Description

Pregabalin Impurity 6 is a designated impurity standard 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 purity, safety, and regulatory compliance. It is primarily utilized in the development, validation, and routine testing of pregabalin drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Pregabalin Impurity 6 in pregabalin API and drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to confirm that pregabalin batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of pregabalin formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the pregabalin manufacturing process to minimize impurity formation.

Basic Information

Product Name	Pregabalin Impurity 6
CAS No.	103011-96-7
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 A (USP); Pregabalin Impurity A; Pregabalin EP Impurity A; Lyrica Impurity A; (S)-4-Isobutyl-γ-aminobutyric acid
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, impurity profile, and analytical results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Assay	97.0% - 103.0% (on anhydrous basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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