Macron™ 7396-08 Sodium Bicarbonate Powder, USP Grade & FCC Grade, 25Kg Poly Pail
Item Number:MAL-7396-08
Manufacturer Part No:MK-7396-08
Manufacturer:Avantor
Units:25Kg Poly Pail
Details
- 25Kg Poly Pail
Product Specifications
| TEST | SPECIFICATION |
| Food GMP Manufactured Product | |
| GMP Manufactured Product | |
| Meets F.C.C. Requirements | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Food Chemical | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (NaHCO₃) (dried basis)(by acidimetry) | 99.0 - 100.5 % |
| USP - Aluminum (Al) | <= 2 ppm |
| USP - Arsenic (As) | <= 2 ppm |
| USP - Calcium (Ca) | <= 0.01 % |
| USP - Carbonate (CO₃) | <= 0.23 % |
| USP - Chloride (Cl) | <= 0.015 % |
| USP - Copper (Cu) | <= 1 ppm |
| USP - Heavy Metals (as Pb)(µg/g) | <= 5 |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Insoluble Substances | Passes Test |
| USP - Iron (Fe) | <= 5 ppm |
| USP - Limit of Ammonia | <= 20 ppm |
| USP - Limit of Sulfur Compounds | <= 0.015 % |
| USP - Loss on Drying | <= 0.25 % |
| USP - Magnesium (Mg) | <= 0.004 % |
| USP - Normal Carbonate | Passes Test |
| USP - Limit of Organics | <= 0.01 % |
| FCC - Assay (NaHCO₃) (dried basis)(by acidimetry) | 99.0 - 100.5 % |
| FCC - Ammonia (as NH₃) | Passes Test |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Insoluble Substances | Passes Test |
| FCC - Lead (Pb) | <= 2 mg/kg |
| FCC - Loss on Drying | <= 0.25 % |
| The net weight of the product in each container is within +/- 2% of the | |
| netweight stated on the label. | |
| 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 |
| Food GMP Manufactured Product | |
| GMP Manufactured Product | |
| Meets F.C.C. Requirements | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Food Chemical | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (NaHCO₃) (dried basis)(by acidimetry) | 99.0 - 100.5 % |
| USP - Aluminum (Al) | <= 2 ppm |
| USP - Arsenic (As) | <= 2 ppm |
| USP - Calcium (Ca) | <= 0.01 % |
| USP - Carbonate (CO₃) | <= 0.23 % |
| USP - Chloride (Cl) | <= 0.015 % |
| USP - Copper (Cu) | <= 1 ppm |
| USP - Heavy Metals (as Pb)(µg/g) | <= 5 |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Insoluble Substances | Passes Test |
| USP - Iron (Fe) | <= 5 ppm |
| USP - Limit of Ammonia | <= 20 ppm |
| USP - Limit of Sulfur Compounds | <= 0.015 % |
| USP - Loss on Drying | <= 0.25 % |
| USP - Magnesium (Mg) | <= 0.004 % |
| USP - Normal Carbonate | Passes Test |
| USP - Limit of Organics | <= 0.01 % |
| FCC - Assay (NaHCO₃) (dried basis)(by acidimetry) | 99.0 - 100.5 % |
| FCC - Ammonia (as NH₃) | Passes Test |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Insoluble Substances | Passes Test |
| FCC - Lead (Pb) | <= 2 mg/kg |
| FCC - Loss on Drying | <= 0.25 % |
| The net weight of the product in each container is within +/- 2% of the | |
| netweight stated on the label. | |
| 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. | |