наименование товара:Tacrolimus
Чистота: 99%
КАС: 104987-11-3
МФ: C44H69NO12
МВт: 804.02
вид: белый порошок
Хранилище: Store in a cool, сухое место. Away from the light, heat and moisture.
Tacrolimus, also known as fujimycin, is an immunosuppressive drug used mainly after allogeneic organ transplant to lower the risk of organ rejection. It achieves this by inhibiting the production of interleukin-2, a molecule that promotes the development and proliferation of T cells, which are vital to the body’s learned (or adaptive) immune response.
Tacrolimus is also used in the treatment of other T cell-mediated diseases such as eczema (for which it is applied to the skin in a medicated ointment), severe refractory uveitis after bone marrow transplants, exacerbations of minimal change disease, Kimura’s disease, and the skin condition vitiligo.
Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ. This medicine may be used with steroids, azathioprine, basiliximab, or mycophenolate mofetil. Tacrolimus belongs to a group of medicines known as immunosuppressive agents.
Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of this medicine as well as the risks of using it. Tacroz Forte Ointment (Tacrolimus) is used to treat atopic dermatitis (more commonly known as eczema). It is a topical medication which is normally prescribed for patients who have not responded successfully to other eczema medication.
The ointment is a type of topical calcineurin inhibitor (TCIs) that works by weakening the patient`s immune system, which as a consequence directly reduces the severity of eczema and its symptoms. It should not be used by patients who have any kind of weak immune system.
Элементы анализа |
Технические характеристики |
Результаты |
Описание |
white to faint yellow,practically odorless,crystalline powder.Slowly oxidizes and acquires a blue color,on prolonged exposure to air. |
white,odorless crystalline powder.slowly oxidizes and acquires a blue color,on proplonged exposure to air. |
solubility |
freely soluble in water,in hot dehydrated alcohol and in chloroform.practically insoluble in ether,in acetone and in ethyl acetate |
freely soluble in water,in hot dehydrated alcohol and in chloroform.practically insoluble in ether,in acetone and in ethyl acetate. |
completeness and clarity of solution |
a solution of 1 в 10 in water,и 1 в 10 in chloroform shall be practically clear and shows not more than a light yellow colour. |
clear and colourless |
Удостоверение личности |
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|
A.IR absorption spectrum |
the positions and relative sizes of the bands in the spectrum of the sample and reference shall be concordant |
the positions and relative sizes of the bands in the spectrum of the sample and reference spectrum are concordant |
B.test for chlorides |
shall comply the test |
complies |
рН(1 в 20 solution) |
between 4.0 и 5.0 |
4.60 |
loss on drying |
НМТ 0.5% |
0.20% |
residue on ignition |
НМТ 0.1% |
0.03% |
bacterial endotoxin |
НМТ 6.9 EU/mg |
less than 6.9 EU/mg |
related substances |
|
|
single impurity |
НМТ 1.0% |
less than 1.0% |
sum of impurities |
НМТ 2.0% |
less than 2.0% |
assay |
97.0%-101.5% |
99.9% |
residual solvents |
|
|
O-xylene |
ICH limit:2170 частей на миллион |
1321 частей на миллион |
isopropyl alcohol |
ICH limit:5000 частей на миллион |
969 частей на миллион |
microbial limits |
|
|
total bacterial count |
НМТ 1000 cfu/gm |
35 cfu/gm |
total fungal count |
НМТ 100 cfu/gm |
less than 10 cfu/gm |
pathogens |
|
|
E.coli |
shall be absent |
absent |
сальмонелла |
shall be absent |
absent |
pseudomonas |
shall be absent |
absent |
staphylococcus |
shall be absent |
absent |
Заключение |
Квалифицированный |