Calcium Levulinate
;)
Pentanoic acid,4-oxo-,calcium salt (2:1),dihydrate.
Calcium levulinate (1:2)dihydrate [5743-49-7].
Anhydrous 270.30 [591-64-0].
»Calcium Levulinate contains not less than 97.5percent and not more than 100.5percent of C10H14CaO6,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Asolution (1in 10)responds to the tests for Calcium á191ñ.
B:
To a solution of 0.5g in 5mLof water add 5mLof 1Nsodium hydroxide,and filter.To the filtrate add 5mLof iodine TS:a precipitate of iodoform is produced.
pHá791ñ:
between 7.0and 8.5,in a solution (1in 10).
Loss on drying á731ñ—
Dry it at a pressure not exceeding 5mm of mercury at 60
for 5hours:it loses between 10.5%and 12.0%of its weight.
for 5hours:it loses between 10.5%and 12.0%of its weight.
Chloride á221ñ—
A1.0-g portion shows no more chloride than corresponds to 1.0mLof 0.020Nhydrochloric acid (0.07%).
Sulfate á221ñ—
A2.0-g portion shows no more sulfate than corresponds to 1.0mLof 0.020Nsulfuric acid (0.05%).
Heavy metals á231ñ:
0.002%.
Reducing sugars—
Dissolve 0.50g in 10mLof water,add 2mLof 3Nhydrochloric acid,boil for about 2minutes,and cool.Add 5mLof sodium carbonate TS,allow to stand for 5minutes,dilute with water to 20mL,and filter.Add 5mLof the clear filtrate to about 2mLof alkaline cupric tartrate TS,and boil for 1minute:no red precipitate is formed immediately.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 600mg of Calcium Levulinate,accurately weighed,in 150mLof water containing 2mLof 3Nhydrochloric acid.While stirring with a magnetic stirrer,add 30mLof 0.05Medetate disodium VSfrom a 50-mLburet,followed by 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and continue the titration to the blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 13.51mg of C10H14CaO6.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 330
Pharmacopeial Forum:Volume No.27(6)Page 3260
Phone Number:1-301-816-8389