Metronidazole oral suspension

Draft proposal for The International Pharmacopoeia (June 201 0). Please address any comments to Quality Assurance and Safety: Medicines, World Health Organization, 1211 Geneva 27, Switzerland. Fax [phone] or e-mail to [email protected]. A subscriber mailing list is now available to speed up consultation. For more information please contact [email protected].

[Note from the Secretariat: This draft text is proposed for inclusion in The International Pharmacopoeia in the context of collaboration between WHO and the Medicines and Healthcare Products Regulatory Agency (MHRA) hosting The British Pharmacopoeia, on which this text is based.]

Category. Antibacterial.

Storage. Metronidazole oral suspension should be kept in a well-closed container, protected from light.

Labelling. The designation of the container of Metronidazole oral suspension should state that the active ingrethent is in the benzoate form and the quantity should be indicated in terms of equivalent amount of metronidazole.

Additional information. Strengths in the current WHO Model List of Essential Medicines: 200 mg per 5 ml (40 mg per ml).

Requirements

Complies with the monograph for "Liquid preparations for oral use".

Definition. Metronidazole oral suspension is a suspension of Metronidazole benzoate in a suitable vehicle which may be flavoured. It contains not less than 90.0% and not more than 110.0% of the amount of metronidazole ( C6H9N3O3) stated on the label.

[Note from the Secretariat: wider limits than those stated in the British Pharmacopoeia monograph (95. 0%- 105. 0%) are proposed, to be in line with the policy and limits applied for similar dosage forms in The International Pharmacopoeia.]

Identity tests

Either test A or any two of tests B, C and D may be applied.

A. To a quantity of the...