Single maximum impurity limit & related Guideline

Quality Assurance
1

Hi …

Can you please provide Single maximum impurity limit & related Guideline reference

2

Refer ICH Q7-Section 6.0 (specifications)

3

Dear sir I think ICH Q7 is not related to specifications it is related to CGMP of API

1 Like
4

Please refer ICH Q3 (A-R2, B-R2, C-R6, D-R1) guidelines for impurities.

5

ICH Q6-SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERION FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:

6

Yes sir thanku for information

7

What is the guidelines for temperature mapping in oral solid dosage units

8

What are the main interview questions on guidelines of tablet manufacturing

9

Dear Naidu,

You will get all the answers and clarity if you refer and read the ICH Q3 guidelines which are for the impurities and their control in the pharmaceuticals. How to set the limits and their control.