An ultra performance liquid chromatographic (UPLC) method was developed for simultaneous determination of seven steroid (dienogest, finasteride, gestodene, levonorgestrel, estradiol, ethinylestradiol, and norethisterone acetate) active pharmaceutical ingredient (API) residues. A new, generic method is presented, with which it is possible to verify the cleaning process of a steroid producing equ...

Technetium-99m ethyl cysteinate dimer (Tc-99m-ECD) is an essential imaging agent used in evaluating the regional cerebral blood flow in patients with cerebrovascular diseases. Determination of active pharmaceutical ingredient, that is, L-Cysteine, N, N'-1,2-ethanediylbis-, diethyl ester, dihydrochloride (ECD) in ECD Kit is a relevant requirement for the pharmaceutical quality control in process...

In the pharmaceutical industry, co-crystals are becoming increasingly valuable as crystalline solids that can offer altered/improved physical properties of an active pharmaceutical ingredient (API) without changing its chemical identity or biological activity. In order to identify new solid forms of diclofenac-an analgesic with extremely poor aqueous solubility for which few co-crystal structur...

Solid dose drugs comprise a considerable segment of the pharmaceutical market. The solid dose form can offer long shelf life, convenient drug delivery, and can be packaged into capsules, tablets, gel caps, and patches. Polymorphism is the ability of a molecule to exist in more than one stable or meta-stable crystalline state. Distinct crystalline forms commonly exhibit differences in pharmacolo...

For several years, near-infrared spectroscopy (NIRS) has become an analytical technique of great interest for the pharmaceutical industry, particularly for the non-destructive analysis of dosage forms. The goal of this study is to show the capacity of this new technique to assay the active ingredient in low-dosage tablets. NIR spectroscopy is a rapid, non-destructive technique and does not need...

A direct, ambient ionization method has been developed using atmospheric pressure thermal desorption-extractive electrospray-mass spectrometry (AP/TD-EESI-MS) for the detection of the genotoxic impurity (GTI) methyl p-toluenesulfonate (MTS) in a surrogate pharmaceutical matrix. A custom-made thermal desorption probe was used to the desorb and vaporize MTS from the solid state, by rapid heating ...

Systematic nonlinear optimisation is a valuable tool towards evaluating the performance of conceptual Continuous Pharmaceutical Manufacturing (CPM) flowsheets. This study considers total cost minimisation of multiple plausible design choices and eight candidate antisolvents for the continuous recovery of artemisinin (a potent antimalarial Active Pharmaceutical Ingredient/API) via continuous cry...

Over the past few decades hot melt extrusion (HME) has emerged as a powerful processing technology for the production of pharmaceutical solid dosage forms in which an active pharmaceutical ingredient (API) is dispersed into polymer matrices. It has been shown that formulations using HME can provide time-controlled, sustained and targeted drug delivery, and improved bioavailability of poorly sol...

Suspension dosage forms require the use of suspending agents in order to deliver a uniform dose of the active ingredient. The purpose of this study is to investigate the properties of a new plant gum as a cheap and effective natural polymer in the formulation of pharmaceutical suspensions. The gum obtained from the incised trunk of Cedrela odorata (family Meliaceae) was compared with hydroxypro...