Sodium chloride 99-100.5% (dried basis), granular USP, FCC endotoxin tested, J.T.Baker®
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
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Management of Change (MOC) category = R
3629-09
3629-07
JT3629-9EA
1100.28
USD
JT3629-9
JT3629-7
Sodium chloride 99-100.5% (dried basis), granular USP, FCC endotoxin tested, J.T.Baker®
Sodium chloride
Avantor excipients are used during the formulation process in a wide range of applications. Avantor provides high-purity and performance excipients that serve as fillers, binders, disintegrants, lubicants, flavors, emulsifiers and preservatives. All the products are cGMP produced and meet USP grade standards.
- Food GMP manufactured product
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Formula:
NaCl 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
| Food GMP Manufactured Product | |
| Meets F.C.C. Requirements | |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| 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 - Arsenic (As) | ≤1 ppm |
| USP - Appearance of Solution | Passes Test |
| USP - Barium (Ba) | Passes Test |
| USP - Endotoxin Concentration (2.5 EU/g max.) | Passes Test |
| USP - Nitrite (NO₂) (Absorbance Value) | ≤0.01 |
| USP - Iron (Fe) | ≤2 ppm |
| USP - Magnesium and Alkaline Earth Metals (as Ca) | ≤100 ppm |
| USP - Loss on Drying | ≤0.5 % |
| USP - Iodide (I) | Passes Test |
| USP - Bromide (Br) | ≤100 ppm |
| USP - Ferrocyanide | Passes Test |
| USP - Phosphate (PO₄) | ≤25 ppm |
| USP - Potassium (K) | ≤500 ppm |
| 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 % |
| 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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