Description

Gabapentin Related Compound D is a high-purity analytical reference standard used for the identification and quantification of impurities in Gabapentin active pharmaceutical ingredients (APIs) and finished drug products. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Gabapentin-based medications by enabling precise quality control during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) focused on neuropathic pain and epilepsy treatments.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference material (CRM) for the identification and quantification of specific impurities in Gabapentin API and formulations.
• Method Development and Validation: Critical component in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Quality Control (QC) Testing: Used as a system suitability standard and for preparing calibration curves in routine QC testing to ensure batch-to-batch consistency.
• Stability Studies: Employed to monitor the formation of degradation products in Gabapentin drug substances and products under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity levels to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Pharmacopoeial Testing: Aids in compliance testing against monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopoeias.

Basic Information

Item	Details
Product Name	Gabapentin Related Compound D
CAS No.	1076198-17-8
Molecular Formula	C9H17NO2
Molecular Weight	171.24 g/mol
Synonyms	1-(Cyclohexylmethyl)amino-2-methylpropan-2-ol; Gabapentin Impurity D; Gabapentin EP Impurity D; Gabapentin Related Substance D; 2-[(Cyclohexylmethyl)amino]-2-methylpropan-1-ol; Cyclohexylmethyl(2-hydroxy-1,1-dimethylethyl)amine; Gabapentin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Gabapentin Related Compound D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity profiles by validated chromatographic methods. Our quality commitment aligns with cGMP principles and supports compliance with ICH guidelines.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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