Macron™ 7727-04 Edetate Disodium (EDTA), GenAR USP Grade, 500g POLYSTORMOR Bottle (Case of 12)
- 12 x 500g POLYSTORMOR Bottles/Case
- Manufacturer Part No: MK-7727-04
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Details
Product Specifications
| TEST | SPECIFICATION |
| Food GMP Manufactured Product | |
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets F.C.C. Requirements | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Food Chemical | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (dried basis) | 99.0 - 101.0 % |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C | Passes Test |
| USP - pH (1 in 20) | 4.0 - 5.5 |
| USP - Loss on Drying (by wt) | 8.7 - 11.4 % |
| USP - Calcium (Ca) | Passes Test |
| USP - Heavy Metals | <= 0.005 % |
| USP - Limit of Nitrilotriacetic Acid (by wt) | <= 0.1 % |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Identification A | Passes Test |
| EP/BP - Assay | 98.5 - 101.0 % |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification D | Passes Test |
| EP/BP - Impurity A and Related Substances - Impurity A | <= 0.1 % |
| EP/BP - Iron (Fe) | <= 80 ppm |
| EP/BP - Heavy Metals (as Pb) | <= 20 ppm |
| EP/BP - pH (1 in 20) | 4.0 - 5.5 |
| Endotoxin Concentration (EU/g) | <= 5 |
| FCC - Assay (anhydrous basis) | 99.0 - 101.0 % |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Identification C | Passes Test |
| FCC - Lead (Pb) | <= 10 mg/kg |
| FCC - pH (1 in 100) | 4.3 - 4.7 |
| FCC - Calcium (Ca) | Passes Test |
| FCC - Limit of Nitrilotriacetic Acid (by wt) | <= 0.1 % |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |
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Product Specifications
| TEST | SPECIFICATION |
| Food GMP Manufactured Product | |
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets F.C.C. Requirements | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Food Chemical | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (dried basis) | 99.0 - 101.0 % |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C | Passes Test |
| USP - pH (1 in 20) | 4.0 - 5.5 |
| USP - Loss on Drying (by wt) | 8.7 - 11.4 % |
| USP - Calcium (Ca) | Passes Test |
| USP - Heavy Metals | <= 0.005 % |
| USP - Limit of Nitrilotriacetic Acid (by wt) | <= 0.1 % |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Identification A | Passes Test |
| EP/BP - Assay | 98.5 - 101.0 % |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification D | Passes Test |
| EP/BP - Impurity A and Related Substances - Impurity A | <= 0.1 % |
| EP/BP - Iron (Fe) | <= 80 ppm |
| EP/BP - Heavy Metals (as Pb) | <= 20 ppm |
| EP/BP - pH (1 in 20) | 4.0 - 5.5 |
| Endotoxin Concentration (EU/g) | <= 5 |
| FCC - Assay (anhydrous basis) | 99.0 - 101.0 % |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Identification C | Passes Test |
| FCC - Lead (Pb) | <= 10 mg/kg |
| FCC - pH (1 in 100) | 4.3 - 4.7 |
| FCC - Calcium (Ca) | Passes Test |
| FCC - Limit of Nitrilotriacetic Acid (by wt) | <= 0.1 % |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |