1.07443
Polyvidone 25
Ph Eur,BP
Synonym(s):
Polyvidone 25
Agency
BP
Ph. Eur.
autoignition temp.
440 °C
potency
>2000 mg/kg LD50, oral (Rat)
mp
220 °C (decomposes)
density
1.2 g/cm3 at 20 °C
bulk density
330 kg/m3
storage temp.
15-25°C
InChI
1S/C6H9NO/c1-2-7-5-3-4-6(7)8/h2H,1,3-5H2
InChI key
WHNWPMSKXPGLAX-UHFFFAOYSA-N
Analysis Note
Appearance: conforms
Identity: conforms
Assay (Nitrogen, calc. on anhydrous substance): 11.5 - 12.8 %
Appearance of solution (5 %; water): conforms
pH-value (5 %; water): 3.0 - 5.0
Heavy metals (as Pb): ≤ 0.0010 %
Viscosity (calc. as k-value): 22.5 - 27.0
Aldehydes (calc. on CH₃CHO): ≤ 0.0500 %
Peroxide (calc. as H₂O₂): ≤ 0.0400 %
Formic acid: ≤ 0.5 %
related substances (Hydrazine): ≤ 1 ppm
related substances (Vinyl pyrrolidone): ≤ 10 ppm
related substances (2-Pyrrolidone*): ≤ 3.0 %
Water: ≤ 5.0 %
Sulfated ash (600 °C): ≤ 0.1 %
* Parameter tested by qualified laboratory
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph Eur , BP
Identity: conforms
Assay (Nitrogen, calc. on anhydrous substance): 11.5 - 12.8 %
Appearance of solution (5 %; water): conforms
pH-value (5 %; water): 3.0 - 5.0
Heavy metals (as Pb): ≤ 0.0010 %
Viscosity (calc. as k-value): 22.5 - 27.0
Aldehydes (calc. on CH₃CHO): ≤ 0.0500 %
Peroxide (calc. as H₂O₂): ≤ 0.0400 %
Formic acid: ≤ 0.5 %
related substances (Hydrazine): ≤ 1 ppm
related substances (Vinyl pyrrolidone): ≤ 10 ppm
related substances (2-Pyrrolidone*): ≤ 3.0 %
Water: ≤ 5.0 %
Sulfated ash (600 °C): ≤ 0.1 %
* Parameter tested by qualified laboratory
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph Eur , BP
Certificates of Analysis (COA)
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