Dear Members,
We are developing a Fixed-Dose Combination (FDC) drug which includes two API. As per literature data, the Maximum daily dose (MDD) of one API is 300 mg and for other API Maximum daily dose is 3 mg.
As per ICH Q3B, Identification threshold for the API with MDD of 3 mg is 0.5% (1 mg - 10 mg) & Identification threshold for the API with MDD of 300 mg is 0.2% (>10 mg - 2 g).
Considering the above, Can anyone please suggest, what would be the limit for unspecified unidentified Impurity in Finished Product. Is it 0.2% or 0.5%. How can we set the unspecified unidentified impurity limit for a Fixed-dose combination product?
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Thanks & Best regards
Rajib Kumar Baishnab
Senior Manager, Regulatory Affairs
The ACME Laboratories Ltd.
Dhamrai, Dhaka-1350, Bangladesh
Ph: +8801990-407587
Email:
rbaishnab.qo@acmeglobal.com------------------------------