| Author | Message | ||
     chenchu sathish kumar (sathish) New member Username: sathish Post Number: 2 Registered: 11-2012 |
Hi sir, thanks for the reply can you send me the journals or articles sites for me for the particle size quantification and hydrate distinguistion... Thanks sathish | ||
| venkatarman (venkynir) Senior Member Username: venkynir Post Number: 158 Registered: 3-2004 |
Hi sathish; I have seen few publication NIRS for particle size . K/R used for it.Path length variation linked up for particle size. | ||
| chenchu sathish kumar (sathish) New member Username: sathish Post Number: 1 Registered: 11-2012 |
Hi every one i am very happy to join in this forum iam working as a research associate on nir instrument,i want to develop estimation of particle size method by nir. Does anyone know how to develop a method and any related journals or articles? Thank you sathish | ||
| David Semmes (dsemmes) Member Username: dsemmes Post Number: 11 Registered: 6-2010 |
There are updated versions of the EMEA document at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000357.jsp&mid=WC0b01ac0580028e8d. Other good NIR guidelines are available from the ASTM and http://pasg.org.uk/NIR/NIR.htm. | ||
| David Cho (davidc) New member Username: davidc Post Number: 2 Registered: 3-2012 |
Thank you all for your help! I'll check back with you when I've looked through the documents. | ||
| Sheelagh Halsey (shalsey) Advanced Member Username: shalsey Post Number: 23 Registered: 12-2006 |
I could not upload the file http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003331.pdf I have enclosed the link. Sheelagh | ||
| Sheelagh Halsey (shalsey) Advanced Member Username: shalsey Post Number: 22 Registered: 12-2006 |
Dear David One key item in method development is that you need to use the same vial for both NIR and reference method, i.e. you scan the vial on your NIR instrument, then use that same sample for you reference analysis. I have seen wide vial to vial variation from the same batch. There is a good EMEA document on method Sheelagh validation which I have attached | ||
| Tony Davies (td) Moderator Username: td Post Number: 281 Registered: 1-2001 |
Hello David, Karl Fischer is the recommended reference method for moisture in pharmaceuticals. I remember agreeing with my friend Fred McClure, in the 1980's, that NIR spectroscopy should replace KF as the official method before the end of the century. I think there is still some way to go! Best wishes, Tony | ||
| Pierre Dardenne (dardenne) Senior Member Username: dardenne Post Number: 70 Registered: 3-2002 |
David, Welcome to the discussion group. Typing "lyophilized drug moisture nirs" in google I got 143000 ref. The application is obvious and easy. Your SEP you should reach will be close to the error of the ref method with 2 or 3 wavelengths in the modeling. Pierre | ||
| thomas ricour (tricour) Advanced Member Username: tricour Post Number: 25 Registered: 2-2006 |
dear david, i have done that several times to determine moisture level under 3% on lyophilised cake directly through glass vials at high speed and for routine job. Maybe i can give some experience or details. feel free to contact me on my mail: [email protected] | ||
| David Cho (davidc) New member Username: davidc Post Number: 1 Registered: 3-2012 |
Hello everyone! I'm glad to have joined this discussion forum. I am a graduate student working on a project of using NIR to determine moisture content in a lyophilized drug (in small vials), to eventually replace the old Karl Fischer (KF) method. 1. When using NIR for quantifying moisture content in lyophilized compounds, would water/moisture be considered as an impurity (versus an assay), with respect to validation requirements? I am not sure whether the "Detection Limit" and "Quantification Limit" ICH categories are required when validating the NIR method to determine moisture content (approx 0.5-1.2% moisture range). 2. Does anyone know of articles/sources of a successful method validation of NIR for determining moisture content in lyophilized drugs? Thank you, David |