Description

Gabapentin Related Compound E (10 Mg) (Carboxymethyl-Cyclohexanecarboxylic Acid) is a high-purity analytical reference standard, specifically a key chemical intermediate and impurity associated with the synthesis of the active pharmaceutical ingredient Gabapentin. This compound is critical for pharmaceutical research, development, and quality control processes, enabling precise analysis and validation. It is primarily utilized by analytical chemists, quality assurance laboratories, and R&D departments within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling and Identification in Gabapentin API and finished dosage forms.
• Analytical Reference Standard for method development and validation in HPLC, GC, and LC-MS systems.
• Quality Control and Assurance testing to ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Process Chemistry Research for studying and optimizing Gabapentin synthesis pathways.
• Stability Studies to monitor degradation products in pharmaceutical formulations.
• Certified Reference Material (CRM) for calibrating analytical instruments and ensuring data integrity.

Basic Information

Product Name	Gabapentin Related Compound E (10 Mg) (Carboxymethyl-Cyclohexanecarboxylic Acid)
CAS No.	667465-00-1
Molecular Formula	C9H14O4
Molecular Weight	186.21 g/mol
Synonyms	1-Carboxymethyl-cyclohexanecarboxylic Acid; 1-(Carboxymethyl)cyclohexanecarboxylic Acid; Gabapentin Impurity E; Gabapentin Related Substance E; Cyclohexaneacetic acid, 1-carboxy-; (1-Carboxycyclohexyl)acetic acid; Gabapentin Carboxylic Acid Impurity; 667465-00-1
EINECS	Contact for details

Quality Control

Our Gabapentin Related Compound E is manufactured under strict quality systems to ensure it meets the exacting requirements for pharmaceutical reference standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles as determined by validated analytical methods (HPLC, NMR, MS). We support compliance with cGMP, ICH Q7, and relevant pharmacopeia 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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

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% w/w

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