Anhydrous Magnesium Citrate BP Ph Eur Grade
Mg3(C6H5O7)2 --- 451.1 --- CAS 3344-18-1
Ph Eur
DEFINITION
Trimagnesium bis(2-hydroxypropane-1,2,3-tricarboxylate).
Content: 15.0 per cent to 16.5 per cent of Mg (dried substance).
CHARACTERS
Appearance: White or almost white, fine, slightly hygroscopic powder.
Solubility: Soluble in water, practically insoluble in ethanol (96 per cent). It dissolves in
dilute hydrochloric acid.
IDENTIFICATION
A. It gives the reaction of citrates.
B. It gives the reaction of magnesium.
C. pH (see Tests).
D. Loss on drying (see Tests).
TESTS
Solution S: Dissolve 5.0 g in carbon dioxide-free water R, heating at 60C, cool and dilute to
100 mL with the same solvent.
Appearance of solution: Solution S is not more opalescent than reference suspension and not
more intensely coloured than reference solutions.
pH: 6.0 to 8.5 for solution S.
Oxalates: Maximum 280 ppm.
Sulfates: Maximum 0.2 per cent.
Calcium: Maximum 0.2 per cent.
Iron: Maximum 100 ppm.
Heavy metals: Maximum 10 ppm.
Loss on drying: Maximum 3.5 per cent, determined on 1.000 g by drying in an oven at
180±10C for 5 h.
ASSAY
Dissolve 0.150 g in 50 mL of water. Carry out the complexometric titration of
magnesium. 1 mL of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg.
STORAGE
In a non-metallic, airtight container.
Magnesium Citrate Dodecahydrate BP Ph eur Grade
Mg3(C6H5O7)2,xH2O --- 451.1 (anhydrous substance)
with x ≈ 12
Ph Eur
DEFINITION
Trimagnesium bis(2-hydroxypropane-1,2,3-tricarboxylate) dodecahydrate.
Content: 15.0 per cent to 16.5 per cent of Mg (dried substance).
CHARACTERS
Appearance: White or almost white, fine powder.
Solubility: Sparingly soluble in water, practically insoluble in ethanol (96 per cent). It
dissolves in dilute hydrochloric acid.
IDENTIFICATION
A. It gives the reaction of citrates.
B. It gives the reaction of magnesium.
C. Loss on drying (see Tests).
TESTS
Solution S: Dissolve 2.5 g in 15 mL of dilute hydrochloric acid with heating. Cool
and dilute to 100 mL with distilled water.
Appearance of solution: Solution S is clear and not more intensely coloured than reference
solution.
pH: 6.0 to 8.5.
Oxalates: Maximum 280 ppm.
Sulfates: Maximum 0.2 per cent.
Calcium: Maximum 0.2 per cent.
Iron: Maximum 100 ppm.
Heavy metals: Maximum 10 ppm.
Loss on drying: 29.0 per cent to 36.0 per cent, determined on 1.000 g by drying in an oven at
180±10C for 5 h.
ASSAY
Dissolve 0.200 g in 5 mL of dilute hydrochloric acid with heating. Cool and add 50 mL of
water. Adjust to pH 7.0 with ammonia. Carry out the complexometric titration of magnesium. 1
mL of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg.
Magnesium Citrate Nonahydrate BP Ph Eur Grade
Mg3(C6H5O7)2,9H2O --- 613 --- CAS 153531-96-5
Ph Eur
DEFINITION
Trimagnesium bis(2-hydroxypropane-1,2,3-tricarboxylate) nonahydrate.
Content: 15.0 per cent to 16.5 per cent of Mg (dried substance).
CHARACTERS
Appearance: White or almost white, fine powder.
Solubility: Sparingly soluble in water, practically insoluble in ethanol (96 per cent). It
dissolves in dilute hydrochloric acid.
IDENTIFICATION
A. It gives the reaction of citrates.
B. It gives the reaction of magnesium (2.3.1).
C. Loss on drying (see Tests).
TESTS
Solution S: Dissolve 2.5 g in 15 mL of dilute hydrochloric acid with heating. Cool
and dilute to 100 mL with distilled water.
Appearance of solution: Solution S is clear and not more intensely coloured than reference
solution.
pH: 6.0 to 8.5.
Oxalates: Maximum 280 ppm.
Sulfates: Maximum 0.2 per cent.
Calcium: Maximum 0.2 per cent.
Iron: Maximum 100 ppm.
Heavy metals: Maximum 10 ppm.
Loss on drying: 24.0 to 28.0 per cent, determined on 1.000 g by drying in an oven at
180±10C for 5 h.
ASSAY
Dissolve 0.200 g in 5 mL of dilute hydrochloric acid with heating. Cool and add 50 mL
of water. Adjust to pH 7.0 with ammonia. Carry out the complexometric titration of magnesium).
1 mL of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg.
Magnesium Citrate USP
C12H10Mg3O14 451.11
1,2,3-Propanetricarboxylic
acid, hydroxy-, magnesium salt (2:3).
Magnesium citrate (3:2) [CAS 3344-18-1].
Magnesium Citrate contains not less than 14.5 percent and not more than 16.4 percent of magnesium (Mg), calculated on the dried basis.
Labeling—
Magnesium Citrate that loses not more
than 2.0% of its weight in the test for Loss on drying may be labeled
as Anhydrous Magnesium Citrate.
Identification—
A: A solution (10 mg per
mL)
responds to the tests for Magnesium.
B: A solution (80 mg per
mL)
responds to the tests for Citrate.
pH: between 5.0 and
9.0, in a suspension (50 mg per mL).
Loss on drying— Dry 1
g in a mechanical convection oven at 135 for 16 hours, then to constant
weight: it loses not more than 29% of its weight, except that where it is
labeled as anhydrous, it loses not more than 2.0% of its weight.
Chloride— A 300-mg portion shows no more
chloride than corresponds to 0.20 mL of 0.020 N hydrochloric acid (0.05%).
Sulfate— A 100-mg portion shows no more sulfate
than corresponds to 0.20 mL of 0.020N sulfuric
acid (0.2%).
Arsenic: 3 6g per g.
Heavy metals— Dissolve 0.4 g in 25
mL of water, and proceed as directed for Test
Preparation, except to use glacial acetic acid to adjust the pH: the
limit is 50 6g per g.
Iron— Boil 50 mg with 5 mL of 2 N nitric acid for 1 minute. Cool, dilute
with water to 45 mL, add 2 mL of hydrochloric acid, and mix: the limit is 200 6g per g.
Limit of calcium— the limit is 1.0%, calculated on the dried
basis. (The method is described in Magnesium Carbonate & Magnesium
Citrate Monograph.
Assay— Weigh accurately about 400 mg of
the substance, dissolve in 50 mL of water,
add 20 mL of ammonia–ammonium chloride buffer TS
and 0.1 mL of eriochrome
black TS, and titrate with 0.05 M edetate disodium VS to a blue endpoint. Perform a blank
determination, and make any necessary correction. From the volume of 0.05 M
edetate disodium
consumed, deduct the volume of 0.05 M edetate disodium corresponding to the amount of calcium
in the portion of Magnesium Citrate taken, based on the amount of calcium
found in the test for Limit of calcium. Each mg of calcium (Ca) is
equivalent to 0.25 mL of 0.05 M edetate disodium.
The difference is the volume of 0.05 M edetate disodium consumed by the magnesium. Each
mL of 0.05 M edetate disodium is equivalent to 1.215 mg of magnesium
(Mg).
We also manufacture and supply micro-encapsulated Magnesium Citrate.
Certifications :
We manufacture Bulk Drugs / API, Excipients,
Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral
Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is
cGMP,
GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL,
EXCiPACT, WC,
COPP, WHO-GMP and WC certified. We are also REACH registered for export to European
countries.