(Ph. Eur. monograph 0807)
C22H38O7 414.5 137-66-6
Action and use
Excipient.
DEFINITION
(2S)-2-[(2R)-3,4-Dihydroxy-5-oxo-2,5-dihydrofuran-2-yl]-2-hydroxyethyl hexadecanoate.
Content
98.0 per cent to 100.5 per cent (dried substance).
CHARACTERS
Appearance
White or yellowish-white powder.
Solubility
Practically insoluble in water, freely soluble in ethanol (96 per cent) and in methanol, practically insoluble in methylene chloride and in fatty oils.
IDENTIFICATION
A. Specific optical rotation (see Tests).
B. Infrared absorption spectrophotometry (2.2.24).
Comparison ascorbyl palmitate CRS.
C. Dissolve about 10 mg in 5 mL of methanol R. The solution decolourises dichlorophenolindophenol standard solution R.
TESTS
Solution S
Dissolve 2.50 g in methanol R using sonication and dilute to 25.0 mL with the same solvent.
Appearance of solution
Solution S is clear (2.2.1) and not more intensely coloured than reference solution BY4 (2.2.2, Method I).
Specific optical rotation (2.2.7)
+ 21 to + 24 (dried substance), determined on solution S.
Related substances
The thresholds indicated under Related substances (Table 2034.-1) in the general monograph Substances for pharmaceutical use (2034) do not apply.
Loss on drying (2.2.32)
Maximum 1.0 per cent, determined on 1.000 g by drying in vacuo at 60 °C for 5 h.
Sulfated ash (2.4.14)
Maximum 0.1 per cent, determined on 1.0 g.
ASSAY
Dissolve 0.200 g in 50 mL of ethanol (96 per cent) R. Add 30 mL of water R and titrate with 0.05 M iodine until a yellow colour is obtained.
1 mL of 0.05 M iodine is equivalent to 20.73 mg of C22H38O7.
STORAGE
In an airtight container, protected from light.
