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1.00803 SAFC

L(+)-Tartaric acid

powder EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,E 334

Synonym: 2,3-Dihydroxybutanedioic acid, L(+)-Tartaric acid

  • CAS Number 87-69-4

  • Linear Formula HOOCCH(OH)CH(OH)COOH

  • Molecular Weight 150.09

  •  MDL number MFCD00064207

  •  E Number E334

  •  EC Index Number 201-766-0

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Acidulents & pH Adjusters, Antioxidants, Biopharmaceutical Process Development and Manufacturing, Excipients,
Agency/Method   BP
  JP
  NF
  Ph. Eur.
Quality Level   500
vapor pressure   <5 Pa ( 20 °C)
product line   Emprove® Essential
assay   99.7-100.5% dry basis (acidimetric)
form   solid
autoignition temp.   425 °C
pH   1.6 (25 °C, 100 g/L in H2O)
mp   168-170 °C
transition temp   flash point 210 °C
solubility   1390 g/L
density   1.76 g/cm3 at 20 °C
bulk density   1000 kg/m3
cation traces   As: ≤0.0001%
  Ca: ≤0.0200%
  Ca:, passes test
  Hg: ≤0.0001%
  Pb: ≤0.0002%
  heavy metals (as Pb): ≤0.0010%
InChI   1S/C4H6O6/c5-1(3(7)8)2(6)4(9)10/h1-2,5-6H,(H,7,8)(H,9,10)
InChI key   FEWJPZIEWOKRBE-UHFFFAOYSA-N
storage conditions   no restrictions.

Description

Application

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (acidimetric; calculated on dried substance): 99.7 - 100.5 %
Identity: conforms
Appearance of solution (10 %; water): conforms
Spec. rotation [α²0/D (20 %; water calculated on dried substance): +12.0 - +12.8 °
Spec. rotation [α²5/D (20 %; water calculated on dried substance): +12.0 - +13.0 °
Chloride (Cl): ≤ 0.0100 %
Sulfate (SO₄): ≤ 0.0150 %
Sulfate (NF): passes test
Heavy metals (as Pb): ≤ 0.0010 %
As (Arsenic): ≤ 0.0001 %
Ca (Calcium): ≤ 0.0200 %
Calcium (JP): passes test
Hg (Mercury): ≤ 0.0001 %
Pb (Lead): ≤ 0.0002 %
Oxalates (as C₂H₂O₄): ≤ 0.01 %
Oxalate (JP): passes test
Oxalate (NF): passes test
Residual solvents (ICH Q3C): excluded by manufacturing process
Sulfated ash (600 °C): ≤ 0.05 %
Loss on Drying (105 °C): ≤ 0.2 %
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 Ph. Eur., BP, JP, NF, E 334
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

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