Single maximum impurity limit & related Guideline

Hi …

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

Refer ICH Q7-Section 6.0 (specifications)

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

1 Like

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

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

Yes sir thanku for information

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

What are the main interview questions on guidelines of tablet manufacturing