Description

Zolpidem Impurity 23 is a specified impurity and degradation product associated with the active pharmaceutical ingredient Zolpidem. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Zolpidem-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Zolpidem drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying chromatographic methods (HPLC, UPLC) to meet ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial specifications (USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) requirements.
• Regulatory Submissions: Provides necessary data on impurity characterization and qualification for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity during Zolpidem manufacturing.

Basic Information

Product Name	Zolpidem Impurity 23
CAS No.	1186313-36-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zolpidem Related Compound 23; Zolpidem Degradant 23; Zolpidem Process Impurity 23; N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide Impurity; Imidazopyridine Impurity; Zolpidem Analog; Zolpidem Specified Impurity
EINECS	Contact for details

Quality Control

Our Zolpidem Impurity 23 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure identity, strength, and composition. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our commitment to traceability and reliability makes this material suitable for GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.