Macron™ 8824-05 Zinc Oxide, Powder, USP Grade, 2.5Kg STAKMOR Case
- 2.5Kg STAKMOR Case
- Manufacturer Part No: MK-8824-05
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Details
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (ZnO) (ignited basis) | 99.0 - 100.5 % |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Alkalinity | Passes Test |
| USP - Loss on Ignition | <= 1.0 % |
| USP - Carbonate and Color of Solution | Passes Test |
| USP - Arsenic (As) | <= 6 ppm |
| USP - Lead (Pb) | Passes Test |
| USP - Iron and Other Heavy Metals | Passes Test |
| Solubility in Dilute Sulfuric Acid | Passes Test |
| Lead (Pb) | <= 0.0010 % |
| Cadmium (Cd) | <= 0.0015 % |
| Iron (Fe) | <= 0.0020 % |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (ZnO) (ignited basis) | 99.0 - 100.5 % |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Alkalinity | Passes Test |
| USP - Loss on Ignition | <= 1.0 % |
| USP - Carbonate and Color of Solution | Passes Test |
| USP - Arsenic (As) | <= 6 ppm |
| USP - Lead (Pb) | Passes Test |
| USP - Iron and Other Heavy Metals | Passes Test |
| Solubility in Dilute Sulfuric Acid | Passes Test |
| Lead (Pb) | <= 0.0010 % |
| Cadmium (Cd) | <= 0.0015 % |
| Iron (Fe) | <= 0.0020 % |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |