环丙贝特

Item of analysis

Standard

Result of analysis

Appearance

White or slight yellow crystalline  powder

Off-white crystalline  powder

Identication

IR 

Positive

Appearance of solution.

Clear and not more than BY4

Conform

Solubility

Practically insoluble

in water, freely soluble in anhydrous ethanol, soluble in toluene.

Conform

Moisture

<0.5%

0.2%

Chlorides

<350PPM

Conform

Aerobic Microorganisms

≤30cfu/g

Conform

Molds and Yeasts

≤10cfu/g

Conform

Pathogens

Absence

Conform

Sulphated ash

< 0.1%

0.03%

Melting point

Around 115℃

116.5~117.5℃

Related substance

ImpurityA ≤0.1%

UDL

Impurity B≤0.2%

0.013%

Impurity C≤0.1%

UDL

Impurity D≤0.1%

0.005%

Impurity E≤0.8%

0.12%

Each other impurity≤0.10%

0.04%

Total impurities≤0.5%

0.12%

Heavy metal

<20PPM

Conform

Residual solvents

Toluene ≤890PPM

372ppm

Hexane ≤290PPM

43ppm

Assay(on Dried Basis)

99.0 ~ 101.0% （anhydrous substance）

99.8%

Conclusion：Conform To EP9.2 , BP2019 Standard

            Storage temperature. Room temperature.

Exam                          Analyst                     Checker