Trisodium Citrate Dihydrate as API

Jungbunzlauer serves a broad range of industries with its natural and sustainable ingredients, including the pharmaceutical industry. Committed to our rigorous quality standards, our active pharmaceutical ingredient (API) and excipient portfolio meets highest quality standards. Jungbunzlauer's products can be used in various applications and provide a comprehensive solution for the entire pharmaceutical industry.

Jungbunzlauer manufactures trisodium citrate dihydrate (TSC) with a GMP certificate, Type II US DMF and a CEP. Sodium citrate is mainly used in its dihydrate form, has excellent pH regulation and buffering properties, and is used in various drug applications. As an API, TSC is widely used as anticoagulant, in rehydration solutions and as a laxative.

Sodium Citrate as rehydration salt

• Oral rehydration salts (ORS) contain TSC as an active ingredient along with glucose, sodium chloride and potassium chloride. ORS are applied after dehydration to facilitate the uptake of water after severe diarrhoea. Salts, as well as sugar are needed in a defined ratio to allow fluid uptake by the intestinal mucosa via osmosis. ORS play a significant role in the effective treatment of Cholera, and follow a defined composition of the WHO, saving millions of lives every year (WHO Cholera annual report).
   

Sodium Citrate as laxative

• Saline TSC is one of the most effective osmotic laxatives besides magnesium citrate. The laxative properties of TSC result in the correction of an osmotic imbalance by attracting and retaining water in the intestinal lumen, stimulating the evacuation of the bowels. In combination with sodium lauryl sulfoacetate and sorbitol, TSC is used in enemas, which help to relieve constipation locally in an easy way and without affecting the body as a whole. 
   

Sodium Citrate as anticoagulant

• TSC is widely used as anticoagulant. It covalently binds calcium, which is an essential factor during blood coagulation. This mechanism can be applied in medical devices such as blood bags for blood storage, or in medicinal products. Another application is the addition of TSC to tubing sets during apheresis in the field of extracorporeal dialysis. In acute situations, typical anticoagulants like heparin cannot be used, and acute dialysis needs to be performed, using TSC as active ingredient.
   

Sodium Citrate as excipient

• In addition to its application as an API, TSC is used as excipient, e.g. as buffer, chelating agent or mineral salt. Jungbunzlauer meets IPEC standards and can provide data like elemental impurities according to ICH Q3D, stability data along ICH and nitrosamine risk assessments for TSC to support the use as excipient in your drug product.
   

Along with trisodium citrate dihydrate, Jungbunzlauer’s current API portfolio contains citric acid, potassium citrate and magnesium citrate. All APIs can be provided with a US DMF and/or CEP to facilitate finished drug registrations in USA, Europe and ROW and comply with the respective monograph (USP, Ph.Eur.).