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Ulipristal Acetate/126784-99-4
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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 acetatateAlmost 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%

ConclusionIt complies to Enterprise standard.


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