Description

Potassium Clavulanate is the potassium salt of clavulanic acid, a potent β-lactamase inhibitor. This compound is critical for enhancing the efficacy of β-lactam antibiotics, such as amoxicillin, by protecting them from enzymatic degradation. It is an essential active pharmaceutical ingredient (API) and intermediate for manufacturers in the pharmaceutical industry, particularly for producing combination antibiotic therapies.

Application

• Primary API in the formulation of potentiated antibiotic combinations (e.g., Amoxicillin/Clavulanate Potassium).
• Critical intermediate in the synthesis of finished pharmaceutical products for human and veterinary use.
• Used in research and development of new antimicrobial agents and resistance-modifying formulations.
• Component in the production of oral solid dosages (tablets, capsules) and oral suspensions.
• Essential for manufacturing injectable formulations in sterile pharmaceutical production.

Basic Information

Product Name	Potassium Clavulanate
CAS No.	61177-45-5
Molecular Formula	C8H8KNO5
Molecular Weight	237.25 g/mol
Synonyms	Clavulanate Potassium; Clavulanic Acid Potassium Salt; Potassium (2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate; BRL 14151K; Clavulanic Acid K Salt; Amoxicillin and Clavulanate Potassium Component; (2R,5R,Z)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Potassium Salt
EINECS	262-647-3

Quality Control

Our Potassium Clavulanate is manufactured under strict quality systems and tested to meet or exceed relevant pharmacopeial standards, including USP and EP monographs. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure full traceability and compliance with cGMP guidelines for pharmaceutical active ingredients.

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 dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (HPLC)	95.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.5%
pH (1% solution)	5.5 - 7.5
Specific Rotation	+55° to +60°
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP

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