Description

Clavulanic Acid 2-Amino-2,4,4-Trimethylpentane Salt is a specialized pharmaceutical salt form of clavulanic acid, designed to enhance stability and handling characteristics. This compound is critical for its role as a potent β-lactamase inhibitor, protecting β-lactam antibiotics like amoxicillin from enzymatic degradation and restoring their efficacy against resistant bacteria. It is an essential intermediate and active pharmaceutical ingredient (API) for manufacturers in the global pharmaceutical industry, particularly for producing advanced combination antibiotic formulations.

Application

• Pharmaceutical API Synthesis: Primary use as a key intermediate in the manufacture of potassium clavulanate, the active component in combination antibiotics like amoxicillin/clavulanate.
• β-Lactamase Inhibitor Formulations: Incorporated into oral and injectable antibiotic preparations to combat bacterial resistance.
• Veterinary Medicine: Used in antibiotic combinations for treating bacterial infections in animals.
• Research & Development: Serves as a reference standard and starting material in antimicrobial research and new drug development.
• Bulk Pharmaceutical Manufacturing: Supplied to contract manufacturing organizations (CMOs) and generic drug producers for large-scale production.

Basic Information

Product Name	Clavulanic Acid 2-Amino-2,4,4-Trimethylpentane Salt
CAS No.	66069-32-7
Molecular Formula	C8H9NO5 • C8H19N
Molecular Weight	328.36 g/mol (for the salt form)
Synonyms	Clavulanate tert-Octylamine Salt; Clavulanic Acid tert-Octylamine Salt; 2-Amino-2,4,4-trimethylpentane Clavulanate; (2R,5R,Z)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Compound with 2-Amino-2,4,4-trimethylpentane; Clavulanic Acid Ammonium Salt (with tert-Octylamine); Tert-Octylammonium Clavulanate
EINECS	Contact for details

Quality Control

Our Clavulanic Acid 2-Amino-2,4,4-Trimethylpentane Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and purity, to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment to guarantee traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Assay (HPLC)	≥ 95.0%
Water Content (KF)	≤ 2.0%
Related Substances (HPLC)	Total impurities ≤ 3.0%
Residual Solvents (GC)	Meets ICH guidelines

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