Description

Pregabalin Impurity 14 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) pregabalin. This compound is critical for ensuring the purity, safety, and efficacy of pregabalin-based drug products by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in pregabalin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopeial Testing: Supports testing to meet the monograph requirements of USP, EP, or other international pharmacopeias.

Basic Information

Product Name	Pregabalin Impurity 14
CAS No.	1610546-44-5
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)-3-Isobutyl GABA; 3-Isobutyl-γ-aminobutyric Acid (S-isomer)
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 14 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of related substances and residual solvents to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results and traceability is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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