how many types of stability in pharma or API industry ?
Answer Posted / 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 |
Post New Answer View All Answers
What is the brigg's raucher reaction?
what is induction on electrical insulators
Why does the experimental lattice enthalpy of NaI differ greatly from the theoretical lattice enthalpy?
a sample of gas occupies a volume of {450.0 ml}at {740 mm Hg}and[16C]determine the volume of this same sample at [760 mm Hg]and [37c]?
WHAT IS THE SYLLABUS OO GROUP -I?
why athanol-water mixtuere have maximum viscocity in wt% 40?
The rate constant for the second order reaction is 0.54/M.s at 300oC. How long (in sec) would it take for the concentration of NO2 to decrease from 0.62M to 0.28 M? 2NO2(g) 2 NO(g) + O2(g)
what does 50 denote in dowex 50 ????
. Given that 2Hg2+ (aq) + 2 e- Hg22+(aq) E0 =0.92V Hg22+ (aq) + 2 e- 2Hg(l) E0 =0.85V Calculate standard free energy change and K for the following process at 25oC Hg22+(aq) Hg2+ (aq) + Hg(l)
what are UV rays absorbs slightly?
Normally entropy is expressed as q/T. But, work and heat have same unit. Why can't it be replaced by work?
4 Identify the substance oxidized, reduced, oxidizing agent and reducing agent for the following reactions
what is the difference between elctrefining and electrolysis?
Find out how to make artifacts the maxwell boltzmann theory of gases . ps. I don't speak English that well
What can be the supporter of combustion except oxygen.