RELATED SUBSTANCES ANALYTICAL METHOD VALIDATION

[@SG73088]

Fantastic lecture. Thank you

[@hemant938]

Nice info...keep it up

[@kishoremane1592]

Very good information sir

[@monynorman5470]

Well done sir, in the middle of pressure cooker distraction

[@sagarsatbhai3154]

Great 1 Sr

[@ramachandrarana7751]

Very useful information, thank you sir

[@bharatbhushansaini2673]

Very Knowledageble vedio sir

[@kalavalakhageshwarrao5370]

Nice videos sir thank you so much

[@abhishekjoshi9650]

Thank u sir,for making video

[@abhishekjoshi9650]

very useful,pl make RS method development

[@anantdhopat9928]

Good information sir, make more videos

[@easyqualitylearning6790]

Sure sir

[@SharonWendyM]

thank you so much, you helped me a lot

[@amarsinhdevkar1480]

Very Good 👍

[@chetanpratap1053]

Good👍👍👍

[@bhausahebhingade3541]

Very nice sir

[@chilakavenkatraju2498]

Very nice explanation.Thanks for sharing knowledge

[@ravinpawar8638]

Excellent!

[@sachinpurkar9291]

Nice

[@pammimallikarjunareddy9119]

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]

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.

[@manojsonawane4039]

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

[@easyqualitylearning6790]

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

[@tanvirahmedsohag4086]

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]

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

[@krish_krish354]

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

[@easyqualitylearning6790]

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

[@easyqualitylearning6790]

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

[@SG73088]

Sir, how to perform area normalisation method with correction factor?

[@deepakmishra9765]

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]

This is based on industry practices

[@deepakmishra9765]

@@easyqualitylearning6790 Thanks for your reply...

[@tanvirahmedsohag4086]

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

[@krish_krish354]

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

[@easyqualitylearning6790]

5 concentrations including LOQ level

[@krish_krish354]

@@easyqualitylearning6790 thank you

[@ketanpatil8351]

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

[@easyqualitylearning6790]

Your question is not clear please elaborate

[@SG73088]

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

[@rahuln2278]

How to set toal impurity limits

[@easyqualitylearning6790]

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.

[@MohammadSalim-sd5vb]

How to decide weight of sample

[@easyqualitylearning6790]

Weight of sample to be taken as per method of analysis

[@raghun287]

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

[@easyqualitylearning6790]

If any thing specific you want to know then please specify

[@heartyplay1986]

What is significant change in RS in stability studies and what is the limit

[@easyqualitylearning6790]

Failure in the specified limits RS will be significant change

[@heartyplay1986]

Variation limit ...like 5% change in assay ...how many variation in RS

[@Amitpadhiyar]

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

[@easyqualitylearning6790]

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]

Both r same result only give

[@SurendraSingh-ek5um]

Sir please hindi version or bana do please sir ji 🙏🙏

[@krish_krish354]

23 min same concentration witten

[@pad480]

Please make this video Hindi language

[@easyqualitylearning6790]

Please check other videos of my channel. This topic is available in Hindi also

[@krish_krish354]

3.49 minutes placebo means a standard solution should be prepared in the same concentration of test

[@easyqualitylearning6790]

Placebo means formula containing all ingredients excluding analyses.

[@krish_krish354]

@@easyqualitylearning6790 can you explain with example