b) if a residue continues to be, it is composed only of the delicate mass getting no strong Main which can not be pressed using a glass rod.
Disintegration test is comes below 2nd group that is definitely qualitative test, to be familiar with the habits of your drug product or can known as it like a physical test.
Agilent offers disintegration devices that satisfy America Pharmacopeia (USP) specifications for disintegration of tablets, capsules, and granules. The Agilent a hundred automated disintegration apparatus is a completely programmable Resolution providing reputable disintegration testing outcomes.
The results of a long time of innovation and working experience in the sector of pharmaceutical testing, the DTGi Series of disintegration testers from Copley simplifies testing inside of R&D and QC environments.
See much more I just needed to provide feed-back on the whole process of obtaining the Distek units in and qualified. It absolutely was pretty quite possibly the ideal knowledge We've got had so far on acquiring, obtaining, putting in and qualifying the models.
Our network of laboratories supports you with testing programs that deliver a full variety of certification and validation expert services to satisfy your one of a kind testing desires.
With its one of a kind power to detect internal partial discharge action in high noise environments it complements the use of the UltraTEV Plus² and UltraDish.
Take note the traveling distance in the basket rack assembly on the device from a calibrated scale. Repeat the test two much more instances to verify the final results.
PROCEDURE:- Spot a get more info person dosage device in each with the six tubes of the basket and when specified insert a disc. Work the apparatus using h2o as the immersion fluid Except Yet another liquid is specified and keep its temperature at 35–39 °C. At the conclusion of the required time elevate the basket with the fluid and notice the dosage models, most of the dosage models have disintegrated absolutely.
The UltraTEV Plus² will be the latest development in the award successful UltraTEV™ variety. This user friendly instrument incorporates added sensing abilities and genuine time developments analytical functions enabling you to differentiate in between legitimate PD, sound together with other interference letting you to produce much better decisions even though saving time and money and boost the security of the staff members and also your network.
This revised common presents information on the dimensional description in the apparatus in typical structure and corrects The outline from the disks Utilized in disintegration testing.
Utilize the developed-in PD classification and interpretation instruments to detect complications early in order to avoid perilous and detrimental failures and lower network downtime/outages
With its special capability to detect internal partial discharge action in superior sound click here environments it complements the usage of the UltraTEV Plus² and UltraDish.
Programmable abilities—uncomplicated keypad interface directs unbiased Charge of up to three different test baskets. Baskets may very well be programmed to automatically carry out on the beakers upon completion of the test