Comments on mechanical & Chemical calibration by an instrument manufacturer

Dissolution Technologies

Volumn 14, Issue 2, 2007, Pages 6-18

  Hanson, Royal ^a   Vangani, Saroj ^b   Salt, Alger ^c   Burmicz, John ^d   Thomas, Saji ^e   Seely, Jeff ^f   Kraemer, Johannes ^g   Kretz, Jonathan ^h   Crist, Bryan ⁱ  

^a Hanson Research Corporation   (United States)

^b AMGEN INC   (United States)

^c GLAXOSMITHKLINE   (United States)

^d Pharma Test Apparatebau GmbH   (United States)

^e Par Pharmaceutical   (United States)

^f Distek   (United States)

^g PHAST GmbH   (United States)

^h Watson Pharmaceuticals Inc   (United States)

ⁱ Varian Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ARTICLE; CALIBRATION; CHEMICAL CALIBRATION; DISSOLUTION TESTER; DRUG INDUSTRY; DRUG SOLUBILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MEASUREMENT ERROR; MECHANICAL CALIBRATION; MEDICAL DEVICE; PERFORMANCE; QUALITY CONTROL; REPRODUCIBILITY; TEST RETEST RELIABILITY;

EID: 84962107062     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT140207P6     Document Type: Article

References (9)

1. Bansal, S. K.; Layloff, T.; Bush, E. D.; Hamilton, M.; Hankinson, E. A.; Landy, J. S.; Lowes, S.; Nasr, M. M.; Jean, P. A.; Shah, V. P. Qualification of Analytical Instruments for Use in the Pharmaceutical Industry:A Scientific Approach. AAPS PharmSciTech 2004; 5 (1), Article 22.
2. Collins, C. C. Vibration: What Is It and How Might It Affect Dissolution Testing? Dissolution Technol. 1998, 5 (4), 16-18.
3. Crist, B.; Spisak, D. Evaluation of Induced Variance of Physical Parameters on the Calibrated USP Dissolution Apparatus 1 and 2. Dissolution Technol. 2005, 12 (1), 28-31.
4. Gray, V.; Beggy, M.; Brockson, R.; Corrigan, N.; Mullen, J. A Comparison of Dissolution Results Using O-Ring vs. Clipped Basket Shafts. Dissolution Technol. 2001, 8 (4), 8-11.
5. Dissolution Testing of Immediate Release Solid Oral Dosage Forms; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, U.S. Government Printing Office: Washington, DC,August 1997; p A2.
6. United States Pharmacopeia and National Formulary USP 30-NF 25;The United States Pharmacopeial Convention, Inc.: Rockville,MD, 2007.
7. United States Pharmacopeia. USP Prednisone Tablets RS Lot O0C056, USP Dissolution Calibrator, Disintegrating Type; Specification Sheet; United States Pharmacopeial Convention, Inc.: Rockville,MD, December 6, 2004.
8. Subcommittee on Dissolution Calibration, Pharmaceutical Research and Manufacturers Association (PhRMA). Dissolution Calibration: Recommendations for Reduced Chemical Testing and Enhanced Mechanical Calibration. Pharm. Forum 2000, 26 (4), 1149-1166.
9. United States Pharmacopeia. <1058> Analytical Instrument Qualification. Pharm. Forum 2006, 32 (6), 1784-1794