Description

Zolpidem Impurity 46 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Zolpidem. This compound is critical for ensuring the purity, safety, and efficacy of Zolpidem-based pharmaceutical formulations by serving as a benchmark for identification and quantification. 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 sedative-hypnotic drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Zolpidem Impurity 46 in Zolpidem API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure batches comply with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., Drug Master Files, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Supports impurity isolation, characterization, and toxicological studies during the drug development process.

Basic Information

Product Name	Zolbidem Impurity 46
CAS No.	82626-71-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zolpidem Related Compound 46; Zolpidem EP Impurity G; Zolpidem USP Impurity; N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide Impurity; Imidazo[1,2-a]pyridine acetamide derivative; Zolpidem Degradation Product; Zolpidem Process Impurity
EINECS	Contact for details

Quality Control

Our Zolpidem Impurity 46 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) that detail batch-specific results, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and relevant ICH guidelines for impurity standards.

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); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture, which could affect stability and purity.

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%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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