Description

Pregabalin Impurity 7 is a high-purity chemical 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 an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are fundamental to maintaining the highest standards in pharmaceutical production.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in pregabalin API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control laboratories.
• Essential material for stability studies and forced degradation studies to understand the degradation pathways of pregabalin.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity profiles and specifications for drug master files (DMFs).
• Valuable research chemical for academic and industrial studies investigating the metabolism and pharmacokinetics of pregabalin.
• Supports pharmacopoeial testing and compliance with standards set by USP, EP, and other international pharmacopoeias.

Basic Information

Product Name	Pregabalin Impurity 7
CAS No.	1094517-98-2
Molecular Formula	C8H17NO2
Molecular Weight	159.23 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-Isobutyl GABA; Pregabalin Related Compound; Pregabalin EP Impurity; Pregabalin USP Impurity; Lyrica Impurity; 3-Isobutyl-4-aminobutyric acid
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 7 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) and purity determination by advanced chromatographic techniques (HPLC, GC). A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and impurities is provided with each shipment to support your regulatory and quality assurance needs.

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 dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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