STABILITY STUDY

The purpose of the stability study is to evaluate the re-test / expiry date for a drug substance or a drug product.

Depends on the actual storage condition, the stability study storage conditions are varied.

a)  General case (25 ± 2°C)

b)   API intended for storage in refrigerator (5 ± 3°C)

c)   API intended for storage in freezer (-20°C ± 5°C)

d)  API intended for storage below -20°C

A)  General Case (25 ± 2°C): Following storage conditions and testing frequency shall be followed for the below mentioned studies.

Study	Storage condition	Testing frequency (Month)
Accelerated	40°C ± 2°C / 75 % RH ± 5 %	0, 1, 2, 3, 6
Intermediate	30°C ± 2°C / 65 % RH ± 5 %	0, 3, 6, 9, 12
Long Term (LT)	25°C ± 2°C / 60 % RH ± 5 %	0, 3, 6, 9, 12,18, 24, 36, 48 & 60
Alternative Long term	30°C ± 2°C / 75 % RH ± 5 %	0, 3, 6, 9, 12,18, 24 36, 48 & 60
Annual stability	25°C ± 2°C / 60 % RH ± 5 %	0,12, 24 36, 48 & 60

B) API intended for storage in a refrigerator:

Study	Storage condition	Testing frequency
Accelerated	25°C ± 2°C / 60 % RH ± 5 %	0, 1, 2, 3, 6
Long term	5°C ± 3°C	0, 3, 6, 9, 12,18, 24, 36, 48 & 60
Annual stability	5°C ± 3°C	0, 12, 24, 36, 48 & 60

C) API intended for storage in a freezer:

Study	Storage condition	Testing frequency
Accelerated	5°C ± 3°C	0, 1, 2, 3, 6
Long term	- 20°C ± 5°C	0, 3, 6, 9, 12,18, 24, 36, 48 & 60
Annual stability	- 20°C ± 5°C	0,12, 24, 36, 48 & 60

D)  API intended for storage below -20°C: It shall be treated on case-by-case basis.

If significant change (failure to meet the specification) occurs at any time during 6 months testing at the Accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria.