Description

Zolpidem Impurity 29 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Zolpidem. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in research and development, method validation, and stability studies for the sedative-hypnotic drug Zolpidem.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of Zolpidem Impurity 29 in the final API, ensuring it meets pharmacopeial limits.
• Research & Development (R&D): Essential for studying the degradation pathways, stability, and impurity profile of Zolpidem during formulation development.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Method Development and Validation: Acts as a key component in developing and validating specific, accurate, and robust HPLC or LC-MS methods for impurity analysis.

Basic Information

Product Name	Zolpidem Impurity 29
CAS No.	258273-49-3
Molecular Formula	C19H21N3O
Molecular Weight	307.39 g/mol
Synonyms	N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide; Zolpidem Related Compound; Zolpidem Impurity; Zolpidem Degradation Product; Zolpidem Process Impurity; Ambien Impurity; Stilnox Impurity
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity 29 is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, GC, MS, and NMR to meet the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified parameters.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 97.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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