L(+)-Glutamin 98,5-101,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®
Lieferant: Avantor
Synonyme:
Q
, Levoglutamid
, (S)-(+)-2-Amino-1,5-pentandisäure-5-amid
, (S)-(+)-Glutamin
, L(+)-2-Amino-1,5-pentandisäure-5-amid
, Gln
, L(+)-Glutaminsäure-5-amid
, H-Gln-OH
, (S)-(+)-Glutaminsäure-5-amid
Veränderungsmanagement-Kategorie= R
2078-07EA
7090.37
EUR
2078-07
2078-06
2078-09
L(+)-Glutamin 98,5-101,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®
L(+)-Glutamin
|
Formel:
C₅H₁₀N₂O₃ Molecular Weight: 146,15 g/mol Siedepunkt: 355 °C (1013 hPa) Schmelzpunkt: 185…186 °C Dichte: 1,5326 g/cm³ (130 °C) Lagertemperatur: Raumtemperatur |
MDL:
MFCD00008044 CAS-Nummer: 56-85-9 EINECS: 200-292-1 Merck Index: 13,04484 |
|
Spezifikation Testergebnisse
| Meets U.S.P Requirements | |
| Meets J.P. Chemical Specifications | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (C₅H₁₀N₂O₃) (dried basis) | 98.5 - 101.5 % |
| USP - Identification | Passes Test |
| USP - Specific Rotation [Å]²º^D (+) | 6.3 - 7.3 Degree |
| USP - Loss on Drying at 105°C | ≤ 0.3 % |
| USP - Residue after Ignition | ≤ 0.3 % |
| USP - Chloride (Cl) | ≤ 0.05 % |
| USP - Sulfate (SO₄) | ≤ 0.03 % |
| USP - Iron (Fe) | ≤ 0.003 % |
| USP - Related Compounds | 0.5% max |
| JP - Assay (C₅H₁₀N₂O₃) (dried basis) | 99.0 - 101.0 % |
| JP - Identification | Passes Test |
| JP - Specific Rotation [Å]²º^D (+) | 6.3 - 7.3 Degree |
| JP - Loss on Drying at 105°C | ≤ 0.30 % |
| JP - Residue after Ignition | ≤ 0.1 % |
| JP - Chloride (Cl) | ≤ 0.021 % |
| JP - Sulfate (SO₄) | ≤ 0.028 % |
| JP - Iron (Fe) | ≤ 10 ppm |
| JP - Heavy Metals (as Pb) | ≤ 10 ppm |
| JP - Related substances | Passes Test |
| JP - pH | 4.5 - 6.0 |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Ammonium | ≤ 0.1 % |
| Solubility of 3% Solution at 30°C | Passes Test |
| Solubility of 3.5% Solution at 30°C | Passes Test |
| Identification (by IR) | Passes Test |
| Endotoxin Concentration (EU/mg) | ≤ 0.06 |
| Endotoxin Concentration, IU/mg | Passes Test |
| No Class 1,2,3 or other solvents are used or produced in the | Passes Test |
| 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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