About Analytical and Technological Reasons of Out-of-Specification Results for Assay and Disolution Tests (Review)

Introduction. Out of specification (OOS) results represent a major challenge in the development, validation and use of the Assay and Dissolution methods. The topic is relevant, which is confirmed by Internet search data for the phrase "Out-of-Specification" + "HPLC" – about 35,30...

Full description

Saved in:
Bibliographic Details
Main Author: N. A. Epshtein
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2023-02-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/1453
Tags: Add Tag
No Tags, Be the first to tag this record!