Natriumkloridi 99.0-100.5% (dried basis), granular USP, FCC, J.T. Baker®

Toimittaja: Avantor
Varoitus


Management of Change (MOC) category = HR

3301-39EA 561.11 EUR
3301-39 3301-37 3301-35 3301-32
Natriumkloridi 99.0-100.5% (dried basis), granular USP, FCC, J.T. Baker®
Natriumkloridi

Must be subjected to further processing during the preparation of injectable dosage forms.

Kaava: NaCl
MW: 58,44 g/mol
Sulamispiste: 801 °C
Tiheys: 2,16 g/ml (25 °C)
MDL numero: MFCD00003477
CAS-numero: 7647-14-5

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GMP Manufactured Product
CAUTION: For Manufacturing, processing or repackaging
USP - Identification A Passes Test
USP - Identification B Passes Test
USP - Acidity or Alkalinity Passes Test
USP - Appearance of Solution Passes Test
USP - Aluminum (Al) ≤ 0.2 ppm
USP - Arsenic (As) ≤ 1 ppm
USP - Barium (Ba) Passes Test
USP - Bromide (Br) ≤ 100 ppm
USP - Ferrocyanide Passes Test
USP - Iodides (I) Passes Test
USP - Iron (Fe) ≤ 2 ppm
USP - Loss on Drying at 105°C ≤ 0.5 %
USP - Magnesium and Alkaline Earth Metals (as Ca) ≤ 100 ppm
USP - Nitrite (NO₂) (Absorbance Value) ≤ 0.01
USP - Phosphate (PO₄) ≤ 25 ppm
USP - Potassium (K) ≤ 500 ppm
USP - Sulfate (SO₄) ≤ 200 ppm
USP - Assay (NaCl) (dried basis) 99.0 - 100.5 %
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 ≤ 0.35 %
FCC - Heavy Metals (as Pb) ≤ 2 ppm
FCC - Loss on Drying at 105°C ≤ 0.5 %
Solution Test 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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