نتایج جستجو برای: parenterals
تعداد نتایج: 30 فیلتر نتایج به سال:
The possibility of replacing the rabbit pyrogen test by the Limulus Amebocyte lysate (LAL) test, as a final release test for Large Volume Parenterals (LVPs) was investigated. The sensitivity and specificity of the LAL test and rabbit pyrogen assay were studied by means of artificially contaminated parenterals. Various LVPs (mostly containing electrolytes) were spiked with 0.5 and 5 EUlml o...
the possibility of replacing the rabbit pyrogen test by the limulus amebocyte lysate (lal) test, as a final release test for large volume parenterals (lvps) was investigated. the sensitivity and specificity of the lal test and rabbit pyrogen assay were studied by means of artificially contaminated parenterals. various lvps (mostly containing electrolytes) were spiked with 0.5 and 5 eulml of e.c...
Threats of pyrogenicity were discovered more than a century ago. Measures to determine the safety of parenterals and, more recently, medical devices and cell therapies for human use have been in place for 70 years. Currently, there are three testing possibilities available: the Rabbit Pyrogen Test, the Limulus Amebocyte Lysate test (Bacterial Endotoxin Test), and test systems using human whole ...
A stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Bendamustine hydrochloride in injectables. Reversed-phase chromatography was performed on Shimadzu Model CBM20A/20 Alite, equipped with SPD M20A prominence photodiode array detector using C18 (250 mm × 4.6 mm, 5 μm particle size) column with acetonitrile: tetra butyl ammoni...
Aim: Poloxamer a block copolymer is well known for its thermoreversible property also has several other properties used in several formulations for its advantage over optimising the drug release from its formulation with a sol-gel transition property. Methods: Poloxamer exhibits in a sol state at less than room temperature and gets converted to a gel state at body temperature (37.2°C) thus modi...
Microorganisms such as Gram-negative or Gram-positive bacteria, viruses and fungi contain components that activate the innate immune system. These components, called pyrogens (Greek: pyros=fire), can occur independently of viable microorganisms and are a major safety concern in parenterally administered drugs, since they can cause severe reactions such as fever, organ failure, and shock in the ...
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