Description

Gabapentin Impurity 6 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Gabapentin. This compound is critical for ensuring the purity, safety, and efficacy of Gabapentin formulations by providing a benchmark for identification and quantification during HPLC analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on method development, validation, and compliance with pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Gabapentin API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating stability-indicating HPLC or UPLC methods for Gabapentin.
• Quality Control & Batch Release Testing: Used in routine QA/QC testing to monitor impurity levels and ensure batches comply with strict ICH guidelines and pharmacopeial monographs (USP, EP, BP).
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Gabapentin products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity profiling and control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Gabapentin under various stress conditions.

Basic Information

Product Name	Gabapentin Impurity 6
CAS No.	1281568-83-9
Molecular Formula	C9H17NO2
Molecular Weight	171.24 g/mol
Synonyms	Gabapentin Related Compound 6; 1-Cyclohexaneacetic acid, 1-(aminomethyl)-; (1-Aminomethylcyclohexyl)acetic acid; Gabapentin Impurity F (EP); Gabapentin EP Impurity F; Gabapentin Process Impurity; Gabapentin Degradant; 1-(Aminomethyl)cyclohexaneacetic acid
EINECS	Contact for details

Quality Control

Every batch of Gabapentin Impurity 6 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents in accordance with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with each lot, confirming its suitability for use as a high-purity reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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