For Liquid Chromatography High-performance liquid chromatography is an efficient type of column chromatography widely used in pharmaceuticals. It is very useful for determination of assay and related substances in drug substance. In general, HPLC is used to separate the components of a mixed drug substance. In ...

Out of specification investigation flowchart for laboratory stage as well as manufacturing.

Out of specification results are not rare in pharmaceutical industries but their investigation and finding the real root cause is time consuming process and includes many steps. Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable ...

Root cause analysis is performed to determine the root cause of errors or problems during the process. Root causes of out-of-specifications, production time deviations, and market complaints must be determined. Various methods are used for root cause analysis in pharmaceuticals. 5 Why is a useful and ...

Out-of-Specifications Deviations of products from pre-determined specifications. This means when a product is unable to meet the predetermined limit for that particular product. There are several possibilities that could account for this deviation. These possible reasons for out-of-specification can ...

A pH meter is used to measure the acidity and alkalinity of a solution, or a pH meter is an electronic device used to measure the pH of any solution. pH meter calibration is required at regular intervals or at defined frequencies to maintain accuracy. pH Meter Principle It measures the voltage between ...

No single technique is perfect and UV-Vis spectroscopy is no exception. But the technique has a few key strengths that make it popular. =>> The technique is non-destructive, allowing the sample to be reused or to proceed to further processing or analysis. =>> Measurements can be made quickly, allowing ...

UV spectroscopy or UV–visible spectrophotometry (UV–Vis or UV/Vis) refers to absorption spectroscopy or reflectance spectroscopy in part of the ultraviolet and the full, adjacent visible regions of the electromagnetic spectrum. Being relatively inexpensive and easily implemented, this methodology ...

Analytical method development is considered an important process in pharmaceuticals. The availability of different types of columns, operating parameters, mobile phase compositions, diluents and pH values makes it important to develop an analytical method. A good analytical procedure should be simple, ...