Description

Pregabalin Impurity 60 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. The compound is identified by the CAS number 959143-48-7.

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 process-related impurities.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to ensure pregabalin batches meet stringent pharmacopeial (USP, EP, ICH) specifications for impurity limits.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of pregabalin products.
• Research & Development (R&D): Used in synthetic chemistry and process research to understand and control the formation pathways of this impurity during API manufacturing.

Basic Information

Product Name	Pregabalin Impurity 60
CAS No.	959143-48-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-3-(Carbamoylmethyl)-5-methylhexanoic acid; Pregabalin Related Compound; Pregabalin Process Impurity; Lyrica Impurity; (S)-3-(Carbamoylmethyl)-5-methylhexanoic Acid; 959143-48-7; Pregabalin Impurity F (potential designation)
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 60 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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