L(+)-Aspartic acid, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, SAFC®
:56-84-8
:
:C₄H₇NO₄
:MFCD00002616
:133.1 g/mol
:13,00845
:311 °C (1013 hPa)
:269…271 °C (dec.)
:1,6613 g/cm³ (13 °C)
:Ambient
:200-291-6
- Assay (alkalimetric, calculated on dried substance):98.5 - 101.5 %
- Identity (IR-spectrum):passes test
- Identity (enantiomeric purity):passes test
- Appearance:white to almost white, crystalline powder or colorless crystals
- Appearance of solution (50 g/l; hydrochloric acid 1 mol/l):clear and not more intense in color than reference solution BY₆
- Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance):+24.0 to +26.0
- Chloride (Cl):≤ 200 ppm
- Sulfate (SO₄):≤ 300 ppm
- Fe (Iron):≤ 10 ppm
- Enantiomeric purity (HPLC) (D-aspartic acid):≤ 0.3 %
- Dicarboxylic acids (HPLC) (malic acid):≤ 0.2 %
- Dicarboxylic acids (HPLC) (fumaric acid):≤ 0.10 %
- Dicarboxylic acids (HPLC) (maleic acid):≤ 0.10 %
- Dicarboxylic acids (HPLC) (any unspecified impurity):≤ 0.10 %
- Dicarboxylic acids (HPLC) (total unspecified impurities):≤ 0.3 %
- Related compounds (HPLC) (maleic acid):≤ 0.05 %
- Related compounds (HPLC) (malic acid):≤ 0.20 %
- Related compounds (HPLC) (fumaric acid):≤ 0.10 %
- Related compounds (HPLC) (any unspecified impurity):≤ 0.05 %
- Related compounds (HPLC) (total unspecified impurities):≤ 0.10 %
- Ninhydrin-positive substances (LC)(impurity C (glutamic acid)):≤ 0.2 %
- Ninhydrin-positive substances (LC)(impurity D (alanine)):≤ 0.2 %
- Ninhydrin-positive substances (LC)(impurity G (asparagine)):≤ 0.2 %
- Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity):≤ 0.10 %
- Ninhydrin-positive substances (LC) (total impurities):≤ 1.0 %
- Ninhydrin-positive substances (LC) (ammonium (570 nm)):≤ 0.02 %
- Residual solvents (ICH Q3C):excluded by manufacturing process
- Sulfated ash (600 °C):≤ 0.1 %
- Loss on drying (105 °C; 3 h):≤ 0.5 %