ITEMS

SPECIFICATION

Appearance

Light yellow powder

Identification

A B

Free steroids

0.65 max

PH Value

10% w/v aqueous suspension: 7.5-9.5

Water

2.0%max

Organic volatile impurity

5000ppm max

Microbial limits test

Staphylococcus aureus : Negative
E.coli : Negative
Pseudomonas aeruginosa : Negative
Salmonella species : Negative
Total aerobic plate count : 1000 max

Assay

Conj.17α-estradiol :2.5-9.5%
Conj.17α-dihydroequilin :13.5-19.5%
Conj.17β-dihydroequilin :0.5-4.0%
Conj. Estrone :52.5-61.5%
Conj. Equilin : 22.5-30.5%
Sum of estrone & equilin :79.5-88.0%
Total Conjugated Estrogens :
Conj.17α-dihydroequilenin :3.25%max
Conj.17β-dihydroequilenin :2.75%max
Conj. Equilenin :5.5%max
Conj.17β-estradiol :2.25%max
Conj.Δ8,9-dehydroestrone :6.25%max

Conclusion

Conform with specification USP29 standard