Description

Zolpidem Impurity 38 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Zolpidem, a widely prescribed sedative-hypnotic. It serves as a key impurity marker for ensuring drug safety, efficacy, and regulatory compliance. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this standard to validate analytical methods and monitor impurity profiles.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Zolpidem API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to separate and measure related substances.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Zolpidem products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products in Zolpidem formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Critical for compiling impurity data in Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research on Drug Metabolism & Impurity Profiling: Supports studies investigating the synthesis pathways, degradation routes, and metabolic fate of Zolpidem.

Basic Information

Item	Details
Product Name	Zolpidem Impurity 38
CAS No.	1553213-99-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zolpidem Related Compound 38; Zolpidem Impurity R; 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
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material carefully to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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