RELATED SUBSTANCES ANALYTICAL METHOD VALIDATION

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RELATED SUBSTANCES ANALYTICAL METHOD VALIDATION

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EASY QUALITY LEARNING

Күн бұрын

Пікірлер: 57

@hemant938 2 жыл бұрын

Nice info...keep it up

@SG73088 3 жыл бұрын

Fantastic lecture. Thank you

@kishoremane1592 3 жыл бұрын

Very good information sir

@ramachandrarana7751 3 жыл бұрын

Very useful information, thank you sir

@monynorman5470 Жыл бұрын

Well done sir, in the middle of pressure cooker distraction

@bharatbhushansaini2673 4 жыл бұрын

Very Knowledageble vedio sir

@sagarsatbhai3154 3 жыл бұрын

Great 1 Sr

@abhishekjoshi9650 Жыл бұрын

very useful,pl make RS method development

@kalavalakhageshwarrao5370 3 жыл бұрын

Nice videos sir thank you so much

@amarsinhdevkar1480 4 жыл бұрын

Very Good 👍

@abhishekjoshi9650 3 жыл бұрын

Thank u sir,for making video

@bhausahebhingade3541 4 жыл бұрын

Very nice sir

@chetanpratap1053 4 жыл бұрын

Good👍👍👍

@sachinpurkar9291 4 жыл бұрын

Nice

@chilakavenkatraju2498 2 жыл бұрын

Very nice explanation.Thanks for sharing knowledge

@anantdhopat9928 3 жыл бұрын

Good information sir, make more videos

@easyqualitylearning6790 3 жыл бұрын

Sure sir

@SharonWendyM 2 жыл бұрын

thank you so much, you helped me a lot

@krish_krish354 4 жыл бұрын

Really wonderful. 22.08 min stock solution impurity B 10mg correct it. 11.02to 11.14can you explain 220% and 2.4%

@easyqualitylearning6790 4 жыл бұрын

Please read as follows stock solution B contains 10 mg impurity B

@easyqualitylearning6790 4 жыл бұрын

Recommended range for linearity is loq to 120 percent and 120 pc of 2 will be 2.4

@pammimallikarjunareddy9119 4 жыл бұрын

Thanks for sharing valuble information sir,but I have some doubts those are SOLUTION STABILITY and mobile phase solution stability concept in if any recovery are identified or not

@easyqualitylearning6790 4 жыл бұрын

solutions stability is evaluated by change in area and Recovery and results are also calculated by comparing the area so solutions stability is comply then recovery will automatically comply.

@deepakmishra9765 4 жыл бұрын

Thanks for sharing the details so beautifully. However, would you please share whether the reference of %RSD in system precision is based on industry practices or have some guideline references?

@easyqualitylearning6790 4 жыл бұрын

This is based on industry practices

@deepakmishra9765 4 жыл бұрын

@@easyqualitylearning6790 Thanks for your reply...

@tanvirahmedsohag4086 3 жыл бұрын

BP 2020 for impurity standard at prescribed level (At or above LOQ)

@tanvirahmedsohag4086 3 жыл бұрын

Is it prescribable that we check conc. for LOQ before validation,and for calculating LOQ and LOD what should be range of conc. compared to LOQ limit,Let say LOQ is 20ppm,then what should be the concentration we should use for LOQ determination.

@pandurangsaratkar3538 2 жыл бұрын

LOD and LOQ determination is part of validation to be done after specificity. We need to anticipate based on the responses we are getting and depending on our limits and asper that dilutions for lod and LOQ shall be prepared

@manojsonawane4039 4 жыл бұрын

What is the reference for % RSD of LOD and LOQ?

@easyqualitylearning6790 4 жыл бұрын

One WHO presentation is available. Moreover this limit is as per industry trend.

@krish_krish354 2 жыл бұрын

Linearity RRF ploting include LOQ concentration or without that. Linearity minimum 5 level in that asking

@easyqualitylearning6790 2 жыл бұрын

5 concentrations including LOQ level

@krish_krish354 2 жыл бұрын

@@easyqualitylearning6790 thank you

@raghun287 3 жыл бұрын

Good introduction, can you please explain in little depth.....

@easyqualitylearning6790 3 жыл бұрын

If any thing specific you want to know then please specify

@ravinpawar8638 4 жыл бұрын

Excellent!

@ketanpatil8351 3 жыл бұрын

Sir can you please explain how to select sample concentration and standard concentration in RS

@easyqualitylearning6790 3 жыл бұрын

Your question is not clear please elaborate

@SG73088 3 жыл бұрын

You have to find out sample preparation standard preparation concentration during Method development.

@Amitpadhiyar 4 жыл бұрын

How to calculate total unknown impurities? 100 - total know impurities or unknown impurities sum ?

@easyqualitylearning6790 3 жыл бұрын

If we want total unknown impurities then area due to unknown impurities peaks is summed up and then it is placed in calculation when it is compared with low conc. Std.

@krish_krish354 3 жыл бұрын

Both r same result only give

@rahuln2278 3 жыл бұрын

How to set toal impurity limits

@easyqualitylearning6790 3 жыл бұрын

If domestic finished product then 0.5 percent for individual impurity and 2.0 percent for total impurities as per general chapter of IP. For API 0.3 percent is individual impurity and 1.0 percent is total impurities.