Calcium chloride dihydrate, granular USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Management of Change (MOC) category = R
1335-07EA
898.89
EUR
1335-07
Calcium chloride dihydrate, granular USP, Multi-Compendial, J.T.Baker®
Calcium chloride dihydrate
Specification Test Results
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Meets J.P. Chemical Specifications | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Identification | Passes Test |
USP - pH of 5% Solution at 25°C | 4.5 - 9.2 |
USP - Iron, Aluminum, and Phosphate | Passes Test |
USP - Magnesium and Alkali Salts | ≤ 1.0 % |
USP - Assay (CaCl₂·2H₂O) | 99.0 - 107.0 % |
Endotoxin Concentration (EU/g) | ≤ 10 |
EP/BP - Assay (CaCl₂·2H₂O) | 97.0 - 103.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Acidity or Alkalinity | Passes Test |
EP/BP - Sulfate (SO₄) | ≤ 300 ppm |
EP/BP - Aluminum (Al) | Passes Test |
EP/BP - Iron (Fe) | ≤ 10 ppm |
EP/BP - Magnesium and Alkali Metals | ≤ 0.5 % |
JP - Assay (CaCl₂·2H₂O) | 96.7 - 103.3 % |
JP - Identification | Passes Test |
JP - pH (1 in 20) | 4.5 - 9.2 |
JP - Heavy Metals (as Pb) | ≤ 10 ppm |
JP - Clarity and Color of Solution | Passes Test |
JP - Sulfate (SO₄) | ≤ 0.024 % |
JP - Hypochlorite | Passes Test |
JP - Iron, Aluminum or Phosphate | Passes Test |
JP - Barium (Ba) | Passes Test |
JP - Arsenic (As) | ≤ 2 ppm |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. |
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