6-O-Palmitoyl-L-ascorbic acid 98.0-100.5%, EMPROVE® ESSENTIAL NF, Ph. Eur., E304, BP, FCC suitable for use as excipient, SAFC®

: MERCK PRODUCTION CHEMICALS

6-O-Palmitoyl-L-ascorbic acid 98.0-100.5%, EMPROVE® ESSENTIAL NF, Ph. Eur., E304, BP, FCC suitable for use as excipient, SAFC®

: MERCK PRODUCTION CHEMICALS

: L-Ascorbic acid 6-palmitate, Palmitoyl-L-ascorbic acid, Ascorbyl Palmitate, (S)-2-((R)-3,4-Dihydroxy-5-oxo-2,5-dihydrofuran-2-yl)-2-hydroxyethyl palmitate, L(+)-Ascorbyl palmitate

:137-66-6

:C₂₂H₃₈O₇

:MFCD00005377

:414.54 g/mol

:∼250 °C

:107…117 °C

:Ambient

:205-305-4

Environmentally Preferable:

Assay (iodometric, calc. on dried substance):
98.0 - 100.5 %
Identity (IR-spectrum):
conforms
Identity (Tillmans-Reaction):
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 α 20/D (100 g/l, Metanol, calc on dried basis):
+21 - +24 °
Spec. rotation α 20/D (50 g/l, methanol):
+21 - +24 °
Spec. rotation α 25/D (100 g/l, Metanol, calc on dried basis):
+21 - +24 °
Spec. rotation α 25/D (100 g/l, methanol):
+21 - +24 °
Heavy metals (as Pb):
≤ 10 ppm
As (Arsenic):
≤ 3 ppm
Cu (Copper):
≤ 25 ppm
Hg (Mercury):
≤ 1 ppm
Pb (Lead):
≤ 2 ppm
Zn (Zinc):
≤ 25 ppm
Ethyl acetate (HS-GC):
≤ 5000 ppm
Methylisobutylketone (HS-GC):
≤ 5000 ppm
Other residual solvents (ICH Q3C):
excluded by manufacuring process
Sulfated ash (600 °C):
≤ 0.1 %
Loss on drying (5 h, 60 °C, Vacuum):
≤ 1.0 %
Residues of metal catalysts or metal reagents acc.to EMEA/CHMP/SWP/4446/2000:
are not likely to be present.
Correspond to Ph Eur, BP, NF, FCC, E 304:
Conforms to the purity criteria on food additives according to the current ECR