@@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.
@ojjaarundhathi797125 күн бұрын
Tq sir I have a doubt when we use retention sample sir will you please explain it
@ebersonleoraj6728Ай бұрын
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
@pharmaworldk1473Ай бұрын
@@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?
@pharmaworldk1473Ай бұрын
@@ebersonleoraj6728 You can give the factor below 5 also.
@dhanasekaran-lc3xtАй бұрын
Thank you for teaching sir
@mowlisharma3941Ай бұрын
Please provide polarimiter calibration in telugu
@pharmaworldk1473Ай бұрын
@@mowlisharma3941 Let me make a video soon.
@mowlisharma3941Ай бұрын
Excellent sir me mobile number ni send cheyyandi
@pharmaworldk1473Ай бұрын
@@mowlisharma3941 please provide your contact number. I'll call you
@Pavan-lq9bvАй бұрын
Temperature can be rounded off?.
@pharmaworldk1473Ай бұрын
@@Pavan-lq9bv Yes. Depending upon number of digits after decimal point with reference to the specifications.
@sachinahire832Ай бұрын
Good presentation and indepth knowledge
@kkuppuluri2 ай бұрын
Nice video🎉🎉🎉🎉🎉
@pharmaworldk14732 ай бұрын
@@kkuppuluri Thank you
@kkuppuluri2 ай бұрын
Good job🎉🎉🎉🎉
@gollakenchanna20042 ай бұрын
Nice video sir
@gollakenchanna20042 ай бұрын
Sir plz HPLC Gc IR UV gurchi telugu lo upload cheyandi me videos bagunnai
@kkuppuluri2 ай бұрын
You did not put the intro correctly, But great job!
@pharmaworldk14732 ай бұрын
Thanks for your observation 👍🏻
@pharmaworldk14732 ай бұрын
I'll correct it
@johnlucas89782 ай бұрын
Very helpful. Any idea on why refrigerated product only allows 1.5 X extension of shelf life vs. room temp product allows 2X?
@pharmaworldk14732 ай бұрын
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.
@sunildarji60033 ай бұрын
Sir 🙏🙏🎉
@kkuppuluri3 ай бұрын
Wow🎉🎉
@nookalasaikrishna3 ай бұрын
Much useful info. Thank u for the update.
@nooshafarinhirad70783 ай бұрын
IT was perfekt but IT Would be better give a Real example
@monica32203 ай бұрын
Your videos are really good. I am learning a lot
@ojjaarundhathi79713 ай бұрын
Tq sir
@ojjaarundhathi79713 ай бұрын
Good evening sir
@ojjaarundhathi79713 ай бұрын
What do you mean by pool sampling sir will you please explain it
@ksaravanan96404 ай бұрын
Excellent ji
@pharmaworldk14734 ай бұрын
Thank you
@repallemuralidhar4 ай бұрын
Very very useful information sir .
@allipilliabishek16754 ай бұрын
Very nice sir
@gkravindran4 ай бұрын
Good teaching I everseen
@Bhagtisansar924 ай бұрын
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?
@kvkrishnareddy40444 ай бұрын
What sampling done and waht is should be anyalise
@pharmaworldk14734 ай бұрын
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.
@NiniUppuluri4 ай бұрын
🎉🎉 awesome job
@user-kn8yb5lh7w5 ай бұрын
hello,the means about traceable i still can not understand fully. and what is the difference between the attributable.
@pharmaworldk14735 ай бұрын
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.
@pharmaworldk14735 ай бұрын
Attributable means who did the activity. It is name of the person who performed that activity.
@pharmaworldk14735 ай бұрын
Read as ''source data' in the first line
@user-kn8yb5lh7w5 ай бұрын
@@pharmaworldk1473 thank you for your kindly responsed.
@BadDrucifer5 ай бұрын
Another great 👍 video keep them coming
@BadDrucifer5 ай бұрын
Very informative!!
@BadDrucifer5 ай бұрын
Good breakdown.
@gayathribabu12145 ай бұрын
Superb teaching sir thank you so much
@srinivasulubhavanasi27345 ай бұрын
Good explanation sir
@pharmaworldk14735 ай бұрын
Thank you. Try to use these tools for evaluation of QC data for assay, HPLC impurities, KF etc. You get wonderful outcomes
@pandiribalakrishna12545 ай бұрын
Balance kosam oka video cheyyara telugu lo
@samarthsinhchauhan28575 ай бұрын
Please prepare video about ICH Q14 and preparation of development report
@pharmaworldk14735 ай бұрын
Let me explore soon
@badukoorinagaraja99245 ай бұрын
Thank you sir,your explanation is very clear and usefull
@user-kn8yb5lh7w5 ай бұрын
thank you sir,i learned a lot
@pharmaworldk1473Ай бұрын
You are welcome
@rameshdatti61766 ай бұрын
Excellent 👌
@ojjaarundhathi79716 ай бұрын
What is the acceptance criteria limit sir
@pharmaworldk14736 ай бұрын
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.
@ojjaarundhathi79716 ай бұрын
Tq sir
@ojjaarundhathi79716 ай бұрын
Sir what is acceptance criteria limit for kf standardization RSD..?
@pharmaworldk14736 ай бұрын
@@ojjaarundhathi7971 It is NMT1.0% or NMT 2.0%, depending upon the capability of the instrument on reproducibility.
@ojjaarundhathi79716 ай бұрын
@@pharmaworldk1473 tq so much sir
@AjnaCloud6 ай бұрын
One video under 16 mins summarizes complex and useful information in a clear and crisp to the point. Thank you for making these videos.
@pharmaworldk14736 ай бұрын
Thank you.
@pharmaworldk14736 ай бұрын
I'll make another video with more indepth information on QR Code soon.
@sachinjoshi276 ай бұрын
Very informative video sir. No doubt companies complying with QR code mandate are helping save patients from counterfeits enter the supply chain.