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1.01791 SAFC

L-Glutamic acid

EMPROVE® EXPERT Ph Eur,JP

Synonym: L-α-Aminoglutaric acid, Glu, L-alpha-Aminoglutaric acid, L-Glutamic acid

  • CAS Number 56-86-0

  • Molecular Weight 147.13

  •  MDL number MFCD00002634

  •  EC Index Number 200-293-7

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Properties

Agency/Method   JP
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
assay   99.0-100.5% dry basis (alkalimetric)
form   solid
potency   >30000 mg/kg LD50, oral (Rat)
pH   3.0-3.5 (25 °C, 8.6 g/L in H2O)
mp   160 °C
solubility   11.1 g/L
density   1.54 g/cm3 at 20 °C
bulk density   460 kg/m3
anion traces   chloride (Cl-): ≤200 ppm
  sulfate (SO42-): ≤200 ppm
cation traces   Fe: ≤10 ppm
  NH4+: ≤200 ppm
  heavy metals (as Pb): ≤10 ppm
InChI   1S/C5H9NO4/c6-3(5(9)10)1-2-4(7)8/h3H,1-2,6H2,(H,7,8)(H,9,10)
InChI key   WHUUTDBJXJRKMK-UHFFFAOYSA-N
storage conditions   Store at +5°C to +30°C.

Description

General description

EMPROVE® EXPERT Ph Eur,JP

Analysis Note

Assay (alkalimetric, calculated on dried substance)99.0 - 100.5 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite to almost white, crystalline powder or colorless crystalsAppearance of solution (100 g/l, hydrochloric acid 1 mol/l)clear and colorlessAppearance of solution (100 g/l, hydrochloric acid  2 mol/l)clear and colorlessSpec. rotation (α 20/D, 100 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)+30.5 to +32.5Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+31.5 to +32.5pH (7 g/l CO₂-free water)2.9 - 3.9Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 200 ppmHeavy metals (as Pb)≤ 10 ppmFe (Iron)≤ 10 ppmNH₄ (Ammonium)≤ 200 ppmNinhydrin - positive substances (TLC)≤ 0.5 %Related substances (LC)(largest single impurity)≤ 0.2 %Related substances (LC)(Sum of all impurities)≤ 0.6 %Residual solvents (ICH (Q3C))excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Bacterial endotoxins≤ 25 I.U./gTotal aerobic microbial count (TAMC)≤ 100 CFU/gTotal combined yeasts/moulds count (TYMC)≤ 100 CFU/gElemental 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 (*).Corresponds to Ph. Eur., JP

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