JT Baker® 3628-F9 Sodium Chloride Granular, USP Grade & FCC Grade, 50Kg Flowmor Container
- 50Kg Flowmor Drum
- Manufacturer Part No: JT-3628-F9
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Details
Product Specifications
TEST | SPECIFICATION |
Meets U.S.P Requirements | |
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 (NaCl) (USP) (dried basis) | 99.0 - 100.5 % |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Acidity or Alkalinity | Passes Test |
USP - Aluminum (Al) | <= 0.2 ppm |
USP - Appearance of Solution | Passes Test |
USP - Arsenic (As) | <= 1 ppm |
USP - Barium (Ba) | Passes Test |
USP - Heavy Metals (as Pb) | <= 2 ppm |
USP - Nitrite (NO₂) (Absorbance Value) | <= 0.01 |
USP - Magnesium and Alkaline Earth Metals (as Ca) | <= 100 ppm |
USP - Iodide (I) | Passes Test |
USP - Bromide (Br) | <= 100 ppm |
USP - Iron (Fe) | <= 2 ppm |
USP - Loss on Drying | <= 0.5 % |
USP - Phosphate (PO₄) | <= 25 ppm |
USP - Potassium (K) | <= 500 ppm |
USP - Ferrocyanide | Passes Test |
USP - Sulfate (SO₄) | <= 200 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 (as Ca) (by EDTA titration)(FCC) | <= 0.35 % |
FCC - Heavy Metals (as Pb) | <= 2 ppm |
FCC - Iron (Fe) | <= 2 ppm |
FCC - Loss on Drying | <= 0.5 % |
Appearance (White crystals or granules) | Passes Test |
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 |
Meets U.S.P Requirements | |
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 (NaCl) (USP) (dried basis) | 99.0 - 100.5 % |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Acidity or Alkalinity | Passes Test |
USP - Aluminum (Al) | <= 0.2 ppm |
USP - Appearance of Solution | Passes Test |
USP - Arsenic (As) | <= 1 ppm |
USP - Barium (Ba) | Passes Test |
USP - Heavy Metals (as Pb) | <= 2 ppm |
USP - Nitrite (NO₂) (Absorbance Value) | <= 0.01 |
USP - Magnesium and Alkaline Earth Metals (as Ca) | <= 100 ppm |
USP - Iodide (I) | Passes Test |
USP - Bromide (Br) | <= 100 ppm |
USP - Iron (Fe) | <= 2 ppm |
USP - Loss on Drying | <= 0.5 % |
USP - Phosphate (PO₄) | <= 25 ppm |
USP - Potassium (K) | <= 500 ppm |
USP - Ferrocyanide | Passes Test |
USP - Sulfate (SO₄) | <= 200 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 (as Ca) (by EDTA titration)(FCC) | <= 0.35 % |
FCC - Heavy Metals (as Pb) | <= 2 ppm |
FCC - Iron (Fe) | <= 2 ppm |
FCC - Loss on Drying | <= 0.5 % |
Appearance (White crystals or granules) | Passes Test |
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. |