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

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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