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Calcium Sulfate USP; Calcium Sulphate BP; Calcium Sulfate Manufacturers
Calcium Sulfate Sulphate USP ACS BP IP Analytical reagent FCC Food grade Manufacturers
For MSDS Sheet Click
MSDS of Calcium Sulfate Sulphate BP USP IP ACS Analytical Reagent FCC Food
grade Manufacturers
Calcium Sulphate as per British Pharmacopoeia 2009
Calcium Sulphate Dihydrate BP Calcium Sulphate BP Dihydrate
CaSO4,2H2O ... 172.2
Action and use
Excipient.
DEFINITION
Content
98.0 per cent to 102.0 per cent of CaSO4,2H2O
i.e. Calcium Sulphate Dihydrate or Calcium Sulfate Dihydrate.
CHARACTERS
Appearance
White or almost white fine powder.
Solubility
Very slightly soluble in water, practically
insoluble in ethanol (96 per cent).
IDENTIFICATION
Loss on ignition.
Solution S gives reaction of sulphates.
Solution S gives reaction of calcium.
TESTS
Solution S
Dissolve 1.0 g in 50 ml of a 10 per cent
V/V solution of hydrochloric acid R by heating at 50°C for 5 min. Allow to
cool.
Acidity or alkalinity
Shake 1.5 g with 15 ml of carbon dioxide-free water
for 5 min. Allow to stand for 5 min and
filter. To 10 ml of the filtrate add 0.1 ml of phenolphthalein solution
and 0.25 ml of 0.01 M sodium hydroxide
. The solution is red.
Add 0.30 ml of 0.01 M hydrochloric acid
. The solution is
colourless. Add 0.2 ml of methyl red solution.
The solution is reddish-orange.
Chlorides
Maximum
300 ppm.
Shake 0.5 g with 15 ml of water R
for 5 min. Allow to stand for 15 min and filter. Dilute 5 ml of
the filtrate to 15 ml with water.
Arsenic
Maximum
10 ppm, determined on 5 ml of solution S.
Iron
Maximum
100 ppm.
To 0.25 g add a mixture of 5
ml of hydrochloric acid R and 20 ml of water R
. Heat to boiling, cool
and filter.
Heavy metals
Maximum
20 ppm.
To 2.5 g add a mixture of 2
ml of hydrochloric acid R and 15 ml of water R
. Heat to boiling. Cool and then add 0.5 ml of
phenolphthalein
solution R .
Cautiously add concentrated ammonia until
the colour changes to pink. Add 0.5 ml of glacial acetic acid R
and dilute to 25 ml with water
R .
Filter. 12 ml of the filtrate complies with test A. Prepare the reference
solution using lead standard solution (2 ppm Pb.
Loss on ignition
18.0 per cent to 22.0 per cent, determined on 1.000 g by ignition to
constant mass at 800 ± 50C.
ASSAY
Dissolve 0.150 g in 120 ml
of water. Carry out the complex o metric
titration of calcium.
1 ml of 0.1 M sodium
edetate is equivalent to 17.22 mg of CaSO4,2H2O.
Calcium Sulfate per US Pharmacopoeia USP
Calcium Sulfate USP
CaSO4 136.14
Sulfuric acid, calcium salt (1:1)
Calcium sulfate (1:1) 136.14
Dihydrate 172.17
Calcium Sulfate is anhydrous or contains two molecules of water of hydration. It contains not less than 98.0 percent and not more than 101.0 percent of CaSO4 i.e. Calcium Sulfate or Calcium Sulphate, calculated on the dried basis.
Labeling— Label it to
indicate whether it is Calcium Sulfate anhydrous or the Calcium Sulphate dihydrate.
Identification— Dissolve about 200 mg by warming in a mixture of 4 mL
of 3 N hydrochloric acid and 16 mL of water.
This solution responds to the tests for Calcium and for
Sulfate.
Loss on
drying— Dry
it at a temperature not lower than 250 to
constant weight: the anhydrous form loses not more than 1.5% of its weight,
and the dihydrate loses between 19.0% and 23.0%
of its weight.
Iron— Dissolve 100 mg
in 8 mL of 3 N hydrochloric
acid, and dilute with water to 47 mL: the
limit is 0.01%.
Heavy metals— Mix 2.0
g with 20 mL of water, add 25
mL of 3 N hydrochloric acid,
and heat to boiling to dissolve the test specimen. Cool, and add ammonium
hydroxide to a pH of 7. Filter, evaporate to a volume of about 25
mL, and re-filter, if
necessary, to obtain a clear solution:
the limit is 0.001%.
Assay— Dissolve about
300 mg accurately weighed, in 100 mL of water and 4
mL of 3 N hydrochloric acid. Boil, if necessary, to dissolve, and cool
before titrating. While stirring, preferably with a magnetic stirrer, add,
in the order named, 0.5 mL of
triethanolamine, 300 mg of hydroxy naphthol blue, and, from a 50-mL
burette, about 30 mL
of 0.05 M edetate disodium
VS. Add sodium hydroxide solution (45 in 100) until the initial red color
changes to clear blue. Continue to add it drop wise
until the color changes to violet, and add an additional 0.5
mL. The pH is between 12.3 and 12.5. Continue
the titration drop wise with 0.05 M
edetate disodium VS
to the appearance of a clear-blue endpoint that persists for not less than
60 seconds. Each mL of 0.05 M edentate
disodium is equivalent to 6.807 mg of CaSO4.
Calcium Sulfate FCC as per US Food Chemical Codex FCC
Calcium Sulfate FCC
CaSO4 Formula wt, anhydrous
136.14
CaSO4·2H2O Formula wt,
dihydrate 172.18
INS: 516 CAS: anhydrous
[7778-18-9]
CAS: dihydrate [10101-41-4]
DESCRIPTION
Calcium Sulfate occurs as a
fine, white to slightly yellow-white powder. It is anhydrous or contains two
molecules of water of hydration.
Function Nutrient; yeast food; dough conditioner; firming
agent; sequestrant.
REQUIREMENTS
Identification: Dissolve about 200 mg of sample by warming it with a mixture of 4
mL of 2.7 N hydrochloric acid and 16
mL of water. A white precipitate forms when 5
mL of ammonium oxalate TS is added to 10
mL of the solution. Upon the addition of barium
chloride TS to the remaining 10 mL, a white
precipitate forms that is insoluble in hydrochloric and nitric acids.
Assay: Not less than
98.0% of CaSO4 i.e. Calcium Sulphate, calculated on the dried basis.
Fluoride: Not more
than 0.003%.
Lead: Not more than 2
mg/kg.
Loss on Drying Anhydrous: Not more than 1.5%; Dihydrate:
Between
19.0% and 23.0%.
Selenium: Not more
than 0.003%.
TESTS
Assay Dissolve 250 mg
of sample, accurately weighed, in 100 mL of
water and 4 mL of 2.7 N hydrochloric
acid, boil to effect solution, and cool. While stirring, preferably with a
magnetic stirrer, add about 30 mL of 0.05 M
disodium EDTA from a 50-mL burette, then add 25 mL
of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue indicator, and continue the
titration to a blue endpoint. Each milliliter of 0.05 M disodium EDTA is equivalent to 6.807 mg of
CaSO4.
Reagent: Calcium Sulphate Dihydrate as per ACS specifications
American Chemical Society Reagent Grade
Calcium Sulfate ACS Dihydrate
Also Called Calcium Sulphate Dihydrate
CaSO4 . 2H2O
Formula Wt 172.17
CAS Number 10101-41-4
REQUIREMENTS
Assay: 98.0-102.0%
CaSO4 . 2H2O
MAXIMUM ALLOWABLE
Insoluble in dilute
hydrochloric acid: 0.02%
Chloride (Cl): 0.005%
Nitrate (NO3): Passes test
Carbonate (CO3): Passes test
Heavy metals (as
Pb): 0.002%
Iron (Fe): 0.001%
Magnesium (Mg): 0.02%
Potassium (K): 0.005%
Sodium (Na): 0.02%
Strontium (Sr): 0.05%
