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Analysis

HPLC parameters using FaSSIF-V2

To compare HPLC profiles of FaSSIF-V2 made with our Buffer Concentrate vs buffer from scratch, the following HPLC method has been used for the different experiments.
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Analysis

HPLC Parameters using FeSSIF-V2

To compare the HPLC profiles of FeSSIF-V2 prepared using a) FeSSIF-V2 Powder with FeSSIF-V2 Buffer Concentrate and b) FeSSIF-V2 Powder with buffer made from scratch, the following HPLC in-house method has been used throughout the different experiments.
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Analysis

How to analyse your drug in Biorelevant Media

Analysing your drug in Biorelevant Media is quite simple; it is just like analysing drugs in other test solutions.
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What is a diluent?

A diluent is a solvent which is added to standard solutions of a drug substance...
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How to dilute and prepare standards

There are three types of standards that need to be prepared when analysing dissolution samples...
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Which dilution ratio to select for HPLC analysis

A suitable diluent ratio should not only keep the sample chemically and physically stable but should also allow the drug to be detected accurately and precisely by HPLC.
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Why Biorelevant Dissolution samples should be diluted for HPLC analysis

Immediately diluting biorelevant dissolution samples with an appropriate organic diluent prevents drug precipitation.
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How to dilute your secondary standard (SS) and dissolution samples with 1:10 dilution ratio whilst keeping the same matrix

The dilution of standard containing biorelevant medium is slightly different from the biorelevant dissolution sample...
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How to examine compatibility and dilution ratio of diluent with Biorelevant Media

Before HPLC analysis of any biorelevant dissolution sample containing drug, it is important to have identified a compatible diluent for the biorelevant media that will be used.
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Why are specificity and precision required with biorelevant media?

Biorelevant dissolution media contain natural surfactants which can affect chromatographic properties leading to erroneous analytical results.
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When are specificity and precision required when testing drugs in biorelevant media using HPLC??

Specificity and precision when analysing drugs in biorelevant media by HPLC
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What is 'specificity'?

Specificity is an integral part of analytical method validation and must be performed by carrying out multiple injections to eliminate potential errors that can occur during experimental sequence.
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How to prepare working sample of dosage unit(e.g. drug and excipients) with biorelevant medium to check interference

Three steps are required to prepare the working sample of dosage unit...
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Which solutions are required to check for interference

The following solutions should be tested to check for interference...
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Why include Biorelevant Media in working standards (WS)

It is important to include a biorelevant medium when diluting the secondary standard (SS) as it keeps the matrix of working standard (WS) and biorelevant dissolution samples similar.
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Selecting the drug concentration range of linearity standards (LS)

The linearity of an analytical method enables (over the range of dissolution concentration) generation of test results...
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What is 'precision'?

The degree of deviation between a set of measurements obtained from multiple analysis of the same homogenous sample under the specified conditions expresses the precision of an analytical method.
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How many HPLC injections are needed when carrying out specificity and precision?

For specificity and precision tests, it is recommended to carry out a similar number of injections that cover the number of samples that will be analysed by HPLC.
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Checking interference by injecting the dosage form in biorelevant medium

Interference of non-drug peaks (originating for example from excipients) should also be evaluated via specificity and precision using a sample which contains the dosage form.
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What to do if the retention time of a drug is reduced during HPLC analysis

Reduced retention time during HPLC analysis
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Which factors can increase the retention time of an analyte during HPLC analysis

Which factors can increase the retention time of an analyte during HPLC analysis
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How to apply a washing cycle when running an HPLC sequence

How to apply a washing cycle when running an HPLC sequence
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Signs of column deterioration

Explains what the common indicators of HPLC column deterioration look like
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How to store HPLC columns after using Biorelevant Media

How to store HPLC columns in the short, mid- and long term after using Biorelevant Media
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What are ghost peaks and why do they occur?

This post describes potential causes of ghost peaks when analysing a drug in biorelevant medium
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Analysis
Guides and Calcs

What is Maximum drug concentration calculator?

Before making PS, calculate theoretical maximum drug concentration required for analysis...
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Analysis
Guides and Calcs

What is Primary standard target concentration calculator?

This calculator helps you to figure out what will be the concentration of primary standard according to the amount of drug in the dosage form