Description

Pregabalin Impurity 23 CAS NO 466678-47-7 is a specified impurity of the active pharmaceutical ingredient (API) Pregabalin, used as a critical reference standard in analytical chemistry. This compound is essential for pharmaceutical manufacturers and quality control laboratories to ensure the purity, safety, and efficacy of Pregabalin-based drug products. It is primarily required by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pregabalin Impurity 23 in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Pregabalin API and formulations.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity profiles and ensure batches comply with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Pharmacopoeial Testing: Supports testing to meet the monograph requirements of USP, EP, BP, or other international pharmacopoeias for Pregabalin.

Basic Information

Product Name	Pregabalin Impurity 23
CAS No.	466678-47-7
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)-Pregabalin Impurity
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 23 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to 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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)
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.