Propilo 4-hidroxibenzoato 99.0-100.5% (by HPLC), EMPROVE® ESSENTIAL FCC, BP, Ph. Eur., JP, NF suitable for use as excipient E216, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
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Atención
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Sinónimos:
Propilparabeno, 4-Hidroxibenzoato de propilo
1.07427.5000
1.07427.9029
1.07427.5000EA
873
EUR
1.07427.5000
1.07427.9029
Propilo 4-hidroxibenzoato 99.0-100.5% (by HPLC), EMPROVE® ESSENTIAL FCC, BP, Ph. Eur., JP, NF suitable for use as excipient E216, SAFC®
Propilo 4-hidroxibenzoato
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Formula:
C₁₀H₁₂O₃ MW: 180.2 g/mol Pto. Ebullición: 292 Pto. de fusión: 95 Densidad: 1.28 g/cm³ (20 °C) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00002354 Núm. CAS: 94-13-3 EINECS: 202-307-7 Índice Merck: 13,07958 |
Resultados test especificaciones
| 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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