Propyle hydroxy-4 benzoate 99.0-100.5% (par HPLC), EMPROVE® ESSENTIAL FCC, BP, Ph. Eur., JP, NF suitable for use as excipient E216, SAFC®
Marques : MERCK PRODUCTION CHEMICALSTotal Evaluation: 0
Moyenne des Notes : 0.0 sur 5
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Attention
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Synonyme(s):
Propylparabene, 4-Hydroxybenzoate de propyle
Formule:
C₁₀H₁₂O₃ Poids moléculaire: 180.2 g/mol Point d'ébullition: 292 Point de fusion: 95 Densité: 1.28 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00002354 Numéro CAS: 94-13-3 EINECS: 202-307-7 Indice Merck: 13,07958 |
Résultats des tests de spécification
Assay (by Acidimetry following Saponification) | 98.0 - 102.0% |
Assay (HPLC) | 99.0 - 100.5% |
Identity | Passes Test |
Appearance of Solution | Passes Test |
Acidic Substances | Passes Test |
Melting range (Lower Value) | ≥96 °C |
Melting range (Upper Value) | ≤98 °C |
Heavy metals (as Pb) | ≤10 ppm |
As (Arsenic) | ≤3 ppm |
Cd (Cadmium) | ≤10 ppm |
Cu (Copper) | ≤10 ppm |
Hg (Mercury) | ≤1 ppm |
Pb (Lead) | ≤2 ppm |
Zn (Zinc) | ≤10 ppm |
Related Substances (HPLC) | Passes Test |
p-Hydroxy Benzoic Acid | ≤0.5% |
Sum of all Impurities | ≤1.0% |
Largest Unspecified Impurity | ≤0.5% |
1-Propylalcohol (HS-GC) | ≤5000 ppm |
Other Residual Solvents (ICH Q3C) | Excluded by Manufactoring Process |
Sulfated Ash | ≤0.05% |
Loss on Drying (80 °C) | ≤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 ,JP, NF, FCC. |
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