Description

Policresulen Impurity 10 is a specified impurity of the antiseptic and hemostatic agent Policresulen, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API). It is primarily required by professionals in pharmaceutical R&D, quality assurance (QA), and regulatory affairs for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Policresulen Impurity 10 in bulk drug substances and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure analytical procedures are performing as intended for impurity detection.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Pharmacopoeial Testing: Supports testing to comply with monograph specifications in pharmacopoeias such as USP, EP, or ChP where impurity limits are defined.

Basic Information

Product Name	Policresulen Impurity 10
CAS No.	95423-93-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Policresulen Related Compound; 4-Methyl-7-hydroxycoumarin sulfonic acid formaldehyde polymer impurity; Policresulen Impurity B; 7-Hydroxy-4-methylcoumarin sulfonic acid polymer impurity; Policresulen Specified Impurity; CAS 95423-93-1; Methylene-bis-(7-hydroxy-4-methylcoumarin-6-sulfonic acid) (potential structure); Contact for detailed list
EINECS	Contact for details

Quality Control

Every batch of Policresulen Impurity 10 is produced and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using validated analytical methods such as HPLC and NMR to ensure they meet the high standards required for pharmaceutical impurity standards. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH Q3C

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