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1.06445 SAFC

Sodium L-glutamate monohydrate

EMPROVE® ESSENTIAL FCC,NF,E 621

Synonym: Sodium L-glutamate Monohydrate, Sodium L-glutamate monohydrate

  • CAS Number 6106-04-3

  • Empirical Formula (Hill Notation) C5H8NNaO4 · xH2O

  • Molecular Weight 169.11 (anhydrous basis)

  •  MDL number MFCD00150138

  •  E Number E621

  •  EC Index Number 205-538-1

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Mineral Salts,
Agency/Method   NF
Quality Level   500
reg. compliance   FCC
product line   Emprove® Essential
form   crystalline powder
potency   15800 mg/kg LD50, oral (Rat)
pH   6.7-7.2 (20 °C, 50 g/L in H2O)
mp   >200 °C (sublimed)
transition temp   flash point >900 °C
bulk density   680 kg/m3
InChI   1S/C5H9NO4.Na.H2O/c6-3(5(9)10)1-2-4(7)8;;/h3H,1-2,6H2,(H,7,8)(H,9,10);;1H2/q;+1;/p-1/t3-;;/m0../s1
InChI key   GJBHGUUFMNITCI-QTNFYWBSSA-M
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (perchloric acid titration, calculated on dried substance): 99.0 - 100.5 %
Identity (IR-spectrum): passes test
Identity (Sodium): passes test
Appearance: white to almost white, crystalline powder or fine crystals
Appearance of solution (100 g/l, water): colorless and not more intense in turbidity than control solution according to NF and FCC
Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance): +24.8 to +25.3
pH (50 g/l CO₂-free water): 6.7 - 7.2
Chloride (Cl): ≤ 0.2 %
Heavy metals (as Pb): ≤ 20 ppm
Al (Aluminium): ≤ 5 ppm
As (Arsenic): ≤ 3 ppm
Mn (Manganese): ≤ 15 ppm
Pb (Lead): ≤ 1 ppm
Cu (Copper): ≤ 10 ppm
Zn (Zinc): ≤ 10 ppm
5-Oxopyrrolidine-2-carboxylic acid (Pyroglutamic acid): ≤ 0.2 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on drying (100 °C, 5 h): ≤ 0.5 %
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 (*).
Corresponds to NF, FCC, E 621
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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