How to define limit for unknown, known and total impurities

[@id4khan007]

I work in pharmaceutical research for an MNC, and I have to say, that you've done a fantastic job of explaining and summarizing the information.

[@tamngoc9394]

ICH Q3B (R2) summarized in detailed and intelligible in less than 30 minutes. Your presentation has saved me from lots of troubles. Many thanks!

[@ChaandTaaree]

Thank you sir, I struggled for many years to understand each concept until watched this video 🙂

[@sanjaykale7157]

Thank you sir for your presentation. Packed a lot of information into a short time. with a very simple and understandable language.

[@sunilshedage9503]

Very informative and knowledge improvement presentation. make videos like this. Thank you lots Sir

[@hanumantgare1891]

Each and every point explain clearly with examples. Thanku sir

[@shashikantnandanikar5388]

Thanks for information session. Well understood. In one of our project of Tablets one known impurity is increasing Initial (0 day) it was 0.12% 6M acc condition 1.8% All unknown impuriites are well within control

[@damthithanhhuong1994]

Thank you so much for the detailed presentation. That helped me understand the ICH guideline for impurity limit establishment as well the meaning of each definition in glossary. I read the guideline several times but cannot understand until I saw your video. I can apply this understanding to some questions in the DL response of Drug Submission that I have to deal with recently . Your video really helps.

[@tejaswinunnam8646]

This is the best explanation for this topic.Thank you!

[@ruturajsinhjadeja9821]

Very Informative Session Sir ❤

[@prashantpandit7806]

Superb Explanations Cleared the Doubt..👍🏻

[@keerthikishore6982]

I'm very very clarified with impurity guidelines Really good explanation

[@rajunaikbadhavath3442]

Your presentations are most useful for getting jobs into new organisations.

[@prasadrane4377]

U r really good teacher👍

[@priyankapathak4882]

Amazing mond map sir! Understood each concept distintly!! Ur a great teacher!

[@alimir8112]

Great Work Mr. Bhaskar Napte

[@pseudotalli]

each and every concept is explained very nicely. You truly are the best teacher.

[@rahulm4068]

Very Informative sir, Giving explanation with Example that’s makes us easy understanding. That’s makes you different from others, I have seen plenty of videos they just read the content that’s all. No explanation 😊 I Hope in future you will make more videos on such topics

[@mudassirshaikh6213]

Tooo easy to understand and time saving thank you sir...

[@bhattkishan6607]

Very nice explanation and important information 👌👌👍👍👍

[@anantdhopat9928]

Excellent explanation to understand, thanks sir 👍

[@saravananram3960]

Excellent video sir

[@ichaffairs4619]

What a teacher you are sir....... fabulous

[@vinayakwadgaonkar5183]

very informative presentation sir

[@kapilkulkarni2594]

very informative and easily understandable information , thanks sir

[@HarikrishnaTirumala9]

Your videos helped me alot to get job sir . Thank you so much Guruji .🙏🙏🙏

[@pankajkhadakban187]

Very Nicely Explained..Sir..

[@neelammahadik8146]

Thank u sir.. Explained in very simple language with examples tht is very helpful.. Looking forward for more informative videos. If possible plz present on PDE calculation.

[@vinittiwari6777]

Explained very well sir.

[@yogeshmandole5953]

sir please keep it up, it's really so usefull at times of interview

[@baraiyavimal102]

Really nice explained sir.👍

[@omjoshi5111]

superb presentation

[@bhargavrana5064]

Thank you very much sir🙇🙇 it's easier understand than ICH guidline

[@computerlearners4636]

really great way of explanation sir

[@ramakrishnaguttula7941]

Excellent video sir 👏

[@madhuchandral5778]

Good Explanation Thank you.

[@chinatobdvisit9578]

Thank you very much for share about impurities

[@amritarajput2597]

So nicely explained sir

[@chinna2680]

Tq so much sir now I got the difference between these limits

[@PharmaceuticalConcept]

Amazing video on impurities #pharmaceuticalconcept

[@mitaligaikwad1152]

Very nice presentation...could you please explain how to calculate regulatory qualification threshold for drug substances

[@sureshpottella2230]

Excellent session.

[@krishasworld1737]

Very nice information explained well

[@АндрійУгнівенко]

Thank you for a great lecture where I found answers to many of my questions. How should the limit of Total impurities be calculated in the case of a combined drug (fixed-dose combination)? It is logical that each API should have its own limit specified in the Specification, but this is not explicitly stated in the EMA guidelines.

[@rajbala3114]

Hi sir , your presentations are good and helpful ,can I get your presentations in PDF form ?

[@duppatigattuaru1223]

Really its amazing sir, ur giving very knowledge to us thank you sir, and if possible show the guideline page also directly this is my request sir.

[@sharmilassharmilas5071]

Very nice explanation sir

[@DipakDhoteNASIK]

Useful Information sir

[@pharmagrowthhub3083]

glad that you found info useful!

[@swapnilchitte6046]

Thank you so much sir,it is really helpful...

[@dilipwagdarikar764]

Nicely explained Sir

[@bhushanborse917]

Good information sir,

[@manojkadam5984]

Very nicely explained 👍

[@muralikrishna2852]

Excellent information

[@RashidAnsari-dk9mk]

Aapne bahut achcha explain kiya...or ICH me bhi kuch jyada difficult nhi likha h...But I am very sad to see this all information available just a click away and still people who are working in pharma since 10 yrs still they are unable to answer some questions at this topic. Or fir kehtey h ki pharma me salary achchi nhi h future achcha nhi h...

[@Dileeppharma]

awesome task sir

[@AjayKumar-eo6em]

Useful information 🙏

[@RohitKadam-n5f]

Very nice explained

[@vijayagrawal2628]

Great presentation sir..request to make video on solubility studies as per USP chapter.It will be very useful for all. Thank you

[@damthithanhhuong1994]

Hello teacher, may I ask if this guideline is to define limit for release specification or shelf life specification?

[@dheerajsharma9304]

Very help full

[@ashishmahajan-y8o]

Hello Sir, Many thanks for explaining entire concept in very simple and understandable way. Could you please let us know that. does unknow also called as unspecified impurity or unspecified impurity is different then unknown impurity? Your prompt response is highly appriciated!

[@PKvaghela0111]

Amazing Sir

[@sanjays1344]

Excellent, thank you sir

[@mohdjouma9437]

What is the software you use to make these nice collapsible and expandable boxes

[@bandikattuvenkatasiva2542]

Super sir, thank you so much sir

[@rahulkulkarni3037]

Well explained 👏

[@mangeshgawade1042]

Very nice sir

[@harshinikotichinthala8480]

Sir as per finished product specifications limit of specified impurities and unspecified impurities

[@Tushar33865]

Thank you sir,

[@kalpanayarram3289]

Thank you soo much sir

[@kashifzayan1699]

How to know maximum daily dose in other dosage forms like dermals ophthalmic solution

[@shantanughodke1224]

Good content

[@srinivasaraovenkatasriniva4387]

Hi sir I want to know on which guidelines basis we fix a run time for RS AND ASSAY

[@narresreenivas6213]

Thanks a lot sir

[@venkataratnams5406]

Nice class

[@Ram-nn6xr]

Just small question sir, the specified unknown was added in the list, but how about the unspecified limit of 0.2%? Does the specified unknown even cover this too?

[@dr.balakrishnaaegurla5560]

super sir

[@tusharadm]

Good presentation

[@pseudotalli]

in case of drug substance having daily dose of more than 2gm per day, the identification and quantification threshold is 0.05%, does that mean that both known and unknown impurties in my drug substance will have the same limit, if the product is official in any of the monograph

[@thirupugazhmg674]

Thanks sir..❤

[@harikrishnanayyappan9179]

Great sir

[@sankarreddy6996]

Sir If possible make a video on ICH Q6A

[@DeepakKumar-te2xl]

How to know maximum daily dose for the product

[@achyutjagdhane9683]

THANK YOU , EXCELLENT

[@shibithaanadar1089]

Sir from were we r calculating X? Value

[@sureshpatel8108]

What is the meaning of impurity above qualifications threshold

[@sarikanalam1249]

For qualifying higher limit how many batches of RLD needs to be analysed ?

[@krish_krish354]

How to know the daily dosage for api drug substance. You have given for products

[@ichaffairs4619]

Dear sir, Kindly also prepare the video about DS impurity (degradent impurity)which is above the qualifications limit and suggest the calculation of how to prepare justification in sec. 3.2.S.3.2 on base repeat dose tox. Study NOAEL. Thank you for above video, it's helpfull

[@stockspower3410]

Very nice 👌👌

[@vivekrajkotia3730]

Nice presentation sir. 👍Keep posting such type of videos. Btw can i know the presentation software you were using for preparation?

[@pharmagrowthhub3083]

Hi Vivek, thank u, its a mind map.

[@vivekrajkotia3730]

@@pharmagrowthhub3083 thank you sir

[@sravanie1235]

Thanks u sir

[@deepaksingla4327]

Sir how I can find the MDD value for any drug because in PIL I don't get the MDD VALUE Of most of the drugs. if there is any other approach then plz tell me.

[@damthithanhhuong1994]

You can find In EMC-UK/MHRA, FDA, EMA, TGA web. They have many SmPC and provide dosage information.

[@abhishekjoshi9650]

Thank you

[@MUSMAN-pc6wf]

Thanks Sir

[@003anwar]

If any impurity limit is 0.5%, then is it possible to calculate the LOQ value theoretically?

[@maheshgupta564]

Good concepr

[@srikanth123yeti5]

Rs by hplc definition

[@sachingadilohar9638]

0.05 percentage written

[@archanachavan2929]

So boring not understanding