Description

Policresulen Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of pharmaceutical products containing Policresulen, ensuring the safety and efficacy of the final drug substance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Policresulen Impurity 11 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurities in Policresulen batches.
• Quality Control & Assurance (QC/QA): Serves as a critical tool in in-process testing and release testing to ensure drug substance purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Policresulen.

Basic Information

Product Name	Policresulen Impurity 11
CAS No.	860351-44-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Policresulen Related Compound; Policresulen Impurity; 4-Methyl-7-hydroxycoumarin derivative (related); 7-Hydroxy-4-methylcoumarin impurity; Degradation product of Policresulen; CAS 860351-44-6; Analytical Standard for Policresulen
EINECS	Contact for details

Quality Control

Our Policresulen Impurity 11 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by validated chromatographic techniques (HPLC). A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results for identity, purity, and related substances. Our quality commitment ensures the material is suitable for its intended use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). For long-term storage, consider storing under inert atmosphere if the compound is found to be easily oxidized. Keep the container tightly sealed to protect from moisture if the material is hygroscopic.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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