曲克芦丁

MFG.  Date

08/01/2022

EXP. Date

07/01/2024

Batch Quantity

1000kg

CAS no

7085-55-4 

ITEMS

SPECIFICATIONS

RESULTS

Appearance

Greenish yellow or yellow fine powder

Greenish yellow or yellow fine powder

Solubility

Freely soluble in water, slightly soluble in ethanol(96%) and practically insoluble in methylene chloride

Complies

Identification

(A)IR

(B)HPLC

Complies

-principal Peak:Tris(hydroxyethyl)rutin

≥80%

83.13%

-Any other peak

For each peak,maximun 5%,except for 1 peak which can be maximun 10%

Complies

Tetrakis(hydroxyethyl)rutin

4.98%

Mono(hydroxyethyl)rutin

1.19%

Bis(hydroxyethyl)rutin

4.45%

Loss on drying (130℃)

≤5.0%

4.55%

Melting point

168℃～176℃

170℃～172℃

Sulfated ash

≤0.4%

0.08%

Residue on ignition

≤0.1%

0.05%

Ethylene oxide

≤1ppm

0.7ppm

Assay （UV）

95.0～105.0%

98.4%

Methanol

≤3000ppm

706ppm

Particle size

100% pass through sieve 80 mesh

100% pass 80 mesh

Total plate count

≤1000cfu/g

130cfu/g

Yeast & mould

≤100cfu/g

20cfu/g

E.Coli

Absent

Absent

salmonellae

Absent

Absent

Staphylococcus Aureus

Absent

Absent

Conclusion

The test results conform to EP9.0