Tirofiban Hydrochloride; CAS No.: 150915-40-5

Item

Specification

Appearance

Off-white powder

Odor

Odorless

Identification

IR: The infrared absorption spectrum of the sample complies with the reference standard.

Identification by Chloride: It gives positive reaction

Acid Basic testing: It gives positive reaction

UV: The absorption maximum at 226nm and 275nm.

Solubility

Freely soluble in ethanol, slightly soluble in water ,0.1mol/L hydrochloric acid, 0.l mol/L sodium hydroxide and practically insoluble in ethyl acetate and chloroform

Clarity of Solution

Not darker than No.l turbidity standard

solution

Color of Solution

Not darker than yellow No.1 standard

solution

Specific Rotation

-11° ~ -15°

Moisture

3.6%~5.6%

Residue on Ignition

≤ 0.1%

Acidity

2.0~4.0

Enantiommer

WI-0227≤ 0.5 %

Related Substances

W1-0069 ≤ 0.1%

Other Single Impurity ≤ 0.1%

Total impurities ≤ 0.3%

Heavy Metals

≤ 20ppm

Pd

≤ 1ppm

Residual Solvents

Ethyl Acetate ≤ 5000ppm

Isopropyl Acetate ≤ 5000ppm

Acetonitrile ≤ 410ppm

Bacterial Endotoxins

< 2.5 Eu/mg

Total Plate Count

≤ 1000cfu/g

Yeasts&Molds

≤ 100cfu/g

E.Coli

Negative

Assay

98.0%~102.0%