Specification :: Troxerutin

Specification T01

(7,3´,4´-tris[O-(2-hydroxyethyl)]rutin)

Molecular Formula: C₃₃H₄₂O₁₉
Molecular Weight: 742.68
C.A.S. No.: [7085-55-4]

Troxerutin is a mixture of hydroxyethylated rutins which contains not less than
80.0 % of 7, 3’, 4’-Tris[O-(2-hydroxyethyl)]rutin

Description: Yellow powder.

Tests:	Limits:	Method:
Identification: a) I.R. spectrum b) TLC		DAB 1999 Ph. Eur. 5 ^th Ed. 2005, <2.2.24> DAB 1999
Clarity of 5 % (w/v) aqueous solution:	clear	Ph. Eur. 5^th Ed. 2005, <2.2.1>
Color of 5 % (w/v) aqueous solution:	yellow	Ph. Eur. 5 ^th Ed. 2005, <2.2.2>
Chloride:	max. 0.2 %	Ph. Eur. 5 ^th Ed. 2005, <2.2.20> Ph. B. MMII page 5537
pH of 5 % (w/v) aqueous solution:	6.0 - 7.0	Ph. Eur. 5^th Ed. 2005, <2.2.3>
Heavy metals (calculation as lead):	max. 20 ppm	Ph. Eur. 5^th Ed. 2005, <2.4.8>
Sulphate ash:	max. 0.10 %	Ph. Eur. 5^th Ed. 2005, <2.4.14>
Loss on drying (130 °C):	max. 4.0 %	Ph. Eur. 5^th Ed. 2005, <2.2.32>
Assay (Spectrophotometry, calculation based on dry substance):	97.0 - 103.0 %	DAB 1999
Acetone (GC):	max. 5000 ppm	NQ T01/D, test No.11 Ph. Eur. 5^thEd. 2005, <2.2.28>
Ethylene glycol (GC):	max. 620 ppm	NQ T01/D, test No.12 Ph. Eur. 5^thEd. 2005, <2.2.28>
Methanol (GC):	max. 1500 ppm	NQ T01/D, test No.13 Ph. Eur. 5^thEd. 2005, <2.2.28>
2-Methoxyethanol (GC):	max. 350 ppm	NQ T01/D, test No.14 Ph. Eur. 5^thEd. 2005, <2.2.28>
Ethylene oxide (GC):	max. 1 ppm	NQ T01/D, test No.15 Ph. Eur. 5^thEd. 2005, <2.2.28>
Related hydroxyethyl-derivates of rutoside (HPLC):	max. 20.0 %	NQ T01/D, test No.16 Ph. Eur. 5^thEd. 2005, <2.2.29>
Bulk weight v/w:	250 - 350 ml /100 g	NQ T01/D, test No. 17
Microbiological test:
Bacteria	max. 1000 cfu/g	Ph. Eur. 5^th Ed. 2005, <2.6.12>
Fungi	max. 100 cfu/g	Ph. Eur. 5^th Ed. 2005, <2.6.12>
Escherichia coli in 1 g	absent	Ph. Eur. 5^th Ed. 2005, <2.6.13>
Shelf life: 3 years.

*NQ = Norm of Quality