Analysis & Testing

Question 1

What is the EP specification for :-
a) Purified Water
b) WFI

Answer 1

Purified:-
TOC <500ppb
Conductivity <4.3ms @20’C
Nitrates <0.2ppm
Heavy Metals <0.1ppm
Aerobic Bacteria <100cfu/ml
Endotoxins <0.25 iu/ml

WFI:-
TOC <500ppb
Conductivity <1.1ms @20’C
Nitrates <0.2ppm
Heavy Metals <0.1ppm
Aerobic Bacteria <10cfu/100ml
Endotoxins <0.25 iu/ml

Question 2

What Guidelines relate to sampling of starting materials?

Answer 2

WHO Annex 4
Annex 8
ISO2859

Question 3

What are the general stability storage conditions according to ICH Q1?

Answer 3

25C 60% RH
30C 65% RH
40C 75% RH
Refrigerated 5C
Frozen -15C

Question 4

What are the dissolution stages of a tablet?

Answer 4

S1 6 units >= Q 5%
S2 Further 6 units mean result of 12 >= Q no individual result less than Q - 15%
S3 Further 12 units mean result of 24 >= Q no 2?individual results less than Q - 15% and no result less than Q- 25%

Question 5

What validation tests would you perform for an ID test?

Answer 5

Specificity only

Question 6

What validation tests would you perform for an assay?

Answer 6

Everything but LOD/LOQ