Clavulanate Potassium

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Cat Number

API61177455

CAS Number

61177-45-5

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Product Detail Description Scientific Support Customer Q&A

CAS Number

61177-45-5

EINECS

262-640-9

Storage

Store at 2-8℃

Synonyms

CLAVULANATE POTASSIUM; Amonate; BRL 14151K

Molecular Formula

C8H8KNO5

Molecular Weight

237.25

Smiles

C1[C@@H]2N(C1=O)[C@H](/C(=C/CO)/O2)C(=O)[O-].[K+]

Appearance

Faint yellow powder

Boiling Point

545.8℃

General Description

Clavulanate potassium is a beta-lactamase inhibitor derived from Streptomyces clavuligerus. It possesses negligible antibacterial activity on its own but serves as a critical adjunctive agent. Chemically, it is a structural analog of penicillin designed to irreversibly bind to bacterial enzymes. It is exclusively formulated in fixed-dose combinations with beta-lactam antibiotics such as amoxicillin.

Mechanism of Action

The drug acts as a suicide inhibitor of serine beta-lactamases, particularly those in the TEM and SHV families commonly found in gram-negative bacteria. By forming a stable, irreversible acyl-enzyme complex, it prevents enzymatic hydrolysis of the co-administered penicillin. This restores the susceptibility of resistant organisms to beta-lactam antibiotics, effectively broadening the spectrum of activity.

Application

It is indicated for the treatment of infections caused by beta-lactamase-producing strains of bacteria, including sinusitis, otitis media, lower respiratory tract infections, and skin and soft tissue infections. The fixed combination with amoxicillin is a cornerstone of empiric outpatient therapy. It is not indicated for infections caused by organisms that are intrinsically resistant to amoxicillin, such as Pseudomonas aeruginosa.

Seeking to shorten the standard 8‑week rifampicin/clarithromycin regimen for Buruli ulcer, this in vitro study tested alternative antibiotic combinations. Time‑kill assays revealed that adding amoxicillin/clavulanate to rifampicin and clarithromycin produced bactericidal activity superior to the standard dual therapy against clinical isolates. The triple combination (rifampicin/clarithromycin/amoxicillin‑clavulanate) showed even greater killing. The authors also validated luminescence measurement as a cost‑effective substitute for traditional colony‑forming unit enumeration in slow‑growing M. ulcerans. These microbiological findings provide preclinical support for the ongoing BLMs4BU clinical trial evaluating shortened treatment durations.

Fig. 1 Time-kill kinetics of rifampicin, clarithromycin and amoxicillin/clavulanate alone and in combination against M. ulcerans isolate ITM 000932 using different bacterial load quantification methodologies. (Sáez-López E, et al., 2024)

References

Sáez-López E, et al. Amoxicillin/clavulanate in combination with rifampicin/clarithromycin is bactericidal against Mycobacterium ulcerans. PLoS Negl Trop Dis. 2024; 18(4):e0011867.

Is Clavulanate Potassium extremely moisture-sensitive, and how is this managed during storage?

Yes, it is highly hygroscopic and rapidly degrades upon moisture exposure. It must be stored in tightly sealed, moisture-proof containers with desiccant, preferably under a nitrogen atmosphere.

What is the recommended storage temperature for Clavulanate Potassium to maintain beta-lactam integrity?

Store at 2-8°C. As a beta-lactamase inhibitor, it is thermally labile and should never be stored at room temperature for extended periods to prevent hydrolysis.

Does Clavulanate Potassium require special handling when combined with amoxicillin in formulations?

Yes, the combination requires strict moisture control. We provide compatibility data and recommend dry granulation or separate packaging to prevent cross-degradation.

How is the impurity profile of Clavulanate Potassium monitored during stability studies?

We specifically monitor for clavulanic acid degradation products using a validated stability-indicating HPLC method, ensuring the material meets pharmacopoeial limits throughout its shelf life.