RP-LC Method Development and Validation for Dasatinib Forced Degradation Study: Isolation and Structural Characterization by NMR and HRMS.

A reverse phase high-performance liquid chromatography (HPLC) method has been developed for the quantification of a typical drug Dasatinib (DST) and its related impurities in pharmaceuticals. Kinetex C18 (4.6 × 150 mm, 5 μm) column was used in the chromatographic separations, using buffer (1.

A Multi-Analyte LC-MS/MS Method for Determination and Quantification of Six Nitrosamine Impurities in Sartans like Azilsartan, Valsartan, Telmisartan, Olmesartan, Losartan and Irbesartan.

A sensitive and robust method for determination and quantification of potential genotoxic impurities in sartans has been developed. These impurities need to be controlled at trace levels during quantification in drug substances and drug products for safe consumption. Recent regulatory requirements also suggested the need to have highly sensitive analytical method for trace level quantification of nitrosamine impurities.

Stable Fatty Acid Solvates of Dasatinib, a Tyrosine Kinase Inhibitor: Prediction, Process, and Physicochemical Properties.

Exploration of alternate solid forms for dasatinib, a potent oncogene tyrosine kinase inhibitor classified under Biopharmaceutics Classification System (BCS) class II drugs with low water solubility and high permeability, has been performed using COSMO-RS excess enthalpy (Hex) to increase dissolution. The theoretical prediction resulted in the potential for the formation of C-C fatty acid solvates with dasatinib. A crystallization process has been identified for the preparation of the predicted solvates and successfully scaled up till the 100 g level.

A Stability Indicating Method Development and Validation for Separation of Process Related Impurities and Characterization of Unknown Impurities of Tyrosine Kinase Inhibitor Ibrutinib Using QbD Approach by RP-HPLC, NMR Spectroscopy and ESI-MS.

A selective RP-HPLC method for separation and determination of potential-related impurities (process related and degradants) of Ibrutinib drug substance has been developed and validated. The separation was accomplished on a X-Bridge C18, (150 x 4.6 mm, 3.

Crystal structure of 3-bromo-acetyl-6-chloro-2H-1-benzo-pyran-2-one.

In the title compound, C11H6BrClO3, the benzo-pyran ring system is essentially planar, with a maximum deviation of 0.036 (2) Å for the O atom. The Cl and Br atoms are displaced by -0.

Crystal packing and melting temperatures of small oxalate esters: the role of C-H···O hydrogen bonding.

The simple dialkyl oxalates are generally liquids at room temperature except for dimethyl and di-tert-butyl oxalate which melt at 327 and 343 K. The crystal structures of diethyl, di-iso-propyl, di-n-butyl, di-tert-butyl and methyl ethyl oxalates were determined. The liquid esters were crystallized using the cryocrystallization technique.

N-(2-Amino-3,5-dibromo-benz-yl)-N-methyl-cyclo-hexan-1-aminium p-toluenesulfonate.

The title compound, C(14)H(21)Br(2)N(2) (+)·C(7)H(7)O(3)S(-), features a salt of protonated bromhexine, a pharmaceutical used in the treatment of respiratory disorders, and the p-toluenesulfonate anion. The crystal packing is stabilized by inter-molecular N-H⋯O, N-H⋯Br and C-H⋯O hydrogen bonds.

3-(2-Bromo-acet-yl)-6-fluoro-2H-chromen-2-one.

The non-H atoms of the title compound, C(11)H(6)BrFO(3), are essentially coplanar (r.m.s.

Quinoxaline: Z' = 1 form.

A new Z' = 1 crystal structure of quinoxaline (or 1,4-diaza-naphthalene), C(8)H(6)N(2), with one-fifth the volume of the earlier known Z' = 5 structure was obtained by means of an in situ cryocrystallization technique.