1) NF11
Identification: (A), (B), (C), (D), ( E ) positive reactions
Assay: 95.0%min
Loss on drying: 5.5-9.0%
Residue on ignition: 0.5%max
Chlorophyll: 0.004%max
Red pigment: 0.004%max
Quercetin: 0.5%max
Microbiological tests:
Total plate count/1g: 1000max
Yeast and mould/1g: 100max
E. Coil/1g: Absence
Package: 25kg/ fibre drum
2) EP9
First identification: B
Second identification: A. C. D
-A (UV/ Vis absorption of methanol solution between 210nm and 450nm ):2maxima at 257nm and 358nm ,specific absorbance at 358nm is 305-330
-B (IR):Comparison : rutoside trihydrate CRS
-C (TLC): Principle spot is similar to that of reference solution
-D: Dissolve 10mg in 5ml of alcohol R, add 1g of Zn r and HCL R1,a red color develops .
Appearance: Yellow or greenish-yellow powder
Assay: 95.0%-101.0% (anhydrous substance)
Titration with 0.1M N(C4H9)4OH
Test:
Light-absorbing-impurities, at-Wave-length between 450nmand 800nm :0.10max
Substances insoluble in methanol: 3.0%max
Related substances:
Impurity A: Isoquercitroside :2.0%max
Impurity B: Kaempferol-3-rutinoside: 2.0%max
Impurity C:Quercetin :2.0%max
Any other impurity:0.1%max
Total:4.0%max
Water:7.5-9.5%
Sulphated ash: 0.1%max
Residual solvents:
Methanol:3000ppm
Acetone: Absence
Propyl alcohol: Absence
Package: 25kg/ fibre drum