Related Substances method development by HPLC

#rs #hplc #method #interview #pharma
Related Substances method development by HPLC
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Please find the main module details below...
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
10. QMS Mastery
» Incident, OOS, OOT, CAPA, Change control
» QMS examples
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
» Preparation, Execution & Review of CSV
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
» 3 Month job search plan
» Job search tracker
» How to connect with TAMs
» How to communicate with TAM
25. Resume & LinkedIn Blueprint
» Resume optimization
» LinkedIn optimization
» Resume writing
» Converting resume templates
26. Job interview blueprint
» Job interview checklist
» Job INTERVIEW questions
» Phrases to avoid
» Power of words
27. Inner circle calls
» Previously recorded sessions
» Opportunity to network with PGH Stars
Payment link (Rs.6990): imjo.in/vPe7Rc
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[@bhaskaryadav739]

Hats off you sir, for your selfless sharing of real practical troubleshooting knowledge

[@HarikrishnaTirumala9]

I got the job in eminent pharma organisation by your valuable knowledge sir.. You are doing a great help to analytical people.. God may bless you with wealth,health and prosperity.. thank you sir..

[@utkarshvyas3185]

Found so interesting... The concept of blending FD samples.....

[@hanumantgare1891]

Very good information for good method development. Thanku so much sir. Very simple language explain.

[@simhachalamvanka9469]

S

[@shekhargoud3964]

Good learning from your videos sir...

[@deepakkulkarni2792]

Thank you sir...This video give much more information and helpful for method development ...

[@rajasekharreddy8610]

Good day sir Could you please elaborate different between Related substances, organic impurities and related compounds

[@kolusuanand7582]

Good information sir , ur english fluency is good

[@rohitkhade4060]

How to perform fd study in normal phase liquid chromatography

[@sanketdalvi2942]

Thanku sir....giving useful information... ❤️

[@SG73088]

Fabulous lecture.

[@jaykumarbhatt8841]

Great 👍

[@prakashbhingude4889]

Very good sir.... keep it up

[@vikasmehta3568]

Good knowledge sharing Sir

[@sarveshkumaryadav7899]

Thanks sir.....

[@abhishekjoshi9650]

I am daily watching video of Analytical method development

[@IsmailKhan-ud7vx]

Tq sir

[@Satish_jannu]

Good morning sir 🌄

[@sumavanthsamayam2992]

Excellent sir

[@rahulkulkarni3037]

Very good information

[@vadlavallikanakarao3154]

Good information sir

[@sagarabhale4028]

Nice video

[@thehealer8330]

How to do RRF estimation without impurities standard? Can you elaborate with sample chromatogram and data table.

[@gulabgorde1152]

Nice

[@abhishekjoshi9650]

Sir make more video of RS Analytical Method development

[@IsmailKhan-ud7vx]

Sir callction impurities rrf solutions Rf solutions Rt cal Accuracy caltion

[@rupanalam1369]

Sir please share a impurity method validation video.

[@srinivasaraomutyala7430]

Please share one video gradient program Isocratic Linear step gradient examples.

[@akshaymodha]

Which software are you using for These explanation?

[@subhanid6656]

Hi sir, I have one doubght in FDS. Why some of the agencies asking more degradation in FDS

[@thehealer8330]

Complete chromatographic demonstration of RRF calculation without using impurities standard?? Also estimation of assay and Impurities Using RRF. And also with chromatogram

[@srikanthkore1601]

Total Ar&d each and everything in Ar&d how can learn..have any material or any training centers.. I have so intrest lo learn but how

[@harireddy5114]

Please share method development of compound with 3 pka values

[@quimicamaxima]

Could you enable subtitles?

[@Aaakashkaushik]

Sir plz make video in hindi