Description

Pregabalin Impurity E CAS NO 1239692-16-0 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pregabalin. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Pregabalin-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Pregabalin Impurity E in API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency complies with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Pharmacopoeial Testing: Supports testing against monograph specifications in pharmacopoeias such as USP, EP, and BP where impurity profiling is mandated.

Basic Information

Product Name	Pregabalin Impurity E
CAS No.	1239692-16-0
Molecular Formula	C8H17NO2
Molecular Weight	159.23 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-3-(Aminomethyl)-5-methylhexanoic acid; (S)-Lyrica Impurity E; (S)-Pregabalin Impurity E; Pregabalin Related Compound E; 3-Isobutyl GABA Impurity; 3-Isobutyl-γ-aminobutyric Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Pregabalin Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C, in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Assay	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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