Description

Gabapentin-D6 Hydrochloride is a stable isotope-labeled analog of the active pharmaceutical ingredient Gabapentin, specifically deuterated at six positions. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative analytical methods in pharmaceutical research and development. It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors for applications such as method development, validation, and bioanalytical studies.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the precise quantification of Gabapentin in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic and Bioavailability Studies: Enables accurate tracking and measurement of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical trials.
• Method Development and Validation: Used as a reference material to develop, optimize, and validate robust analytical methods in compliance with ICH, FDA, and EMA guidelines.
• Quality Control and Assurance: Acts as a certified reference material for in-house quality control testing to ensure the potency and purity of Gabapentin active pharmaceutical ingredients (APIs) and finished dosage forms.
• Metabolite Identification and Profiling: Aids in the identification and study of Gabapentin metabolites using mass spectrometry due to its distinct isotopic pattern.
• Doping Control and Forensic Analysis: Employed in sports anti-doping laboratories and forensic toxicology for the definitive identification and quantification of Gabapentin.

Basic Information

Product Name	Gabapentin-D6 Hydrochloride
CAS No.	60142-95-2
Molecular Formula	C9H11D6ClNO2
Molecular Weight	215.73 g/mol
Synonyms	1-(Aminomethyl)cyclohexaneacetic-d6 acid hydrochloride; Gabapentin-d6 HCl; [2H6]-Gabapentin hydrochloride; Gabapentin (hexadeuterated) hydrochloride; 1-(Aminomethyl)-1-cyclohexaneacetic-d6 Acid Hydrochloride; (1-Aminomethyl-cyclohexyl)-acetic-d6 acid hydrochloride; GP 47680-d6 hydrochloride; Neurontin-d6 hydrochloride
EINECS	Contact for details

Quality Control

Our Gabapentin-D6 Hydrochloride is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic purity (D-enrichment), chemical purity (HPLC), residual solvents, and other critical parameters. We support compliance with cGMP and relevant pharmacopeial standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by titration)	97.0% - 103.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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