Description

Zolpidem Impurity 1 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 pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Zolpidem API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity characterization data to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation of degradation products in Zolpidem formulations under various stress conditions.
• Research & Development: Used in R&D laboratories for studying the degradation pathways and impurity profile of Zolpidem.

Basic Information

Product Name	Zolpidem Impurity 1
CAS No.	109461-64-5
Molecular Formula	C19H21N3O
Molecular Weight	307.39 g/mol
Synonyms	Zolpidem Related Compound A; Zolpidem Impurity A; N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide; 2-[6-Methyl-2-(p-tolyl)imidazo[1,2-a]pyridin-3-yl]-N,N-dimethylacetamide; Zolpidem EP Impurity A; Zolpidem USP Impurity A
EINECS	Contact for details

Quality Control

Our Zolpidem Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized and qualified against pharmacopeial standards (USP, EP) where applicable. A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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