Description

Pregabalin Impurity 99 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 Reference Standard for the identification and quantification of impurities in pregabalin API and finished dosage forms.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Quality Control and Assurance to monitor and control impurity levels during pregabalin manufacturing processes.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and other global health authorities.
• Stability Studies to track the formation of degradation products in pregabalin formulations over time.
• Research and Development for studying the chemical pathways and toxicological profiles of pregabalin-related substances.

Basic Information

Product Name	Pregabalin Impurity 99
CAS No.	949890-75-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregabalin Related Compound 99; Pregabalin EP Impurity 99; Pregabalin USP Impurity 99; (3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Lyrica Impurity 99; Pregabalin Process Impurity; Pregabalin Degradation Product
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 99 is manufactured under strict quality systems to ensure batch-to-batch consistency and high purity. Each lot undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications suitable for pharmaceutical analysis.

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 handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
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 guidelines
Water Content (KF)	≤ 1.0%

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