Sodium chloride 99.0-100.5% (dry basis), granular FCC, USP, J.T.Baker®
Supplier: Avantor
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Warning
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Synonyms:
Saline, NaCl, Sea salt, Halite
Management of Change (MOC) category = R
3628-B1EA
49383.24
INR
3628-B1
3628-B2
3628-B3
3628-B4
3628-B5
3628-B6
3628-D2
3628-SA
3628-SD
Sodium chloride 99.0-100.5% (dry basis), granular FCC, USP, J.T.Baker®
Sodium chloride
Certifications: Must be subjected to further processing during the preparation of injectable dosage forms. Meets USP and FCC requirements. GMP manufactured product.
Caution: Preserve in tightly sealed containers.
Formula:
NaCl MW: 58,44 g/mol Boiling Pt: 1413 °C (1013 hPa) Melting Pt: 801 °C Density: 2,16 g/cm³ Storage Temperature: Ambient |
MDL Number:
MFCD00003477 CAS Number: 7647-14-5 EINECS: 231-598-3 Merck Index: 14,08599 |
Specification Test Results
GMP Manufactured Product | |
Meets U.S.P Requirements | |
Meets F.C.C. Requirements | |
Food GMP Manufactured Product | |
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 - 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 - 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. | |
This product has been filled to +/- 1% of the stated net weight. |
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