Great information thank you. Is the expectation to perform a health based calculation for dedicated enclosed equipment? The product does not have any degradants.
@helenanunan It depends on the type of potential impurities that could have an impact on health. A detailed risk assessment (ICHQ9) helps to justify if there are no potential health hazards possible. Data should support this justification.
@@ojjaarundhathi7971 Section 11.7 of ICH Q7 prescribed to have a control sample of the product fir future evaluation if necessary. The packaging system should be same as the sale pack or equivalent packaging system rmore protected packaging. The control sample should be kept in reserve before the batch is released to the market.
In a kfr bottle for 5mg water consumes 1ml reagent, then factor is 5. But how to give 5 to 6, kfr solution strength decrease slowly so factor also below 5. Can you explain
@@ebersonleoraj6728 Even if the factor is below 5 mg/ml, it can be used to estimate water content. 5 to 6 factor is only a guiding reference. USP <921> allows to use KF with lower than 5 factor. Is it clear now?
It doesn't depend upon whether it is stored at different temperature conditions. It totally depends on 'significant change' in the data beyond acceptable limits. The detailed statistical evaluation can help asign shelf life up to 2x also. Data amenability to statistical evaluation is important. I hope that the query is classified. If not, please let me know. I'll try to explain in more elaborate way.
Hlo sir Thanks for this video I have one question about the volumetric solutions expiry. If I made for example, 0.1 m Agno3 on 26 April its standardization is on after 24 hours 27 April and on which day I calculate 15 days for restandardzation is it 26 April or 27 April?
You can have rinse sample for easy-cleanable equipment and swab sample for hard-to-reach areas of equipment. You have to evaluate the possible impurities for which the equipment will be cleaned.
Traceable means the source dara of each activity done from start. For example for production of a batch all the input materials, necessary calculations that go into the process to produce final priduct to establish what are all materials and activities gone into the process. I hope that this explanation is useful...If still not clear, please ask again. I can give another example.
Generally, factor will be between 5.0 mg per ml to 6.0 mg per ml. You can also have up to 2 mg per ml KF factor for very low water content samples. Please refer USP <921> for more details.
