Manual in situ fiber optic dissolution analysis in quality control

Dissolution Technologies

Volumn 7, Issue 2, 2000, Pages 6-12

  Schatz, C ^a   Ulmschneider, M ^a   Altermatt, R ^a   Marrer, S ^a   Altorfer, H ^b  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b ETH ZURICH   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

BENZODIAZEPINE; GELATIN; HELIUM; PLACEBO; SOFT GELATIN CAPSULE; UNCLASSIFIED DRUG;

ANALYTICAL EQUIPMENT; ANALYTICAL PARAMETERS; ARTICLE; CONTROLLED STUDY; DEGASSING; DISSOLUTION; DISSOLUTION VESSEL; FIBER OPTICS; LINEARITY; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; QUALITY CONTROL; RELIABILITY; REPRODUCIBILITY; ROBUSTNESS; SPECTROMETRY; TABLET; TURBIDITY; VALIDATION PROCESS;

EID: 0004213962     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT070200P6     Document Type: Article

References (11)

1. USP 23 NF 18, United States Pharmacopeial Convention, Inc., Rockville, MD, (1995)
2. Rohrs B. R., Stelzer D. J., Deaeration Techniques for Dissolution Media, Dissolution Technologies, 2 (2) 1-9 (1995)
3. International Conference on Harmonization, Validation of Analytical Procedures: Methodology, ICH Harmonised Tripartite Guideline Q2B (1995)
4. Pharma Switzerland, Quality Assurance and Quality Control, Validation of Analytical Methods, F. Hoffmann-La Roche Ltd., Basel (1998)
5. Roth H. J., Eger K., Troschütz R., Arzneistoffanalyse, Gustav Fischer, Stuttgart, Jena, Lübeck, Ulm, 3 (1997)
6. Debesis E., Revised Analytical Data Sheet for the Active Substance*, Red Corner Research Report No. N-33671, F. Hoffmann-La Roche Ltd., Nutley (1979) Fiber Optic References. continued
7. Stricker H. (ed.), Physikalische Pharmazie, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, 3 (1987)
8. Lide D. R. (ed.), Handbook of Chemistry and Physics, CRC Press, Boca Raton, New York, London, Tokyo, 76 (1996)
9. Schatz C., Internal Communication about the Benzodiazepine Tablets, F. Hoffmann-La Roche Ltd., Basel (1999)
10. Schatz C., Internal Communication about the Soft Gelatin Capsules, F. Hoffmann-La Roche Ltd., Basel (1999)
11. Kostek L. J. et al., Automated Dissolution Testing Utilizing On-line Fiber Optic Probe UV Analysis, ISLAR '95 Proceedings, 355-367 (1995)