Product name

Conjugated Estrogens

CAS

12126-59-9

Labeled content

30.0mg/g

Test Date

2013.12.24

Expire Date

2016.12.22

Test Standard

USP(3.00% w/w basis)

Item

Specification

Result

Appearance

Light yellow powder

Complies

Identification

A:The chromatogram exhibits peaks for 17α-dihydroequilin, estrone and equilin at relative retention times corresponds to those exhibited in the chromatogram of the standard preparation.

B:The chromatogram of Conjugated Estrogens exhibits additional peaks or shoulders, corresponds to 17α-eatradiol and 17-β dihydroequilin at retention times of about 0.26 and 0.36,respectively, relative to that of 3-O-methylestrone.

Complies

Complies

Assay(as % of labeled content)

Estrone

52.5%-61.5%

57.9%

Equilin

22.5%-30.5%

27.6%

Sum of Estrone&Equilin

79.5%-88.0%

85.5%

Concomitant components(as % of labeled content)

17α- dihydroequilin

2.5%-9.5%

14.5%

17-β dihydroequilin

52.5%-61.5%

2.2%

17α-estradiol

52.5%-61.5%

2.8%

Signal impurities (as % of labeled content)

17α- dihydroequilin

≤3.25 %

1.01%

17-β dihydroequilin

≤2.75%

0.66%

Equilenin

≤5.5%

1.8%

Related substances(as % of labeled content)

17β-estradiol

≤2.25%

1.08%

8,9-Dehydroestrone

≤6.25%

4.38%

Free steroids

Ru/Rs

≤0.65

0.27

pH

10% w/v aqueous solution

7.0-9.0

8.7

Loss on drying

Loss on drying (105°C,2h)

≤2.0%

0.8%

Residual solvents

<467> Method V

≤5000ppm

<5000ppm

Microbial limits test

Staphylococcus aureus

Negative

Negative

Escherichia coli

Negative

Negative

Pseudomonas aeruginosa

Negative

Negative

Total aerobic microbial count

≤100cfu/g

<10cfu/g

Total combined yeasts/molds

<10cfu/g

<10cfu/g

All estrogens reported as the sodium salts of the 3-monosulfate esters.

Labeled content:

A sum of sodium salts of the 3-sulfate esters of 17α- dihydroequilin, equilin and estrone.

Conclusion

This subject product conforms to USP requirements for Conjugated Estrogens..