How to Calculate Impurity Limits of drug?

How to Calculate Impurity Limits?

Ever got confused with impurity limits? Let’s make it easy with a simple example!

Example: Here I am taking Paracetamol (500 mg Tablet)

Step 1: Find the Maximum Daily Dose (MDD)
Let’s assume a person can take 4000 mg (4g) per day.

Step 2: Find the Impurity Limit (as per ICH Q3B(R2))
If MDD is more than 2g/day, the limit is 0.15% (Qualification Threshold).
Here, MDD = 4g/day, so the limit = 0.15%.

Step 3: Calculate the Impurity Limit in mg
🔹 Formula: (MDD × Limit) ÷ 100
🔹 (4000 mg × 0.15) ÷ 100 = 6 mg/day

Final Answer:
✅ Any identified impurity in Paracetamol should be less than 6 mg per day to meet regulatory guidelines.

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