Description

Pregabalin Impurity 9 CAS NO 44855-96-1 is a designated impurity standard used in the pharmaceutical development and quality control of Pregabalin, a widely prescribed medication. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals involved in research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Pregabalin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Pregabalin products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Pregabalin formulations.
• Research & Development: Facilitates process chemistry research aimed at minimizing or eliminating this impurity during the synthesis of Pregabalin.

Basic Information

Product Name	Pregabalin Impurity 9
CAS No.	44855-96-1
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 EP Impurity G; Pregabalin USP Impurity; (S)-3-Isobutyl GABA; 3-Isobutyl-γ-aminobutyric acid; (S)-3-Isobutyl-4-aminobutyric acid
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profile as per current pharmacopeial guidelines (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and light-sensitive (store away from light); precautions must be taken to prevent exposure to moisture and prolonged light to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 1.5%
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.