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5.00090 SAFC

L(+)Ascorbyl palmitate

EMPROVE® ESSENTIAL Ph Eur,BP,NF,FCC,E 304

Synonym: L(+)Ascorbyl palmitate, Palmitoyl-L-ascorbic acid

  • CAS Number 137-66-6

  • Empirical Formula (Hill Notation) C22H38O7

  • Molecular Weight 414.53

  •  MDL number MFCD00005377

  •  E Number E304

  •  EC Index Number 205-305-4

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Antioxidants, Biopharmaceutical Process Development and Manufacturing, Excipients, Semisolid Dosage Forms,
Agency/Method   BP
  NF
  Ph. Eur.
Quality Level   500
reg. compliance   FCC
product line   Emprove® Essential
form   fine powder
potency   >5000 mg/kg LD50, oral (Rat)
mp   107-117 °C
bulk density   180 kg/m3
InChI   1S/C22H38O7/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-18(24)28-16-17(23)21-19(25)20(26)22(27)29-21/h17,21,23,26-27H,2-16H2,1H3
InChI key   NULLRXHRYOXSEW-UHFFFAOYSA-N
storage conditions   Store at +15°C to +25°C.

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 (iodometric, calc. on dried substance): 98.0 - 100.5 %
Assay (HPLC, calc. on dried substance): 95.0 - 100.5 %
Identity (IR-spectrum): conforms
Identity (Tillmans-Reaction): conforms
Identity (HPLC): conforms
Appearance: white or yellowish-white powder
Appearance of solution (100 g/l, Methanol): clear and not more intense in colour than colour reference solution BY₄ (Ph Eur)
Melting range (lower value): ≥ 107 °C
Melting range (upper value): ≤ 117 °C
Spec. rotation [α²0/D (100 g/l, Methanol,calc. on dried basis): +21 - +24 °
Spec. rotation [α! 20/D (50 g/l, Methanol): +21 - +24 °
Spec. rotation [α²5/D (100 g/l, Methanol,calc. on dried basis): +21 - +24 °
Spec. rotation [α! 25/D (100 g/l, Methanol): +21 - +24 °
As (Arsenic): ≤ 3 ppm
Cu (Copper): ≤ 25 ppm
Hg (Mercury): ≤ 1 ppm
Ni (Nickel)*: ≤ 2 ppm
Pb (Lead): ≤ 2 ppm
Zn (Zinc): ≤ 25 ppm
Ethyl acetate (HS-GC): ≤ 5000 ppm
Methylisobutylketone (HS-GC): ≤ 4500 ppm
Other residual solvents (ICH Q3C): excluded by production process
Sulfated ash (600 °C): ≤ 0.1 %
Loss on drying (5 h, 60 °C, Vacuum): ≤ 1.0 %
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, NF, FCC, E 304
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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