Pharmacopoeial Analysis of Barium Sulphate to USP 29 - Test Method
Accurate purity determinations are required at several stages of product manufacture, to ensure product safety and meet regulatory requirements. To meet demand from its clients, Lucideon offers an extended portfolio of pharmacopoeial analyses to USP, EP and JP standards.
Applications and Benefits
Barium sulphate (the name barium coming from the Greek word for heavy, barys) is a white or yellowish odourless powder which has many medical and industrial applications. The chemical inertness of barium sulphate makes it suitable for use as a filler in plastics, paint, rubber and resins, as a pigment in photographic papers and, due to its radio-opaque properties, as a component of concrete to screen nuclear reactors. It has also found application in clutch and brake linings due to its high temperature stability.
Although barium and all of its soluble compounds are toxic, barium sulphate can safely be used in medical devices and procedures due to its lack of solubility in water or other body fluids. It is for example used as a filler in root canal fillings and bone cements. The ability of barium sulphate to absorb both gamma and X-radiation makes it particularly useful as a radio-opaque substance within the medical area, a common example being the ‘barium meal' suspension or enema used during X-ray procedures of the gastrointestinal tract to increase the contrast of the image.
All materials produced for use within the healthcare sector need to comply with the relevant international regulatory requirements, as well as any national regulations within the country in which the product is being sold. A greater harmonization of these requirements is being progressed via the ICH (The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a tri-regional organization representing the drug regulatory authorities of the European Union, Japan and the United States. However, the complexity of the process means that specific monographs are slow to change, with traditional methods of analysis being considered more robust and providing a lower risk of error compared to some of the more advanced instrumental analytical techniques.
The chemical analysis of barium sulphate is covered by very similar test methods in both the US and EU pharmacopoeias. They involve qualitative identification tests for barium and sulphate, pH, heavy metals, limit tests for sulphide, acid-soluble substances and soluble barium salts plus a quantitative gravimetric assay for barium as the insoluble chromate salt.
The use of traditional analytical procedures is quite common for regulatory submissions and Lucideon is experienced in providing this analysis to the healthcare sector.
Form of Results
The results are reported as a certificate of analysis together with a summary report of the procedures and results.
- Dissolution rate of Hydroxyapatite
- Solubility Product of Hydroxyapatite
- Cleanliness validation of medical implants
- Elemental analysis by ICP-OES