As per IP 2018 what should be mentioned on carton of cefepime for light senstive product
Storage:…
Which one is right?
A) Store protected from light.
B) Protected from light.
ORANGE BOOK/FDA SITE WE CAN COLLECT THE LABELING PART WHERE STORAGE REQUIREMENT I.E. PROTECT FROM LIGHT
however in India, Injection: In dry state: Store at 2-25°C and protected from light. After reconstitution: This solution is stable for 24 hour at controlled room temperature (2-25°C) and for 7 days under refrigeration (2-8°C).
So, I would suggest to storage condition as , " protected from light" as other storage condition is also part of labeling part i.e. In dry state: Store at 2-25°C , After reconstitution: This solution is stable for 24 hour at controlled room temperature (2-25°C) and for 7 days under refrigeration (2-8°C).
Following instructions are correct
1)store at 2-25°C and protected from light.
2)store at 2-25°C, protected from light.
3))Store at 2-25°C.
Protect from light.
But this is wrong.
- Store at 2-25°C.
Protected from light.
Then what would be filling requirement (temp and relative humidity) for filling of vials???
Filing requirement is come under manufacturing instruction which is not part of storage condition of finish dosage form.
If our product is official in proposed country pharmacopoeia then we have to use that storage condition only. If we not obey then state FDA or DCGI will never allow to use that type storage condition/precaution as respective drug regulatory authority always reject/to be corrected our application as they have IH procedure to check storage condition from official hazard i.e. I.P.