Description

Pregabalin Impurity Pd0224377 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in pregabalin API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of pregabalin batches to ensure compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Employed to track the formation of degradation products in pregabalin formulations under various storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purer synthesis routes for pregabalin.

Basic Information

Product Name	Pregabalin Impurity Pd0224377
CAS No.	501665-97-0
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 Impurity; Pregabalin EP Impurity; Lyrica Impurity; CI-1008 Impurity; PD 0224377.
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity Pd0224377 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.