Blog articles

Validation of microbiological methods

Written by Dr. Janet Thode on . Posted in Method validation

Microbiological methods are used in many applications in the pharmaceutical industry. Since it involves working with living organisms, various factors must be considered during an ongoing experiment. Many traditional methods have been established over the years and are listed universal methods in the pharmacopoeias. Considering the given requirements in the instruction their application doesn’t need a validation, only a verification is sufficient. Due to recent technological advancements, it is possible to use alternative methods developed by the laboratory or a company itself. To ensure the new method also demonstrably leads to correct results, a previous validation is must.

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Method optimization to increase sensitivity in case of LOQ / LOD problems

Written by Dr. Eva Arnold on . Posted in High performance liquid chromatography

In our first blog article on increasing the sensitivity in case of limit of detection (LOD) / limit of quantitation (LOQ) problems in HPLC methods, we addressed the increase in sensitivity primarily by reducing baseline noise. Now we will look on the same topic from another perspective – with the eyes of “method optimization”. What can be optimized to increase the peak size and thus the overall signal to noise ratio (S/R)?

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Linear versus non-linear regression: What should be considered?

Written by Dr. Eva Arnold on . Posted in Method validation

In any quantification method of a drug or its active ingredient, the linearity of the calibration line is a crucial criterion for the correctness of the values. The measured values should, in the best case, be directly proportional to the concentration of the analyte in the sample. Most methods have their limits; therefore, you often narrow the measurable range (linear range).

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