Antibiotics composed of amino- and cyclohexan- modified sugars.
The mechanism of action bases on an error in the synthesis of the cell membrane. This causes the ruin of the bacterial cell. Aminoglycoside are active against gram-negative Enterobacter and gram-positive staphylococcus.
Aminoglycoside are bactericidal and quick acting.
Impurities like plasticizers derived from primary packaging materials. A distinction is made between extractables, which can be extracted from the primary packaging material under exaggerated conditions and leachables, which are typically a subset of extractables. These compounds migrate into the drug formulation from any product contact material (including elastomeric, plastic, glass, stainless steel, or coating components) as a result of direct contact under normal process conditions or accelerated storage conditions. These are likely to be found in the final drug product.
The ion chromatography is a chromatographic method for ionic species. The method bases on the characteristics of ions to bind on an ionic adsorbens (stationary phase) regulated by the manner and dimensions of the substance. Appropiate electrolytes are used as eluent (mobile phase). The separation of the components bases on different solvent- and adsorption prosperities, which lead to different dwell times in the chromatographic system followed by detection with suitable detectors.
Verification of the used method regarding suitability, precision, robustness, limits of quantification and detection as well as several additional parameters. The validation has to be done before the application for approval or in cases of a method transfer from one laboratory to another.
The department quality control is concerned with the sampling and execution of testings, according to specific methods and procedures.The QC takes care for the complete execution of all relevant testings and ensures the quality of the products. The quality control is an essential part of the quality management system.
Stability indicating methods are quantitative methods which are able to indicate changes of active ingredients or medicinal products during the shelf-life. The information about manner and amount of impurities is important for the pharmaceutical safety. The used methods for these testing must have a clearly design and must be validated.