Magnesiumklorid hexahydrat, crystallised, EMPROVE® API Ph. Eur., BP, JPC, USP suitable for use as an active pharmaceutical ingredient, SAFC®
Leverantör: MERCK PRODUCTION CHEMICALS
Synonyms:
Magnesium dichloride
1.02367.5000
1.02367.9029
1.02367.9525
1.02367.5000EA
4125
SEK
1.02367.5000
1.02367.9029
1.02367.9525
Magnesiumklorid hexahydrat, crystallised, EMPROVE® API Ph. Eur., BP, JPC, USP suitable for use as an active pharmaceutical ingredient, SAFC®
Magnesiumklorid hexahydrat
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Certifikat: Corresponds to PhEur, BP, JPC, USP
Formel:
MgCl₂·6H₂O MW: 203.3 g/mol Kokpunkt: 1412 Smältpunkt: 117 Densitet: 1.57 g/cm³ (25 °C) Storage Temperature: Omgivande |
MDL Number:
MFCD00149781 CAS nummer: 7791-18-6 EINECS: 232-094-6 Merck Index: 13,05684 |
Specifikation testresultat
Assay (complexometric) | 99.0 - 101.0 % |
Identity | passes test |
Appearance of solution | passes test |
Insoluble matter | ≤ 0.005 % |
Acidity or alkalinity | passes test |
pH-value (5 %; water) | 5.0 - 7.0 |
Bromide (Br) | ≤ 0.05 % |
Sulfate (SO₄) | ≤ 0.005 % |
Heavy metals (as Pb) | ≤ 0.001 % |
Al (Aluminium) | ≤ 0.0001 % |
As (Arsenic) | ≤ 0.0002 % |
Ba (Barium) | passes test |
Ca (Calcium) | ≤ 0.01 % |
Fe (Iron) | ≤ 0.0005 % |
Hg (Mercury) | ≤ 0.0001 % |
K (Potassium) | ≤ 0.0500 % |
NH₄ (Ammonium) | ≤ 0.005 % |
Pb (Lead) | ≤ 0.0004 % |
Water | 51.0 - 55.0 % |
Total aerobic microbial count | ≤ 100 CFU/g |
Total yeast and mould count | ≤ 100 CFU/g |
Endotoxins | ≤ 3.0 I.U./g |
Residual solvents (Ph Eur/USP/ICH) | excluded by manufacturing process |
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