Validation of simultaneous volumetric and HPLC methods for the determination of pridinol mesylate in raw material.

Simple, sensitive, and economical simultaneous volumetric and HPLC methods for the determination of pridinol mesylate in raw material have been developed. The volumetric method is based on the reaction of pridinol with sodium lauryl sulphate in diluted sulphuric acid. Dimethyl yellow was used as indicator to detect the end point of the titration in aqueous/organic layer.

Validation of a paper chromatographic methodology as an alternative for determination of the radiochemical purity of Na18F.

Unlabelled: The aim of the present work was to validate a paper chromatography system as an alternative way to determine the radiochemical purity of Na(18)F.

Methods: The evaluated parameters were specificity, limit of quantification, measurement interval, linearity, precision, accuracy, and robustness.

Results: The proposed method proved to be linear (P > 0.

Quality control validation for exogenous natural surfactant labeled with 99mTc.

Objective: Exogenous natural surfactant (ENS) labeled with 99mTc shows an elevated lung specificity allowing the acquisition of high-quality images for ventilation scintigraphy.

Methods: The methods for 99mTc-ENS quality control (physical properties, pH determination, radiochemical studies, and biologic studies) were evaluated and validated.

Results: The physical properties of the nonradioactive precursor and of the radiopharmaceutical were analyzed as general descriptors of the product.