Новые продукты
Найти Порошок Глюкозы , Эпросартан Мезилат, Декстроза Безводная на Промышленность Directory, надежный производитель / поставщик / завод из Китая
Срок поставки: | 3 дней |
---|
Модель: Conjugated Estrogens powder
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.. |
Packaging Detail |
25kgs/drum, paper-drums and two plasticbags inside We can pack according to your individual requirements as well. |
Storage |
Store in a well-closed container away from moisture |
Shelf Life |
2 years if sealed and store away from direct sun light. |
Delivery Detail |
Within 7-15 days after order confirmation |
Группа Продуктов : Новые Лекарства И Конкретного Препарата