Description

Pemetrexed Impurity 33 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of process-related impurities in Pemetrexed drug substances and products. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Pemetrexed Impurity 33 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Used as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Pemetrexed analysis.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Pemetrexed to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in R&D laboratories to study the chemical behavior, synthesis pathways, and degradation mechanisms of Pemetrexed and its related substances.

Basic Information

Product Name	Pemetrexed Impurity 33
CAS No.	1417656-72-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pemetrexed Related Compound 33; Pemetrexed EP Impurity G; Pemetrexed USP Impurity; ALIMTA Impurity 33; N-{4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamic Acid Impurity; L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, impurity; Pemetrexed Process Impurity
EINECS	Contact for details

Quality Control

Our Pemetrexed Impurity 33 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including batch-specific results for purity, related substances, and residual solvents, supporting compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

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)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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