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23 Δεκ 2020 · Standard Operating Procedure (SOP) and Guideline for Preparation and Standardization of Volumetric Solution (s) used during analysis of Raw material and drug product at pharmaceutical quality control department. The purpose of this SOP is to describe a procedure for Preparation & Standardization of Volumetric solution.
The so-called titer determination or standardization of a volumetric solution used for titration is one of the most important preconditions for reliable and transparent titration results. Accurate and reliable titration results are only achievable when we work with the exact concentration of the volumetric solution.
Standardization procedures for the various titrants are described in the Volumetric Solution section of the USP - NF (3). Specificity is the ability to assess the analyte without any interference from other components that might be present in the sample. Other components could include impurities, excipients, or degradation products.
4 Ιουν 2018 · Learn the guidelines to prepare and standardize the volumetric solutions for chemical analysis in Pharmaceuticals. It is not always possible nor is it essential, to prepare volumetric solutions of a desired theoretical molarity.
17 Απρ 2024 · 5.1 Volumetric solutions shall be standardized by titration against a primary standard or by titration with a standard solution that has been recently standardized against a primary standard. 5.2 Solutions of primary standard or highly purified salts that are of primary standard quality do not require standardization initially.
Volumetric solutions are standardised by the methods described below. When a volumetric solution is to be used in an assay in which the end-point is determined by an electrochemical process (for example, amperometry or potentiometry) the solution is standardised by the same method. The composition of the medium in which a
4.1 Volumetric solutions should be prepared by accurately weighing a suitable quantity and dissolve it in freshly boiled and cooled water or other appropriate solvent to produce a specific volume as per the procedure.