|
|
|
|
|
TESTS ON FINISHED FORMULATIONS
S. No |
Name of Test |
Type of estimation |
Evaluation parameter
rh-Insulin |
1 |
Identification |
Species identification |
HPLC-Reverse Phase |
2 |
Potency |
Potency in solution |
HPLC-Reverse Phase |
Potency in supernatant |
HPLC-Reverse Phase |
3 |
Purity
Impurity product related |
Related proteins |
HPLC-Reverse phase |
Hr Molecular weight proteins (HMWP) |
HPLC –size exclusion |
Zinc metal ion estimation |
Atomic absorption spectrometer |
4 |
Safety |
Endogenous pyrogen |
Bacterial endotoxin: Gel clot and
Kinetic chromogenic assay(KCA) |
Microbial contamination: fungal/bacterial |
Sterility: membrane filtration &
media Inoculation |
5 |
Physical Quality |
Color/ clarity/ Appearance |
Chemical method & visual inspection |
Particulate analysis |
Liquid particle monitoring-light obscuration |
Sizing by microscopy |
Potentiometric |
pH determination |
|
|
|
|
