We are having a product which is stable on 30 degree & RH 65% but it
is failing at accelerated study temperature of 40 degree & RH 75%.
So my question is
1)Will the regulatory bodies of any country will approve of the
product with such stability data or we have to develpoe the product
again.
2) Is it necessary that any product which is intended to be stored at
room temperature should be stable both at accelerated condition and
real time conditions too or are there any exceptions to it
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Luv Wadhwani
luv_w21@yahoo.co.in
Unijules life sciences
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