ЧАСТО ЗАДАВАЕМЫЕ ВОПРОСЫ
Часто задаваемые вопросы о тесте растворимости содержат ответы на распространенные вопросы о настройке, эксплуатации, техническом обслуживании и устранении неисправностей оборудования для тестирования растворения. Он охватывает ключевые темы, такие как процедуры тестирования, калибровка и соответствие отраслевым стандартам, предлагая ценную информацию для обеспечения точных и надежных результатов испытаний в фармацевтической промышленности.
Frequently asked questions
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Q:
How to choose the right type of cell for the flow cell dissolution device?
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22.6mm standard flow cell is the commonly used cell type, which can be adapted to almost all the needs of dissolution experiments of dosage forms. For soft capsule and suppository testing, we can try the Lipophilic Solid Dosage Forms (LSDF) test cell listed in the European Pharmacopoeia according to your needs. Powder and implant test cells are also available.
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Q:
What are the advantages of flow cell over general purpose dissolution meters:
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The flow cell method can provide a more flexible range of solvent volume adjustment (a minimum of 50mL can be used, with no upper limit on the maximum). It can provide a drug release environment and hydrodynamic conditions closer to the human gastrointestinal tract. Can automatically switch between 4 dissolution media. Reduces the impact of mechanical problems such as shaking in the center of the dissolution cup.
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Q:
What validation documents and procedures are in place for flow-through cell?
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Currently, Raytor Instruments provides IQ and OQ validation documents for flow cell, and there is no relevant regulation for the time being about PQ validation of flow cell method.
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Q:
How to solve the problem of bacteria growing in the water bath of general dissolution tester?
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Users are recommended to clean and air-dry the dissolution cup in time after each test (try not to install the wet dissolution cup on the dissolution tester). Pure water should be used in the water bath and replaced frequently (e.g. once a week). If necessary, a bacteriostatic agent can be added to the water bath.
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Q:
What are the validation documents and procedures for RT6 Series Dissolution Tester?
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At present, Raytor Instruments provides IQ and OQ validation documents for RT6 series dissolution tester, as well as PQ validation documents (of which the PQ validation can be selected from prednisone or salicylic acid validation according to the demand).