Protocols
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HPLC-ASSAY
HPLC potency assay
Release assay with preparation and a chromatographic run
2 stepsEdit
1
Sample and standard preparation
HPLC operation L1
2h
hands-on
2
Chromatographic run
HPLC operation L1HPLC system L1
4h
hands-on
BIO
Microbial bioburden
Aseptic preparation, incubation, enumeration, and review
3 stepsEdit
1
Aseptic sample preparation
Aseptic microbiology L1
2h
hands-on
2
Incubation
Qualified incubator L1
24h
unattended
3
Enumeration and review
Aseptic microbiology L1
2h
hands-on
DISS
Tablet dissolution
Six-vessel dissolution followed by HPLC quantitation
3 stepsEdit
1
Media and apparatus preparation
Dissolution operation L1Dissolution bath L1
1h
hands-on
2
Dissolution run
Dissolution operation L1Dissolution bath L1
2h
hands-on
3
HPLC quantitation
HPLC operation L1HPLC system L1
3h
hands-on