DEFINITION

Calcium Gluconate is anhydrous or contains one molecule of water of hydration. The anhydrous form contains NLT 98.0% and NMT 102.0% of calcium gluconate (C₁₂H₂₂CaO₁₄), calculated on the dried basis. The monohydrate form contains NLT 99.0% and NMT 101.0% of calcium gluconate monohydrate (C₁₂H₂₂CaO₁₄·H₂O) where labeled as intended for use in preparing injectable dosage forms, and NLT 98.5% and NMT 102.0% of calcium gluconate monohydrate (C₁₂H₂₂CaO₁₄·H₂O) where labeled as not intended for use in preparing injectable dosage forms.