Dextran 40 CAS 9004-54-0 CP2015 EP8.0 Specification

Dextran 40 for injection
Dextranum 40 ad iniectabile
Definition
Mixture of polysaccharides, principally of the α-1,6-glucan tyupe.
Average relative molecular mass: about 40 000.
Production
It is obtained by hydrolysis and fractionation of dextrans produced by fermentation of sucrose using Leuconostoc mesenteroides strain NRRL B-512 = CIP 78.59 or substrains thereof (for example L. mesenteroides B-512F = NCTC 10817).
It is prepared in conditions designed to minimise the risk of microbial contamination.
Characters
Appearance: white or almost white powder.
Solubility: very soluble in water, very slightly soluble in ethanol (96 percent).
Identification
A. Specific optical rotation (2.2.7): +195 to +201 (dried substance).
Dissolve 1.0g in water R, heating on a water-bath, and dilute to 50.0ml with the same solvent.
B. Infrared absorption spectrophotometry (2.2.24).
Comparison: Dextran CRS.
C. Molecular-mass distribution (see Tests).
Tsets
Solution S. Dissolve 5.0g in distilled water R, heating on water-bath, and dilute to 50ml with the same solvent.
Appearance of solution. Solution S is clear (2.2.1) and colourless (2.2.2, Method II).
Acidity or alkalinity. To 10ml of solution S add 0.1ml of phenolphthalein solution R. The solution remains colourless. Add 0.2ml of 0.01M sodium hydroxide. The solution is red. Add 0.4ml of 0.01M hydrochloric acid. The solution is colourless. Add 0.1ml of methyl red solution R. The solution is red or orange.
Nitrogen-containing substances: maximum 110ppm N.
Carry out the determination of nitrogen by sulfuric acid digestion (2.5.9), using 0.200g and heating for 2h. Collect the distillate in a mixture of 0.5ml of bromocresol green solution R, 0.5ml of methyl red solution R and 20ml of water R. Titrate with 0.01M hydrochloric acid. Not more than 0.15ml of 0.01M hydrochloric acid is required to change the colour of the indicator.
Residual solvents. Gas chromatography (2.2.28).
Internal standard: propanpl R.
Test solution. Dissolve 5g of the substance to be examined in 100ml of water R and distil. Collect the first 45ml of the distillate, add 1ml of a 25g/L solution of propanol R and dilute to 50ml with water R.
Reference solution. Mix 0.5mL of a 25g/L solution of anhydrous ethanol R, 0.5ml of a 25g/L solution of propanol R and 0.5ml of a 2.5g/L solution of methanol R and dilute to 25.0ml with water R.
Column:
- material: stainless steel;
- size: l=1.8m, ø=2mm;
- stationary phase: ethylvinylbenzene-divinylbenzene copolymer R (125-150μm).
Carrier gas: nitrogen for chromatography R.
Flow rate: 25mL/min.
Temperature:
- column: 190℃;
- ingection port: 240℃
- detector: 210℃
Detection: flame ionisation.
Injection: the chosen volum of each solution.
Limits:
- ethanol: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.5 percent);
- methanol: not more than the area of the corresponding peak in the chromatogram obtained with the reference solution (0.05 percent);
- sum of solvents other than ethanol, methanol and propanol: not more than the area of the peak due to the internal standard (0.5 percent, caclulated as propanol).
Molecular-mass distribution (2.2.39). The average molecular mass (M10) is 35 000 to 45 000. The average molecular mass of the 10 percent
high fraction is not greater than 110 000. The average molecular mass of the 10 percent low fraction is not less than 7000.
Heavy metals (2.4.8): maximum 10ppm.
12mL of solution S complies with test A. Prepare the reference solution using lead standard solution (1 ppm Pb)R.
Loss on drying (2.2.32): maximum 7.0 percent, determined on 0.200g by heating in an oven at 105±2℃ for 5 hours.
Sulfated ash (2.4.14): maximum 0.3 percent, determined on 0.50g.
Bacterial endotoxins(2.6.14): less than 10 IU/g.
Microbial contamination
TAMC: acceptance criterion 100 CFU/g (2.6.12).