Medical gases can be used as active ingredients in medicinal products or excipients, in the manufacture of medical gas mixtures administered to patients, or as pharmaceutical gases used in the manufacture, storage or distribution of all medicinal products.
Medical gases are generally regulated under the same rules as finished pharmaceuticals. These rules are implemented at a national level and are covered in an official publication known as a Pharmacopeia.
The world’s leading Pharmacopeias are the European Pharmacopeia (EP) and the US Pharmacopeia-National Formulary (USP-NF). While each Pharmacopeia is different, there are many similarities.
Within a Pharmacopeia, each medical gas has its own official specification known as a monograph. Each monograph states the minimum acceptable assay/purity level of the gas, the impurities that must be analysed with their maximum acceptable concentrations, and the official test methods. The EP also describes the typical production process and a required technical specification for the gas analyser used.
EP and USP-NF standards are widely regarded as the most stringent globally, and so gas analysis solutions that can meet their requirements will generally be capable of meeting the requirements of other national Pharmacopeia.
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