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
. 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)
Normally entropy is expressed as q/T. But, work and heat have same unit. Why can't it be replaced by work?
What can be the supporter of combustion except oxygen.
In testing of Cement the formula for water requirement for setting time is as below- Water required for setting time = NC x 0.85 The question is that what is the logic of 0.85 in this formula??
why athanol-water mixtuere have maximum viscocity in wt% 40?
How to accelerate electron capture decay?
what is the difference between elctrefining and electrolysis?
what is induction on electrical insulators
WHAT IS THE SYLLABUS OO GROUP -I?
what kind of question can be asked in interview for UV- VISIBLE & give me answer ?
what kind of question can be asked in interview for polarimeter related ?
what are UV rays absorbs slightly?
what is allowable limit Of stray light for a spectrophotometer laboratory instruments ?
During Soundness testing of Cement by Lechatelier method the Cement mould expands about 20 mm when merged in curing water for 24 hours after mould preparation.In that Cement MgO content is about 3.0%,SO3 is about 2.6% & Blaine is about 360 M2/Kg.Guess the reason & suggest solution.
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]?