Description

Gabapentin Ep Impurity G is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient Gabapentin. This reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial guidelines. It is primarily utilized in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Gabapentin Ep Impurity G in Gabapentin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and improve manufacturing processes for Gabapentin.

Basic Information

Product Name	Gabapentin Ep Impurity G
CAS No.	1500558-49-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gabapentin Related Compound G; Gabapentin Impurity G; Gabapentin EP Impurity G; 1-(Aminomethyl)cyclohexaneacetic acid impurity G; (1RS,3SR,5RS)-3-(2-Carboxyethyl)-2-azabicyclo[3.2.0]heptan-2-one; Gabapentin Lactam Impurity; Gabapentin Degradation Product
EINECS	Contact for details

Quality Control

Our Gabapentin Ep Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (HPLC, IR), assay (by HPLC), and related substance analysis. We ensure compliance with relevant pharmacopeial standards and ICH guidelines for impurities in new drug substances.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.