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替米沙坦

基本信息
化學名稱:4′-[4-甲基-6-(1-甲基-1H-苯并咪唑-2-基)-2-丙基-1H-苯并咪唑基甲基]聯苯基-2-羧酸
分子式:C33H30N4O2
分子量: 514.62
CAS NO:144701-48-4
質量標準:USP/ EP/ 國家標準, 可提供DMF/ CEP/ GMP。


 Specification

     According to European Pharmacopoeia 7.8

Items

Specification

Results

Appearance

White or slightly yellowish crystalline powder

White crystalline powder

Solubility

Should meet the requirement

Conforms

IR Identification

Should correspond to the RS Infrared Absorption

Correspond to the reference substance

Appearance of solution

Should meet the requirement

Conforms

Related substance

Impurity A

≤0.15%

0.05%

Impurity B

≤0.15%

0.02%

Impurity C

≤0.2%

0.03%

Impurity D

≤0.2%

0.05%

Unspecified Ims.

≤0.1%

0.06%

Total

≤1.0%

0.30%

Residual solvents

Methanol

≤0.3%

Not detected

Ethanol

≤0.5%

0.031%

Methylene dichloride

≤0.06%

Not detected

n-hexane

≤0.029%

Not detected

Acetic acid ethyl ester

≤0.5%

Not detected

Toluene

≤0.089%

0.025%

Acetic acid

≤0.5%

0.036%

Loss on drying

≤0.5%

0.20%

Sulphated ash

≤0.1%

Conforms

Melting point

    261 ºC -263 ºC

     261.1 ºC -262.2 ºC

Particle size

    90% Less than 200um

     Conforms

Assay

    99.0%~101.0%

     99.9%

Conclusion

   It conforms to European Pharmacopoeia 7.0

作用與用途:用于原發性高血壓的治療。

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