FAQ
Drugs

Nitrogen filled in injections does not react with drug product and is not absorbed by human body. Is it necessary to be listed in the composition statement in the application form?

刊登日期:2019-11-22  |  點閱次數 : 1610 次 

Yes. According to “Regulations for Registration of Medicinal Products“ Article 17, solvents, solubilizing agents, stabilizers and any other excipients used for injections should be listed in the composition statement in the application form. Nitrogen, which is used as a replacement gas for air to prevent oxidation of the product, should be listed in the composition statement. The amount can be recorded as “q.s.”.

 

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