Description

Pregabalin Impurity 38 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Pregabalin, a widely prescribed medication. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and impurity profiling studies to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Pregabalin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used to develop and validate sensitive HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Quality Control & Assurance: Essential for routine batch testing in QC laboratories to monitor and control impurity levels according to ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to identify and quantify degradation products that may form during the forced degradation and long-term stability testing of Pregabalin.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's profile and its potential impact.

Basic Information

Item	Details
Product Name	Pregabalin Impurity 38
CAS No.	1141362-94-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 38; Pregabalin Related Compound 38; Lyrica Impurity 38; CI-1008 Impurity 38; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Pregabalin EP Impurity; Pregabalin USP Impurity
EINECS	Contact for details

Quality Control

Our Pregabalin Impurity 38 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances.

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 desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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