Conjugated
Estrogen extracted from Pregnant Mare's
Urine. Conjugated estrogen is a mixture of estrogens
obtained exclusively from natural sources, occurring
as the sodium salts of water-soluble estrogen sulfates
blended to represent the average composition of material
derived from pregnant mares' urine. It contains estrone, equilin,
and 17 a-dihydroequilin, together with
smaller amounts of 17 a-estradiol, equilenin,
and 17 a-dihydroequilenin as salts of
their sulfate esters.
Premarin is
a drug made up of conjugated estrogens obtained from the
urine of pregnant mares is produced in many forms (pills,
creams, injections, patches, vaginal rings) and is used to
reduce the symptoms of menopause in women or women who have
had a hysterectomy. It is also prescribed to nearly eliminate
the risk of osteoporosis (the brittling of
bones) and reduce the chance of heart disease in
women over 50.
Conjugated Estrogen Specifications
Synonyms: Premarin,
Conjugated equine estrogens
CAS: 12126-59-9
Manufacturing Capacity: over 1000kg
per month
Test Items |
Specification |
Appearance |
Light yellow
powder |
Free
Steroids |
0.65 max |
Assay |
Conj.17a-estrsdiol |
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 |
Conforms |
|
|
Conj.17α-dihydroequilenin |
3.25% max |
Conj.17β-dihydroequilenin |
2.75% max |
Conj.equilenin |
5.5% max |
Conj.17β-estrsdiol |
2.25% max |
Conj.Δ8,9-dehydroestrone |
6.25% max |
PH |
10% w/v aqueous suspension |
8.5-9.5 |
Water(Titrimetric) |
2.0% max |
Organic
Volatile imputities |
<467> Method
V |
Microbial
Limits Test |
Staphylococcus aureus |
Negative |
Escherichia
coli |
Negative |
Pseudomonas
aeruginosa |
Negative |
Salmonella
species |
Negative |
Total aerobic
plate count |
1000 max |
Water |
0.5% max |
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