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.

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

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

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

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

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.

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

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

Each and every point explain clearly with examples. Thanku sir

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

U r really good teacher👍

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.

Superb Explanations Cleared the Doubt..👍🏻

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.

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

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.

Excellent video sir

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

Explained very well sir.

Excellent explanation to understand, thanks sir 👍

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

superb presentation

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...

Useful Information sir

Very nice explanation and important information 👌👌👍👍👍

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

Great sir

Very well explained sir 😊

Great Work Mr. Bhaskar Napte

very informative presentation sir

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

Very nice sir

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

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

Good content

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

Amazing video on impurities #pharmaceuticalconcept

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

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!

Excellent session.

Really nice explained sir.👍

very informative and easily understandable information , thanks sir

Nice class

super sir

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

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

Amazing Sir

Very nice information explained well

really great way of explanation sir

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

Thank you very much for share about impurities

Very Nicely Explained..Sir..

Good information sir,

Excellent video sir 👏

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?

So nicely explained sir

Excellent information

Nicely explained Sir

Very nice explained

Thank you sir,

Very nice explanation sir

Good presentation

awesome task sir

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

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

Very nicely explained 👍

Useful information 🙏

Very help full

Good Explanation Thank you.

Excellent, thank you sir

Thanks a lot sir

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

Thanks sir..❤

How to know maximum daily dose for the product

Well explained 👏

Very nice 👌👌

Thanks sir

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

Super sir, thank you so much sir

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

THANK YOU , EXCELLENT

Sir If possible make a video on ICH Q6A

Sir from were we r calculating X? Value

What is the meaning of impurity above qualifications threshold

Good concepr

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

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

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

Thank you

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.

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

Rs by hplc definition

0.05 percentage written

So boring not understanding

Thanks u sir

Thanks Sir