Factory supply APIs High purified and extraction from bovine lung Aprotinin

Product Description Appearance
Almost white powder, hygroscopic
Solubility
Soluble in water and 0.9% NaCl solution practically insoluble in organic solvents (5 mg / ml)
Clarity of solution
≤Ref . Ⅲ (15 Ph.Eur.U./ ml)
Absorbance
A ≤ 0.80 (absoption-max. : 277nm ± 2nm ; 3.0 Ph.Eur.U. / ml)
Identification
Positive
Aprotinin oligomers
Max. 1.0%
Pyroglutamyl-aprotinin and related compounds
Pyroglutamyl-aprotinin max. 1.0%
Any other impurity max. 0.5%
Sum of impurity other than pyroglutamyl-aprotinin max. 1%
Loss on drying
≤ 6.0 % (0.100 g , drying in vacuo)
Potency
≥3.0 Ph.Eur.U. /mg
PH
5.5-7.0
Endotoxin
≤ 0.14 EE / Ph.Eur.U.
Microbial Limit
TAMC : ≤ 102 CFU/g API
TYMC : ≤ 102 CFU/g API
escherobacteriaceae , Pseudomonas aeruginose and Staphylococcus aureus should be absent .
Abnormal toxicity
Non toxic at 2 Ph.Eur.U. / ml
Histamine
0.1 μg histamine base / 3 Ph.Eur.U.Foam box with ice-bagOur ServicesFree sampleCOA, DMF will be provided after receving your inquiryTechnical supportCompany Information
Ever since its establishment, our company has been successively judged the high-tech enterprises ,Nanchang science and technology model enterprises, Nanchang enzyme engineering technology research center from Jiangxi Provincial Governent and Nanchang Government. The products,such as Urokinase, Aprotinin, pancreatic kiniogenase, chorionic gonadotrophin, have been hornored as national important new products; The products, such as Aprotinin, pancreatic kiniogenase, menotrophin, have won several progress prizes in science and technology in Jiangxi province and Nanchang City. Since 2008, our company has been identified as high-tech enterprises in Jiangxi province.
Our main products is Urokinase, Aprotinin, (HCG)chorionic gonadotrophin, menotrophin, Ulinastatin, ox-gallpaste, which mainlyexportedtoEurope,America, Asiaandsoon.
Our company configured the equipments corresponding to production according to production requirements of biochemical API and GMP to select model. In addition, our company has established a set of complete and operable file system and DMF documents required by the exported state enterprise registration according to the requirments of the latest version EU GMP .
In order to expand production scale, in 2016 ,our company has launched a new plant construction (located in Jiahai industrial park, Tianxiang road of Nanchang high-tech development zone). Our company designs the new production workshop according to the standard of the European Union and China's new GMP.The new production workshop is due to formally put into production in 2018.