Calcium Gluceptate
;)
Glucoheptonic acid,calcium salt (2:1).
Calcium glucoheptonate (1:2) [29039-00-7].
»Calcium Gluceptate is anhydrous or contains varying amounts of water of hydration.It consists of the calcium salt of the alpha epimer of glucoheptonic acid or of a mixture of the alpha and beta epimers of glucoheptonic acid.It contains not less than 95.0percent and not more than 102.0percent of C14H26CaO16,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Labeling—
Label it to indicate whether it is hydrous or anhydrous;if hydrous,label it to indicate also the degree of hydration.
Identification—
A:Infrared Absorption á197Kñ.
B:
Asolution (1in 50)responds to the tests for Calcium á191ñ.
pHá791ñ:
between 6.0and 8.0,in a solution (1in 10).
Loss on drying á731ñ(see Thermal Analysis á891ñ)—
[NOTE—The quantity taken for the determination may be adjusted,if necessary,for instrument sensitivity.Weight loss occurring at temperatures above about 160
,indicative of decomposition,is not to be interpreted as Loss on drying.]Determine the percentage of volatile substances by thermogravimetric analysis on an appropriately calibrated instrument,using 10to 25mg of Calcium Gluceptate accurately weighed.Heat the specimen under test at a rate of 5per minute in an atmosphere of nitrogen,at a flow rate of 40mLper minute.Record the thermogram to 150:the anhydrous form loses not more than 1.0%,the 2H2Oform not more than 6.9%,and the 3½H2Oform not more than 11.4%,of its weight.
,indicative of decomposition,is not to be interpreted as Loss on drying.]Determine the percentage of volatile substances by thermogravimetric analysis on an appropriately calibrated instrument,using 10to 25mg of Calcium Gluceptate accurately weighed.Heat the specimen under test at a rate of 5per minute in an atmosphere of nitrogen,at a flow rate of 40mLper minute.Record the thermogram to 150:the anhydrous form loses not more than 1.0%,the 2H2Oform not more than 6.9%,and the 3½H2Oform not more than 11.4%,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—
Dissolve 1g in 25mLof water:the limit is 0.002%.
Reducing sugars—
Dissolve 0.50g in 10mLof hot 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 800mg of Calcium Gluceptate,accurately weighed,in 150mLof water containing 2mLof 3Nhydrochloric acid.While stirring,preferably with a magnetic stirrer,add about 25mLof 0.05Medetate disodium VSfrom a 50-mLburet.Add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and continue the titration to a blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 24.52mg of C14H26CaO16.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 325
Pharmacopeial Forum:Volume No.27(6)Page 3257
Phone Number:1-301-816-8389