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Tadalafil

  • Tadalafil  CAS No. 171596-29-5
  • Tadalafil  CAS No. 171596-29-5
  • Tadalafil  CAS No. 171596-29-5
Tadalafil  CAS No. 171596-29-5Tadalafil  CAS No. 171596-29-5Tadalafil  CAS No. 171596-29-5

Tadalafil CAS No. 171596-29-5

  • Tadalafil,EP/USP
  • Pakage:1kg/25kg/as required
  • Capacity:1ton~2ton per month
  • Stock:500kg
  • Product description: tadalafil 171596-29-5
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Name

Tadalafil

Appearence

White crystalline powder

Cas

171596-29-5

Assay

≥99.5%

Solubility

Insoluble in water or alcohol, soluble in Acetic acid, ethyl ester

Melting point

300-303°C

Loss on drying

≤0.5%

Heavy Metal

≤10ppm

Specific rotation

+ 78.0°to + 84.0°

Dosage

20-40mg

Onset time

30 minites

Grade

Pharmaceutical Grade

Package

1 kg in an aluminum foil bag, 25kg/drum.

分析项目

ITEM OF ANALYSIS

指标

STANDARD

性状Appearance

白色或类白色粉末White or almost white crystalline powder

溶解度

Solubility

几乎不溶于水,易溶于二甲亚砜,微溶于二氯甲烷

Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride

熔点

Melting point

302~303

鉴别

Identification

红外图谱与参照图谱一致

The infrared absorption spectrum is concordant with the reference spectrum

供试品溶液中主峰的保留时间应与鉴别溶液中主峰的保留时间一致

The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution

比旋度

Rotation

+ 78.0°to + 84.0°

杂质A,B,C

Impurities A, B and C

杂质 A, B and C0.1%

Impurity  A, B and C0.1%

干燥失重

Loss on drying

0.5%

炽灼残渣

Residue on ignition

0.1%

重金属

Heavy metals

10ppm

有关物质(HPLCRelated substances

单项杂质≤0.1%

individual impurity0.1%

总杂质≤0.3%

Total unknown impurity0.3%

残留溶剂Residual Solvents

甲醇≤0.3%

Methanol;0.3%

乙酸乙酯≤0.5%

EA0.5%

异丙醇≤0.5%

IPA0.5%

乙酸甲酯≤0.5%

Methyl acetate0.5%

二氯甲烷≤0.06%

DCM0.06%

醋酸≤0.5%

AceticAcid0.5%

含量Assay

98% ~ 102.0 % (干品计dried substance).

结论

Conclusion

本品按EP 9/USP40标准检验,结果符合规定。

The test results conform with EP 9/USP40 Specification.