Description

Zolpidem Impurity 27 is a high-purity 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Zolpidem API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and GC analytical methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure product purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., FDA, EMA) and supports investigations into stability and degradation pathways.
• Research & Development: Utilized in R&D for studying the degradation chemistry, metabolism, and stability of Zolpidem.
• Contract Research Organizations (CROs): A key material for third-party testing and analysis services offered to the pharmaceutical industry.

Basic Information

Product Name	Zolpidem Impurity 27
CAS No.	329744-21-0
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 27; Zolpidem Impurity K; Zolpidem EP Impurity K; Zolpidem USP Impurity; Ambien Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity 27 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current industry and pharmacopeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses.

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 must be kept under anhydrous conditions. 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)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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