Description

Zolpidem Impurity A CAS NO 1346600-85-8 is a high-purity reference standard used for analytical and research purposes. This compound is a specified impurity of Zolpidem, a widely prescribed medication for the treatment of insomnia. It is essential for pharmaceutical manufacturers and analytical laboratories engaged in quality control, method development, and regulatory compliance testing. The availability of this well-characterized impurity is critical for ensuring the safety, efficacy, and purity of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Zolpidem Impurity A in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities in Zolpidem.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Zolpidem drug substances and products meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity profiles.
• Regulatory Compliance & Submission: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and the development of new analytical techniques.

Basic Information

Product Name	Zolpidem Impurity A
CAS No.	1346600-85-8
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 Impurity 1; Zolpidem Related Compound A; 2-(6-Methyl-2-p-tolylimidazo[1,2-a]pyridin-3-yl)-N,N-dimethylacetamide; Zolpidem Desmethyl Impurity; Ambien Impurity A
EINECS	Contact for details

Quality Control

Every batch of Zolpidem Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results against established specifications, is provided with each shipment to support your quality and regulatory requirements.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 103.0%

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