Description

Amoxicillin-Potassium Clavulanate Combination is a fixed-ratio pharmaceutical active ingredient combining a broad-spectrum penicillin antibiotic with a potent β-lactamase inhibitor. This synergistic formulation is critical for overcoming bacterial resistance, making it a cornerstone in the treatment of a wide range of bacterial infections. It is an essential raw material for global pharmaceutical manufacturers producing oral and injectable antibiotic formulations for human and veterinary medicine.

Application

• Pharmaceutical Formulations: Primary API for manufacturing oral solid dosage forms (tablets, capsules) and powder for suspensions.
• Veterinary Medicine: Used in the production of antibiotics for treating bacterial infections in companion animals and livestock.
• Hospital Compounding: Serves as a key ingredient for preparing intravenous (IV) infusions in hospital pharmacy settings.
• Generic Drug Production: Critical for generic pharmaceutical companies producing cost-effective versions of this widely prescribed antibiotic combination.
• Clinical Trial Materials: Supplied as a high-purity reference standard or active component for new drug formulation research and development.

Basic Information

Product Name	Amoxicillin-Potassium Clavulanate Combination
CAS No.	74469-00-4
Molecular Formula	C16H19N3O5S • C8H8KNO5
Molecular Weight	Amoxicillin: 365.4 g/mol; Clavulanate Potassium: 237.3 g/mol
Synonyms	Amoxicillin and Clavulanate Potassium; Co-amoxiclav; Amoxicillin Trihydrate - Potassium Clavulanate; Augmentin (Brand Name Equivalent); Amoxicillin/Clavulanic Acid; (2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid - Potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
EINECS	Contact for details

Quality Control

Our Amoxicillin-Potassium Clavulanate Combination is manufactured and tested under strict quality management systems. It is typically produced to meet or exceed the stringent specifications of major pharmacopoeias, including USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia). Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, detailing parameters such as assay, impurity profile, water content, and microbiological quality.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as specified on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to prevent degradation. For long-term stability, storage under nitrogen atmosphere in a desiccated container is recommended.

Specification

Item	Specification
Description	White or almost white powder
Identification (HPLC/IR)	Conforms to standard
Assay (HPLC)	90.0% - 110.0% of labeled claim
Water Content (KF)	≤ 6.0%
Related Substances (HPLC)	Meets pharmacopoeial limits
Potassium Content	Contact for details
Residual Solvents (GC)	Meets ICH guidelines
Microbial Limits	Meets EP/USP requirements

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