Calcium Lactate Tablets
DEFINITION
Calcium Lactate Tablets contain NLT 94.0% and NMT 106.0% of the labeled amount of calcium lactate pentahydrate (C6H10CaO6·5H2O).
[NoteAn equivalent amount of Calcium Lactate with less water of hydration may be used in place of calcium lactate pentahydrate (C6H10CaO6·5H2O) in preparing Calcium Lactate Tablets. ]
IDENTIFICATION
• A. Identification TestsGeneral, Calcium 191
Sample solution:
A filtered solution, equivalent to 50 mg/mL of calcium lactate pentahydrate from powdered Tablets
Acceptance criteria:
Meet the requirements
• B. Identification TestsGeneral, Lactate 191
Sample solution:
A filtered solution, equivalent to 50 mg/mL of calcium lactate pentahydrate from powdered Tablets
Acceptance criteria:
Meet the requirements
ASSAY
• Procedure
Sample:
A portion of the powder from NLT 20 finely powdered Tablets, equivalent to 350 mg of calcium lactate pentahydrate (C6H10CaO6·5H2O)
Blank:
Proceed as directed in the Analysis without the Sample.
Titrimetric system
(See Titrimetry 541.)
Mode:
Direct titration
Titrant:
0.05 M edetate disodium VS
Indicator:
Hydroxy naphthol blue, 300 mg
Endpoint detection:
Visual
Analysis:
Transfer the Sample to a suitable container, and add 150 mL of water and 2 mL of 3 N hydrochloric acid. Stir, using a magnetic stirrer, for 35 min. While stirring, add 30 mL of Titrant from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Perform a Blank determination.
Calculate the percentage of the labeled amount of calcium lactate pentahydrate (C6H10CaO6·5H2O) in the portion of Tablets taken:
Result = {[(VS VB) × M × F ]/W} × 100
Acceptance criteria:
94.0%106.0%
PERFORMANCE TESTS
• Dissolution, Procedure for a Pooled Sample 711
Medium:
Water; 500 mL
Apparatus 1:
100 rpm
Time:
45 min
Analysis:
Determine the amount of calcium lactate pentahydrate (C6H10CaO6·5H2O) dissolved, as directed in the Assay, making any necessary modifications.
Tolerances:
NLT 75% (Q) of the labeled amount of calcium lactate pentahydrate (C6H10CaO6·5H2O) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• Labeling:
The quantity of Calcium Lactate stated in the labeling is in terms of calcium lactate pentahydrate.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2458
Pharmacopeial Forum: Volume No. 31(6) Page 1609
|