Calcium Pantothenate
(kal' see um pan" toe then' ate).

C18H32CaN2O10 476.53
-Alanine, N-(2,4-dihydroxy-3,3-dimethyl-1-oxobutyl)-, calcium salt (2:1), (R)-;
Calcium d-pantothenate (1:2)     [137-08-6].
DEFINITION
Calcium Pantothenate is the calcium salt of the dextrorotatory isomer of pantothenic acid. It contains NLT 5.7% and NMT 6.0% of nitrogen (N), and NLT 8.2% and NMT 8.6% of calcium (Ca), both calculated on the dried basis.
IDENTIFICATION
A 50-mg/mL solution meets the requirements.
COMPOSITION
Sample:  500 mg
Analysis:  Proceed as directed in the chapter.
Acceptance criteria:  5.7%–6.0% on the dried basis
•  Content of Calcium
Sample:  800 mg of Calcium Pantothenate
Blank:  150 mL of water containing 2 mL of 3 N hydrochloric acid
Titrimetric system
Mode:  Direct titration
Titrant:  0.05 M edetate disodium VS
Endpoint detection:  Visual
Analysis:  Dissolve the Sample in 150 mL of water containing 2 mL of 3 N hydrochloric acid. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and titrate with Titrant to a distinct blue endpoint. Perform the Blank determination.
Calculate the percentage of calcium (Ca) in the Sample 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 = = Sample weight (mg)
Acceptance criteria:  8.2%–8.6% on the dried basis
IMPURITIES
Test preparation:  1.0 g in 25 mL of water
Acceptance criteria:  NMT 20 ppm
Standard solution:  Use water as the solvent. Use USP Beta Alanine RS, in place of USP Calcium Pantothenate RS, as the Standard.
Test solution:  Use water as the solvent.
Eluant:  Alcohol and water (65:35)
Visualization:  4
Acceptance criteria:  NMT 1.0%
SPECIFIC TESTS
Sample solution:  50 mg/mL in water
Acceptance criteria:  +25.0 to +27.5
•  Alkalinity
Sample:  1.0 g
Analysis:  Dissolve the Sample in 15 mL of carbon dioxide-free water in a small flask. As soon as the solution is complete, add 1.0 mL of 0.10 N hydrochloric acid, then add 0.05 mL of phenolphthalein TS.
Acceptance criteria:  No pink color is produced within 5 s.
Dry a sample at 105 for 3 h: it loses NMT 5.0% of its weight.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight containers.
USP Beta Alanine RS
3-Aminopropionic acid.
USP Calcium Pantothenate RS
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Huy T. Dinh, M.S.
Scientific Liaison
1-301-816-8594
(DS2010) Monographs - Dietary Supplements
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 2461
Pharmacopeial Forum: Volume No. 32(1) Page 62