Description

Pregabalin Impurity 30 is a high-purity reference standard used 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 is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in pregabalin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure pregabalin batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of pregabalin formulations.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Utilized in R&D to study the degradation pathways, synthesis impurities, and metabolism of pregabalin.

Basic Information

Product Name	Pregabalin Impurity 30
CAS No.	1094517-91-5
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 Impurity; 3-Isobutyl GABA derivative; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 30 is manufactured under strict quality management systems and undergoes rigorous analytical testing. Our products are characterized using advanced techniques including HPLC, GC, MS, and NMR to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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