L(+)-Asparagine monohydrate 99.0-101.0% (dry basis), EMPROVE® EXPERT Ph. Eur. suitable for use as excipient, SAFC®
EM1.01565.5000
:
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- Pack type:Poly drum
- Size:5 kg
- Cat. No.:EM1.01565.5000
- Supplier no.:1.01565.5000
- 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
:
:150.13 g/mol
:14,00837
:215…217 °C
:215 - 217 °C
:1.567 g/cm³ (20 °C)
:Ambient
:200-735-9
:5794-13-8
:C₄H₈N₂O₃·1H₂O
:MFCD00151038