L(+)-Aspartic acid, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

Synonyms: (S)-(+)-Aspartic acid, L(+)-2-Amino-1,4-butanedioic acid, (S)-(+)-2-Amino-1,4-butanedioic acid, H-Asp-OH, L-α-Aminosuccinic acid, L-αlpha-Aminosuccinic acid, (S)-2-Aminosuccinic acid, Asp, D

1.00129.0100 1.00129.1000 1.00129.9025
1.00129.0100EA 0 GBP
1.00129.0100 1.00129.1000 1.00129.9025
L(+)-Aspartic acid, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, SAFC®
L(+)-Aspartic acid

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 (*).


Certifications: Corresponds to Ph. Eur., BP, USP.

Formula: C₄H₇NO₄
MW: 133,1 g/mol
Boiling Pt: 311 °C (1013 hPa)
Melting Pt: 269…271 °C (dec.)
Density: 1,6613 g/cm³ (13 °C)
Storage Temperature: Ambient
MDL Number: MFCD00002616
CAS Number: 56-84-8
EINECS: 200-291-6
Merck Index: 13,00845

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Specification Test Results

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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