.	1644286-36-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pemetrexed Related Compound 19; Pemetrexed Impurity; ALIMTA Impurity 19; L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-; (2S)-2-[[4-[2-(2-Amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioic acid
EINECS	Contact for details

Quality Control

Our Pemetrexed Impurity 19 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is 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 Certificate of Analysis. For long-term storage, keep desiccated to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets internal specifications
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.