매우 복잡 까다로운 용출기 Validation 과정들 입니다.USP 규약이  매우 까다롭고 복잡하며 강제규정사항도도 많습니다.
USP WEB SITE에서 적합여부를 확인해 주는 액셀 계산 소프트웨어를 무료로 사용할 수 있습니다.
 

 

 

 

 

 

 

 
 

 



 
용출기 Validation 과정들 입니다.USP 규약이 매우 까다롭고 복잡하며 강제규정사항도도 많습니다.
USP WEB SITE에서 적합여부를 확인해 주는 액셀 계산 소프트웨어를 무료로 사용할 수 있습니다.
 

 

 

 

 
 

USP has published some impotant information for us (especially for the 12 Vessel bath).

 

1)Salicylicacid needs not to be tested anymore

2) a new Lot of Prednisone Lot PI1300 should be tested. The testprocedure is different: For the single stage test the 6 vessels of a 6-8 Vessel dissolution Tester needs to be tested 2 times using 6 Prednisone Tablets. For a 12 Vessel bath the test must be performed only once for 12 Vessels and 12 Tablets>>

For two 6or 7or 8 Positon Dissolution Testers the customer will need to perform all in all 4 Prednsione Tests with 24 Tablets.

With the PTWs1210 the customer needs only to perfrom 1 Test with 12 Tablets only.

Conclusion is that a lot of time and money can be safed using our 12 Vessel Dissolution Tester
 

Best Regards

Dirk Beilke

Best regards / Mit freundlichen Grüßen

Dr. Dirk Beilke

Chemist ● Sales Director & Dissolution Product Manager