Description

Pregabalin Impurity 6 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) pregabalin by serving as a key marker in impurity profiling and method development. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance and quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in pregabalin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) for impurity separation and analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and behavior of this specific impurity under various stress conditions during drug product shelf-life studies.
• Research & Development: Facilitates studies on the synthesis pathways, degradation profiles, and toxicological assessment of pregabalin-related substances.

Basic Information

Product Name	Pregabalin Impurity 6
CAS No.	2102350-92-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 6; Pregabalin Related Compound 6; Pregabalin EP Impurity G; Pregabalin USP Impurity; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Lyrica Impurity 6; 3-Isobutyl GABA Impurity 6
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity, aligning with ICH Q3A, Q3B, USP, and EP guidelines for impurities. Comprehensive characterization is performed using advanced techniques including HPLC, GC, MS, and NMR. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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