Reference standard/Primary reference standard evaluation requirements.
Characterization shall be done.
The elements of characterization are 1)NMR 2)Mass 3)IR 4)UV 5)CHN analysis.
Impurities(all impurities) tests shall be done :
Organic impurities, Water content, Loss on drying/Residual solvents.
Potency : 100- All impurities.
In this way the reference standards are qualified.
All pharmacopeial standards comes under this category. No further testing is required for the primary reference standards.
Working standard/Secondary standard :
Select one approved batch to qualify the working standard
Analyse the sample against Pharmacopoeial reference standard for the Assay test and quantify for the assay.
Identification by Infrared spectroscopy using reference standard shall be done.
Preparation and usage of standards are very important. the batch release depends on the standards effectiveness and accuracy.
Characterization shall be done.
The elements of characterization are 1)NMR 2)Mass 3)IR 4)UV 5)CHN analysis.
Impurities(all impurities) tests shall be done :
Organic impurities, Water content, Loss on drying/Residual solvents.
Potency : 100- All impurities.
In this way the reference standards are qualified.
All pharmacopeial standards comes under this category. No further testing is required for the primary reference standards.
Working standard/Secondary standard :
Select one approved batch to qualify the working standard
Analyse the sample against Pharmacopoeial reference standard for the Assay test and quantify for the assay.
Identification by Infrared spectroscopy using reference standard shall be done.
Preparation and usage of standards are very important. the batch release depends on the standards effectiveness and accuracy.
5,6-dehydrogensenoside Rd, a triterpenoid reference standard, is a protopanaxadiol isolated from ginsenosides. Protopanaxadiol has been studied to have broad physiological activities, especially the antitumor biological activity. 5,6-dehydrogensenoside Rd
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