Dextran 10

CAS Number: 9004-54-0

Specification

Test/Characteristic Limit Test Method
Appearance White to off-white powder EP
Specific Optical Rotation +190⁰-199⁰ Internal
ID by IR Identical to reference, correlation ≥ 0.90 EP
Molecular Weight Distribution, Dalton:
Mw 9.000 - 11.000 Internal
Absorbance, 375 nm ≤ 0,05 Internal
Acidity/Alkalinity Complies with Ph. Eur. Internal
Nitrogen ≤ 0,01 (100 ppm) Internal
Heavy Metals ≤ 5 ug/g USP
Loss on Drying ≤ 5,0 % EP / USP
pH 4,5-7,0 Internal
Residual Solvents:
Ethanol ≤ 0,5 % (5.000 ppm) Internal
Methanol ≤ 0,3 % (3.000 ppm) Internal
i-Propyl Alcohol ≤ 0,5 % (5.000 ppm) Internal
Sulphated Ash (ROI) ≤ 0,3% USP
Microbial Contamination:
TAMC ≤ 100 cfu/g Internal
TYMC ≤ 100 cfu/g Internal
Endotoxins < 25 EU/g EP / USP
Sodium Chloride ≤ 1,0 % Internal
Branching by NMR ≤ 5% C3 branching with no C2 or C4 branching Internal

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