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

Leverandør: Avantor
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Management of Change (MOC) category = HR

3301-37EA 2950 NOK
3301-37 3301-39 3301-32 3301-35
Natriumklorid 99.0-100.5% (dried basis), granular USP, FCC, J.T.Baker®
Natriumklorid

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

Formel: NaCl
Smeltepunkt: 801 °C
Tetthet: 2,16 g/ml (25 °C)
MDL nummer: MFCD00003477
CAS-nummer: 7647-14-5

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Spesifikasjon Testresultater

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 ≤1 ppm
manufacturing or purification of the product. ≤0.35%
Must be subjected to further processing during the preparation of ≤2 ppm
injectable dosage forms ≤0.5%
Elemental Impurities (USP 232, EP 5.20) - Information on elemental Passes Test
impurities for this product is available on the associated Product
Regulatory Data Sheet and elemental impurity profile report.

SPESIFIKASJONER

Environmentally Preferable

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