Pharmacopoeial Requirements For Oral Drops

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Item
Definition

Specifications

Reference

Oral drops are solutions, emulsions or suspensions which are administered in small volumes such as drops by the means of a suitable device. The label states the number of drops per milliliter of preparation or per gram of preparation if the dose is Labelling measured in drops. No single mass deviates by more than 10 per cent from the Dose and uniformity average mass. The total of 10 masses does not differ by of dose of oral drops more than 15 per cent from the nominal mass of 10 doses. See reference for more details Liquid preparations for oral use supplied in multi-dose Uniformity of mass of delivered doses from containers comply with the test.

BP 2007 BP 2007 BP 2007

multi-dose containers
(a) Total viable aerobic count. Not more than 100 aerobic bacteria and not more than 10 fungi per gram. (b) Absence of Escherichia coli per gram. See reference for more details

BP 2007

Microbial testing

BP 2007

Reference: British Pharmacopoeia 2007.

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QC-05-002 f2