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The understanding, identification, quantification and control of impurities in drug substances are essential as new molecular entities are evaluated in clinical development. As chemical processes used to produce drug substances mature from the early phases of development through registration, a concomitant maturing of process-related impurity understanding… (More)
To optimize a controlled release (CR) matrix formulation with two goals: (1) effectively deliver a prodrug to a preferred absorption region of the upper GI tract, and (2) afford a PK profile similar to a “reference” CR formulation. A pharmacoscintigraphic clinical study was conducted using a flexible formulation design space. A six-arm, three-prototype… (More)
Quantification of impurities in drug substances and dosage forms using HPLC assays with UV detection is often done by comparison to a standard of the drug itself. Depending on the spectra of the compounds involved, small changes in wavelength may cause response factors to vary from day to day and instrument to instrument. Lack of assay ruggedness with… (More)
An efficient synthetic approach leading to introduction of the hydroxymethyl group to an aryl moiety via combination of the Bouveault formylation and hydride reduction has been optimized using a rational, mechanistic-based approach. This approach enabled telescoping of the two steps into a single efficient process, readily amenable to scaleup.
This vapour-phase acid decomposition of small biological samples (50-165 mg) and concurrent purification of the reagent acid were achieved in a mini-quartz sample holder inserted in a commercial high-pressure digestion vessel. A 3.1 ml volume sample contained was developed to hold the sample and to maximize the successful decomposition of a variety of… (More)