Potassium Clavulanate Production Cost Reports

The report provides a detailed analysis essential for establishing a Potassium Clavulanate production plant. It encompasses all critical aspects necessary for Potassium Clavulanate production, including the cost of Potassium Clavulanate production, Potassium Clavulanate plant cost, Potassium Clavulanate production costs, and the overall Potassium Clavulanate production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Potassium Clavulanate production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Potassium Clavulanate is a beta-lactamase inhibitor utilised in the pharmaceutical industry, mostly combined with antibiotics like amoxicillin to create broad-spectrum formulations such as Augmentin. It effectively counters bacterial resistance in treating infections of the respiratory tract, urinary tract, skin, and abdomen. Additionally, its crystalline variants, like rosette or starburst forms, improve flowability, stability, and purity during tablet, capsule, or injectable production, reducing polymerisation and extending shelf life.

The market demand for potassium clavulanate is propelled by surging global antimicrobial resistance, which heightens demand for beta-lactamase inhibitors paired with antibiotics like amoxicillin to effectively treat resistant infections in respiratory, urinary, skin, and abdominal systems. Additionally, improved healthcare access, rising infection rates, and regulatory support for advanced formulations boost the market growth.

Moreover, price stabilisation from optimised production processes and ongoing R&D for stable, extended-release variants further sustain procurement and supply chain dynamics. However, stringent regulatory compliance, such as GMP certification, FDA approvals, and pharmacopeial standards to ensure purity, stability, and safety in formulations like amoxicillin combinations influence industrial potassium clavulanate procurement.

Raw Material for Potassium Clavulanate Production

According to the Potassium Clavulanate production plant project report, the raw material for Potassium Clavulanate production includes Streptomyces clavuligerus.

Production Process of Potassium Clavulanate

The extensive Potassium Clavulanate production cost report consists of the following major industrial production process:

1. Production via fermentation of Streptomyces clavuligerus: The production process of potassium clavulanate occurs via fermentation of Streptomyces clavuligerus to yield clavulanic acid. In the next step, the acid undergoes primary isolation through acidification of clarified broth (pH 1-2) and extraction into water-immiscible solvents like methyl isobutyl ketone (MIBK). The purified organic extract, dried to 1-3% water and concentrated to 1-5 mg/mL clavulanic acid, contacts potassium 2-ethylhexanoate (KEH, 1.1-1.5 molar excess) to directly form and salt out potassium clavulanate into a concentrated aqueous phase (20-30% w/w), bypassing amine salt intermediates to minimise hydrolysis and impurities. This aqueous solution, or an alternative back-extracted concentrate (15-25% w/v with IPA co-solvent), precipitates via stepwise isopropanol addition (optionally with ethyl acetate), followed by chilling, filtration, IPA/EtOAc washing, and low-temperature vacuum drying to produce ≥83% pure pharmaceutical-grade crystals free of organic amines (<0.00005%).

Properties of Potassium Clavulanate

Potassium clavulanate (C8H8KNO5, molecular weight 237.25 g/mol) appears as an off-white to pale yellowish crystalline powder with rosette or starburst habits that enhance flowability in pharmaceutical production. It has high water solubility (>100 mg/mL), slight solubility in ethanol, and negligible solubility in acetone or nonpolar solvents, while being hygroscopic and moisture-sensitive, decomposing above 160 degree Celsius and requiring storage at 2-8 degree Celsius under inert conditions to prevent hydrolysis, polymerisation, or epimerisation. It is the potassium salt of clavulanic acid, a β-lactamase inhibitor featuring a characteristic oxazolidine-β-lactam bicyclic core, with pKa ≈5.2 (parent acid), neutral pH stability, and short-term stability in solution. It has a specific rotation of +55° to +60° (c=1 in water), bulk density of 0.4-0.6 g/mL, and classification as a flammable solid (GHS H228) with potential skin sensitisation.