Description

Zolpidem Impurity 17 is a designated impurity 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 reference marker for identification and quantification. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development, quality assurance, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Zolpidem Impurity 17 in API and finished drug products.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities in Zolpidem manufacturing processes.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure Zolpidem batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• 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 necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research and Development: Supports impurity characterization, synthesis pathway research, and the development of purer synthetic routes for Zolpidem API.

Basic Information

Product Name	Zolpidem Impurity 17
CAS No.	61960-32-5
Molecular Formula	C19H21N3O
Molecular Weight	307.39 g/mol
Synonyms	N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide; Zolpidem Related Compound; Zolpidem Impurity B; Zolpidem EP Impurity B; 2-[6-Methyl-2-(p-tolyl)imidazo[1,2-a]pyridin-3-yl]-N,N-dimethylacetamide; Ambien Impurity; Stilnox Impurity
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (e.g., HPLC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic purity, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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