Edetate Disodium, USP, Multi-Compendial, EDTA, Disodium Salt Dihydrate Crystal, J.T.Baker®
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Edetate Disodium, USP, Multi-Compendial, EDTA, Disodium Salt Dihydrate Crystal, J.T.Baker®
(edta, disodium salt dihydrate crystal)
Formula: C10H14N2Na2O8·2H2O
Formula Weight: 372.24
| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets J.P. Chemical Specifications |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| USP- Identification A |
Passes Test |
| USP- Identification B |
Passes Test |
| USP- Identification C |
Passes Test |
| USP- pH (1 in 20) |
4.0 - 6.0 |
| USP- Loss on Drying |
8.7 - 11.4% |
| USP- Calcium (Ca) |
Passes Test |
| USP- Nitrilotriacetic Acid |
<= 0.1% |
| USP- Assay (C10H14N2Na2O8) (dried basis) |
99.0 - 101.0% |
| Endotoxin Concentration (EU/g) |
<= 5 |
| EP/BP- Assay |
98.5 - 101.0% |
| EP/BP- Identification A |
Passes Test |
| EP/BP- Identification B |
Passes Test |
| EP/BP- Identification D |
Passes Test |
| EP/BP- Impurity A |
<= 0.1% |
| EP/BP- Appearance of Solution |
Passes Test |
| EP/BP- pH (1 in 20) |
4.0 - 5.5 |
| EP/BP- Iron (Fe) |
<= 80 ppm |
| JP- Assay |
99.0 - 101.0% |
| JP- Identification A |
Passes Test |
| JP- Identification B |
Passes Test |
| JP- Identification C |
Passes Test |
| JP- pH of 1% Solution at 25°C |
4.3 - 4.7 |
| JP- Clarity and Color of Solution |
Passes Test |
| JP- Cyanide (CN) |
Passes Test |
| JP- Heavy Metals (as Pb) |
<= 10 ppm |
| JP- Arsenic (As) |
<= 2 ppm |
| JP- Residue after Ignition |
37.0 - 39.0% |
|
| 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 |
6381-92-6 |
| HTS Number |
2922498000 |
| Specific Gravity |
1L = 0.00kg |
| Storage Color Code |
Green |
| Management of Change |
R |