Description

Zolpidem Impurity 31 is a high-purity chemical 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 tartrate. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in zolpidem tartrate API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and levels of this impurity during forced degradation and long-term stability studies of zolpidem products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Facilitates research into the synthesis, degradation pathways, and toxicological profile of zolpidem-related substances.

Basic Information

Product Name	Zolpidem Impurity 31
CAS No.	763889-81-2
Molecular Formula	C19H21N3O
Molecular Weight	307.39 g/mol
Synonyms	Zolpidem Related Compound 31; Zolpidem Impurity K; 2-(4-Methylphenyl)-N,N,6-trimethylimidazo[1,2-a]pyridine-3-acetamide; N,N,6-Trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide; Zolpidem Metabolite Impurity; Zolpidem Degradation Product
EINECS	Contact for details

Quality Control

Our Zolpidem Impurity 31 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. We adhere to relevant industry standards for reference materials to support your compliance with ICH, 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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