ANDA dissolution method development and validation

Dissolution Technologies

Volumn 4, Issue 1, 1997, Pages 5-18

  Leeson, Lewis J ^a,b  

^a LJL Associates Inc   (United States)

^b AAPS Dissolution Short Course   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ANALYTICAL PARAMETERS; ARTICLE; CALIBRATION; CONTAINER; DISSOLUTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LINEARITY; MEASUREMENT PRECISION; PERFORMANCE; RANGE; RUGGEDNESS; TEMPERATURE; ULTRAVIOLET SPECTROPHOTOMETRY; VALIDATION PROCESS;

EID: 84962129240     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT040197P5     Document Type: Article

References (7)

1. USP 23/NF 18, <711>, <724>, 1985.
2. Gray, V A, and Hubert, B.B., Pharm. Forum, 20:6(1994)8571.
3. Rohrs, B.R. and Seltzer, D.F., Diss, Tech., 2, lsme 2, pag' I. Spring 1995.
4. Moore, T. W, 3, Ism, 2, pag' 3, May 1996.
5. Qureshi, S.A, and McGilveray, I.F., Phanll. Forum, 20:6(1994)8565.
6. Martin, G.P. et al., Diss, Tech" 3, Issue 1, February 1996.
7. USP 231NF 18, d 225>, 1995.