📊Formulas of Active Pharmaceutical Ingredient (API) Calculations in Pharma Formulation🔬💊

 

In pharmaceutical development, accurate API (Active Pharmaceutical Ingredient) calculations are essential to ensure dosage precision, regulatory compliance, and product safety.

Here's a quick breakdown of key API calculations used in everyday formulation work:

1️⃣  API Quantity for a Batch

📌Formula:
Dosage Strength (mg) x No. of Units + 1000 = API Required (g)

✅Example:
For 10,000 tablets of 500 mg: 500 × 10,000+1000 5,000 g (5 kg)
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2️⃣  Purity Adjustment

📌Formula:
Target Dose + Purity (%) = Adjusted API Amount

✅Example:
Need 500 mg dose using 98% pure API: 5000.98510.2 mg
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3️⃣  Salt to Base Conversion

📌Formula:
Amount of Salt x (MW of Base + MW of Salt) = Base Equivalent

🧪Crucial when label claim is based on the active moiety, not the salt.

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💡Why It Matters

Proper API calculations:
✅Ensure therapeutic effectiveness
✅Reduce batch rejections
✅Maintain GMP & regulatory compliance...