How to decide the concentration for the sample and standard in related substances?

How to set the concentration for the sample and standard in related substances?
More than 1000+ pharma professionals have chosen Pharma Growth Hub as their career acceleration partner, now it’s your turn!
27 courses worth Rs. 1,16,690/- are available for just Rs. 6990/- This offer may not stay for long, so take action.
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
Alternate payment options(GPay/PhonePe): 9766383968
WhatsApp @9766383968 for more info…

[@huteshbharambe8558]

Plz make video on "How to develop method from a given molecular structure"

[@rajunaikbadhavath3442]

yours videos are highly appreciable and useful...thank you lot

[@radhakrishna8186]

Hi Bhaskar sir, this is the first ever channel which is providing enormous knowledge to our pharma professionals. God bless you and your family 👌❤

[@pharmagrowthhub3083]

Thanks a lot

[@durgalavanya7037]

Very worthable vedio to me. Tq sir.. Please educate like this way with more vedios

[@lvramirdy84]

Cleary understood ....how to set standard and sample concertration... Thank you.........

[@ingisproduction8072]

Thanks Sir, it's new for me. Thanks for upgrading....

[@harikrishnareddybhumireddy4198]

ur explanation is very good thanks sir

[@achyutjagdhane9683]

thank you , it is very helpful

[@arunvishwakarma5109]

Thank you very much sir for such support

[@bhausahebhingade3541]

Thanks sir very good keep it up work

[@sravanthithota8951]

Sir thanku for ur valuable information

[@sathishkorumilli6064]

very good explaination sir

[@bharathivendhan]

Easy understanding

[@subratmishra6468]

It's nice explaination..

[@rupchandpitekar3772]

Thank you for describe

[@jitendratarmale6310]

Very helpful

[@sachinsawant6932]

Sir, your all vedios are knowledgeable and helpful 🙏🙏

[@pharmagrowthhub3083]

So nice of you

[@basavarajuraju323]

Thank you sir it's nice vedeo

[@bandikattuvenkatasiva2542]

Thank you so much sir

[@RazaKhan-ds8by]

where 1ppm come from and how did find SN 10. please not clear

[@balajiorchid]

Dear sir, First of all thanks for helping me to improve the knowledge. In this class I have one small doubt sir, I am not understand to set the concentration of standard clearly sir

[@remborathod-ry2bx]

Standard concentration is set according to the specifications of the highest unknown specifications impurity for eg. Unknown impurity specifications are 0.2% and sample concentration is 1000ppm simply cross multiplication we will get standard concentration.

[@shekhargoud3964]

Good videos sir..

[@shankarsharma2822]

Thanks

[@prasadmallavarapu7740]

Thank you sir

[@sagarsatbhai]

Pls mk vdo on how to rectify process and degrade impurity if possible. Thnk you!!

[@lovehindustan710]

Thank you

[@NaushadAlam-vs9ij]

Very good

[@abhishekjoshi9650]

Thank u sir

[@pimaop2553]

sir I need to know use of buffer compostion and its pH? WITH SOLVENT

[@srinivaschintha9958]

I am hapy to you,thank you very much sir,your vedio was very useful for whom studying drug analysis by HPLC Sir i need to how to calculate for LOD and LOQ in both sample and standard drug and formulation using HPLC with perfectly Thank you sir

[@vinodpatil9202]

Great

[@sutraina2474]

Sir how to fix limit for dissolution of tablets or capsules dosage forms???

[@rahulkulkarni3037]

Perfect

[@tadalavenkateswararao2090]

Sir why prepared std concentration in unknown level? And why must be our reporting threshold with inthe

[@mahahussein-c2e]

My standard is 0.00146 mg/ml and test is 0.0146 in method. How to disregard 0.05% ??calculation

[@Mukesh-ne3yj]

Nice

[@harishasnayak5249]

Good video Please make video on RS qualifications techniques

[@harishasnayak5249]

Rs quantification techniques

[@abhishekjoshi9650]

Pl make different video of method development Related Substance..

[@gopalgirase-01]

How decide sample conc in assay?

[@vijaykumar-md2xk]

Very well explained

[@pharmagrowthhub3083]

Glad it was helpful!

[@dils2678]

@@pharmagrowthhub3083sir.... requesting you to make vedio on Analytical method development Reply sir

[@amirkhusru4603]

informative

[@gopalgirase-01]

Sir, What is chart purity?

[@buddepumohanarao8309]

Excellent sir

[@buddepumohanarao8309]

Sir Plese make video on how to start analytical method development for new molecule

[@pharmagrowthhub3083]

So nice of you

[@tadalavenkateswararao2090]

Sir why taken standard concentration higher unknown impurity %

[@Mukesh-ne3yj]

RS sple concentration in API afyer method set

[@Bhavisyacreations2019]

Sir, Can you elaborate how 1ppm = 0.025 percentage I think that is 25 ppm right

[@harikrishnanayyappan9179]

There is very simple calculation, Impurity LOQ in % /100 × Sample Concentration in ppm = Impurity in ppm 0.025/100× 4000= 1ppm, Note: above calculation I used 100 because your Impurity LOQ in %, hence Example: Assay in % : mg per mL / Labled Amount × 100 = content in %

[@pharmagrowthhub3083]

💊How to develop skill set to advance your career📈 in QA, QC, AR&D💊 Join me online on SUNDAY, 1st Aug between 7:00 pm to 9:00 pm to learn below ✔4 steps to build technical competency in QA, QC, AR&D 💥💥 ✔3 pillars to reach your full potential 🚀🚀 ✔3 strategies to influence your marketplace 🤩🤩 Free Webinar Registration link: us02web.zoom.us/webinar/register/7616276120910/WN_5nss-f3ETuaJ4lr_BzrPBQ Join WhatsApp Group: chat.whatsapp.com/HB5rP5P1rgy62fT8FgNBlS I look forward to meet you inside room

[@AliRaza-wp8tr]

Can somebody tell me how 1ppm equals to 0.025%

[@SG73088]

Sir, please take lecture on isolation of impurities by Preparative HPLC and it's profile topic.

[@Aaakashkaushik]

Sir plz translate in hindi

[@NaushadAlam-vs9ij]

Sir you can't explain proper

[@mopurirahul2929]

😂😂😂😂😂😂😂