Description

Zolpidem Impurity 18 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Zolpidem. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Zolpidem Impurity 18 in Zolpidem API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial limits for related substances (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports impurity profiling and route scouting during the synthetic process development of Zolpidem.

Basic Information

Product Name	Zolpidem Impurity 18
CAS No.	887282-93-1
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 18; Zolpidem Impurity K; Zolpidem EP Impurity K; Zolpidem USP Impurity; Ambien Impurity 18
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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