Disodium Hydrogen CitrateThird Party Manufacturing in India

Disodium Hydrogen Citrate acts as a urinary alkalinizer by increasing urine pH through its metabolic conversion to bicarbonate. Following oral administration, the citrate component is absorbed from the gastrointestinal tract and transported to the liver where it undergoes oxidation via the citric acid cycle to produce bicarbonate ions. These bicarbonate ions are then excreted by the kidneys, resulting in a net increase in urine pH. This alkalinization effect raises the urinary solubility of uric acid and cystine, preventing the formation of urinary crystals and facilitating the dissolution of existing uric acid calculi. By elevating urinary pH above 7.0, disodium hydrogen citrate creates an unfavorable environment for the precipitation of calcium oxalate and calcium phosphate crystals. In addition, citrate ions directly chelate calcium in the urine, forming soluble calcium-citrate complexes that reduce the concentration of free calcium available for stone formation. This dual mechanism—both alkalinizing the urine and complexing urinary calcium—provides effective prophylaxis against recurrent nephrolithiasis. The alkalinization effect begins within hours of dosing and is sustained with regular administration, maintaining urinary pH within the therapeutic range throughout the treatment period. Disodium hydrogen citrate is particularly valuable in managing conditions associated with acidic urine and hypercalciuria, offering a physiological approach to stone prevention without altering systemic acid-base balance.

Therapeutic Uses

Disodium Hydrogen Citrate is indicated for the management and prevention of urinary tract stone disease and other conditions requiring urinary alkalinization:

• Uric Acid Nephrolithiasis: Prevents the formation and promotes the dissolution of uric acid stones by maintaining urinary pH in the alkaline range, where uric acid exists in its more soluble ionized form
• Cystinuria: Reduces cystine stone formation by raising cystine solubility at higher urinary pH levels, often used in combination with thiol-binding agents
• Metabolic Acidosis: Corrects chronic acidotic states by providing an alkaline citrate load that is metabolized to bicarbonate
• Calcium Oxalate Stones: Reduces calcium oxalate supersaturation through calcium-citrate complexation, providing a dual mechanism of stone prevention

Why Manufacturers Choose Disodium Hydrogen Citrate

Disodium hydrogen citrate is a well-established urinary alkalinizer with consistent demand driven by the high prevalence of urolithiasis in India, where approximately 12% of the population is affected by urinary tract stones. The syrup formulation, particularly the 1.37g/5ml strength, is the preferred dosage form for paediatric and geriatric patients who may have difficulty swallowing tablets. This makes it a staple product in nephrology and urology practices across the country.

For third party manufacturers, disodium hydrogen citrate syrup offers straightforward formulation requirements with well-documented stability profiles. The API is readily available from domestic suppliers, and the manufacturing process for oral liquid formulations is well within the capability of WHO-GMP certified facilities in India. The product commands steady demand from hospital tenders, institutional buyers, and retail pharmacy channels. Its inclusion in national essential medicines lists across several countries provides long-term procurement visibility for export-oriented manufacturers.

This makes Disodium Hydrogen Citrate one of the most sought-after molecules for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.