Ulipristal Acetate/126784-99-4

BATCH NO.: HF161220

QUANTITY:  2.1kg

MFG. DATE : Dec. 20, 2016

PACKAGE: as required

REP. DATE : Dec. 26, 2016

EXP. DATE : Dec, 2018

ITEMS

STANDARDS

RESULTS

Appearance

White or light yellow crystalline powder

Light yellow crystalline powder

Melting point

183-188℃

186~188℃

Solubility

Feely soluble in methylene chloride,sparingly soluble in methanol, soluble in ethyl acetatate，Almost insoluble in water。

Complies

Identification

UV identification

IR identification

Complies

Complies

Specific rotation

+195.0°～+205.0°  

+198.0°

Related substances

≤1.0%

0.28%

Max unknown single impurity

≤0.1%

0.05%

Impurity A

≤0.5%

0.09%

Acetic acid

≤0.5%

N.D.

Loss on drying

≤0.5%

0.11%

Residue on ignition

≤0.1%

0.06%

Heavy metal

≤10ppm

Complies

Residual solvent

THF ≤0.072％ 

N.D.

Ethyl acetate ≤0.5％

N.D.

Ethanol ≤0.5％

0.008%

2-propanol ≤0.5％

N.D.

Dichloromethanel ≤0.06％

0.004%

ASSAY

≥98.5%

99.6%

Conclusion：It complies to Enterprise standard.