Ácido L(+)-aspartico, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, SAFC®
Proveedor: MERCK PRODUCTION CHEMICALS
Sinónimos:
D
, (S)-(+)-Ácido aspartico
, Asp
MERP1.00129.9999EA
0
EUR
MERP1.00129.9999
1.00129.0100
1.00129.1000
1.00129.9025
Ácido L(+)-aspartico, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, SAFC®
Ácido L(+)-aspartico
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Certificaciones: Corresponds to Ph. Eur., BP, USP.
|
Formula:
C₄H₇NO₄ MW: 133,1 g/mol Pto. de fusión: 269…271 °C (desc.) Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00002616 Núm. CAS: 56-84-8 EINECS: 200-291-6 Índice Merck: 13,00845 |
Resultados test especificaciones
| 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 % |
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