Macron™ 1115-24 Potassium Iodide Powder, GenAR®,BioReagent Grade, USP Grade, 50Kg Poly Drum
Item Number:MAL-1115-24
Manufacturer Part No:MK-1115-24
Manufacturer:Avantor
Units:50Kg Poly Drum
Details
- 50Kg Poly Drum
Product Specifications
| TEST | SPECIFICATION |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| Food GMP Manufactured Product | |
| Meets F.C.C. Requirements | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Bulk Food Chemical | |
| USP - Assay (KI)(U.S.P.) | 99.0 - 101.5 % |
| USP - Identification (Potassium) | Passes Test |
| USP - Identification (Iodide) | Passes Test |
| USP - Heavy Metals (as Pb) | <= 0.001 % |
| USP - Loss on Drying at 105°C | <= 0.50 % |
| USP - Iodate (IO₃) | <= 4 mg/kg |
| USP - Thiosulfate and Barium | Passes Test |
| USP - Alkalinity | Passes Test |
| USP - Nitrate, Nitrite, and Ammonia | Passes Test |
| EP/BP - Assay (Dried Basis) | 99.0 - 100.5 % |
| EP/BP - Identificaton A (Iodides) | Passes Test |
| EP/BP - Identification B (Potassium) | Passes Test |
| EP/BP - Alkalinity | Passes Test |
| EP/BP - Appearance (white, granular) | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Iodates | Passes Test |
| EP/BP - Sulfate (SO₄) | <= 150 ppm |
| EP/BP - Thiosulphates | Passes Test |
| EP/BP - Iron (Fe) | <= 20 ppm |
| EP/BP - Loss on Drying | <= 1.0 % |
| EP/BP - Heavy Metals (as Pb) | <= 10 ppm |
| Free Alkali, For Information Only | |
| FCC - Assay (KI)(F.C.C.) | 99.0 - 101.5 % |
| FCC - Identification (Potassium) | Passes Test |
| FCC - Identification (Iodide) | Passes Test |
| FCC - Identification B (FCC) | Passes Test |
| FCC - Lead (Pb) | <= 4 mg/kg |
| FCC - Loss on Drying at 105°C | <= 0.50 % |
| FCC - Iodate (IO₃) | <= 4 mg/kg |
| FCC - Thiosulfate and Barium | Passes Test |
| FCC - Nitrate, Nitrite, and Ammonia | Passes Test |
| 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 |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| Food GMP Manufactured Product | |
| Meets F.C.C. Requirements | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Bulk Food Chemical | |
| USP - Assay (KI)(U.S.P.) | 99.0 - 101.5 % |
| USP - Identification (Potassium) | Passes Test |
| USP - Identification (Iodide) | Passes Test |
| USP - Heavy Metals (as Pb) | <= 0.001 % |
| USP - Loss on Drying at 105°C | <= 0.50 % |
| USP - Iodate (IO₃) | <= 4 mg/kg |
| USP - Thiosulfate and Barium | Passes Test |
| USP - Alkalinity | Passes Test |
| USP - Nitrate, Nitrite, and Ammonia | Passes Test |
| EP/BP - Assay (Dried Basis) | 99.0 - 100.5 % |
| EP/BP - Identificaton A (Iodides) | Passes Test |
| EP/BP - Identification B (Potassium) | Passes Test |
| EP/BP - Alkalinity | Passes Test |
| EP/BP - Appearance (white, granular) | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Iodates | Passes Test |
| EP/BP - Sulfate (SO₄) | <= 150 ppm |
| EP/BP - Thiosulphates | Passes Test |
| EP/BP - Iron (Fe) | <= 20 ppm |
| EP/BP - Loss on Drying | <= 1.0 % |
| EP/BP - Heavy Metals (as Pb) | <= 10 ppm |
| Free Alkali, For Information Only | |
| FCC - Assay (KI)(F.C.C.) | 99.0 - 101.5 % |
| FCC - Identification (Potassium) | Passes Test |
| FCC - Identification (Iodide) | Passes Test |
| FCC - Identification B (FCC) | Passes Test |
| FCC - Lead (Pb) | <= 4 mg/kg |
| FCC - Loss on Drying at 105°C | <= 0.50 % |
| FCC - Iodate (IO₃) | <= 4 mg/kg |
| FCC - Thiosulfate and Barium | Passes Test |
| FCC - Nitrate, Nitrite, and Ammonia | Passes Test |
| 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. | |