Description

Policresulen Impurity 13 is a specified impurity of the antiseptic and astringent agent Policresulen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and quality control of active pharmaceutical ingredients (APIs). The availability of a well-characterized impurity standard is essential for meeting stringent regulatory requirements for drug substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Policresulen Impurity 13 in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Policresulen API.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Policresulen formulations.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Policresulen Impurity 13
CAS No.	15534-74-4
Molecular Formula	C21H16O8S2
Molecular Weight	460.48 g/mol
Synonyms	4,4'-[2-Hydroxy-5-methyl-1,3-phenylene)bis(methylene)]bis[6-hydroxy-m-benzenedisulfonic acid]; 4,4'-(2-Hydroxy-5-methyl-m-phenylene)dimethylene-di-(6-hydroxy-m-benzenedisulfonic acid); Policresulen Related Compound; Policresulen Impurity B; 1,3-Bis[(2,4-dihydroxy-5-sulfophenyl)methyl]-5-methyl-2-hydroxybenzene; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our Policresulen Impurity 13 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR), and residual solvent testing, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
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.