Description

Pregabalin Impurity D: Pregabalin-2-Ene is a high-purity chemical reference standard, specifically identified as a process-related impurity and degradation product of the active pharmaceutical ingredient Pregabalin. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities to ensure drug safety and efficacy. It is an essential material for analytical laboratories, regulatory compliance teams, and manufacturers within the global pharmaceutical and life sciences industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Pregabalin-2-Ene in active pharmaceutical ingredient (API) batches and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for purity analysis.
• Stability Studies: Employed to monitor the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) as part of ICH guideline stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies for Pregabalin.
• Quality Control (QC) Testing: Acts as a system suitability standard and for routine quality control release testing of Pregabalin API to ensure compliance with pharmacopeial specifications (USP, EP).
• Research and Development: Utilized in synthetic chemistry R&D to study impurity formation pathways and to develop purification processes for Pregabalin.

Basic Information

Product Name	Pregabalin Impurity D: Pregabalin-2-Ene
CAS No.	1956426-34-8
Molecular Formula	C8H11NO2
Molecular Weight	153.18 g/mol
Synonyms	(S)-3-(Aminomethyl)-5-methyl-3,4-dihydro-2H-pyrrole; (3S)-5-Methyl-3,4-dihydro-2H-pyrrol-3-ylmethanamine; Pregabalin Related Compound D; Pregabalin EP Impurity D; Pregabalin USP Impurity D; Pregabalin-2-ene; (S)-3-(Aminomethyl)-5-methyl-2,3-dihydropyrrole
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
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.