Description

Pralatrexate Impurity 9 is a designated impurity of the antineoplastic agent Pralatrexate, used in analytical research and pharmaceutical development. This compound is critical for ensuring the quality, safety, and efficacy of Pralatrexate drug substances and products through rigorous impurity profiling and control. It serves as a vital reference standard for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Pralatrexate Impurity 9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in Pralatrexate batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Pralatrexate meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing robust purification processes.

Basic Information

Product Name	Pralatrexate Impurity 9
CAS No.	1548618-61-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pralatrexate Related Compound 9; Folotyn Impurity 9; 10-Propargyl-10-deazaaminopterin Impurity 9; PDX Impurity 9; (2S)-2-[[4-[(1S)-1-[(2,4-Diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]amino]pentanedioic acid (related); Pralatrexate Process Impurity; Pralatrexate Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Pralatrexate Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and chromatographic profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing desiccated under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
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.