BICAR® PHARMA  

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.

 

 
Depending on those different applications in ethical medicines or OTC products Sodium Hydrogen Carbonate 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 medicinal 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 of Suitability of the monograph of the European Pharmacopoeia) which we can be provided on request. The CEP certificate simplifies the marketing authorization process and is even recognized by a number of non EU countries and institutions.

The following restriction has to be taken into account: 
BICAR^® PHARMA is not authorized to be used in parenteral formulations or in peritoneal dialysis. Those applications demand more severe and specific requirements, which are not fulfilled by BICAR^® PHARMA.
 
BICAR^® PHARMA is available in different particle size distributions.