Business Type:Trading Company
Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Trading Company
CAS NO.104987-11-3
Enterprise standard(1-10)GramEnterprise standard(11-100)Gram
99% Puirty pharmaceutical material API Tacrolimus for anti inflamatory
Synonym |
prograf; tsukubaenolide |
CAS NO |
104987-11-3 |
MF |
C44H69NO12 |
MW |
804.02 |
Purity |
99% |
Appearance |
White powder |
Melting point |
113-115° C |
Certification |
ISO 9001, USP, SGS |
Standard |
Enterprise standard |
Usage |
treatment of Cushing's syndrome |
Packing |
Discreet packing ways as your requirement, 100% go through. |
Storage |
Store in a cool, dry place. Do not store in direct sunlight. Store in a tightly closed container. |
Usage:
Tacrolimus is used to prevent rejection of organ transplants.
Tacrolimus is 10 to 100 times superior to cyclosporin in improving graft survival and preventing acute rejection
after transplantation, but decreasing the toxin side effects.
Tacrolimus is an Anti-rejection in organ transplantation.
Tacrolimus is can treat skin diseases. like atopic dermatitis (AD), systemic lupus erythematosus (SLE),autoimmune
eye disease and other autoimmune diseases.
Description:
Tacrolimus (also FK-506 or fujimycin, trade names Prograf, Advagraf, Protopic) 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.
Application:
L Immunosuppression following transplantation It has similar immunosuppressive properties to ciclosporin, but is
much more potent. Immunosuppression with tacrolimus was associated with a significantly lower rate of acute
rejection compared with ciclosporin-based immunosuppression (30.7% vs 46.4%) in one study. Clinical outcome
is better with tacrolimus than with ciclosporin during the first year of liver transplantation. Long term outcome has
not been improved to the same extent. Tacrolimus is normally prescribed as part of a post-transplant cocktail
including steroids, mycophenolate and IL-2 receptor inhibitors. Dosages are titrated to target blood levels.
Typical starting doses for once daily tacrolimus are 0.15-0.20 mg/kg body weight.
COA:
Tests |
Specifications |
Results |
Description |
A white or off-white crystalline powder |
Conform |
Identification |
1. IR (USP <197K>) |
Conform |
2. HPLC retention times |
Conform |
|
Water (USP <921> Method I) |
1.6 ~ 3.0% |
2.1% |
Residue on ignition (USP <281>) |
<0.2% |
0.08% |
Heavy metals (USP <231> II) |
<20 ppm |
<20 ppm |
Related substances (Inhouse HPLC method) |
Ascomycin £ 0.8% |
0.064% |
Residual solvents(Inhouse method) |
Acetone £ 2000 ppm |
Not detected |
Assay (on anhydrous basis) |
98.0% ~ 102.0% |
100.0% |
Conclusion |
Complied with In-House standard |