99.5% up, DMF, EU-GMP Altrenogest 850-52-2

Product Information

Product name

Altrenogest

CAS No.

850-52-2

Molecular Formula

C21H26O2

Molecular Weight

310.4

Quality Standard

99.5% up, Medicine Grade

Appearance

Light yellow powder

COA of Altrenogest

TEST

SPECIFICATION

RESULTS

Appearance

Light yellow or yellow crystalline powder

Light yellow crystalline powder

Melting point

116。C -121。C

117.2。C - 118.0。C

Specific optical rotation

-69。- -75。

-74.3。 

Identification

  A.The retention time of HPLC

  B. IR

Examine the chromatograms obtained in the assay: the retention time to the principal peak in the chromatograms obtained with the rest solution is similar in retention time to the principal peak in the chromatograms obtained with reference solution

The IR spectrum of the sample is same as the reference standard.

Conform

Conform

Related substances

  Impurity A

  Impurity C

  Any unspecified impurity

  Total impurities

≤ 0.5%

≤ 0.5%

≤ 0.20%

≤ 2.0%

0.19%

Not detected

Not detected

0.19%

Loss on drying

≤ 0.5%

0.07%

Residue on ignition

≤0.20%

0.05%

Assay

98.0%-102.0% (on the dried basis)

99.6%

Residual Solvents

  Methanol

  Dichloromethane

  n-Hexane

  Ethyl acetate

  Tetrahydrofuran

≤ 3000ppm

≤ 600ppm

≤ 290ppm

≤ 5000ppm

≤ 720ppm

Not detected

Not detected

Not detected

800 ppm

Not detected

Conclusion

Complies with the in-house standards

Usage