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Glossary

Aminoglycoside antibiotics (aminoglycosides)
Aminoglycoside antibiotics (aminoglycosides)

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.

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Analytical methods
Analytical methods

Basic procedures for analytical testings

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Enzyme activity
Enzyme activity

Examination of the activity of the enzyme in phytopharmaceutics by measuring the appropriate reaction of the enzyme. The activity is relevant for the shelf-life of a medicinal product or drug.

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Extractables and Leachables
Extractables and Leachables

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.

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Ion Chromatography
Ion Chromatography

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.

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Method Development
Method Development

Development of appropriate analytical methods for testing defined values.

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Method Validation
Method Validation

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.

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Microbiology
Microbiology

Sciences and teaching of microorganism. The microbiological testings are quantification of bioburden. These tests are done with raw materials as well as medicinal products and samples from the monitoring of production area and equipment.

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Photostability
Photostability

Verification of the impact of light on the product quality of active substances and medicinal products.

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QP-Service
QP-Service

Execution of the release for market for a medicinal product by a qualified person (QP). Phytos possess the required manufacturing license for this service.

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Quality Control
Quality Control

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.

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Reference Substances
Reference Substances

Substances with a defined quality to compare the quality of a medicinal product esp. content and purity. The reference substances of the different pharmacopoeia can be purchased from the different agencies.

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Registration Service
Registrierungsservice

Support with assembling all relevant records and documents for application of a medicinal product.

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Stability Indicating Methods
Stability Indicating Methods

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.

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Stability Testing
Stability Testing

Studies to verify the constant quality of the product during the complete shelf-life.

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Veterinary Medicines
Veterinary Medicines

Medicines for animals. The legal requirements for animal medicines and human medicines are different because animals are often used for food-production, which leads to very stringent requirements and limits of use for the relevant products.

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25 Years