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Determination of the appearance of the substance:
- Take about 1 g of the substance to be examined on a glass watch.
- Examine under white illumination.
- Determine the color and appearance of the substance.
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Determination of hygroscopicity:
- This method is to be carried out on a substance that complies with the test for loss on drying or water content of the monograph
- The method gives an indication of the degree of hygroscopicity rather than a true determination.
- Use a glass weighing vessel 50 mm in external diameter and 15 mm high.
- Weigh the vessel and stopper (m1).
- Place the amount of substance prescribed for the test for loss on drying or water in the vessel and weigh (m2).
- Place the un-stoppered vessel in a desiccator at 25 ºC containing saturated solution of ammonium chloride or ammonium Sulphate or place it in a climatic cabinet set at 25 ± 10C and 80 ± 2 percent relative humidity.
- Allow to stand for 24 h.
- Stopper the weighing vessel and weigh (m3).
- Calculate the percentage increase in mass using the expression:
- The result is interpreted as follows
- Deliquescent: sufficient water is absorbed to form a liquid.
- Very hygroscopic: increase in mass is equal to or greater than 15 percent (≥ 15%).
- Hygroscopic: increase in mass is less than 15 percent and equal to or greater than 2 percent (≥ 2% and < 15%).
- Slightly hygroscopic: increase in mass is less than 2 percent and equal to or greater than 0.2 percent < 2% and ≥ 0.2%).
Determination of Solubility procedures
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Very soluble substance:
- Weigh accurately 1.0 g of finely powdered substance, in a stoppered tube (16 mm in internal diameter and 160 mm long), or volumetric flask 10 ml add 1.0 ml of the solvent.
- Shake vigorously for 1 min and place in a constant temperature device (Incubator), maintained at a temperature of 25.0 ± 0.5 °C for 15 min.
- If the substance is not completely dissolved, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min.
- If the substance is completely dissolved, it is very soluble
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Freely soluble substance:
- Weigh accurately 1.0 g of finely powdered substance, in a stoppered tube, or volumetric flask 25 ml, add 1.1 ml of the solvent.
- Shake vigorously for 1 min and place in a constant temperature device (Incubator), maintained at a temperature of 25.0 ± 0.5 °C for 15 min.
- If the substance is not completely dissolved, add gradually another 8.9 ml of the solvent (0.5 ml in each addition) and after each addition, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min.
- If the substance is completely dissolved, it is freely soluble in that specified volume of solvent
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Soluble substance:
- Weigh accurately 1.0 g of finely powdered substance, in a stoppered tube, or volumetric flask 50 ml, add 10 ml of the solvent.
- Shake vigorously for 1 min and place in a constant temperature device (Incubator), maintained at a temperature of 25.0 ± 0.5 °C for 15 min.
- If the substance is not completely dissolved, add gradually another 20 ml of the solvent (1 ml in each addition) and after each addition, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min.
- If the substance is completely dissolved, it is soluble in that specified volume of solvent.
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Sparingly soluble substance:
- Weigh accurately 1.0 g of finely powdered substance, in a stoppered tube, or volumetric flask 100 ml, add 30 ml of the solvent.
- Shake vigorously for 1 min and place in a constant temperature device (Incubator), maintained at a temperature of 25.0 ± 0.5 °C for 15 min.
- If the substance is not completely dissolved, add gradually another 70 ml of the solvent (5 ml in each addition) and after each addition, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min.
- If the substance is completely dissolved, it is sparingly soluble in that specified volume of solvent.
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Slightly soluble substance:
- Weigh accurately 0.250 g of finely powdered substance, in a stoppered tube, or volumetric flask 250 ml, add 25 ml of the solvent.
- Shake vigorously for 1 min and place in a constant temperature device (Incubator), maintained at a temperature of 25.0 ± 0.5 °C for 15 min.
- If the substance is not completely dissolved, add gradually another 225 ml of the solvent (5 ml in each addition) and after each addition, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min.
- If the substance is completely dissolved, it is slightly soluble in that specified volume of solvent.
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Very slightly soluble substance:
- Weigh accurately 0.100 g of finely powdered substance, in a stoppered tube, or volumetric flask 1000 ml, add 100 ml of the solvent.
- Shake vigorously for 1 min and place in a constant temperature device (Incubator), maintained at a temperature of 25.0 ± 0.5 °C for 15 min.
- If the substance is not completely dissolved, add gradually another 900 ml of the solvent (50 ml in each addition) and after each addition, repeat the shaking for 1 min and place the tube in the constant temperature device for 15 min.
- If the substance is completely dissolved, it is very slightly soluble in that specified volume of solvent.
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Practically insoluble or insoluble substance:
- Weigh accurately 0.100 g of finely powdered substance, in a stoppered tube, or volumetric flask 2000 ml, add 1100 ml of the solvent.
- Shake vigorously for 1 min and place in a constant temperature device (Incubator), maintained at a temperature of 25.0 ± 0.5 °C for 15 min.
- If the substance is completely dissolved, it is practically insoluble or insoluble substance.
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Descriptive | Parts of solvent required for 1 part of solute |
Very soluble | Less than 1 |
Freely soluble | From 1 to 10 |
Soluble | From 10 to 30 |
Sparingly soluble | From 30 to 100 |
Slightly soluble | From 100 to 1000 |
Very slightly soluble | From 1000 to 10000 |
Practically insoluble or insoluble | More than 10000 |