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Determination of visible particles in parenteral dosage forms and ophthalmic dosage forms

Abstract

The present article describes the approaches to the choice of methods for assessing the content of visible particles in parenteral and ophthalmic dosage forms, recognized in general pharmacopoeia monograph «Visible particles in parenteral dosage forms and ophthalmic dosage forms», as well as a special approach to the assessment of visible particles in individual preparations according to the batch volume, package type, the amount of drug in a package, drug nature etc., requiring unusual conditions and evaluation criteria.

About the Authors

Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


T. N. Bokovikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


L. A. Stronova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


E. P. Gernikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


L. I. Mitkina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


S. A. Manaeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


Yu. B. Purim
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


A. V. Pichugin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


References

1. Braun B. Melsungen AG Hospital Care. Particulate Contamination Risk Prevention in Infusion Therapy. Sharing expertise. Available from: http://www.safeinfusiontherapy.com/.

2. Grunewald M. Pflege von Patienten mit Erkrankungen des Herz-Kreislauf-und Gefassystems. In: Kellnhauser E, Schewior-Popp, et al. Thiemes Pflege. Stuttgart, New York; 2004. Ð. 316–17.

3. General pharmacopoeial article «Visible mechanical inclusion in the formulations for parenteral and ophthalmic dosage forms» (in Russian).

4. The State Pharmacopoeia of Republic of Belarus. 1st ed. V. 1. Minsk: Tsentr ekspertiz i ispytaniy v zdravoohranenii; 2006 (in Russian).

5. The State Pharmacopoeia of Republic of Kazakhstan. 1st ed. V. 1. Almaty: Zhibek Zholy; 2008 (in Russian).

6. European Pharmacopoeia. 8th edition. European Directorate for the Quality of Medicines and Healthcare (EDQM). Available from: http://online.edqm.eu/entry.htm.

7. United States Pharmacopeia. 35th ed. United States Pharmacopeial Convention. Available from: http://www.uspnf.com/uspnf/login.

8. The Japanese Pharmacopeia. 16th ed. Pharmaceuticals and medical devices agency. Available from: http://www.pmda.go.jp/english/.

9. British Pharmacopoeia. British Pharmacopoeia Commission. Available from: http://www.pharmacopoeia.co.uk/.

10. Annex III to the British Pharmacopoeia «SC I N. Particulate Contamination».

11. Working document WHO QAS/11.405.

12. The International Pharmacopoeia. 4th ed. World Health Organization. Available from: http://apps.who.int/phint/en/p/about/.


Review

For citations:


Olefir Yu.V., Bokovikova T.N., Stronova L.A., Gernikova E.P., Mitkina L.I., Manaeva S.A., Purim Yu.B., Pichugin A.V. Determination of visible particles in parenteral dosage forms and ophthalmic dosage forms. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(1):37-40. (In Russ.)

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ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)