Description

Polaprezinc Impurity 3 is a specified impurity of the anti-ulcer drug Polaprezinc, a zinc-carnosine complex. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for manufacturers and analytical laboratories requiring precise identification and quantification of impurities to ensure drug safety and regulatory compliance. The use of this high-purity standard supports the development of robust and reliable analytical procedures.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Polaprezinc Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Polaprezinc synthesis.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Polaprezinc batches meet stringent pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Polaprezinc to minimize the formation of this impurity.

Basic Information

Product Name	Polaprezinc Impurity 3
CAS No.	103646-38-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Polaprezinc Related Compound 3; Zinc L-Carnosine Impurity 3; N-(3-Aminopropionyl)-L-histidinato zinc Impurity; Z-103; L-Carnosine, zinc complex impurity; Zinc acexamate impurity; UNII-1M5U6WMF1P (Polaprezinc) Impurity; PepZin GI Impurity C
EINECS	Contact for details

Quality Control

Our Polaprezinc Impurity 3 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is characterized using advanced analytical techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and identification data. Our quality commitment aligns with the standards required for pharmaceutical research and regulatory applications.

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 maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
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.