Development,stability-indicating assessment,and evaluation of influential method conditions using a full factorial design for the determination of Nintedanib esylate-related impurities

The design of an appropriate analytical method for assessing the quality of pharmaceuticals requires a deep understanding of science, and risk evaluation approaches are appreciated. The current study discusses how a related substance method was developed for Nintedanib esylate. The best possible separation between the critical peak pairs was achieved using an X-Select charged surface hybrid Phenyl Hexyl (150 × 4.6) mm, 3.5 μm column. A mixture of water, acetonitrile, and methanol in mobile phase-A (70:20:10) and mobile phase-B (20:70:10), with 0.1% trifluoroacetic acid and 0.05% formic acid in both eluents. The set flow rate, wavelength, and injection volumes were 1.0 ml/min, 285 nm, and 5 μl, respectively, with gradient elution. The method conditions were validated as per regulatory requirements and United States Pharmacopeia general chapter < 1225 >. The correlation coefficient for all impurities from the linearity experiment was found to be > 0.999. The % relative standard deviation from the precision experiments ranged from 0.4 to 3.6. The mean %recovery from the accuracy study ranged from 92.5 to 106.5. Demonstrated the power of the stability-indicating method through degradation studies; the active drug component is more vulnerable to oxidation than other conditions. Final method conditions were further evaluated using a full-factorial design. The robust method conditions were identified using the graphical optimization from the design space.     

Partial Geometric Difference Families

We introduce the notion of a partial geometric difference family as a variation on the classical difference family and a generalization of partial geometric difference sets. We study the relationship between partial geometric difference families and both partial geometric designs and difference families, and show that partial geometric difference families give rise to partial geometric designs. We construct several infinite families of partial geometric difference families using Galois rings and the cyclotomy of Galois fields. From these partial geometric difference families, we generate a list of infinite families of partial geometric designs and directed strongly regular graphs.     

An Enumeration of Certain Projective Ternary Two‐Weight Codes

We detail the enumeration of all two‐intersection sets of the five‐dimensional projective space over the field of order 3 that are invariant under an element of order 7, which include the examples of Hill (1973) and Gulliver (1996). Up to projective equivalence, there are 6,635 such two‐intersection sets.     

Current status of the TwinMic beamline at Elettra: a soft X‐ray transmission and emission microscopy station

The current status of the TwinMic beamline at Elettra synchrotron light source, that hosts the European twin X‐ray microscopy station, is reported. The X‐ray source, provided by a short hybrid undulator with source size and divergence intermediate between bending magnets and conventional undulators, is energy‐tailored using a collimated plane‐grating monochromator. The TwinMic spectromicroscopy experimental station combines scanning and full‐field imaging in a single instrument, with contrast modes such as absorption, differential phase, interference and darkfield. The implementation of coherent diffractive imaging modalities and ptychography is ongoing. Typically, scanning transmission X‐ray microscopy images are simultaneously collected in transmission and differential phase contrast and can be complemented by chemical and elemental analysis using across‐absorption‐edge imaging, X‐ray absorption near‐edge structure or low‐energy X‐ray fluorescence. The lateral resolutions depend on the particular imaging and contrast mode chosen. The TwinMic range of applications covers diverse research fields such as biology, biochemistry, medicine, pharmacology, environment, geochemistry, food, agriculture and materials science. They will be illustrated in the paper with representative results.     

(s,l)-叠加码的构作及其性质

一个二元叠加(s,l)-码在许多领域有着极为广泛的应用.利用有限集[n]的子集构作了一个(0,1)-矩阵C,并证明了它是一个(s,l)-码,给出了(s,l)-码的性质.