L-Threonin 98,5-101,5% (Trockenmasse) USP, Multikompendial
Lieferant: Avantor Performance Materials
Veränderungsmanagement-Kategorie= R
MACR4947-06EA
0
CHF
MACR4947-07
MACR4947-06
L-Threonin 98,5-101,5% (Trockenmasse) USP, Multikompendial
L-Threonin
Formel:
C₄H₉NO₃ MW: 119,12 g/mol Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00064270 CAS-Nummer: 72-19-5 EINECS: 200-774-1 |
Spezifikation Testergebnisse
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (C₄H₈NO₃) (dried basis) | 98.5 - 101.5 % |
USP - Identification | Passes Test |
USP - Specific Rotation [Å]²⁵ ^D | -29.1 - -26.7 Degree |
USP - pH | 5.0 - 6.5 |
USP - Loss on Drying at 105°C | ≤ 0.2 % |
USP - Residue on Ignition | ≤ 0.4 % |
USP - Chloride (Cl) | ≤ 0.05 % |
USP - Sulfate (SO₄) | ≤ 0.03 % |
USP - Iron (Fe) | ≤ 0.003 % |
USP - Related Compounds - Individual Impurities | ≤ 0.5 % |
USP - Related Compounds - Total Impurities | ≤ 2.0 % |
EP/BP - Assay (C₄H₈NO₃) (dried basis) | 99.0 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - pH | 5.0 - 6.5 |
EP/BP - Specific Rotation [Å]²º^D | -29.0 - -27.6 Degree |
EP/BP-Ninhydrin-Positive Substances-Each | ≤ 0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities | ≤ 0.5 % |
EP/BP - Chloride (Cl) | ≤ 200 ppm |
EP/BP - Sulfate (SO₄) | ≤ 300 ppm |
EP/BP - Ammonium (NH₄) | ≤ 0.02 % |
EP/BP - Iron (Fe) | ≤ 10 ppm |
EP/BP - Loss on Drying | ≤ 0.5 % |
EP/BP - Ash (sulfated) | ≤ 0.1 % |
JP - Assay (C₄H₈NO₃) (dried basis) | 98.5 - 101.0 % |
JP - Identification | Passes Test |
JP - Optical Rotation | -29.0 - -26.0 Degree |
JP - pH | 5.2 - 6.2 |
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 | ≤ 0.20 % |
JP - Residue on Ignition | ≤ 0.10 % |
Endotoxin Concentration, IU/mg, For Information Only | |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
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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