Macron™ 7532-19 Sodium Chloride, Granular, USP Grade & FCC Grade, 12Kg Poly Pail
Item Number:MAL-7532-19
Manufacturer Part No:MK-7532-19
Manufacturer:Avantor
Units:12Kg Poly Pail
Details
- 12Kg 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 (NaCl)(USP) (dried basis) | 99.0 - 100.5 % |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Loss on Drying at 105°C | <= 0.5 % |
| USP - Acidity or Alkalinity | Passes Test |
| USP - Iodide (I) | Passes Test |
| USP - Barium (Ba) | Passes Test |
| USP - Magnesium and Alkaline Earth Metals (as Ca) | <= 100 ppm |
| USP - Arsenic (As) | <= 1 ppm |
| USP - Nitrite (NO₂) (Absorbance Value) | <= 0.01 |
| USP - Heavy Metals (as Pb) | <= 2 ppm |
| USP - Sulfate (SO₄) | <= 200 ppm |
| USP - Phosphate (PO₄) | <= 25 ppm |
| USP - Iron (Fe) | <= 2 ppm |
| USP - Bromide (Br) | <= 100 ppm |
| USP - Appearance of Solution | Passes Test |
| USP - Ferrocyanide | Passes Test |
| USP - Aluminum (Al) | <= 0.2 ppm |
| USP - Potassium (K) | <= 500 ppm |
| FCC - Assay (as NaCl) (FCC) (ignited basis) | 99.0 - 100.5 % |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Arsenic (As) | <= 1 ppm |
| FCC - Calcium and Magnesium | <= 0.35 % |
| FCC - Heavy Metals (as Pb) | <= 2 ppm |
| FCC - Loss on Drying at 105°C | <= 0.5 % |
| Solubility (10 in 50) | Passes Test |
| Appearance (white, crystalline granules, slightly hygroscopic) | |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Must be subjected to further processing during the preparation of | |
| injectable dosage forms. | |
| 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 (NaCl)(USP) (dried basis) | 99.0 - 100.5 % |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Loss on Drying at 105°C | <= 0.5 % |
| USP - Acidity or Alkalinity | Passes Test |
| USP - Iodide (I) | Passes Test |
| USP - Barium (Ba) | Passes Test |
| USP - Magnesium and Alkaline Earth Metals (as Ca) | <= 100 ppm |
| USP - Arsenic (As) | <= 1 ppm |
| USP - Nitrite (NO₂) (Absorbance Value) | <= 0.01 |
| USP - Heavy Metals (as Pb) | <= 2 ppm |
| USP - Sulfate (SO₄) | <= 200 ppm |
| USP - Phosphate (PO₄) | <= 25 ppm |
| USP - Iron (Fe) | <= 2 ppm |
| USP - Bromide (Br) | <= 100 ppm |
| USP - Appearance of Solution | Passes Test |
| USP - Ferrocyanide | Passes Test |
| USP - Aluminum (Al) | <= 0.2 ppm |
| USP - Potassium (K) | <= 500 ppm |
| FCC - Assay (as NaCl) (FCC) (ignited basis) | 99.0 - 100.5 % |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Arsenic (As) | <= 1 ppm |
| FCC - Calcium and Magnesium | <= 0.35 % |
| FCC - Heavy Metals (as Pb) | <= 2 ppm |
| FCC - Loss on Drying at 105°C | <= 0.5 % |
| Solubility (10 in 50) | Passes Test |
| Appearance (white, crystalline granules, slightly hygroscopic) | |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Must be subjected to further processing during the preparation of | |
| injectable dosage forms. | |
| 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. | |