2-Propanol, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, extra_pure suitable for use as excipient, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
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Peligro
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Sinónimos:
Alcohol isopropílico, IPA
1.00995.1000
1.00995.2500
1.00995.6010
1.00995.6025
1.00995.6190
1.00995.9180
1.00995.9950
1.00995.1000EA
133
EUR
1.00995.1000
1.00995.2500
1.00995.6010
1.00995.6025
1.00995.6190
1.00995.9180
1.00995.9950
2-Propanol, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP, extra_pure suitable for use as excipient, SAFC®
2-Propanol
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 (*).
Certificaciones: Conforms to Ph Eur, BP, JP, USP
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Formula:
(CH₃)₂CHOH MW: 60.1 g/mol Pto. Ebullición: 82 Pto. de fusión: –89 °C Densidad: 0.786 g/cm³ (20 °C) Pto. de inflamación: 12 Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00011674 Núm. CAS: 67-63-0 EINECS: 200-661-7 UN: 1219 ADR: 3 II IR: 01-2119457558-25 Índice Merck: 13,05228 |
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Resultados test especificaciones
| Assay (GC) | ≥ 99.5 % |
| Identity (IR) | conforms |
| Identity B (USP) | conforms |
| Identity (JP) | conforms |
| Appearance | conforms |
| Clarity of solution | conforms |
| Acidity or alkalinity | conforms |
| Acidity | conforms |
| Refractive index (n 20/D) | 1.376 - 1.378 |
| Density (d 20 °C/20 °C) | 0.785 - 0.788 |
| Density (d 25 °C/25 °C) | 0.783 - 0.787 |
| Boiling range (81-83°C) | ≥ 94 % (v/v) |
| Absorbance (at 230 nm) | ≤ 0.300 |
| Absorbance (at 250 nm) | ≤ 0.100 |
| Absorbance (at 270 nm) | ≤ 0.030 |
| Absorbance (at 290 nm) | ≤ 0.020 |
| Absorbance (at 310 nm) | ≤ 0.010 |
| The spectrum shows a steadily descending curve with no observable peaks or shoulders | conforms |
| Peroxides | conforms |
| Volatile Impurities (GC) (individual) | ≤ 0.1 % (v/v) |
| Volatile Impurities (GC) (total) | ≤ 1.0 % (v/v) |
| Benzene and related substances (GC) (Benzene) | ≤ 2 ppm |
| Benzene and related substances (GC) (total of impurities apart from 2-butanol) | ≤ 0.3 % |
| Cyclohexane (GC) | ≤ 50 ppm |
| Acetone (GC) | ≤ 50 ppm |
| Ethanol (GC) | ≤ 50 ppm |
| 1-Propylalcohol (GC) | ≤ 50 ppm |
| Isopropylether (GC) | ≤ 0.01 % |
| Other residual solvents (ICH Q3C) | excluded by manufacturing process |
| Evaporation residue | ≤ 0.0020 % |
| Water | ≤ 0.20 % |
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