High Quality Peptide API 99% CAS 128270-60-0 Bivalirudin Powder

Details:

 CAS 128270-60-0 Bivalirudin

Product Name	Bivalirudin Trifluoroacetate
Cas No.	128270-60-0
Molecular Formula	C98H138N24O33
Molecular Weight	2180.33
Purity (HPLC)	99.0%min.
Appearance	White powder
Single Impurity (HPLC)	0.5%max
Amino Acid Composition	±10% of theoretical
Peptide Content (N%)	≥80.0%
Water Content (Karl Fischer)	≤8.0%
Acetate Content (HPIC)	≤12.0%
MS (ESI)	Consistent
Mass Balance	95.0~105.0%

Bivalirudin has a inhibitory effect on soluble and thrombus-bound thrombin in vitro. That effect cannot be affected by

products that are released by platelet, and it can extend plasma activated partial thromboplastin time, thrombin time

and prothrombin time of normal human with a dose-dependent manner. It is suitable for percutaneous coronary

intervention (PCI) unstable angina. In 2010, domestic PCI operation cases reached 300,000. The annual compound

growth rate was over 30%. This showed that sales prospects of bivalirudin after the listing are considerable.

 

Bivalirudin is a DTI that overcomes many limitations seen with indirect thrombin inhibitors, such as heparin. Bivalirudin

is a short, synthetic peptide that is potent, highly specific, and a reversible inhibitor of thrombin.It inhibits both

circulating and clot-bound thrombin,while also inhibiting thrombin-mediated platelet activation and aggregation.

Bivalirudin has a quick onset of action and a short half-life.It does not bind to plasma proteins (other than thrombin)

or to red blood cells. Therefore it has a predictable antithrombotic response. There is no risk for Heparin Induced

Thrombocytopenia/Heparin Induced Thrombosis-Thrombocytopenia Syndrome (HIT/HITTS).It does not require a

binding cofactor such as antithrombin and does not activate platelets.These characteristics make bivalirudin an ideal

alternative to heparin.

Application & Function 

Bivalirudin is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal

coronary angioplasty (PTCA). Bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) is indicated for use as

an anticoagulant in patients undergoing percutaneous coronary intervention (PCI). Bivalirudin is indicated for patients

with, or at risk of HIT/HITTS undergoing PCI. Bivalirudin is intended for use with aspirin and has been studied only in

patients receiving concomitant aspirin.

 

Clinically experiments prove that bivalirudin is more effective than the current mainstream unfractionated heparin/low

molecular weight heparin and platelet glycoprotein receptor antagonist in applications around PCI.

Especially the risk of bleeding has a significant reduction, and the use safety of anticoagulants is greatly improved: 

1. It can significantly reduce the incidence of bleeding in elective PCI patients. The total clinical outcome risk fell 14%.
2. It does not cause antibody-mediated thrombocytopenia.
3. Reversibly bind with thrombin. Short half-life. Hard to develop ischemic and hemorrhagic complications. 
4. It is not mainly excreted through the kidneys and can be safely used in patients with renal impairment. 

test	specification		results
1. characteristic	white or almost white powder.		white powder
2. identification a. hplc	retention time conforms to that of the reference standard		conforms
b. amino acids	asp: 0.90-1.10;glu: 0.90-1.10 pro: 0.90-1.10;gly: 0.90-1.10 leu: 0.90-1.10;tyr: 0.7-1.05 half-cys: 1.4-2.1;ile: 0.90-1.10		conforms
3. ph	3.0-6.0		5.0
4. related substances (hplc)	impurity a≤1.5%		0.15%
	impurity b≤1.5%		0.20%
	impurity c≤1.5%		not detected
	other single impurity≤0.5%		0.13%
	total impurities≤5.0%		0.7%
5. acetic acid (hplc)	6.0%-10.0%		7.1%
6. water(kf)	nmt 5.0%		1.4%
7. bacterial endotoxins	less than 300 iu/mg		conforms
8. acn(gc)	not more than 0.041%		conforms
9. meoh(gc)	not more than 0.3%		conforms
10. triethylamine(gc)	not more than 0.032%		conforms
11. assay calculated with reference toanhydrous,aceticacid free substance	93.0%-102.0%		98.8%
on powder	nlt 80.0 %		90.4%
	nlt 480 iu/mg		542iu/mg

 

 

1. All inquiries will be replied within 12 hours.

2. Dedication to quality, supply & service.

3. Strictly on selecting raw materials.

4. OEM/ODM Available.

5. Reasonable & competitive price, fast lead time.

6. Sample is available for your evaluation & Formulation development.

7. Faster delivery:Sample order in stock and 3-7 days for bulk production.

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9. After-Sale Service:
1) International Authorized Third-Party Test For The Products You Demand.

2) 30 Days Warranty of quality of goods. 

 

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Julong Bio-Tech Co., Ltd. is located in Xi'an City, Shaanxi Province, China. It is a biotechnology enterprise engaged

in the research, development, production and sales of animal and plant extracts, cosmetics, pharmaceutical raw materials

and intermediates. The company has complete experimental facilities. And advanced testing instruments ensure the stability

of product quality from all aspects. The company has a complete sales service system, the products are exported to countries

all over the world, and have won a good international reputation with excellent quality and excellent service.

The company has been adhering to the basic principles of "integrity, quality, service, and win-win" to serve customers,

constantly strict requirements, set goals, and implement win-win development.

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