Description

Pregabalin Impurity 12 is a specified, structurally characterized impurity used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pregabalin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by monitoring and controlling impurity levels. It is primarily used by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and as a reference standard.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Pregabalin and related substances.
• Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods for Pregabalin API and finished dosage forms.
• Quality Control & Batch Release: Used in routine QC testing to identify, quantify, and control this specific impurity to meet ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the US FDA and EMA.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Pregabalin, enabling process optimization.

Basic Information

Product Name	Pregabalin Impurity 12
CAS No.	930280-44-7
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)-3-Isobutyl GABA; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture. Certificates of Analysis (COA) with detailed chromatographic data, including retention time and relative response factor, are available upon request.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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