Clavulanic Acid
Clavulanic Acid is a β-lactamase inhibitor widely used in combination with β-lactam antibiotics to enhance their effectiveness against resistant bacterial strains. As a leading supplier of pharmaceutical ingredients, we provide high-quality Clavulanic Acid that meets international pharmacopoeia standards.
Product Specifications
- Chemical Name: (2R,5R,Z)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
- Molecular Formula: C8H9NO5
- Molecular Weight: 199.16 g/mol
- CAS Number: 58001-44-8
- Appearance: White to off-white crystalline powder
- Purity: ≥98% (HPLC)
| Parameter | Specification |
|---|---|
| Solubility | Soluble in water and methanol, slightly soluble in ethanol |
| Melting Point | 62-68°C (decomposes) |
| Storage Conditions | 2-8°C in airtight container, protected from light |
| Shelf Life | 24 months when stored properly |
| pH (1% solution) | 2.5-4.5 |
| Residual Solvents | Meets ICH Q3C guidelines |
Applications
Clavulanic Acid is primarily used in combination with amoxicillin (as Augmentin) or ticarcillin (as Timentin) to treat various bacterial infections including:
- Respiratory tract infections
- Urinary tract infections
- Skin and soft tissue infections
- Otitis media
- Sinusitis
FAQ Section
What is the mechanism of action of Clavulanic Acid?
Clavulanic Acid works by irreversibly binding to β-lactamase enzymes produced by resistant bacteria. This binding prevents the enzymes from breaking down β-lactam antibiotics, allowing them to remain active against the bacteria. While Clavulanic Acid has weak antibacterial activity itself, its primary function is to protect the co-administered antibiotic from enzymatic degradation.
How should Clavulanic Acid be stored to maintain stability?
Clavulanic Acid should be stored in airtight containers at 2-8°C, protected from light and moisture. Prolonged exposure to higher temperatures, humidity, or light can lead to degradation. The crystalline form is more stable than solutions, which should be prepared immediately before use. Always check the product for discoloration or precipitation before use, as these may indicate decomposition.
What are the common side effects associated with Clavulanic Acid combinations?
When used in combination with antibiotics, Clavulanic Acid may contribute to gastrointestinal disturbances (diarrhea, nausea, vomiting), skin rashes, and in rare cases, hepatotoxicity. The potassium salt form may cause electrolyte imbalances in sensitive patients. Allergic reactions, though uncommon, may occur in individuals sensitive to β-lactam compounds. Always follow prescribed dosages and consult healthcare providers for any adverse effects.
Quality Assurance
Our Clavulanic Acid undergoes rigorous quality control testing including:
| Test | Method | Specification |
|---|---|---|
| Identification | HPLC, FTIR | Conforms to reference standard |
| Assay | HPLC | 98.0-102.0% |
| Related Substances | HPLC | Individual ≤0.5%, Total ≤1.5% |
| Water Content | Karl Fischer | ≤1.0% |
| Residue on Ignition | Gravimetric | ≤0.1% |
| Heavy Metals | ICP-MS | ≤10 ppm |
Packaging Options
- 1 kg aluminum foil bags with HDPE inner liner
- 5 kg HDPE bottles with tamper-evident caps
- 25 kg fiber drums with double polyethylene bags
- Custom packaging available upon request
Additional FAQ
What is the typical shelf life of Clavulanic Acid?
When stored under recommended conditions (2-8°C in airtight containers protected from light), Clavulanic Acid typically maintains its specified quality characteristics for 24 months. Stability studies show that under accelerated conditions (40°C/75% RH), the product remains stable for at least 6 months, indicating good long-term stability when properly stored.
Can Clavulanic Acid be used as a standalone antibiotic?
No, Clavulanic Acid has very weak antibacterial activity on its own and should always be used in combination with appropriate β-lactam antibiotics. Its primary therapeutic value lies in its ability to inhibit β-lactamase enzymes, thereby protecting the co-administered antibiotic from degradation. Using Clavulanic Acid alone would not provide effective antibacterial treatment.
What analytical methods are used to test Clavulanic Acid purity?
High Performance Liquid Chromatography (HPLC) is the primary method for assessing Clavulanic Acid purity and potency. Other analytical techniques include Fourier Transform Infrared Spectroscopy (FTIR) for identification, Karl Fischer titration for water content, and inductively coupled plasma mass spectrometry (ICP-MS) for heavy metal analysis. All methods are validated according to ICH guidelines.