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OEM/ODM China Niacinamide 98-92-0 - Tacrolimus monohydrate 109581-93-3 Antibiotic – Neore

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OEM/ODM China Niacinamide 98-92-0 - Tacrolimus monohydrate 109581-93-3 Antibiotic – Neore Detail:

Payment: T/T, L/C
Product Origin: China
Shipping Port: Beijing/Shanghai/Hangzhou
Production capacity: 1kg/month
Order(MOQ): 1g
Lead Time: 3 Working Days
Storage condition: Stored in cool, dry place, room temperature.
Package material: vial, bottle
Package size: 1g/vial, 5/vial, 10g/vial, 50g/bottle, 500g/bottle
Safety information:  UN 2811 6.1/PG 3

Tacrolimus monohydrate

Introduction

Tacrolimus, is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate. To lower the risk of organ rejection, tacrolimus is given. The drug can also be sold as a topical medication in the treatment of T-cell-mediated diseases such as eczema and psoriasis. It can be used to treat dry eye syndrome in cats and dogs.

Tacrolimus inhibits calcineurin, which is involved in the production of interleukin-2, a molecule that promotes the development and proliferation of T cells, as part of the body’s learned (or adaptive) immune response.

Specification (USP43)

Item

Specification

Appearance

White or almost white crystalline powder

Identification

IR, HPLC

Solubility

Very soluble in methanol, freely soluble in N,N dimethylformamide and in alcohol, practically in soluble in water.

Residue on ignition

≤0.10 %

Organic impurities

 (procedure-2)

Ascomycin 19-epimer ≤0.10 %

Ascomycin ≤0.50 %

Desmethyl tacrolimus ≤0.10 %

Tacrolimus 8-epimer ≤0.15 %

Tacrolimus 8-propyl analog ≤0.15 %

Unknown impurity -I ≤0.10 %

Unknown impurity -II ≤0.10 %

Unknown impurity -III ≤0.10 %

Total impurities ≤1.00 %

Optical rotation (on as is basis)

 (10mg/ml in N,Ndimethylformamide)

-110.0° ~ -115.0°

Water content (by KF)

≤4.0%

Residual solvents (by GC)

Acetone ≤1000ppm (In-house)

Di-isopropyl ether ≤100ppm (In-house)

Ethyl ether ≤5000ppm

Acetonitrile ≤410ppm

Toluene ≤890ppm

Hexane ≤290ppm

Microbial test (in house)

Total aerobic microbial count ≤100cfu/gm

Total yeast and mould count ≤10cfu/gm

Specified organisms (Pathogens) (E.coil, salmonella sps., S.aureus. Pseudomonas aeruginosa) should absent

Assay (by HPLC) (on anhydrous and solvent free basis)

98%~102%


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Our firm promises all consumers with the first-class products as well as most satisfying post-sale services. We warmly welcome our regular and new consumers to join us for OEM/ODM China Niacinamide 98-92-0 - Tacrolimus monohydrate 109581-93-3 Antibiotic – Neore , The product will supply to all over the world, such as: New Zealand, Ethiopia, Argentina, Upon today, we have customers from all over the world, including USA, Russia, Spain, Italy, Singapore, Malaysia, Thailand, Poland, Iran and Iraq. The mission of our company is to provide the highest quality products with best price. We are looking forward to doing business with you!
  • This enterprise in the industry is strong and competitive, advancing with the times and develop sustainable, we are very pleased to have a opportunity to cooperate!
    5 Stars By Doris from Qatar - 2017.11.20 15:58
    Speaking of this cooperation with the Chinese manufacturer, I just want to say"well dodne", we are very satisfied.
    5 Stars By May from Tunisia - 2018.11.04 10:32