Packaging and storage
Preserve in tight containers. Store at 25
, excursions permitted between 15
and 30
.
Loss on drying 731
Dry it at 250
to constant weight: it loses between 33.0% and 36.5% of its weight.
Limit of sodium
Stock solution
Transfer 40.0 g of Cupric Sulfate to a 200-mL volumetric flask, add water, and swirl to dissolve. Add 5 mL of nitric acid, dilute with water to volume, and mix. This solution contains 0.2 g of cupric sulfate per mL.
Test solutions
To three 25-mL volumetric flasks add a volume of Stock solution equivalent to the weight of test specimen given in the accompanying table. To two of the flasks add the amounts of reference analyte ion specified in the accompanying table. Add 2 mL of potassium chloride solution (1 in 20) to each flask, dilute with water to volume, and mix.
Procedure
Using atomic absorption spectrophotometry (see
Spectrophotometry and Light-Scattering 851), analyze the
Test solutions by the method of standard addition analysis according to the accompanying table. The limit is 0.02%.
Limit of potassium
Stock solution
Use the Stock solution prepared in the test for Limit of sodium.
Test solutions
To three 25-mL volumetric flasks add a volume of Stock solution equivalent to the weight of test specimen given in the accompanying table. To two of the flasks add the amounts of reference analyte ion specified in the accompanying table, dilute with water to volume, and mix.
Procedure
Using atomic absorption spectrophotometry (see
Spectrophotometry and Light-Scattering 851), analyze the
Test solutions by the method of standard addition analysis according to the accompanying table. The limit is 0.01%.
Limit of calcium
Stock solution
Use the Stock solution prepared in the test for Limit of sodium.
Test solutions
To three 25-mL volumetric flasks add a volume of Stock solution equivalent to the weight of test specimen given in the accompanying table. To two of the flasks add the amounts of reference analyte ion specified in the accompanying table, dilute with water to volume, and mix.
Procedure
Using atomic absorption spectrophotometry (see
Spectrophotometry and Light-Scattering 851), analyze the
Test solutions by the method of standard addition analysis according to the accompanying table. The limit is 0.005%.
Limit of iron
Stock solution
Use the Stock solution prepared in the test for Limit of sodium.
Test solutions
To three 25-mL volumetric flasks add a volume of Stock solution equivalent to the weight of test specimen given in the accompanying table. To two of the flasks add the amounts of reference analyte ion specified in the accompanying table, dilute with water to volume, and mix.
Procedure
Using atomic absorption spectrophotometry (see
Spectrophotometry and Light-Scattering 851), analyze the
Test solutions by the method of standard addition analysis according to the accompanying table. The limit is 0.003%.
Limit of nickel
Stock solution
Use the Stock solution prepared in the test for Limit of sodium.
Test solutions
To three 25-mL volumetric flasks add a volume of Stock solution equivalent to the weight of test specimen given in the accompanying table. To two of the flasks add the amounts of reference analyte ion specified in the accompanying table, dilute with water to volume, and mix.
Procedure
Using atomic absorption spectrophotometry (see
Spectrophotometry and Light-Scattering 851), analyze the
Test solutions by the method of standard addition analysis according to the accompanying table. The limit is 0.005%.
Limit test |
Wavelength
(nm) |
Test specimen weight (g) |
Reference ion added (mg) |
Flame type |
Background correction |
Sodium |
589.0 |
0.05 |
0.005/0.01 |
air-acetylene |
No |
Potassium |
766.5 |
0.4 |
0.02/0.04 |
air-acetylene |
No |
Calcium |
422.7 |
0.8 |
0.05/0.10 |
air-acetylene |
No |
Iron |
248.3 |
4.0 |
0.12/0.24 |
air-acetylene |
Yes |
Nickel |
232.0 |
4.0 |
0.10/0.20 |
air-acetylene |
No |
Organic volatile impurities, Method IV 467:
meets the requirements.
Assay
Place about 650 mg of Cupric Sulfate in an accurately weighed container fitted with a ground-glass stopper, dry, allow to cool in a desiccator, and weigh again to obtain the weight of the specimen. Dissolve in 50 mL of water, add 4 mL of 6 N acetic acid and 3 g of potassium iodide, and titrate the liberated iodine with 0.1 N sodium thiosulfate VS, adding about 2 g of potassium thiocyanate and 3 mL of
starch TS as the endpoint is approached. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N sodium thiosulfate is equivalent to 15.96 mg of CuSO
4.
Auxiliary Information
Staff Liaison :
Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29NF24 Page 602
Pharmacopeial Forum : Volume No. 29(5) Page 1447
Phone Number : 1-301-816-8394