Buy USP Tacrolimus Immunosuppressive Drug lower organ rejection risk Online CAS 104987-11-3
Tacrolimus Specification
Product Name: Tacrolimus
CAS: 104987-11-3
Standard: USP
Level: Pharmaceutical grade
Content: 99%
Packing: 10G/Aluminum foil bag
Ingredients: Tacrolimus 99%
Physicochemical properties: white powder
Category: Pharmaceutical Raw Materials
Industry: Pharmaceuticals
Field: Antibiotics
Deferred products: macrolide antibiotics.
Use: macrolide antibiotics. Immunosuppressive agents. The mechanism of action is the same as that of cyclosporine, which is mainly to inhibit the synthesis of interleukin-2. Rejection for organ transplantation.
Tacrolimus Description and application
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 Certificate of Analysis
| Product name |
Tacrolimus |
| CAS No. |
104987-11-3 |
Outer Packing |
50g/bag |
| Production date |
Apr-2018 |
Shelf life |
Mar-2023 |
| Standard adopted |
USP |
| Items of analysis |
Specification |
Results |
| Description |
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 in 10 in water,and 1 in 10 in chloroform shall be practically clear and shows not more than a light yellow colour. |
clear and colourless |
| Identification |
|
|
| 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 |
| pH(1 in 20 solution) |
between 4.0 and 5.0 |
4.60 |
| loss on drying |
NMT 0.5% |
0.20% |
| residue on ignition |
NMT 0.1% |
0.03% |
| bacterial endotoxin |
NMT 6.9 EU/mg |
less than 6.9 EU/mg |
| related substances |
|
|
| single impurity |
NMT 1.0% |
less than 1.0% |
| sum of impurities |
NMT 2.0% |
less than 2.0% |
| assay |
97.0%-101.5% |
99.9% |
| residual solvents |
|
|
| O-xylene |
ICH limit:2170 ppm |
1321 ppm |
| isopropyl alcohol |
ICH limit:5000 ppm |
969 ppm |
| microbial limits |
|
|
| total bacterial count |
NMT 1000 cfu/gm |
35 cfu/gm |
| total fungal count |
NMT 100 cfu/gm |
less than 10 cfu/gm |
| pathogens |
|
|
| E.coli |
shall be absent |
absent |
| Salmonella |
shall be absent |
absent |
| pseudomonas |
shall be absent |
absent |
| staphylococcus |
shall be absent |
absent |
| Conclusion |
Qualified |
Tacrolimus Side Effects
Stinging, burning, soreness, or itching in the area of treated skin may occur during the first few days of treatment. Headache, acne, “hair bumps” (folliculitis), stomach upset, flu-like symptoms (e.g., fever, chills, runny nose, sore throat, muscle aches), or increased sensitivity of the skin to hot/cold/pain/touch may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
