Calcium Acetate Tablets
DEFINITION
Calcium Acetate Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of calcium acetate (C4H6CaO4).
IDENTIFICATION
• Identification TestsGeneral, Calcium 191 and Acetate 191
Sample solution:
100 mg/mL of calcium acetate from powdered Tablets
Acceptance criteria:
Meet the requirements
ASSAY
• Procedure
Sample:
Amount equivalent to 300 mg of calcium acetate from NLT 20 powdered Tablets
Analysis:
Dissolve the Sample in 150 mL of water containing 2 mL of 3 N hydrochloric acid. While stirring, add 30 mL of 0.05 M edetate disodium VS from a 50-mL buret, and add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue. Continue the titration with the 0.05 M edetate disodium VS to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 7.909 mg of calcium acetate (C4H6CaO4).
Acceptance criteria:
90.0%110.0%
PERFORMANCE TESTS
• Dissolution 711
Medium:
Water; 900 mL
Apparatus 2:
50 rpm
Time:
30 min
Instrumental conditions
Mode:
Atomic absorption spectrometry
Analytical wavelength:
422.8 nm
Standard solution:
Calcium at a known concentration in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary, to a concentration that is similar to the Standard solution.
Acceptance criteria:
NLT 80% (Q) of the labeled amount of calcium acetate (C4H6CaO4) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
IMPURITIES
• Limit of Aluminum
Buffer:
Dissolve 50 g of ammonium acetate in 150 mL of water, adjust with glacial acetic acid to a pH of 6.0, and dilute with water to 250 mL.
Aluminum standard solution
1.0 µg/mL of aluminum. Prepare as directed for Standard Preparation under Aluminum 206.
Standard solution:
Prepare a solution containing 2.0 mL of Aluminum standard solution, 5 mL of Buffer, and 48 mL of water, and extract this solution with successive portions of 10, 10, and 5 mL of 0.5% 8-hydroxyquinoline in chloroform. Combine the chloroform extracts in a 50-mL volumetric flask, and dilute the combined extracts with chloroform to volume.
Sample solution:
Dissolve a portion of powdered Tablets (NLT 10) equivalent to 1.0 g of calcium acetate in 50 mL of water, and add 5 mL of Buffer. Extract this solution with successive portions of 10, 10, and 5 mL of 0.5% 8-hydroxyquinoline in chloroform. Combine the chloroform extracts in a 50-mL volumetric flask, and dilute the combined extracts with chloroform to volume.
Blank:
Prepare a solution containing 50 mL of water and 5 mL of Buffer. Extract this solution with successive portions of 10, 10, and 5 mL of 0.5% 8-hydroxyquinoline in chloroform. Combine the chloroform extracts in a 50-mL volumetric flask, and dilute the combined extracts with chloroform to volume.
Instrumental conditions
Mode:
Fluorescence
Excitation wavelength:
392 nm
Emission wavelength:
518 nm
Analysis
Samples:
Standard solution, Sample solution, and Blank. Use the Blank solution to zero the instrument.
Acceptance criteria:
The fluorescence of the Sample solution does not exceed that of the Standard solution (NMT 2 ppm).
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2440
Pharmacopeial Forum: Volume No. 27(6) Page 3254
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