ICH Q3D Guidance for Elemental Impurities | Example for calculating | Permitted Daily Dose (PDE)

ICHQ3(D) for Elemental Impurities define the requirements for complying the drug products with the PDE requirements, carrying out the risk assessment for elemental impurities and control of elemental impurities.
This methodology explains USFDA Guidance for Elemental Impurities, United States Pharmacopoeia Chapter 232 & Chapter 233.
The presentation defines sources of elemental impurities including incoming materials, equipment, container closure system. It defines intentionally added as well as unintentionally introduced elemental impurities.
It gives examples for determining the elemental impurities in drug products including calculating PDE values using different approaches.
The presentation also covers the USP Chapter requirement for carrying out finished product testing by ICP-MS or ICP-AES.
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[@06_shravasti7]

Searching for this clarity since ages thank you soo much 🙏

[@proftalks1680]

Thank you very much

[@kristamcharan]

Crystal clear presentation . . . Keep up good work 👍

[@proftalks1680]

Thank you very much for constant support

[@ramyav5054]

Very good presentation and easy to understand for everyone. Please cover all ICH,US FDA and EU guidelines.

[@proftalks1680]

Thank you very much

[@marutiojha5941]

Thank you for more things are giving the clarity
But some things are confusing.

[@ahmedginidi2020]

More than perfect, sir

[@proftalks1680]

Thank you🌹

[@geetanjalipant6687]

Nice one. Want more lectures on ICH and USFDA Guidance.

[@proftalks1680]

Thank you for encouragement. Will surely have more presentations on ICH & USFDA guidances.

[@Herbaltutor369]

Good presentation nice 👍

[@proftalks1680]

Thank you🙏

[@nitingonjare6527]

Very good information

[@proftalks1680]

Thank you🙏

[@Hollywoodbollywood2265]

Nice explanation

[@proftalks1680]

Thanks

[@sambhajimasal4248]

its Wonderfull, Thank You so much sir, Appreciate your efforts!!!!!!, God Bless UU!!
Plz Upload for the Residual solvents also!!
waiting for your video!!

[@proftalks1680]

Thank you very much Sambhaji bro... Sure will upload the same

[@poojasalunkhe7142]

Hello sir
Can considering option 1for limit and EI data from manufacturing can be taken for assessment

[@ragulraj8341]

Good explanation

[@proftalks1680]

Thanks🙏

[@PramodKumar-mu9bn]

Nice presentation but you are saying grams as mg

[@dahalerahul123]

17:51 , 21:24 it is mg or g ?