Is Fiber Optic UV analysis USP and/or FDA approved?
— A: USP is silent on specification and performance parameters specifically related to Fiber Optics, therefore the chemist should follow general USP guidelines for spectrophometry. With regard to the use of fiber optic probes or other sampling probes, in Article #71: “If automated equipment is used for sampling and the apparatus is modified, validation of the modified apparatus is needed to show that there is no change in the agitation characteristics of the test.” FDA has approved Fiber Optic UV Dissolution analysis as an alternate analytical test technique for a known N.D.A.
