Description

Pregabalin Impurity 3 CAS NO 1928754-83-9 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pregabalin. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential tool for professionals engaged in method development, stability studies, and batch release testing within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Pregabalin API.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and GC methods for impurity detection.
• Stability-Indicating Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles in Pregabalin formulations.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data for health authorities like the FDA and EMA.
• Research & Development: Serves as a key intermediate or marker in synthetic pathway research and impurity synthesis studies.
• Contract Research Organizations (CROs): Essential for third-party testing and analytical services for pharmaceutical clients.

Basic Information

Product Name	Pregabalin Impurity 3
CAS No.	1928754-83-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregabalin Related Compound 3; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 3; Lyrica Impurity 3; CI-1008 Impurity 3; PD-0144723 Impurity; 3-Isobutyl GABA Impurity; Pregabalin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic techniques (HPLC, GC) and spectroscopic methods (NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality assurance protocols.

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 solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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