Sodium chloride 99.0-100.5% (dry basis), granular FCC, USP, J.T.Baker®

Supplier: Avantor
Warning

Synonyms: Saline, NaCl, Sea salt, Halite

3628-01EA 7382.02 INR
3628-01 3628-05 3628-06 3628-07 3628-20 3628-60 3628-65 3628-08 3628-68 3628-F7 3628-F9 3628-K2 3628-K1 3628-K3 3628-K4 3628-K5 3628-A1 3628-A2 3628-B7 3628-W2 3628-W3 3628-S1 3628-X3
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

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Specification Test Results

Meets F.C.C. Requirements 99.0 - 100.5%
Meets U.S.P Requirements Passes Test
GMP Manufactured Product Passes Test
Food GMP Manufactured Product Passes Test
CAUTION: For Manufacturing, processing or repackaging ≤0.2 ppm
Bulk Food Chemical Passes Test
Bulk Pharmaceutical Chemical ≤1 ppm
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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