Table 2.
Summary of the methods for determination of “loss on drying” and “water” in European Pharmacopoeia and Chinese Pharmacopoeia
European Pharmacopoeia | Chinese Pharmacopoeia |
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Loss on drying | |
Dry the sample under the specified temperature to constant mass (Δma ≤ 0.5 mg) or for the prescribed time by one of the following procedures and calculate the difference in the mass of the sample before and after drying, expressed as a percentage (m/m): In a desiccator In vacuo In an oven at a specified temperature |
Place about 1 g or specified amount of sample in a tared, shallow weighing bottle and dry the sample under 105 °C until constant weight (Δm ≤ 0.3 mg) except as otherwise herein provided. Calculate the loss of mass expressed as per cent Test may also be done with desiccator with temperature control or vacuum |
Water | |
Distillation with toluene (procedure similar to method 4 in Chinese Pharmacopoeia) |
Method 1: Karl-Fischer’s titration Method 2: Drying in the oven (100–105 °C until Δm ≤ 5 mg) Method 3: Drying under reduced pressure (≤ 2.67 kPa at room temperature for 24 h) Method 4: Toluene distillation Method 5: Gas chromatography |
a Δm: the difference in the mass of the sample between two consecutive weighings