| Author | Message | ||
     raed salah |
I'm pharmaceutical analyst working in Q.C and R&D labs I have read a lot about NIR technology , but unfortunately I havenot used it yet. Most of our analysis is done using HPLC for Q.C release or for stability studies. I want to ask if NIR can completly replace HPLC and if it is acceptable for regulatory authorities or not and if it is a stability indicating instrument or not. Please help me in that. | ||
| Bruce H. Campbell (Campclan) |
Dear Raed, In almost all cases, NIR can replace HPLC for organic samples. There is a caveat to this, though. The calibration samples for NIR must be analyzed by an independent technique, such as HPLC. Thus, you would have to keep that reference method available both for the initial analyses of the calibration samples and for occaisonal checks of the NIR calibration. As far as if regulatory agencies accept NIR as a valid technique, that would depend on which country you are in and therefore, it would be best if you contact them directly. The advantages of NIR do make the switch to that method very desirable. Advantages such as increased precision, faster analyses, the ability to go in-line, easier usage, no sample preparation, and several others. Bruce Campbell | ||
| W. Fred McClure (Mcclure) |
Raed, I suggest you get in touch with Gary Ritchie, an NIR vetran,who is now working with USP (Pharmacopeia: Gary's Email: [email protected] Also, I can put you on to the largest database in the NIR field: Just get in touch with me directly - [email protected] Fred | ||
| Ronaldo Galv�o (Rgalvao) |
Gary I'm Chemical Engeneering working in Q.C and R&D labs I have been using NIR for identification analysis and we would like to work with quantification. Most of our analysis is done using HPLC or UV for Q.C release or for stability studies. I want to ask if NIR can completly replace HPLC or UV and if it is acceptable for regulatory authorities or not and if it is a stability indicating instrument or not. If I can validade it´s OK ? Please help me in that. Best regards Ronaldo Galvão | ||
| Gary |
Ronaldo, To first question: 1. " I want to ask if NIR can completely replace HPLC..." The answer is no, not completely. NIR is a secondary method, thus the primary method (your HPLC) will be required to create values for the NIR spectra that you will then correlate to. You would then need to keep HPLC to check every so often (every 6 months say, or depending on frequency and number of new batches analyzed, say every 30 lots) the NIR model to ensure that it is in fact still predicting without any significant bias. Also from a regulator point of view, the primary method will still be required for filing purposes, since you would file the NIR method as an alternative method. 2. "and if it is acceptable for regulatory authorities or not" The agencies are all anxious and receptive to this technology, and there is really nothing in most regs to preclude filing for this application. Good scientific judgement coupled with complying to acceptable validation criteria will serve as underpinnings to your filing a NIR method. Remember though, you will still need to develop and file a primary method (HPLC or otherwise) and you would most likely file the NIR method initially for alternative use until you acquire a lot of supporting data to justify establishing it as a primary release test. In most cases, an Agency would like to do this with you so that they too also" learn" the application. 3. ..."and if it is a stability indicating instrument or not." The sensitivity of NIR methods generally are at the 0.1% level, so that people are not generally developing stability indicating assays using NIR. Remember, your NIR spectra will contain all of the components present in your sample, so that achieving detection of impurities, or related substance in the presence of matrix at quantitative levels required by most agencies is essentially unachievable. Now there are some applications at very low levels, but not meant for low level quantitative work. I hope between this answer and the NIR discussion board, I have answered you questions. Please continue to use the Discussion board, as these fellows are the worlds experts in NIR and applied chemometrics for spectroscopic analysis. I will continue to guide with respect to regulatory concerns involving this technique. Gary Ritchie |