Urokinase
CAS No. : 9039-53-6 (Plasminogen activator;fibrinolytic; enzyme)

Short Description:

Source: Extracted from fresh male urine
Function and use: Urokinase is a fibrinolytic drug, which can hydrolyze protein, has no antigenicity, and can directly activate plasminogen. This product is mainly used for the treatment of acute myocardial infarction, acute cerebral thrombosis, cerebral vascular occlusion, peripheral arteriovenous thrombosis, central retinal vein thrombosis and other infarct diseases caused by the formation of new blood clots.

Urokinase-Pharmacopoeia?Standard:?BP/EP/JP

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Product Detail

Product Tags

CAS No.: 9039-53-6
Complies with?CP2020,?USP43,?JP18, BP2022, EP10.0

Specification

Urokinase
Source			Fresh human urine
Process description			This product is an enzyme obtained from fresh human urine that activates plasminogen. It consists of a mixture of low-molecular-mass (LMM) (33 000) and high-molecular-mass (HMM) (54 000) forms.
Manufacturing requirements			This product should be extracted from healthy human urine. The production process should conform with the requirements of current version of Good Manufacturing Practice. This product should have virus safety control measures in the production process, and the process needs to be heated at 60℃?for 10 hours to inactivate the virus.
Pharmacopoeia standard			CP	EP/BP	JP
Character			White or almost white, amorphous powder.	white or almost white, amorphous powder.?Solube in water	Urokinase is a clear and colorless liquid. The pH is between 5.5 and 7.5.
Identification			Coagulate within 30~45 seconds, and the clot should re-dissolve within 15 minutes.	In both tubes, a clot forms and lyses within 30 min.	Lysis circle appears.
			The clot is insoluble within 2 hours	Carry out identifification by a suitable immunodiffusion test.	Stand for overnight: a clear precipitin line appears.
Tests	Appearance of solution		The solution is clear and colorless	The solution is clear and colorless	Clear and colorless liquid
	Hepatitis B surface antigen		Negative（10mg/ml）	Negative	_________
	Purity	(1)Heavy metals	_________	_________	Not more than 10ppm
		(2)Blood group substances	_________	_________	The agglutination is equal in both lanes.
	Loss on drying		≤5.0% (dry at 60°C under reduced pressure to constant weight)	_________	_________
	Thromboplastic contaminants		Not less than 150 IU/mL.	Not less than 150 IU/mL.	_________
	Molecular fractions.		_________	Not less than 2.0	_________
	High-molecular mass Urokinase (SDS-PAGE)		Not less than 90%	_________	_________
	High-molecular mass Urokinase (HPLC)		Not less than?85 %	_________	Not less than 0.85
	Total protein		_________	Conform with regulations	_________
	Abnormal toxicity		Conform with?regulations（5 000 IU/ml）	_________	Conform with regulations
	Pyrogens		_________	Equivalent to 20 000 IU/mL.	_________
	Bacterial Endotoxin		≤1.0 EU/10000?units	_________	_________
Potency	Assay		_________	_________	Not less than 60000IU/mL
	Specific activity		Not less than 120000IU/mg.pr	Not less than 70000IU/mg.pr	Not less than 120000IU/mg.pr
Microbial limit	TAMC		≤10³CFU/g	≤10³CFU/g	≤10³CFU/g
	TYMC		≤10²CFU/g	≤10²CFU/g	≤10²CFU/g
	Escherichia coli		Should not be detected（10mg/ml）	Should not be detected	Should not be detected
Virus	Hbs Ag		Should be negative（10mg/ml）	Should be negative	Should be negative
	HCV antibodies		_________	Should be negative	Should be negative
	HIV I+II		_________	Should be negative	Should be negative
Storage			Store in an airtight container, protected from light, at a temperature not exceeding 10°C.	Store in an airtight container, protected from light, at a temperature not exceeding 8 °C.	Containers—Tight containers.Storage—Not exceeding －20°C.
Preparation			Urokinase for injection
Category			Thrombolytic drugs