Development and Validation of a Procedure for Subvisible Particles Determination in Water for Injections by the Coulter Principle (Electrical Sensing Zone Method)

Water for injections is one of the most popular diluents used for preparation of parenteral dosage forms. The European  Pharmacopoeia recommends two methods for the determination of  subvisible particulate matter: Light Obscuration Particle Count Test  and Microscopic Particle Count Test. The Russia...

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Bibliographic Details
Main Authors: A. A. Voropaev, O. V. Fadeikina, T. N. Ermolaeva, D. S. Davydov, R. A. Volkova, D. V. Shvedov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-06-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
Online Access:https://www.biopreparations.ru/jour/article/view/136