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Presence of an impurity can be a real issue in drug development. It can considerably lengthen and complicate development times if not characterized in time and incur considerable extra-costs. Sometimes the entire formulation has to be reviewed. That’s why impurity profiling analysis is an important step in drug development and drug storage.
An impurity is defined as an unwanted compound remaining in a drug formulation other than the active pharmaceutical ingredient (API) or excipients. It can potentially have an effect on the efficacy or safety of the drug.For this reason, impurity profiling has became essential in order to meet various regulatory requirements, such as ICH, FDA or EMA.
KS-V PEPTIDE offers to isolate, identify and quantify impurities that may be present in a peptide-based formulation.In order to meet these challenges, KS-V PEPTIDE has state-of-the-art technologies at its disposal. High Performance Liquid Chromatography (HPLC) is used to separate and quantify chemical compounds. Mass Spectrometry (MS) is used to identify and elucidate the structure of these compounds. NMR can also be employed for further characterizations.
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Presence of an impurity can be a real issue in drug development. It can considerably lengthen and complicate development times if not characterized in time and incur considerable extra-costs. Sometimes the entire formulation has to be reviewed. That’s why impurity profiling analysis is an important step in drug development and drug storage.
An impurity is defined as an unwanted compound remaining in a drug formulation other than the active pharmaceutical ingredient (API) or excipients. It can potentially have an effect on the efficacy or safety of the drug.For this reason, impurity profiling has became essential in order to meet various regulatory requirements, such as ICH, FDA or EMA.
KS-V PEPTIDE offers to isolate, identify and quantify impurities that may be present in a peptide-based formulation.In order to meet these challenges, KS-V PEPTIDE has state-of-the-art technologies at its disposal. High Performance Liquid Chromatography (HPLC) is used to separate and quantify chemical compounds. Mass Spectrometry (MS) is used to identify and elucidate the structure of these compounds. NMR can also be employed for further characterizations.