Description

Pregabalin Impurity 48 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 method development, validation, and impurity profiling. The compound is supplied with comprehensive analytical data to support its use in quality control and research applications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in pregabalin API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating chromatographic methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in GMP environments to ensure pregabalin products meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track and quantify the formation of degradation products in pregabalin formulations under various storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies as per ICH guidelines.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop robust purification processes for pregabalin.

Basic Information

Product Name	Pregabalin Impurity 48
CAS No.	1239856-83-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregabalin Related Compound 48; (S)-3-(Aminomethyl)-5-methylhexanoic acid Impurity 48; Lyrica Impurity 48; Pregabalin Process Impurity; Pregabalin Degradant; 3-Isobutyl GABA Impurity; 3-(Aminomethyl)-5-methylhexanoic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 48 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry and research standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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