Description

Pregabalin-D4 is a stable isotope-labeled analog of pregabalin, where four hydrogen atoms are replaced with deuterium. This high-purity reference standard is critical for ensuring analytical accuracy and reliability in quantitative research. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities for applications such as method development and validation.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a crucial internal standard for the precise quantification of pregabalin in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic and Metabolite Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development: Used to develop and validate robust, sensitive, and specific analytical methods compliant with FDA and ICH guidelines.
• Drug Impurity Profiling and Characterization: Aids in the identification and quantification of related substances and degradation products in active pharmaceutical ingredient (API) batches.
• Forensic and Toxicology Analysis: Supports accurate detection and measurement of pregabalin in forensic investigations and toxicology screenings.
• Quality Control in Pharmaceutical Manufacturing: Acts as a reference material for in-process testing and final product release to ensure batch consistency and purity.

Basic Information

Product Name	Pregabalin-D4
CAS No.	1276197-54-6
Molecular Formula	C8H13D4NO2
Molecular Weight	167.24 g/mol
Synonyms	(3S)-3-(Aminomethyl)-5-methylhexanoic-3,4,4,5-d4 acid; (S)-3-(Aminomethyl)-5-methylhexanoic-3,4,4,5-d4 acid; Lyrica-D4; CI-1008-D4; PD-144723-D4; (S)-Pregabalin-D4; Pregabalin (deuterated); Deuterated Pregabalin
EINECS	Contact for details

Quality Control

Every batch of Pregabalin-D4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure exceptional isotopic purity and chemical identity. Our quality protocols are designed to meet the stringent requirements of research and regulatory standards. A comprehensive Certificate of Analysis (COA), detailing results for isotopic enrichment, chemical purity, and related substances, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 0.5%

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