Sodium chlorure 99.0-100.5% (base substance sèche), granuleux USP, FCC, J.T.Baker®
Marques : AvantorTotal Evaluation: 0
Moyenne des Notes : 0.0 sur 5
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Attention
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Synonyme(s):
Chlorure de sodium
Certifications: Must be subjected to further processing during the preparation of injectable dosage forms. Meets USP and FCC requirements. GMP manufactured product.
Attention: Preserve in tightly sealed containers.
Formule:
NaCl Poids moléculaire: 58.44 g/mol Point d'ébullition: 1413 °C (1013 hPa) Point de fusion: 801 °C Densité: 2.16 g/cm³ Température de stockage: Température ambiante |
Numéro MDL:
MFCD00003477 Numéro CAS: 7647-14-5 EINECS: 231-598-3 Indice Merck: 14,08599 |
Résultats des tests de spécification
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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