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1.00681 SAFC

Succinic acid

cryst., EMPROVE® ESSENTIAL NF,JPE,ACS

Synonym: Butanedioic acid, Succinic acid

  • CAS Number 110-15-6

  • Empirical Formula (Hill Notation) C4H6O4

  • Molecular Weight 118.09

  •  EC Index Number 203-740-4

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Solid Dosage Forms,
Quality Level   500
grade   ACS reagent
  JPE
  NF
autoignition temp.   470 °C
potency   2260 mg/kg LD50, oral (Rat)
pH   2.7 (20 °C, 10 g/L in H2O)
bp   235 °C/1013 hPa
mp   185-190 °C
transition temp   flash point 206 °C
solubility   58 g/L
density   1.56 g/cm3 at 20 °C
bulk density   940 kg/m3
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (acidimetric): 99.0 - 100.5 %
Assay (HPLC): 99.0 - 100.5 %
Identity: conforms
Appearance of solution (5 %; water): conforms
In water insoluble matter: ≤ 0.01 %
Melting range (lower value): ≥ 185.0 °C
Melting range (upper value): ≤ 190.0 °C
Melting point: 185.0 - 190.0 °C
Chloride (Cl): ≤ 0.001 %
Phosphate (PO₄): ≤ 0.001 %
Sulfate (SO₄): ≤ 0.003 %
Heavy metals (as Pb): ≤ 0.0020 %
Heavy metals (as Pb) (ACS): ≤ 5 ppm
Nitrogen compounds (as N): ≤ 0.001 %
Fe (Iron): ≤ 5 ppm
As (Arsenic): ≤ 0.0002 %
Substances reducing permanganate: conforms
Residual solvents (ICH Q3C): excluded by production process
Sulfated ash (600 °C): ≤ 0.02 %
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, JPE, ACS

Safety & Documentation

Safety Information

Symbol 
GHS05  GHS05
Signal word 
Danger
Hazard statements 
Precautionary statements 
Supplemental Hazard Statements 
irritant
WGK Germany 
1
RTECS 
WM4900000

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