Calcium Pantothenate Tablets
Calcium Pantothenate Tablets contain NLT 95.0% and NMT 115.0% of the labeled amount of the dextrorotatory isomer of calcium pantothenate (C18H32CaN2O10).
•  A. Identification Tests—General, Calcium 191
Sample solution:  Digest a quantity of powdered Tablets, equivalent to 150 mg of calcium pantothenate, with 15 mL of 1 N sodium hydroxide, and filter.
Acceptance criteria:  Meet the requirements
•  B.
Sample solution:  5 mL of the filtrate obtained in Identification test A
Analysis:  Add 5 mL of 1 N hydrochloric acid and 2 drops of ferric chloride TS to the Sample solution.
Acceptance criteria:  A strong yellow color is produced.
•  Calcium Pantothenate Assay 91
Assay preparation:  Weigh and finely powder NLT 20 Tablets. Weigh a portion of the powder, equivalent to 25 mg of calcium pantothenate, and transfer, with the aid of about 50 mL of water, to a 1000-mL volumetric flask. Add 2 mL of 1 N acetic acid and 100 mL of sodium acetate solution (1 in 60), then dilute with water to volume. Make further accurate dilutions, with water, to a concentration between 0.01 and 0.04 µg/mL of calcium pantothenate.
Acceptance criteria:  95.0%–115.0%
•  Content of Calcium
Sample:  A portion of the powder from NLT 20 finely powdered Tablets, equivalent to 500 mg of calcium pantothenate
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 a suitable crucible. Ignite, gently at first, until free from carbon. Cool the crucible. Add 10 mL of water, and dissolve the residue by adding sufficient 3 N hydrochloric acid, dropwise, to achieve complete solution. Transfer the solution to a suitable container, and dilute with water to 150 mL. Add 15 mL of 1 N sodium hydroxide, then add the Indicator. Titrate with Titrant to a distinct blue endpoint. Perform a Blank determination.
Calculate the percentage of calcium in the content of calcium pantothenate, as determined by the Assay, 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, 40.08 mg/mM
W== weight of calcium pantothenate in the Sample taken, as determined by the Assay (mg)
Acceptance criteria:  7.9%–9.7% of the weight of calcium pantothenate (C18H32CaN2O10) in the Tablets, as determined by the Assay
•  Dissolution, Procedure for a Pooled Sample 711
Medium:  Water; 900 mL
Apparatus 2:  50 rpm
Time:  45 min
Mobile phase:  Phosphoric acid and water (1:1000)
Standard solution:  A known concentration of USP Calcium Pantothenate RS in Medium
Sample solution:  A filtered portion of the solution under test, suitably diluted with Medium if necessary, having a concentration of C18H32CaN2O10 similar to that of the Standard solution
Chromatographic system 
Mode:  LC
Detector:  UV 210 nm
Column:  3.9-mm × 15-cm; packing L1
Flow rate:  1.5 mL/min
Injection size:  10 µL
System suitability 
Sample:  Standard solution
Suitability requirements 
Relative standard deviation:  NMT 3.0%
Samples:  Standard solution and Sample solution
Calculate the percentage of the labeled amount of calcium pantothenate (C18H32CaN2O10) dissolved:
Result = (rU/rS) × (CS × D × V/L) × 100
rU== peak area of calcium pantothenate from the Sample solution
rS== peak area of calcium pantothenate from the Standard solution
CS== concentration of the Standard solution (mg/mL)
DS== dilution factor for the Sample solution
V== volume of Medium, 900 mL
L== label claim (mg/Tablet)
Tolerances:  NLT 75% (Q) of the labeled amount of calcium pantothenate (C18H32CaN2O10) is dissolved.
•  Uniformity of Dosage Units 905: Meet the requirements
•  Packaging and Storage: Preserve in tight containers.
•  Labeling: Label the Tablets to indicate the content of dextrorotatory calcium pantothenate.
•  USP Reference Standards 11
USP Calcium Pantothenate RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Natalia Davydova
Scientific Liaison
(DS2010) Monographs - Dietary Supplements
711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
(GCDF2010) General Chapters - Dosage Forms
Reference Standards RS Technical Services
USP35–NF30 Page 2461
Pharmacopeial Forum: Volume No. 30(1) Page 81