Description

Pregabalin Impurity CAS NO 159029-27-3 is a high-purity chemical 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) pregabalin. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in pregabalin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency in pharmaceutical manufacturing.
• Stability Studies: Used to track the formation of degradation products in pregabalin formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Utilized in pharmaceutical R&D to study the synthesis pathways, degradation mechanisms, and metabolic pathways related to pregabalin.

Basic Information

Product Name	Pregabalin Impurity
CAS No.	159029-27-3
Molecular Formula	C8H17NO2
Molecular Weight	159.23 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-(Aminomethyl)-5-methylhexanoic Acid; Pregabalin Related Compound; Pregabalin Impurity A; (S)-Pregabalin; (S)-3-Isobutyl GABA; CI-1008; PD-144723; S-(+)-3-Isobutylgaba
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including identity confirmation by IR and NMR, purity assessment by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) providing batch-specific results is supplied with every 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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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