L(+)-Asparagine monohydraté 99.0-101.0% (base substance sèche), EMPROVE® EXPERT Ph. Eur., très pur pouvant être utilisé comme excipient, SAFC®

L(+)-Asparagine monohydraté 99.0-101.0% (base substance sèche), EMPROVE® EXPERT Ph. Eur., très pur pouvant être utilisé comme excipient, SAFC®

: L-Asparagine monohydrate, H-Asn-OH·H₂O, (S)-(+)-Asparagine monohydrate, (S)-2,4-Diamino-4-oxobutanoic acid hydrate, H-Asn-OH.H2O

:5794-13-8

:C₄H₈N₂O₃·1H₂O

:MFCD00151038

:150.13 g/mol

:14,00837

:215…217 °C

:1.567 g/cm³ (20 °C)

:Température ambiante

:200-735-9

Assay (perchloric acid titration, calculated on dried substance):
99.0 - 101.0 %
Identity (IR-spectrum):
passes test
Appearance:
white to almost white crystalline powder or colorless crystals
Appearance of solution (20 g/l, CO₂-free water):
clear and colorless
Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance):
+33.7 to +36.0
pH (20 g/l, CO₂-free water):
4.0 - 6.0
Chloride (Cl):
≤ 200 ppm
Sulphate (SO₄):
≤ 200 ppm
Fe (Iron):
≤ 10 ppm
NH₄ (Ammonium):
≤ 0.1 %
Aspartic acid:
≤ 0.5 %
Ninhydrin - positive substances (TLC) (Glutamic acid):
≤ 0.5 %
Ninhydrin - positive substances (TLC) (any other impurity):
≤ 0.5 %
Ethanol (HS-GC):
≤ 5000 ppm
Other residual solvents (ICH Q3C):
excluded by manufacturing process
Sulfated ash (600 °C):
≤ 0.1 %
Loss on drying (130 °C, 3 h):
10.5 - 12.5 %
Bacterial endotoxins:
≤ 3.0 I.U./g