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

Supplier: AVANTOR PERFORMANCE MATERIALS

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Management of Change (MOC) category = R

3628-B1EA 49383.24 INR InStock
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 USP, FCC, 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
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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