Clavulanic acid is a β-lactamase inhibitor used in combination with β-lactam antibiotics to inhibit bacterial β-lactamases and enhance antibacterial activity. In pharmaceutical products, clavulanic acid is commonly supplied as potassium clavulanate.
| Parameter | Value |
|---|---|
| Product Name | Clavulanic Acid |
| API Form | Potassium Clavulanate |
| CAS Number | 61177-45-5 |
| Molecular Formula | C₈H₈KNO₅ |
| Molecular Weight | 237.3 g/mol |
| Category | β-Lactamase Inhibitor |
| Appearance | White or almost white crystalline powder |
| Solubility | Freely soluble in water; slightly soluble in ethanol; very slightly soluble in acetone |
| Physical Form | Crystalline powder |
| Nature | Hygroscopic |
| Storage | 2°C–8°C, protected from light |
These are from the International Pharmacopoeia monograph for potassium clavulanate.
Clavulanic acid is used to inhibit β-lactamase enzymes that can otherwise inactivate β-lactam antibiotics. It is commonly formulated with antibiotics such as amoxicillin.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR spectrum concordant with Potassium Clavulanate reference spectrum; HPLC retention time corresponds to clavulanic acid reference |
| Assay (HPLC) | 96.5% – 102.0% |
| Loss on Drying | NMT 0.5% |
| pH (1% Solution) | 5.5 – 8.0 |
| Total Impurities | NMT 2.0% |
| Solubility | Freely soluble in water; slightly soluble in ethanol; very slightly soluble in acetone |