Preparation of Primary Standards for Non Pharmacopoeial Products

To lay down the procedure for preparation, standardization and use of primary standards for Non-pharmacopoeial products. This SOP is applicable for Non-pharmacopoeial products in Quality Control Department.
Non-pharmacopoeial standards shall be procured from APL, R&D or from any vendor or shall be prepared from any of the plant batch by full characterization. Code number shall be allocated as mentioned below for the characterized primary standards.
Pharmacopoeial, Products, Primary Standards, Annexure, amber coloured glass vials
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OFLOTAL - OR

Ofloxacin - 200mg + Orinidazole-500mg, Model of pack:10x10's, Packing:BlisterOfloxacin - 200mg + Orinidazole-500mg, OFLOTAL - OR TABLETS

Table of contents (toc) for republic of uzbekistan

Table of contents for dossier requirments (republic of uzbekistan). Toc for republic of uzbekistan , toc formate for dossier

Preparation of mercuric acetate solution 10 percent

Pour about 75 ml of Glacial Acetic Acid into a 250 ml capacity beaker. Weigh 10.0 grams of Mercuric Acetate LR and transfer slowly, into above-said beaker, though it‘s sidewalls, while gentle mixing by using a glass rod. Transfer prepared solution into a 100 ml volumetric flask, by using a glass funnel. Rinse the beaker and funnel with few ml of Glacial Acetic Acid, and allow to add into the contents of volumetric flask. Make up the volumetric flask to mark with Glacial Acetic Acid , remove the funnel, keep the lid to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution into a suitable container and label with all necessary details. The resultant solution is having the concentration of 10.0% w/v. Mercuric Acetate , Glacial Acetic Acid , Glass funnel, Volumetric flask

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