Sodium chloride 99.0-100.5% (dry basis), granular FCC, USP, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
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Warning
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Synonyms:
Saline, NaCl, Sea salt, Halite
Management of Change (MOC) category = R
BAKR3628-20
BAKR3628-06
BAKR3628-60
BAKR3628-65
BAKR3628-07
BAKR3628-F7
BAKR3628-01
BAKR3628-05
3628-01
3628-07
3628-68
BAKR3628-F9
BAKR3628-08
BAKR3628-68
BAKR3628-B7
CAJT3628-20EA
1250.1
CAD
CAJT3628-20
CAJT3628-6
CAJT3628-60
CAJT3628-65
CAJT3628-7
CAJT3628-F7
CAJT3628-1
CAJT3628-5
JT3628-1
JT3628-7
JT3628-68
CAJT3628-F9
CAJT3628-8
CAJT3628-68
CAJT3628-B7
Sodium chloride 99.0-100.5% (dry basis), granular FCC, USP, J.T.Baker®
Sodium chloride
White crystals or granules. Must be subjected to further processing during the preparation of injectable dosage forms. Meets USP and FCC requirements. GMP manufactured product. Preserve in tightly sealed containers.
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.
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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
| Meets F.C.C. Requirements | |
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| 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 | |
| Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
| impurities for this product is available on the associated Product | |
| Regulatory Data Sheet and elemental impurity profile report. |
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