Provepharm - Back to HomepageMethylene Blue
The first pure pharma grade Methylene Blue produced under cGMP in the World
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Typical Analysis


Item Typical analysis
of Provepharm
Methylene Blue		 Limits
Ph.Eur USP*
Assay (dry basis) (%) 95 -101 95 -101 98 - 103
Identification Complies Complies -
Insoluble in methanol (%) - NMT 1 -
Azur B (%) < 2 < 5 -
Related substances - - -
Loss on drying (%) 16 8 - 22 8 - 18
Sulphated ash/loss on ignition (%) < 0,25 < 0,25 1,2
Chromatographic purity - - Complies
Organic volatile impurities (ppm) - - Complies
Al < 2 < 100 -
As Not detected - < 6
Cd < 0,01 < 1 -
Cr < 3 < 100 -
Cu < 3 < 300 < 200
Sn < 0,2 < 10 -
Fe < 3 < 200 -
Mn < 0,5 < 10 -
Hg < 0,5 < 1 -
Mo < 1 < 10 -
Ni < 2 < 10 -
Pb Not detected < 10 -
Zn < 2 < 100 Absence

*Current USP monograph before harmonization cf. www.usp.org
Provepharm Methylene Blue complies with DRAFT "GUIDELINE ON THE SPECIFICATION LIMITS FOR RESIDUES OF METAL CATALYSTS"
Doc. Ref. CPMP/SWP/QWP/4446/00 corr. London 2007
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