Characteristics:

A white to pale yellow powder or

flaky crystals; Hygroscopic.

Conforms

Solubility:

Very soluble in Acetonitrile and Chloroform.

Soluble in water and practically insoluble in Ether

Conforms

Identification:

A. UV

B. I.R.

Conforms

Conforms

PH:

Appearance of solution:

Methyl benzenesulphonate:

Toluene

Related substances:

Total impurities

Impurity Laudinocine

Impurity RRT 0.47

Impurity RRT 0.56

Impurity RRT 0.73

Cis-cis,cis-trans mono quat

Cis-Trans

Trans-Trans

Any other secondary impurity

Loss on drying:

Sulphated ash:

Assay:

Microbiological limits:

Total microorganic aerobics:

Fungus and yeast:

Pathogens:

Bacterial endotoxins:

3.5 - 5.0

Clear to yellow standard No.7

≤10ppm

≤890ppm(ICH)

≤ 3.5%

≤ 0.5%

≤ 0.5%

≤ 1.0%

≤ 1.0%

≤ 0.5%

≤ 1.0%

≤ 0.5%

≤ 1.0%

≤ 3.0%

≤ 0.2%

97.0 ~ 103.0%

< 100 ufc/g

<10 ufc/g

not detected

< 5.56 EU/mg

4.2

Conforms

Conforms

0ppm

2.5%

0.2%

0.16%

0.35%

0.55%

0.1%

0.8%

0.0%

Conforms

0.7%

0.03%

98.7%

Conforms

Conforms

Conforms

Conforms