Description

Pregabalin Impurity 31 L-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 serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and routine quality control testing. The availability of this well-characterized impurity standard is fundamental for meeting stringent pharmacopeial requirements and supporting robust drug development processes.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in pregabalin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure pregabalin products comply with ICH guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation of degradation products in pregabalin formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports synthetic chemistry research for understanding impurity formation pathways and developing purification processes.

Basic Information

Product Name	Pregabalin Impurity 31 L-Tartrate
CAS No.	1094518-26-9
Molecular Formula	C14H25NO8
Molecular Weight	335.35 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid L-Tartrate; Pregabalin Related Compound 31 L-Tartrate; (S)-3-(Aminomethyl)-5-methylhexanoic acid (2R,3R)-2,3-Dihydroxybutanedioate; Lyrica Impurity 31 Tartrate; (S)-Pregabalin Tartrate Impurity; Pregabalin EP Impurity 31 L-Tartrate; Pregabalin USP Impurity 31 L-Tartrate
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 31 L-Tartrate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with industry standards, including ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques such as HPLC, NMR, and MS. We are committed to supplying reference materials that meet the exacting requirements of pharmaceutical quality control and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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