Description

Pregabalin Impurity CAS NO 1786719-42-3 is a high-purity reference standard used in the analytical profiling and quality control of Pregabalin, a widely prescribed pharmaceutical active ingredient. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams focused on impurity characterization and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods in accordance with ICH guidelines.
• Method Development and Validation: Used in the development and validation of HPLC, UPLC, and GC methods for the precise analysis of Pregabalin and its related substances.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to monitor and control impurity levels, ensuring product consistency and compliance with pharmacopeial monographs (USP, EP, BP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles, specifications, and the safety of the drug substance.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to track the formation of impurities over time and under various stress conditions.
• Research and Development: Aids in synthetic route optimization and process chemistry by identifying and quantifying process-related impurities.

Basic Information

Product Name	Pregabalin Impurity
CAS No.	1786719-42-3
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; Pregabalin Process Impurity; Lyrica Impurity; (S)-Pregabalin; CI-1008 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity (CAS 1786719-42-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.