where S is surface area of the dissolving phase, V is leachate volume, ke is rate constant for electrochemical dissolution, f(E) is dissolution rate as a function of electrochemical potential E, k. is rate constant for SF dissolution, Cs is effective solubility limit of dissolving phase, Ct...
The limit of detection (LOD) was found to be 10 μg/mL for Acamprosate calcium and limit of quantitation (LOQ) was found to be 31 μg/mL for Acamprosate calcium. Hence it can be concluded that effective dissolution method by UV spectroscopy is developed and validated as per ICH guidelines...
Sublingual Tablets—Apply the test forUncoated Tablets. At the end of the time limit specified in the individual monograph, all of the tablets disintegrate completely. If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets: not fewer than 16 of the total o...
However, material properties and environmental factors play an important role; a higher diffusion coefficient for the solute in the solvent increases the rate of mass removal, and as the bulk concentration of solute in the entire solution approaches the solubility limit, the rate of approaches zero...
Dissolution data of half of the carbonyl iron capsules (viz CI-03, CI-05, CI-07, CI-08 and CI-10) did not meet pharmacopoeial specification i.e., their Q value (percent released of the labeled amount of the drug) was below the acceptance limit (75%) of USP. To conclude, only ...
The lower limit of quantification (LLOQ) results demonstrate that the analytical technique for ALB can accurately determine concentrations within the LLOQ. The accuracy and precision of ALB in rat plasma are shown in Table 3. Table 3. Results of in-day precision and accuracy. R2 was equal to...
Further, this technique is especially promising for poorly water-soluble compounds as previous studies have pointed out the difficulties of measuring the IDR from standardized dissolution methods, i.e., a compressed disc, since the dissolved material can be below the detection limit [11,32]. In ...
that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as CO...
The system suitability parameters such as theoretical plate count, tailing and percentage RSD between six standard injections were within the limit. The peak purity plots show that the Ivabradine hydrochloride peak is homogeneous and that there are no co eluting peaks indicating that the method is ...
The % recoveries at 20%, 50%, 100% and 120% were found to be within the limit of 95-105%. The method was validated as per ICH and USP guideline and the values were found to be within the limits. So, the proposed method was found to be simple, lin...