Isopropanol ( IPA ) JTBaker, Macron GMP USP/ EP / BP / JP
Thương hiệu: Jtbaker - Avantor
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Mã SP: 9037-01
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Isopropyl Alcohol, U.S.P.- JTBaker Avantor
Thương hiệu: JTBaker Avantor
Mã SP: 9037-
Link website nhà sản xuất: Click here
Synonyms: Isopropyl alcohol , Isopropyl Rubbing Alcohol , 2-Hydroxy propane , Dimethyl carbinol , Propan-2-ol , IPA , Isopropanol
Qui cách: 500ml, 4L, 20L, 345Lb
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028 38 688 284
| GMP Manufactured Product | |
| Meets BP Chemical Specifications | |
| Meets EP Chemical Specifications | |
| Meets JP Chemical Specifications | |
| Meets USP Requirements | |
| CAUTION: For Manufacturing, Processing or Repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Specific Gravity at 25/25 °C | 0.783 - 0.787 |
| USP - Refractive Index, nD | 1.376 - 1.378 |
| USP - Acidity | Passes Test |
| USP - Nonvolatile Residue | ≤0.005% |
| USP - Assay | ≥99.0% |
| USP - Water (H₂O) | ≤0.5% |
| USP - Volatile Impurities - Ethyl ether | ≤0.1% |
| USP - Volatile Impurities - Acetone | ≤0.1% |
| USP - Volatile Impurities - Diisopropyl ether | ≤0.1% |
| USP - Volatile Impurities - 1-Propanol | ≤0.1% |
| USP - Volatile Impurities - 2-Butanol | ≤0.1% |
| USP - Volatile Impurities - Total | ≤1.0% |
| USP - Benzene | ≤2 ppm |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| Appearance | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Benzene (C₆H₆) | ≤2 ppm |
| EP/BP - Any Peak other than 2-Butanol | ≤0.3% |
| EP/BP - Peroxide | Passes Test |
| EP/BP - Nonvolatile Matter | ≤20 ppm |
| EP/BP - Water (H₂O) | ≤0.5% |
| EP/BP - UV Absorbance - 310 nm | ≤0.010 |
| EP/BP - UV Absorbance - 290 nm | ≤0.020 |
| EP/BP - UV Absorbance - 270 nm | ≤0.030 |
| EP/BP - UV Absorbance - 250 nm | ≤0.100 |
| EP/BP - UV Absorbance - 230 nm | ≤0.300 |
| EP/BP - Spectrum Appearance | Passes Test |
| JP - Identification A | Passes Test |
| JP - Identification B | Passes Test |
| JP - Specific Gravity at 20/20 °C | 0.785 - 0.788 |
| JP - Clarity of Solution | Passes Test |
| JP - Acidity | Passes Test |
| JP - Residue on Evaporation, mg/20ml | ≤1.0 |
| JP - Water (H₂O) | ≤0.75% |
| JP - Distilling Range (Lower) | 81 - 83 °C |
| JP - Distilling Range (Upper) | 81 - 83 °C |
| Residual Solvents ñ The Class 1 Solvent Benzene is likely to be Present as a Result of the Production Process for this Material. It is Tested for and Reported for Every Batch | |
| The Class 2 Solvent Cyclohexane is likely to be Present and its level is Controlled to <20 ppm by the Production Process | |
| Class 3 Solvents Acetone, n-Butanol, sec-Butanol and iso-Butanol are likely to be Present at levels <20 ppm | |
| The Class 4 Solvent Diisopropyl Ether is likely to be Present at a level of <20 ppm |
| GMP Manufactured Product | |
| Meets BP Chemical Specifications | |
| Meets EP Chemical Specifications | |
| Meets JP Chemical Specifications | |
| Meets USP Requirements | |
| CAUTION: For Manufacturing, Processing or Repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Specific Gravity at 25/25 °C | 0.783 - 0.787 |
| USP - Refractive Index, nD | 1.376 - 1.378 |
| USP - Acidity | Passes Test |
| USP - Nonvolatile Residue | ≤0.005% |
| USP - Assay | ≥99.0% |
| USP - Water (H₂O) | ≤0.5% |
| USP - Volatile Impurities - Ethyl ether | ≤0.1% |
| USP - Volatile Impurities - Acetone | ≤0.1% |
| USP - Volatile Impurities - Diisopropyl ether | ≤0.1% |
| USP - Volatile Impurities - 1-Propanol | ≤0.1% |
| USP - Volatile Impurities - 2-Butanol | ≤0.1% |
| USP - Volatile Impurities - Total | ≤1.0% |
| USP - Benzene | ≤2 ppm |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| Appearance | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Benzene (C₆H₆) | ≤2 ppm |
| EP/BP - Any Peak other than 2-Butanol | ≤0.3% |
| EP/BP - Peroxide | Passes Test |
| EP/BP - Nonvolatile Matter | ≤20 ppm |
| EP/BP - Water (H₂O) | ≤0.5% |
| EP/BP - UV Absorbance - 310 nm | ≤0.010 |
| EP/BP - UV Absorbance - 290 nm | ≤0.020 |
| EP/BP - UV Absorbance - 270 nm | ≤0.030 |
| EP/BP - UV Absorbance - 250 nm | ≤0.100 |
| EP/BP - UV Absorbance - 230 nm | ≤0.300 |
| EP/BP - Spectrum Appearance | Passes Test |
| JP - Identification A | Passes Test |
| JP - Identification B | Passes Test |
| JP - Specific Gravity at 20/20 °C | 0.785 - 0.788 |
| JP - Clarity of Solution | Passes Test |
| JP - Acidity | Passes Test |
| JP - Residue on Evaporation, mg/20ml | ≤1.0 |
| JP - Water (H₂O) | ≤0.75% |
| JP - Distilling Range (Lower) | 81 - 83 °C |
| JP - Distilling Range (Upper) | 81 - 83 °C |
| Residual Solvents ñ The Class 1 Solvent Benzene is likely to be Present as a Result of the Production Process for this Material. It is Tested for and Reported for Every Batch | |
| The Class 2 Solvent Cyclohexane is likely to be Present and its level is Controlled to <20 ppm by the Production Process | |
| Class 3 Solvents Acetone, n-Butanol, sec-Butanol and iso-Butanol are likely to be Present at levels <20 ppm | |
| The Class 4 Solvent Diisopropyl Ether is likely to be Present at a level of <20 ppm |
