Chemical names: Sodium hydrogen carbonate, Sodium bicarbonate, Natrii hydrogenocarbonas, Carbonic acid mono sodium salt, Baking soda
Sodium Hydrogencarbonate is widely used in pharmaceutical formulations, for pH adjustment, as buffering agent, as antacid or in dialysis solutions. In effervescent tablets in conjunction with citric or tartaric acid it releases carbon dioxid, which enhances the dispersion and dissolution of medication.
Depending on those different applications in ethical medicines or OTC products Sodium Hydrogencarbonate can be used as an active pharmaceutical ingredient (API), as an excipient or as a component in a medical device.
According to the current European legislation APIs have to be manufactured under GMP conditions, as defined in the EUDRALEX Vol. 4 part II. BICAR® PHARMA fulfills these requirements and can therefore be used as active pharmaceutical ingredient in pharmaceutical products.
The compliance of BICAR® PHARMA with the monograph of the European Pharmacopoeia and the European Directives 2001/83/EC can be demonstrated by a CEP certificate (= Certificate of Suitability of the monograph of the European Pharmacopoeia), that we can provide on request. The CEP certificate can be used by the manufacturer of pharmaceutical products in their application for the marketing authorisation.
The following restriction has to be taken into account: BICAR® PHARMA is not intended to be used in parenteral formulations or in peritoneal dialysis. Those applications stipulate more severe and specific requirements, which are not fulfilled by BICAR® PHARMA or BICAR® CODEX.
Chemical and physical properties
BICAR® PHARMA consists of white crystals or of white, granular or crystalline powder. It is soluble in water and decomposes during heating in the dry state or in solution to sodium carbonate under evolution of CO2 gas.
2 NaHCO3 --> CO2 + H2O + Na2CO3
CO2 gas is also formed during reaction with acids:
NaHCO3 + HCl --> NaCl + CO2 + H2O
NaHCO3 + CH3CHOHCOOH --> CH3CHOHCOONa + CO2 + H2O
The pH value of Sodium Hydrogen Carbonate in an aqueous 1 % solution is about 8,4.
BICAR® PHARMA is available in different particle size distributions.
For more technical documentation, please contact us.
