The Agilent a hundred automated disintegration apparatus is a totally programmable solution that provides dependable disintegration testing success. Our disintegration testing techniques are compact and easy to deal with, that includes exact temperature control and Assembly regulatory compliance needs.
The revision for the harmonized regular for disintegration testing of pharmaceutical dosage forms has actually been authorized by the Pharmacopeial Discussion Group (PDG) as described inside the PDG indication-off cover sheet.
To start out the test, push Start off/End crucial and also the timer crucial of the particular basket assembly on which the sample is placed.
File the temperature proven via the instrument and calculated by a calibrated thermometer inside the file e-book.
PD activity in cables is calculated by attaching the split-Main HFCT accent around the cable earth floor. The outcomes are displayed over the instrument in pico Coulombs (Computer) as numerical values.
It can help make sure that the dosage varieties satisfy the expected criteria and are appropriate for administration to individuals.
The manufacturing unit performs calibrations for the right wavelength range of your spectrometer utilizing NIST traceable calibration lamps (calibration provider IRRAD-CAL have to be ordered with spectrometer and correct measurement accessories)
The interaction through the entire method was great from Distek’s aspect, the pace, attention to our will need of ASAP once we get more info finally got approval to purchase was excellent and the two folks that arrived instantly just after produce had been incredible.
with 9 incremental actions to whole electricity available. Further calibration files and luminance knowledge might be furnished at Every single step.
The roll security test is widely Employed in requirements. Test success are important insofar as they can display a directional modify in consistency that could occur in assistance. No correct correlation is founded involving the test success and shear security in genuine service.
The roll steadiness test is commonly used in specs. Test results are considerable insofar as they can exhibit a directional change in regularity that may happen in support. No exact correlation is set up in between the test effects and shear stability in actual provider.
It aims to aid the recognition of pharmacopoeial procedures with the disintegration test by regulatory authorities within the ICH areas. It describes Distinctive specifications for this test to become considered interchangable for use while in the ICH locations.
The apparatus is made of a basket-rack assembly, a 1-liter beaker, a thermostatic arrangement for heating the more info fluid plus a mechanical system for raising and lowering the basket from the immersion fluid at a relentless frequency charge. Basket-rack assembly. The basket-rack assembly is rigid and supports 6 cylindrical glass tubes, seventy seven.
The amount time and expense is becoming wasted in keeping up with validating the calibration of each and every tape measure, sq. and stage used by staff? Why not get rid of the hassle all together?