Description

Pregabalin Impurity 1 is a high-purity 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 research institutions involved in drug development, quality control, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in pregabalin API and finished dosage forms.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS systems.
• Quality Control (QC) and Quality Assurance (QA) as a certified reference material.
• Stability Studies to monitor and quantify impurity levels in drug products over time.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA and EMA.
• Research and Development of pregabalin synthesis pathways and degradation studies.
• Calibration Standard for ensuring accuracy and precision in quantitative analysis.

Basic Information

Item	Detail
Product Name	Pregabalin Impurity 1
CAS No.	1568181-40-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregabalin Related Compound 1; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Pregabalin EP Impurity A; Pregabalin USP Impurity; Lyrica Impurity 1; (3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Pregabalin Process Impurity
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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