Calculation of an Unknown Impurity in the Combination Drug Product

#impurity #interview #pharma
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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
10. QMS Mastery
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11. ICH Quality Blueprint
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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
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[@sridevipulakanam9626]

Through ur lecture vedios most of the students will gain a clear idea about hplc method development, quantification of unknown impurities..like so many things...tq sir

[@sridevipulakanam9626]

Tq so much sir for doing these vedios...making analytical people more clear about theorical knowledge applied practically

[@nighthunterism]

Thank you so much for your educational videos.i had great interview after watching your videos & today I got offer letter...Thanks to you Bhaskar sir.

[@pharmagrowthhub3083]

Wonderful!

[@suranjanpaul16]

Sir please make a brief video on 21CFR which is very useful for us...

[@ajaychandel86]

Thanks sir for sharing knowledge Big fan 🙏

[@bhushanborse917]

Sir best explanation, sir make more video about nitrosamine, MRM technique, Aims test, control strategy for Nitrosamines. In details plz

[@trendbizz2743]

Thanks you sir for answering

[@manojmodi414]

Thank you very much sir 🙏

[@prajapatisohal8641]

Sir, good morning, aap carryover study in drugs substance ke liye video Bnaye na

[@sarikanalam1249]

What if the unknown impurity is a process induced one...then you will not find it in API 1+ placebo and API2+placebo

[@shubhamsrivastava2244]

Can you tell me sir how to check related substance and dissolution crtieria of any drug if its monograph is not available in indian pharmacopeia.

[@md.nazmulhossainmd.nazmulh1822]

If the strength of both API is same, then how can i calculate?

[@EARTH_THAKUR]

How to calculate LOQ & LOD concentration for impurities?

[@sridevipulakanam9626]

In most of the pharmacy colleges...there is no felicities to run the hplc and and also lack of practically knowledged faculty members ...students are coming out with no knowledge about hplc

[@sagadev15]

If we monitor API 1 and API 2 in different wavelength nm.then what could be the case