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Chemical Name:Mirabegron 
Cas No.:223673-61-8 
Molecular Formula:C21H24N4O2S 
Molecular Weight:396.506 
Specification:99%MIN 
Appearance:White to light yellow solid 
Molecular Structure: 

 

Appearance

White to light yellow solid

Light yellow powder

Visual

Solubility

Very soluble in methanol and chloroform, practically insoluble in water

Conforms

Visual

Identification

HPLC retention time correspond to WRS under assay item

Conforms

HPLC

Water

NMT 1.0%

0.23%

USP<921>

Residue on ignition

NMT 0.5%

0.26%

USP<281>

Heavy metals

NMT 20ppm

Conform

USP<231>

Related Substance

Single impurity: NMT 0.5%

0.08%

HPLC

Total impurities: NMT 1.0%

0.18%

HPLC

Chiral impurity: NMT 2.0%

0.07%

HPLC

Residual Solvents

N,N-Dimethylformamide: NMT880ppm

Not detected

USP<467>

Methanol: NMT 3000ppm

Not detected

USP<467>

Ethanol: NMT 5000ppm

Not detected

USP<467>

Isopropyl Alcohol: NMT 5000ppm

Not detected

USP<467>

Isopropyl Ether: NMT 5000ppm

Not detected

USP<467>

Tetrahydrofuran: NMT 720ppm

Not detected

USP<467>

Toluene: NMT 890ppm

Not detected

USP<467>

Ethyl acetate: NMT 5000ppm

Not detected

USP<467>

Assay

98.0%~102.0%(on dried basis)

99.5%

HPLC

 

Storage

 



 

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