Sodium Phosphate, Monobasic, Monohydrate, USP, Multi-Compendial, Endotoxin Tested, J.T.Baker®
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Sodium Phosphate, Monobasic, Monohydrate, USP, Multi-Compendial, Endotoxin Tested, J.T.Baker®
Formula: NaH2PO4·H2O
Formula Weight: 137.99
| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| 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- Arsenic (As) |
<= 2 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 |
| For EP notated requirements, results are derived from testing Sodium Phosphate, Monobasic Monohydrate, U.S.P. to the EP Chemical specifications for Sodium Dihydrogen Phosphate Dihydrate. |
| For JPE notated requirements, results are derived from testing Sodium Phosphate, Monobasic Monohydrate, U.S.P. to the JPE Chemical specifications for Sodium Dihydrogen Phosphate Dihydrate. |
| |
| 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. |
| CAS Number |
10049-21-5 |
| Merck Index |
14,8660 |
| HTS Number |
2835220000 |
| Specific Gravity |
1L = 2.04kg |
| Storage Color Code |
Green |
| Management of Change |
HR |