Description

Pregabalin Impurity 49 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 quality control testing. The use of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining batch-to-batch consistency.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in pregabalin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in compliance with ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products in pregabalin formulations under various stress conditions.
• Research & Development (R&D): Used in synthetic chemistry and pharmacology research to study the formation pathways and biological impact of specific impurities.
• Pharmacopeial Testing: Applied as a reference standard to verify compliance with monographs from USP, EP, BP, or other international pharmacopeias.

Basic Information

Item	Details
Product Name	Pregabalin Impurity 49
CAS No.	1568110-05-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 49; Pregabalin Related Compound 49; Pregabalin EP Impurity I; Pregabalin Process Impurity; Lyrica Impurity 49; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; 1568110-05-3
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 49 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP).

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 degradation. 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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