how many types of stability in pharma or API industry ?
Answers were Sorted based on User's Feedback
Answer / sanjay bute (teva pharmaceutic
The type of stability study for API and Pharmaceuticals as
per ICH guideline are as follows.
1) Long term stability study (25°C/60%RH)
2) Intermidiate condition (30°C/65%RH)
3) Accelerated study (40°C/75%RH)
4) Photostabiltiy study
please refer the following link for detail information
http://www.ich.org/products/guidelines/quality/article/quali
ty-guidelines.html
| Is This Answer Correct ? | 16 Yes | 3 No |
What is Downward Displacement of Water?
How can be set a responds factor for evaluating a unknown impurity by HPLC
What is unsaponifiable matters?
what is little silver
what is the difference between elctrefining and electrolysis?
Sr-90, a radioactive isotope, is a major product of an atomic bomb explosion. It has a half life of 28.1 year. Calculate the first order rate constant for this nuclear decay and the fraction of 90Sr that remains after 10 half lives?
What can be the supporter of combustion except oxygen.
How much is the molar extinction coefficient of methylene blue at wavelenght 664 nm? Are molar extinction coefficient depend on concentration of solution?
what kind of question can be asked in interview for polarimeter related ?
what is induction on electrical insulators
how many types of stability in pharma or API industry ?
what are the advantage and disadvantages of evaporation?