Residual Solvent Analysis, Part-1 GC Headspace Calculations of Residual Solvents In Pharmaceuticals

[@aickiy]

Very very informative. Thank you.

[@MaheshKumar-uk9qq]

thank u sir it was very helpful video

[@AjaySharma-jn4sr]

Good Presentation

[@R96612]

Hi Dr. Arvind Thank you so much for your helpful content I have a question if you would help me please, in the calculation of residual solvents (ethanol for example) do we include the density or relative density of ethanol in the equation? And if so, what will be the unit of density in this case? Thank you so much in advance.

[@drarvindmittal7353]

Hello Randa Gamal, Nice to hear you. As explained in the video, one should avoid putting in density while calculating weights of solvents, for the obvious reason of change in density and volume with temperature. I have explained the technique of weighing the solvents. One more point, which I would like to emphasize is that results are reported on ppm (parts per million) basis which are truly expressed if they are reported in ug/g basis (microgram per gram basis). From your query, I can conjecture that you intend to use micro-pipette for weighing of solvents, which is practically not correct. Hope this shall help.

[@rahulchowdary9355]

how to calculate ppm for in solution foam?

[@Parthasarathivvc]

In calculation part =sample area/std area×dilution factor× 2mL/samplewt×purity of solvent ×10000. Doubt was that 2mL was std solution taken in his vial or diluent +sample hss vial sir?

[@drarvindmittal7353]

Dear Sarathi, the volume of blank, standard and sample has to be the same. Only then we can expect equivalent concentration of analytes. If we are taking 2 mil as blank, then 2 mL of standard and 2 mL of diluent (as blank) shall be taken along with the sample in HSS vial. For more clarity, try to understand procedure. 1 vial blank (2mL diluent), 6 vials of standard containing 2 mL each of standard solution and 2 vials of sample+ 2 mL diluent in each sample vial. Hope this will clear the doubt.

[@achyutjagdhane9683]

thanks a lot sir

[@sivajinerella]

Thank you sir

[@pinaldesai4559]

Sir, What is possible cause for vial skipping in HSS GC. Related to configure related

[@karthick38208]

Sensor issue due to dust in G1888

[@karthick38208]

Improper vial crimping in 7697 has and vial grip error

[@ankushthakur213]

Hello Sir, I want to know how we select sample concentration or sample size in RS e.g. in some cases 200 mg/ml or in some cases 500mg/ 2ml

[@drarvindmittal7353]

Sample amount/size depends on the ICH limits of the solvents and cost of the sample. If-only Class-3 solvents are of interest, whose limits are generally 0.5% (5000 ppm), you may opt for lesser amounts. However, if Class-1 solvents are to be determined along with other solvents, then you will have to choose bigger amount, in order to increase impurity's response. Another factor is cost of the sample! In case of HPAPIs or oncological substances, price is one of the limiting factor.

[@ankushthakur213]

@@drarvindmittal7353 Thanks Sir

[@parmjeetsingh8646]

Sir ,i want to contact u to some help regarding residual solvent ...can be possible sir?

[@drarvindmittal7353]

You can reach me at [e-mail]

[@anjaneyaprasad4241]

please upload gc calibration procedure

[@bhaskarlakavath]

Sir how to derivation of methoxy amaine hydrochloride in how elluted peak can u inform sir

[@drarvindmittal7353]

Have you tried Schotten-Baumann reaction? Try to use benzoyl chloride in pyridine.