Description

Pregabalin Impurity 4 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. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in pregabalin API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure pregabalin products meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of pregabalin.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing robust purification processes.

Basic Information

Product Name	Pregabalin Impurity 4
CAS No.	1955498-14-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 4; Pregabalin Related Compound 4; Pregabalin EP Impurity D; Pregabalin USP Impurity; Pregabalin Process Impurity; Lyrica Impurity 4; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 4 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes rigorous analytical testing, including HPLC purity assay, spectroscopic identification (IR, NMR, MS), and residual solvent analysis. Comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

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 under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.