How To Determine Detection Limit (LoD) and Quantitation Limit (LoQ)

Determination of LoD & LoQ
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1. Assay method validation mastery
» Everything you need to know to perform assay validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements
2. Dissolution method validation mastery
» Everything you need to know to perform dissolution validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements
3. Related substances method validation mastery
» Everything you need to know to perform RS validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements
4. Residual Solvents method validation mastery
» Everything you need to know to perform Res sol. validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements
5. Extractables & Leachables Blueprint
» What is E&L
» What is the source of E&L
» How to use Risk-based approach for safety assessment
» What are Thresholds for E&L
» How to design E&L Study
6. Stability Study Mastery
» Basic terms in stability study
» Stability study for submission
» Preparation of stability protocol, report
» IQ, OQ,PQ of stability chamber
7. Method development blueprint
» HPLC, GC, Dissolution, Spectroscopy Method Development
8. Cleaning validation blueprint
» How to perform cleaning validation
9. Mutagenic & Nitrosamines
» Understand regulatory aspects of mutagenic & nitrosamines
» Testing need of Mutagenic & Nitrosamine into your product
» LOQ requirement for Nitrosamine test procedure
» Limit for new Nitrosamine impurity
» Limit for mutagenic impurity
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11. ICH Quality Blueprint
» Comprehensive course on ICH Quality guidelines
12. FDA 483 Observations
» Comprehensive info on FDA 483 recd. By Indian Pharma (10-12 yrs)
13. Impurity Management blueprint
» Limit for known, unknown, total impurity
» Limit for residual solvents
» Release & Stability specification for Impurity
14. Instrument Calibration Mastery
» Calibration of common lab instrument
» Calibration templates & formats
15. Instrument Qualification mastery
» Qualification of common lab instruments
» Calibration templates & formats
16. Information Technology Blueprint
» Electronic data management
» Server Data Backup, Retrieval, and Verification
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17. Specification design blueprint
» Specification for API/Finished product
» Specification for unknown impurity
» Specification for known impurity
18. Pharma tech blueprint
» More than 90+ videos on various topics of QC, QA, AR&D
19. Concentration matrix design mastery
» Concentration matrix for method validation
» Confirmation on selected weighing and dilution details
» Mapping expected concentrations for API/Impurities
20. Calculation formula design mastery
» Reporting and rounding of analytical results
» Basic calculation functions in excel
» Basic calculation formulas in Analytical chemistry
» Preparation of automated calculation sheet
21. Concentration design blueprint
» Conc. Optimization for assay, RS, Dissolution, Residual solvent
22. Lab Operation Blueprint
» Basic Lab Set-Up Guidance
23. Interview Question Model
» Likely Interview Questions
24. Job Search Strategy
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» How to connect with TAMs
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25. Resume & LinkedIn Blueprint
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[@bheema2196]

ur explanation was amazing and crystal clear, keep making the lectures to enrich knowledge

[@pradipagarwal2946]

Your explanation is very powerful and easily understand by anyone. Appreciate.

[@OrnellaBracco-k7e]

Good video. I see that the y-intercept is not used in the LOD calculations. Where does y intercept feature?

[@abbasahamed1372]

Thank you sir, Highly informative. Please put video for gradient method development in HPLC

[@amolshinde5762]

dear sir, thanks for the superb explanation. Where i can get this formula for residual calculations? Which regulatory document mentions the formula for residual calculations? I am unable to find out the regulatory reference for this calculation.

[@arana2542]

It was very informative & useful information and you explained ina detail so anyone can understand, Great ..Help

[@dishxpert]

When do you use the SD of the Y- intercept vs SS of regression line to find LOD?

[@sunnyupadhyay4273]

Sir please made a video for set the LOQ limit for 2 to 5 impurity present in sample having different uv Please made all clear about the method validation with the example it will be helpful for us

[@rohitagrawal2905]

For LoQ S/N ratio is more than 10 reqired . Any maximun limit for S/N ratio like if its found like 800 is it acceptable ...??

[@a.g.k.satish1979]

Great sir,your explanation is very versatile 👌, useful for us.

[@nitinapte3947]

Great efforts

[@KarnakarThumpilla]

Hi sir Why In visual observation LOQ not determined . Ple send the answer

[@masterbunnyathemc224]

Thank you so much. I need some clarity, when I iniect blank, I will get very more than 1 peak response. I may have 2 to 5 areas, who can I handle that???. So if IAM looking at the impurities in my sample but when there is no impirity, no peak for impurity. How do I handle this?

[@satnamom4667]

Which concentrations need to be selected while determine the lod and loq?can we go below 1 ppm too in the given example...

[@rupanalam1369]

Very helpful sir, can we have a video about impurity method validation from protocol preparation to report generation?

[@kalavalakhageshwarrao5370]

Yes sir

[@sharmasandipkumar]

Why lod loq value are comming different through regression method

[@katiahebbache1936]

Salam. Sometimes I find in the articles quoting 3 SDV/b, sometimes 3.3 SDV/b, which formula is taken in general that of 3 or that of 3.3. what's the difference?

[@krish_krish354]

Actual value and predictable value explain with another one more example in visible manner

[@kishorsingh2498]

In case of AAS atomic absorption spectroscopy The linearity start from 0.1 ppm to 0.5 ppm (LOD) and the concentration fall below the 0.1 i.e 0.023 then What will be the result? Should we calculate this or not If not then what will be the result? If anyone have answer Plz let me know

[@sarojmonikalita190]

Why the number 3 comes in the formula for LOD?

[@sumitchangra4943]

Is there need of seprate calibration curves for QL and DL.

[@sudhirnagardalekar6805]

Highly informative sir 👍🙏

[@navyasrimankina8596]

What if the specification limit is below to the quantification limit then is that LOQ is valid?

[@devendrarajak1385]

Hello sir... according to ich guidelines loq value considered maximum 50% of our spec limit if our loq not stablish 50% or below spec limit than what will be do...?? Please suggest me sir...and explain what is the reason not stablish loq below 50%..

[@tadalavenkateswararao2090]

Sir ur expalnation is very good but ihave a one doubt for blank mesurement method 1. We are inject blank solution or placebo 60 mesurements but the solutions not present in our analyte then how integrate peak and caliculate sddeviation

[@pharmagrowthhub3083]

The response may be expected due to detector background noise and diluent or matrix effect...

[@masterbunnyathemc224]

How can I determine slope I'm Excel?

[@amruthamk6863]

Very Informative lecture😍

[@dhanrajmistari5293]

You made video on related substances

[@ljin5468]

hi Can you explain more about how to ca the calculate the residuals, I'm confused about the formula

[@kimjama2523]

Hello Sir I got confused with how to compute the residuals especially the predictable response which you mentioned (mx + c). Kindly explain in detailed. And thank you in advance if you will notice my comment and query.

[@rajeshgoud1274]

Residual formula: Observed Area - Predicted area Predicted area shall be calculated from the Regression curve Y=MX+C Example: the obtained area for the below conc. is stated below 1ppm - 400 2ppm - 800 3ppm - 1189 4 ppm - 1600 5 ppm - 1985 NOw plot a linearity plot to obtained ur regression equation. y = 397x + 3.8 from the above ontained value, now will calculate the residuals as stated below for 1ppm level: Y=397 (1)+3.8 Y=397+3.8 Y=400.8 So your residual is (Practical obtained area - predicted area from the regression line) Residual = 400 - 400.8 Residual = - 0.8 SO the observed residual for 1 ppm is -0.8. similarly the residual for other concentrations will be caluculated in the same way. Hope u got the answer.

[@priyadharshini.n3352]

@@rajeshgoud1274 why we are using y= 397x +3.8 ?? Plz let me know the ans

[@naboria5]

Thank you very much.

[@krish_krish354]

Seperate curve for detection limit in that LOQ should not be added other linearity level can be added. Is it so

[@pharmagrowthhub3083]

Slope can be better evaluated with a calibration curve comprising higher concentrations and LOQ conc need not be considered in it.

[@krish_krish354]

@@pharmagrowthhub3083 thank you sir

[@areejmohammed3392]

Thank you👏🏼👏🏼👏🏼

[@Rajatkumar-xn5zy]

Why we determined lod and loq??

[@dhanrajmistari5293]

Sir what is maximum limit of impurity

[@nagarajuyakkati2501]

Super sir

[@katiahebbache1936]

What is the real formula?

[@enzolong9085]

Thank you so much sir

[@jaydeeppatil7003]

Sir please make a vidio in hindi language for better understanding.then will be more grow your channel and views and gain subscribers.

[@Parashar92]

can we get the PPT PDF plz

[@manjeetsingh-mc7sb]

can i get it in pdf

[@azanibinishakfs831]

TQ Sir..

[@battunagarajutechnologys3996]

Send me excel sheet sir plz.

[@satishkumaryadav6473]

you are not tell residual actual calculations properly

[@krish_krish354]

10.35 minutes can u explain a little elaborate with other example

[@tadesseabrham9614]

Tanks