USP dissolution calibrator tablets - Recommendations for reduced dissolution calibration testing

Pharmacopeial Forum

Volumn 23, Issue 3, 1997, Pages 4238-4242

  Chukwumerije, Onyenoha ^a  

^a HOFFMANN LA ROCHE INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33845211578     PISSN: 03634655     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Lindauer RF. USP Dissolution Calibration Tablets-Is it Time to Reduce the Amount of Testing Required to Calibrate Apparatus 1 and 2? Pharm Forum 1996; 21(5):1397-1402.
2. Qureshi SA, McGilveray IJ. A Critical Assessment of the USP Dissolution Apparatus Suitability Test Criteria. Drug Dev and Ind Pharm 1995; 21(8):905-924.
3. Skoug JW. Calibration of Dissolution Rate Apparatuses: A User's Perspective. Dissolution Technologies 1994; l(2):3-5.
4. Workshop Report-AAPS/USP Workshop on Dissolution Calibration and Testing. Pharm Res 1996; 13(1):69.
5. Cox DC, Furman WB, Thornton LK, Moore TWO, Jefferson HE. Systematic Error Associated with Apparatus 2 of the USP Dissolution Test III: Limitations of Calibrators and the USP Suitability Test. J Pharm Sciences 1983; 72(8):910-913.
6. Moore TWO, Tango RFD, Habit Y. Dissolution Calibrator Tablets: A Recommendation for New Calibrator Tablets to Replace Both Current USP Calibrator Tablets. Pharm Forum 1996; 22(3):2423-2428.
7. Hamilton JF, Moore TWO, Kerner CM. Reproducibility of Dissolution Test Results. Pharm Forum 1995; 21(5):1383-1386.
8. Gray VA, Hubert BB, Krasowski, JA. Calibration of Dissolution Apparatuses 1 and 2-What To Do When Your Equipment Fails. Pharm Forum 1994; 20(6):8571-8573.
9. The USP Dissolution Calibrator Collaborative StudyAn Overview of the 1994 Process. Report of the Pharmaceutical Research and Manufacturers of America. Pharm Forum 1994; 20(5):8177-8201.
10. The 1989 and 1991 test results were provided by David Whiteman (Hoechst Marion Roussel and member of the PhRMA Dissolution Committee). A published source is not available.
11. Compilation of data into tables of percent failures detected for each test or test combination is automatically completed using the same statistical package used to analyze the collaborative data. Thus, the analysis is based on the statistically-determined acceptable ranges.