Description

Pregabalin Impurity 37 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 laboratories and pharmaceutical manufacturers for method development, validation, and impurity profiling studies. Ensuring the identity and purity of this impurity is essential for drug safety and meeting stringent pharmacopeial standards.

Application

Pregabalin Impurity 37 serves as a vital tool in various pharmaceutical quality assurance processes. Its primary applications include:

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify and quantify related substances in Pregabalin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Acts as a critical standard for developing and validating stability-indicating HPLC/UPLC methods in compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Quality Control (QC) Testing: Serves as an in-house reference standard for routine batch release testing of Pregabalin to ensure it meets specified purity limits.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Pregabalin Impurity 37
CAS No.	1567946-71-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid impurity 37; Pregabalin Related Compound 37; (S)-3-(Aminomethyl)-5-methylhexanoic acid impurity; Lyrica Impurity 37; (S)-3-Isobutyl GABA Impurity 37; CI-1008 Impurity 37; A specific stereoisomer or structural analog of Pregabalin.
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity 37 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing purity, identification, and impurity profiles, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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