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).
[Note—An 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 Tests—General, 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 Tests—General, 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 
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 3–5 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
VS== Titrant volume consumed by the Sample (mL)
VB== Titrant volume consumed by the Blank (mL)
M== actual molarity of the Titrant (mM/mL)
F== equivalency factor, 308.4 (mg/mM)
W== nominal weight of calcium lactate pentahydrate in the Sample taken (mg)
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.
Topic/Question Contact Expert Committee
Monograph Natalia Davydova
Scientific Liaison
1-301-816-8328
(DS2010) Monographs - Dietary Supplements
711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 2458
Pharmacopeial Forum: Volume No. 31(6) Page 1609