Description

Policresulen Impurity 14 is a specified impurity of the antiseptic and hemostatic agent Policresulen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Policresulen-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Policresulen active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of degradation products in Policresulen formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Policresulen Impurity 14
CAS No.	41481-17-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Policresulen Related Compound; 4-Methyl-7-hydroxycoumarin derivative (specific); Policresulen EP Impurity; Policresulen USP Impurity; Policresulen Degradant; Policresulen Process Related Impurity; 7-Hydroxy-4-methylcoumarin polymer impurity
EINECS	Contact for details

Quality Control

Our Policresulen Impurity 14 is produced under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques, including HPLC, GC-MS, and NMR, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the purity, chromatographic profile, and other critical quality attributes. Our quality standards align with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.