Description

Zolpidem Impurity 39 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Zolpidem and its related drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Zolpidem API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Used to track the formation of degradation products in Zolpidem formulations under various stress conditions.
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Supports R&D efforts in understanding the degradation pathways and metabolism of Zolpidem.

Basic Information

Product Name	Zolpidem Impurity 39
CAS No.	1546495-80-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zolpidem Related Compound 39; Zolpidem Impurity K; Zolpidem EP Impurity K; Zolpidem USP Impurity; Ambien Impurity 39; N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide impurity; (Exact IUPAC name available on request)
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity 39 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity data, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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