Description

Pregabalin Dimer Impurity is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for accurately identifying and quantifying the dimeric impurity during the manufacturing and stability testing of Pregabalin active pharmaceutical ingredient (API). It is primarily used by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments like HPLC and LC-MS.
• Method Development and Validation: Used to develop, optimize, and validate chromatographic methods for impurity profiling of Pregabalin.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor and control the level of the dimer impurity in Pregabalin API and finished dosage forms.
• Stability Studies: A key marker for forced degradation and long-term stability studies to understand the degradation pathways of Pregabalin.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study impurity formation mechanisms and develop purification processes.

Basic Information

Product Name	Pregabalin Dimer Impurity
CAS No.	2361911-35-3
Molecular Formula	C14H25N2O3
Molecular Weight	269.36 g/mol
Synonyms	(3S)-3-[(1S)-1-Carbamoyl-2-methylpropyl]-5-oxo-3,4,5,6-tetrahydro-2H-1,4-oxazine-4-acetic acid; Pregabalin Dimer; Pregabalin Related Compound Dimer; (S)-3-(Aminomethyl)-5-methylhexanoic acid dimer impurity; Lyrica dimer impurity; CI-1008 dimer impurity
EINECS	Contact for details

Quality Control

Every batch of our Pregabalin Dimer Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that include data from multiple orthogonal analytical techniques to ensure identity, purity, and strength. Our quality commitment aligns with ICH Q3A, Q3B, and Q6A guidelines for impurities in new drug substances and products. COAs are available for review and audit upon request.

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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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