Description

Zolpidem Impurity 35 is a high-purity reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Zolpidem. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark for impurity identification and quantification during manufacturing and quality control processes. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies engaged in method development, stability studies, and regulatory compliance for sedative-hypnotic drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Zolpidem Impurity 35 in API and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Zolpidem.
• Quality Control and Assurance (QC/QA): Used in routine batch testing to ensure Zolpidem API and drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH impurity guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the impurity profile.
• Research and Development: Supports impurity isolation, characterization, and toxicological studies during the drug development lifecycle.

Basic Information

Product Name	Zolpidem Impurity 35
CAS No.	1186313-33-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zolpidem Related Compound 35; 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 Process Impurity; Zolpidem Degradant
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity 35 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (HPLC, MS), assay (HPLC), and related substance analysis. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be opened only under low-humidity conditions and resealed immediately after use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.