Description

Pregabalin Ep Impurity A CAS NO 181289-23-6 is a high-purity reference standard and a critical pharmaceutical impurity. This compound is essential for analytical method development, validation, and quality control in the manufacturing of Pregabalin, a widely prescribed active pharmaceutical ingredient (API). It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Pregabalin and related substances.
• Method Development & Validation: Critical for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities in Pregabalin API and finished dosage forms.
• Quality Control & Assurance: Employed in routine batch testing to ensure Pregabalin products meet stringent pharmacopeial specifications (e.g., EP, USP) for impurity profiles.
• Stability Studies: Used to identify and quantify degradation products that may form during the shelf-life studies of Pregabalin formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in optimizing synthesis and purification processes for Pregabalin by identifying and tracking this specific impurity.

Basic Information

Product Name	Pregabalin Ep Impurity A
CAS No.	181289-23-6
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 A; Pregabalin Impurity A; Lyrica Impurity A; (S)-3-Isobutyl GABA; 3-Isobutyl-4-aminobutyric acid; (S)-3-(Aminomethyl)-5-methyl-hexanoic acid
EINECS	Contact for details

Quality Control

Our Pregabalin Ep Impurity A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment.

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 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 (HPLC)	Retention time corresponds to reference standard
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.