L-Threonin 98,5-101,5% (Trockenmasse) USP, Multikompendial

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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

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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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