Description

Gabapentin Related Compound E is a high-purity chemical reference standard, essential for analytical and quality control processes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of gabapentin-based drug products by serving as a key impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Gabapentin Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or GC methods to meet ICH Q2(R1) and USP guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing data for impurity identification as per ICH Q3A(R2) and Q3B(R2) requirements.
• Stability Studies: Used to track the formation of degradation products in gabapentin formulations under various stress conditions.
• Research & Development (R&D): Facilitates synthetic route optimization and impurity fate mapping during the development of gabapentin and related compounds.

Basic Information

Product Name	Gabapentin Related Compound E
CAS No.	67950-95-2
Molecular Formula	C9H17NO2
Molecular Weight	171.24 g/mol
Synonyms	1-(Aminomethyl)cycloheptaneacetic acid; Gabapentin Impurity E; Gabapentin EP Impurity E; Gabapentin Related Substance E; Cycloheptaneacetic acid, 1-(aminomethyl)-; (1-(Aminomethyl)cycloheptyl)acetic acid; Gabapentin Carboxylic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Gabapentin Related Compound E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay	97.0% - 103.0% (on anhydrous basis)

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