Résultats des tests de spécification
GMP Manufactured Product |
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Meets ChP Chemical Specifications |
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Meets U.S.P Requirements |
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Meets B.P. Chemical Specifications |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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Appearance (White crystals or granules) |
Passes Test |
USP - Assay (anhydrous basis) |
98.0 - 103.0 % |
USP - Aluminum, Calcium, and Related Elements |
Passes Test |
USP - Arsenic (As) |
≤ 8 ppm |
USP - Chloride (Cl) |
≤ 0.014 % |
USP - Identification A |
Passes Test |
USP - Identification B |
Passes Test |
USP - Insoluble Substances |
≤ 0.2 % |
USP - pH (1 in 20) |
4.1 - 4.5 |
USP - Sulfate (SO₄) |
≤ 0.15 % |
USP - Water (H₂O) |
10.0 - 15.0 % |
EP - Identification A |
Passes Test |
EP - Identification B |
Passes Test |
EP - Identification C |
Passes Test |
EP - Assay (anhydrous basis) |
98.0 - 100.5 % |
EP - Chloride (Cl) |
≤ 200 ppm |
EP - Sulfate (SO₄) |
≤ 300 ppm |
EP - Reducing Substances |
Passes Test |
Endotoxin Concentration (EU/g) |
≤ 2.5 |
EP - Iron (Fe) |
≤ 10 ppm |
EP - Appearance of Solution |
Passes Test |
EP - pH |
4.2 - 4.5 |
BP - Identification A |
Passes Test |
BP - Identification B |
Passes Test |
BP - Identification C |
Passes Test |
BP - Identification D |
Passes Test |
BP - Acidity |
4.2 - 4.5 |
BP - Clarity and Color of Solution |
Passes Test |
BP - Arsenic (As) |
≤ 2 ppm |
BP - Iron (Fe) |
≤ 10 ppm |
BP - Chloride (Cl) |
≤ 200 ppm |
BP - Sulfate (SO₄) |
≤ 300 ppm |
BP - Reducing Substances |
Passes Test |
BP - Loss on Drying at 130°C |
11.5 - 14.5 % |
BP - Assay (dried basis) |
98.0 - 100.5 % |
JPE - Assay (dried basis) |
≥ 98.0 % |
JPE - Identification |
Passes Test |
JPE - pH |
4.1 - 4.7 |
JPE - Clarity and Color of Solution |
Passes Test |
JPE - Chloride (Cl) |
≤ 0.005 % |
JPE - Sulfate (SO4) |
≤ 0.019 % |
JPE - Heavy Metals |
≤ 10 ppm |
JPE - Arsenic (As) |
≤ 2 ppm |
ChP - Assay (dried basis) |
≥ 98.0 % |
ChP - Identification |
Passes Test |
ChP - Acidity (pH) |
4.1 - 4.7 |
ChP - Clarity and color of solution |
Passes Test |
ChP - Chlorides |
≤ 0.01 % |
ChP - Sulfates |
≤ 0.05 % |
ChP - Loss on Drying |
10.0 - 15.0 % |
ChP - Aluminum |
≤ 0.01 % |
ChP - Calcium |
≤ 0.01 % |
ChP - Heavy metals |
≤ 0.001 % |
ChP - Arsenic |
≤ 0.0002 % |
ChP - Water insoluble substanc |
≤ 0.2 % |
ChP - Reducing substances |
Passes Test |
ChP - Iron |
≤ 0.001 % |
For EP notated requirements, results are derived from testing Sodium |
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Phosphate, Monobasic Monohydrate, U.S.P. to the EP Chemical |
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specifications for Sodium Dihydrogen Phosphate Dihydrate. |
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For JPE notated requirements, results are derived from testing Sodium |
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Phosphate, Monobasic Monohydrate, U.S.P. to the JPE Chemical |
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No Class 1,2,3 or other solvents are used or produced in the |
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manufacturing or purification of the product. |
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Elemental Impurities (USP 232, EP 5.20) - Information on elemental |
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impurities for this product is available on the associated Product |
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Regulatory Data Sheet and elemental impurity profile report. |
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