Description

Polaprezinc Impurity 2 is a specified impurity reference standard used in the analytical profiling and quality control of the pharmaceutical agent Polaprezinc. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic and spectroscopic analyses. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Polaprezinc-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Polaprezinc API and finished dosage forms.
• Analytical Method Development: Used to establish and optimize HPLC, UPLC, or GC methods for the accurate identification and quantification of this specific impurity.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Polaprezinc under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) that specify limits for known and unknown impurities.
• Process Chemistry Optimization: Used by chemical development scientists to identify and minimize the formation of this impurity during the synthesis and purification of Polaprezinc.

Basic Information

Product Name	Polaprezinc Impurity 2
CAS No.	17332-34-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zinc L-carnosine Impurity 2; Polaprezinc Related Compound 2; N-(3-Aminopropionyl)-L-histidinato zinc Impurity; L-Carnosine, zinc complex impurity; Z-103 Impurity 2; Promac Impurity 2; Zinc Acexamate Impurity 2
EINECS	Contact for details

Quality Control

Our Polaprezinc Impurity 2 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical impurity analysis and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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