Having validated analysis methods for medicinal ingredients is attractive for pharmaceutical companies. When a new molecule is introduced to the market, there is not any pharmacopeial analysis method for that. After publishing official methods, correlation between validated in-house methods and the official one could stablish the value of the in-house method. Sitagliptin phosphate is a new anti...

In the present study, we aimed to determine whether shelf life of effervescent tablets may be assessed during storage using total directional hemispherical reflectance (THR). We also analyzed selected pharmacopeial parameters and used X-ray microtomography assess internal structure tablets. Two types one commercial product containing magnesium vitamin B6 (expired unexpired) were analyzed. addit...

Cefuroxime axetil immediate release tablets were formulated by direct compression method with different percentages of sodium lauryl sulphate (SLS) such as 0.5, 1.0, 1.5 and also without SLS. Resulting batches of tablets were evaluated by both pharmacopeial and non-pharmacopeial methods to ascertain the physico-mechanical properties. Dissolution test were carried out in different medium like 0....

A simple and inexpensive titrimetric method for the determination of magnesium ion in esomeprazole magnesium raw material was developed and validated according to International Conference on Harmonization guidelines and the United States Pharmacopoeia. The method depends on complex formation between EDTA and magnesium ion. The method was proven to be valid, equivalent and useful as an alternati...

Pharmacopeial microbiological tests detect and/or enumerate microbes that replicate in the presence of microbiological media. The challenge presented by adopting modern rapid microbiological methods is determining whether or not they represent the automation of a current compendial method or if they represent an “alternative” to a compendial method. The answer impacts how a firm should qualify ...

In this Stimuli article, the USP Validation and Verification Expert Panel discusses how the modern concept of a lifecycle model, which is based on process validation and described in ICH guidelines Q8, Q9, and Q10, can be applied to analytical procedures. The Expert Panel proposes that the traditional approaches to validation, transfer, and verification should be integrated into the analytical ...

The performance of the analytical methodologies recommended by the United States Pharmacopoeia (USP) monograph (1) for dissolution testing of lansoprazole (LPZ) enteric-coated solid dosage forms (capsules/tablets) was critically evaluated. While USP adopts an essentially nonselective UV method, the British Pharmacopoeia (2) recommends a highperformance liquid chromatography (HPLC) method capabl...