Description

Zolpidem Tartrate Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities in Zolpidem Tartrate drug substances and finished products. It is an essential tool for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry who require reliable standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of Impurity 6 in Zolpidem Tartrate Active Pharmaceutical Ingredients (APIs) and formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC methods for impurity analysis.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure batches of Zolpidem Tartrate meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies and Forced Degradation Testing: Acts as a marker to track the formation of this specific impurity under various stress conditions (light, heat, humidity).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Utilized in R&D to study the synthesis pathway, degradation mechanisms, and physicochemical properties of Zolpidem-related compounds.

Basic Information

Product Name	Zolpidem Tartrate Impurity 6
CAS No.	82644-31-3
Molecular Formula	C22H23N3O9
Molecular Weight	473.43 g/mol
Synonyms	Zolpidem Impurity F; Zolpidem Related Compound F; N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide L-Tartrate; Zolpidem Tartrate EP Impurity F; Ambien Tartrate Impurity 6; Zolpidem Hemitartrate Impurity F; (2RS)-2-Hydroxy-3-carboxypropanoic acid compound with N,N-dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide (1:1)
EINECS	Contact for details

Quality Control

Our Zolpidem Tartrate Impurity 6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is fully characterized using techniques including HPLC, NMR, and Mass Spectrometry. We provide comprehensive Certificates of Analysis (COA) that detail all testing results against established specifications, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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