Description

Pregabalin Impurity 19 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 method development, validation, and routine batch 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: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance: Employed in routine QC testing to ensure pregabalin batches meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B) for impurity limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Used to track the formation of degradation products in pregabalin formulations under various stress conditions.
• Research & Development: Facilitates research into the synthesis, degradation pathways, and metabolism of pregabalin.

Basic Information

Product Name	Pregabalin Impurity 19
CAS No.	89015-27-0
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; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing results for purity (HPLC), identification (IR, NMR), and other critical parameters is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.