Acide salicylique 99.5-105.0% (par acidimétrie sur substance anhydre), EMPROVE® ESSENTIAL USP, Ph. Eur., BP, très pur suitable for use as excipient, SAFC®
Marques : MERCK PRODUCTION CHEMICALSTotal Evaluation: 0
Moyenne des Notes : 0.0 sur 5
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Danger
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Synonyme(s):
Acide o-hydroxybenzoïque, Acide 2-hydroxybenzoïque
Formule:
(HO)C₆H₄CO₂H Poids moléculaire: 138.12 g/mol Point d'ébullition: 336 Point de fusion: 157…159 °C Densité: 1.443 g/cm³ (20 °C) Point éclair: 157 Température de stockage: Température ambiante |
Numéro MDL:
MFCD00002439 Numéro CAS: 69-72-7 EINECS: 200-712-3 Indice Merck: 13,08411 |
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Résultats des tests de spécification
Assay (acidimetric; calculated on dried substance) | 99.5 - 100.5 % |
Assay (HPLC, calc.on dried substance) | 98.0 - 102.0 % |
Identity | passes test |
Appearance of solution (10 %; ethanol 96 %) | passes test |
Chloride (Cl) | ≤ 0.0100 % |
Sulfate (SO₄) | ≤ 0.0200 % |
Related substances / HPLC (EP) (4-Hydroxybenzoic acid) | ≤ 0.1 % |
Related substances / HPLC (EP) (4-Hydroxyisophthalic acid) | ≤ 0.05 % |
Related substances / HPLC (EP) (Phenol) | ≤ 0.02 % |
Related substances / HPLC (EP) (Largest unspecified impurity) | ≤ 0.05 % |
Related substances / HPLC (EP) (Sum of all impurities) | ≤ 0.2 % |
Related substances / HPLC (USP) (4-Hydroxybenzoic acid) | ≤ 0.1 % |
Related substances / HPLC (USP) (4-Hydroxyisophthalic acid) | ≤ 0.05 % |
Related substances / HPLC (USP) (Phenol) | ≤ 0.02 % |
Related substances / HPLC (USP) (Largest unspecified impurity) | ≤ 0.05 % |
Related substances / HPLC (USP) (Sum of all impurities) | ≤ 0.2 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Sulfated ash | ≤ 0.05 % |
Loss on drying | ≤ 0.5 % |
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). | |
corresponds to Ph Eur, BP, USP |
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