Description

Pregabalin Impurity 21 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 regulatory bodies involved in drug development and quality control. The precise characterization of such impurities is fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in pregabalin API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to ensure impurity levels are within specified limits.
• Stability Studies: Employed to monitor the formation of degradation products in pregabalin formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development (R&D): Used in synthetic chemistry research to study the formation pathways and properties of pregabalin-related impurities.

Basic Information

Product Name	Pregabalin Impurity 21
CAS No.	1083246-65-4
Molecular Formula	C8H11NO2
Molecular Weight	153.18 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-(Aminomethyl)-5-methylhexanoic Acid; Pregabalin Related Compound; Pregabalin EP Impurity; Pregabalin USP Impurity; Lyrica Impurity; (S)-3-Isobutyl GABA
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 21 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, meeting the requirements for use as a reference standard in pharmaceutical applications. Specifications are aligned with major pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, storage at 2-8°C is recommended. The material is hygroscopic (moisture-sensitive) and should be handled in a dry atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.