API Tacrolimus, CAS104987-11-3, GMP/DMF manufacturer

Basic Info

Model No.: LYN- 104987-11-3

CAS: 104987-11-3

Name:: Tacrolimus Monohydrate

Shelf Life: 2 Years

Sample: Available

Additional Info

Packaging:  25kg/Drum

Productivity: 10000kg

Brand: zhishang

Transportation: Ocean,Land,Air

Place of Origin: Shandong, China (Mainland)

Supply Ability: in stock

Certificate: ISO CE

HS Code: 1060.24000

Port: Shanghai,Tianjin,Qingdao

Product Description

API Tacrolimus, CAS104987-11-3, GMP/DMF manufacturer 

Introduction:

 

Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis.  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.

Certificate of Analysis for Tacrolimus :

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 (In-house HPLC method)

Ascomycin £ 0.8%

0.064%

 

Dihydrotacrolimus £ 0.6%

0.089%

 

Total impurities £ 1.5%

0.15%

Residual solvents 

(In-house method)

Acetone £ 2000 ppm

Not detected

 

Ethanol £ 2000 ppm

Not detected

Assay (on anhydrous basis)

98.0% ~ 102.0%

100.0%

Conclusion: Complied with In-House standard

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