| Author | Message | ||
     Sanette van der Merwe (Sanette) |
What identification tests described by the USP and BP can the NIRS replace once an identification method is validated? I have posed this question to two different vendors and both argued that you could replace all tests since none of the pharmacopoeias have specific guidelines on what you may and may not do. They do however suggest periodic testing. Specific rotation is one of the identification tests that we would wish to replace. Any suggestions on how we should approach this issue? Sanette | ||
| hlmark |
Sanette: one of the biggest, and still rapidly growing, applications of NIR in the pharm industry is 100% identification of incoming raw materials. While some of these are near-universal (lactose or microcrystalline cellulose, for example), each company also has it's unique and proprietary materials. Thus there does in fact seem to be no limit on what can be identified. You do have to be careful, of course, about similar materials, when the differences are important: the same material with different particle sizes, for example, or anhydrous material versus the same with H2O of crystallization. Howard \o/ /_\ | ||
| David W. Hopkins (Dhopkins) |
Sanette, My understanding is that the NIR test can replace one test. Therefore, if you are required or decide to do 2 tests, you can select to replace either validated method. If one test is required, that one may then be the validated NIR method. Dave | ||
| DJDahm |
If by "Specific rotation is one of the identification tests that we would wish to replace." ; you mean that you now use the rotation of plane polarized light to determmine the fraction of an optical isomer that you have, I don't think you will have much luck replacing it with NIR. |