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how many types of stability in pharma or API industry ?
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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 |
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