Description

Pregabalin Impurity 5 Tartrate is a high-purity reference standard specifically designed 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. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards for drug substance and finished product quality.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material for the qualitative and quantitative analysis of pregabalin and related drug substances.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels as per ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances.

Basic Information

Product Name	Pregabalin Impurity 5 Tartrate
CAS No.	1484267-23-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregabalin Related Compound 5 Tartrate; (3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 5 tartrate; Lyrica Impurity 5 Tartrate; Pregabalin EP Impurity D Tartrate; Pregabalin USP Impurity Tartrate; 3-Isobutyl GABA Impurity 5 Tartrate; (S)-3-(Aminomethyl)-5-methylhexanoic Acid Impurity Tartrate Salt
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 5 Tartrate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced techniques such as HPLC, GC, MS, NMR, and IR spectroscopy. Certificates of Analysis (COA) are available upon request, providing detailed information on purity, identity, and analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent moisture absorption and ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Water Content	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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