Study Set Content:
S1 number tested
6
S2
6
S3
12
Each unit is not less than Q+ 5%
S1
Average of 12 units (S1+S2) is equal to or greater than Q, and no unit is less than Q – 15%
S2
Average of 24 unites (S1 +S2 +S3) is equal to or greater than Q not more than 2 unites are less than Q – 15%, and no unit is less than Q – 25%
S3
Liquid Dosage Form
Control Test:
Relative Density
pH
Surface tension
Microbial limit tests
Stability of the active ingredients (s), and identification tests
Light stability
Container and closure compatibility
Redispersibility
Suspendibility
Storage conditions
visual inspection for the presence of gross particulate matter
Appearance
Stability
Chemical
Physical
degradation products, potency
Chemical
pH, Viscosity, odor, color, taste, clarity (should remain clear under temp (4-47 C)
Physical
b. Suspensions
Sedimentation Volume
Size of particles
Zeta Potential
Rheological properties
Temperature and gravitational stress
HIGH SEDIMENTATION RATE
SLOW SEDIMENTATION RATE
HARD CAKE (-)
