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Magnesium Pidolate BP Ph Eur Grade & Calcium Pidolate Supplier, Manufacturer's Representative, CAS Number 62003-27-4 C10H12N2O6Mg and 31377-05-6 C10H12CaN2O6
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For MSDS Sheet Click MSDS SDS of Magnesium Pidolate Suppliers
For MSDS Sheet Click MSDS SDS of Calcium Pidolate Suppliers
Magnesium Pidolate Calcium Pidolate
CAS Number 62003-27-4 C10H12N2O6Mg and 31377-05-6 C10H12CaN2O6 BP Ph Eur Grade Suppliers
Magnesium Pidolate BP Ph Eur Grade
C10H12N2O6Mg -- 280.5 -- CAS Number 62003-27-4
Content: 8.49 per cent to 8.84 per cent of Mg (Ar = 24.31) (anhydrous substance).
Appearance: Amorphous, white or almost white powder, hygroscopic.
Solubility: Very soluble in water, soluble in methanol, practically insoluble in methylene chloride.
A. Thin-layer chromatography.
Test solution: Dissolve 60 mg in 2 ml of water and dilute to 10 ml with methanol.
Reference solution: Dissolve 55 mg of pidolic acid CRS in 2 ml of water and dilute to 10 ml with methanol.
Plate:TLC silica gel plate.
Mobile phase: methanol, glacial acetic acid, methylene chloride (15:20:65 V/V/V).
Development: Over 2/3 of the plate.
Drying: At 100-105C for 15 min.
Detection: Spray with concentrated sodium hypochlorite solution. Allow to stand for 10 min and spray abundantly with glacial acetic acid. Allow to stand again for 10 min and dry the plate at 100-105C for 2 min. Spray with potassium iodide and starch solution until spots appear.
Results: The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution. The chromatogram obtained with the test solution may show 2 faint secondary spots.
B. To 0.15 ml of solution S (see Tests) add 1.8 ml of water. The solution gives the reaction of magnesium.
Solution S: Dissolve 5.00 g in carbon dioxide-free water prepared from distilled water and dilute to 50.0 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
pH: 5.5 to 7.0 for solution S.
Specific optical rotation: - 23.3 to - 26.5 (anhydrous substance), determined on solution S.
Impurity B (2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentanedioic acid.
Impurity B: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
total of other impurities: not more than half of the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);
disregard limit: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent); disregard any peak corresponding to the nitrate ion (NO3–).
Impurity A glutamic acid.
Impurity A: any spot corresponding to impurity A in the chromatogram obtained with the test solution is not more intense that the spot in the chromatogram obtained with reference solution (a) (0.6 per cent).
Chlorides: Maximum 500 ppm.
Nitrates: Examine the chromatogram obtained with the test solution in the test for related substances.
nitrates: not more than the area of the principal peak in the chromatogram obtained with reference solution (d) (200 ppm).
Sulphates: Maximum 0.1 per cent.
Arsenic: Maximum 2 ppm.
Iron: Maximum 200 ppm.
Heavy metals: Maximum 20 ppm.
Water: Maximum 8.0 per cent, determined on 0.200 g.
Specifications of Calcium Pidolate:
Description: White crystalline or granular powder.
CAS Number 31377-05-6
Assay (On dried substance): 98.5% to 102.0%
Identification: Shall pass the test.
Solubility: Freely soluble in water.
Clarity of solution (5% w/v of solution): Clear.
pH (5% w/v solution): 6.0 - 7.5
Chloride: 0.1% maximum
Sulphate: 0.1% maximum
Heavy Metals: 10 ppm maximum
Arsenic: 3 ppm maximum
Loss on drying: 6.0% maximum.
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16 March, 2022