The linearity of test solution was prepared at six concentration levels, 0.01 to 2.0 mg/mL for AR, from 6 to 60 μg·ml-1 for impurity 2 and 1, from 10too 100 μg·ml-1 for impurities 3, 4 and 5.
The same method was used for LC-MS analysis to identify m/z and fragmentation of maximum unknown impurities (Non-Pharmacopoeial) i.e. Impurity-I (1), Impurity-III (3), Impurity-V (5) and Impurity-VIII (9) formed during stability studies.
Based on the results, degradation pathway for the drug has been proposed and synthesis of identified impurities i.e. impurities (Impurity-I (1), Impurity-III (3), Impurity-V (5) and Impurity-VIII (9)) are discussed in detail to ensure in-depth understanding of OMP and its related impurities and optimum performance during lifetime of the product.
Figure 6 Impurity Green function in the time domain.
Beyond this doping level, however, Gd2O3 impurity phase in the LTO led to adverse electrochemical performance.
The developed method effectively separated the degradation products (3 degradation peaks under acidic stress, 3 impurity peaks under basic stress, 5 impurity peaks under oxidative stress, 2 impurity peaks under dry heat stress) from analyte peaks (Figure 3).
The developed method effectively separated the degradation products or impurities (6 impurity peaks under acidic stress, 6 impurity peaks under basic stress, 6 impurity peaks under oxidative stress, 7 impurity peaks under photolytic stress,) from analyte peaks [Figures 3, 4, 5, 6, 7].
The band at around 1580 cm−1 corresponds to H2O impurity that resides in structural voids [23].
The Li3PO4 coating process cleans the Li2CO3 impurity on the surface of the material.
This maybe due to some Mn2O3 impurity existing in the sample.
