Glicina 98.5-101.5% USP, Multi-Compendial, J.T.Baker®
Proveedor: Avantor
0582-01EA
152.51
EUR
0582-01
0582-05
0582-07
0582-09
Glicina 98.5-101.5% USP, Multi-Compendial, J.T.Baker®
Glycine
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Formula:
NH₂CH₂COOH Pto. Ebullición: 181 °C (1013 hPa) Pto. de fusión: 83 °C Densidad: 1,64 g/cm³ (20 °C) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00008131 Núm. CAS: 56-40-6 EINECS: 200-272-2 Índice Merck: 13,04504 |
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Resultados test especificaciones
| Meets J.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| Meets E.P. Chemical Specifications | |
| Meets B.P. Chemical Specifications | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | Passes Test |
| USP - Identification | Passes Test |
| USP - Loss on Drying at 105°C | ≤0.2 % |
| USP - Residue on Ignition | ≤0.1 % |
| USP - Chloride (Cl) | ≤0.007 % |
| USP - Sulfate (SO₄) | ≤0.0065 % |
| USP - Hydrolyzable Substances | Passes Test |
| USP - Assay (C₂H₅NO₂) (dried basis) | 98.5 - 101.5 % |
| USP - Endotoxin Concentration (EU/g) | ≤2.5 |
| USP - Related Compounds: Glycine anhydride | ≤0.1 % |
| USP - Related Compounds: Monochloroacetic acid (For Information Only) | Passes Test |
| USP - Related Compounds: Iminodiacetic acid | ≤0.1 % |
| USP - Related Compounds: Diglycine | ≤0.1 % |
| USP - Related Compounds: Triglycine | ≤0.1 % |
| USP - Related Compounds: Hexamethylenetetramine | ≤0.1 % |
| USP - Related Compounds: Any unspecified impurity (For Information Only) |
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| USP - Related Compounds: Total impurities | ≤1.0 % |
| EP/BP - Assay (C₂H₅NO₂) (dried basis) | 98.5 - 101.0 % |
| EP/BP - Identification A | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - pH | 5.9 - 6.4 |
| EP/BP - Chloride (Cl) | ≤75 ppm |
| EP/BP - Loss on Drying at 105°C | ≤0.5 % |
| EP/BP - Ash (sulfated) | ≤0.1 % |
| EP/ BP - Related substances: Glycine anhydride | ≤0.10 % |
| EP/ BP - Related substances: Diglycine | ≤0.10 % |
| EP/ BP - Related substances: Triglycine | ≤0.10 % |
| EP/ BP - Related substances: Unspecified impurities, each | ≤0.10 % |
| EP/ BP - Related substances: Total impurities | ≤0.2 % |
| EP/BP - Ninhydrin Positive Substances - Each Impurity | ≤0.10 % |
| EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤1.0 % |
| EP/BP - Ammonium (NH₄) | ≤0.02 % |
| JP - Assay (C₂H₅NO₂) (dried basis) | 98.5 - 101.0 % |
| JP - Identification | Passes Test |
| JP - pH (1 in 20) | 5.6 - 6.6 |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Chloride (Cl) | ≤0.021 % |
| JP - Sulfate (SO₄) | ≤0.028 % |
| JP - Ammonium (NH₄) | ≤0.02 % |
| JP - Heavy Metals (as Pb) | ≤20 ppm |
| JP - Arsenic (As) | ≤2 ppm |
| JP - Related Substances | Passes Test |
| JP - Loss on Drying at 105°C | ≤0.30 % |
| JP - Residue on Ignition | ≤0.10 % |
| Only Class 2 Solvents (Methanol) are likely to be present. All are | |
| below Option 1 limits. | |
| Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
| impurities for this product is available on the associated Product | |
| Regulatory Data Sheet and elemental impurity profile report. |
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