TEST

STANDARD

RESULT

Appearance:

white or almost white powder,

slightly hygroscopic, ordorless

 Confirms

Very solutable in acetonitrile or chloroform, Soluble in Water, very soluble and practically insolutable in ethyl ether

  Confirms

Identification

(1)     IR

Conforms

      (2)     HPLC

Conforms

Water

NMT 5.0%

0.6%

Residue on ignition

NMT 0.2%

0.1%

Methyl benzenesulfonate

NMT 0.1%

undetected

Toluene

NMT 890ppm (ICH)

102ppm

Chromatographic purity

(1) Laudanosine: NMT 0.5%

(2) Other individual impurities: NMT 1.0%

(3) Total Impurities: NMT 3.5%

0.01%

0.38%

1.3%

Isomer Ratio

Trans-Trans Isomer: 5%-6.5%

5.7%

Cis-Trans Isomer: 34.5%-38.5%

36%

Cis-Cis Isomer: 55%-60%

58.2%

Assay

96%-102%

  (C65H82N2O18S2 on anhydrous basis)

100.2%

Residue Solvents

(1) Dichloromethane: NMT 600ppm

(2) Acctonitrile: NMT 410ppm

(3) Ethyl ether: NMT 5000ppm

Undetected

Undetected

1739ppm

Result

Confirms to USP34