Bivalirudin Powder Cas No.128270-60-0
Product Source: Synthetic
Product content: ≥ 98%
CAS Number: 128270-60-0
Detection Method: HPLC
Active Ingredient: Cetrorelix Acetate
Product shape: White to off white
Product Mesh: 80-120 mesh
Product Uses: Assisted reproductive technology (ART), gynecological disease treatment, research purposes
Product Packaging: Lyophilized powder: Usually packaged in glass ampoules or aluminum foil bags, with the capacity of each bottle/bag customized according to requirements (such as 1mg, 5mg, 10mg, etc.)
Liquid form: Requires sterile injection vials or vials, with solvent packaged separately
Product Storage: Usually stored in a light-proof, sealed environment at 2-8°C.
Shelf Life: When unopened and stored at 2-8°C in a light-proof manner, the shelf life is typically 2-3 years.
Products Description
High-Quality, High-Purity Bivalirudin Powder
Our bivalirudin powder is characterized by high purity and superior quality, strictly adhering to international pharmaceutical manufacturing standards. Its purity is validated through HPLC (High Performance Liquid Chromatography) and mass spectrometry analysis, meeting the requirements of USP/NF, EP, and ChP pharmacopoeias.
Our product delivers consistent batch-to-batch quality, stringent impurity control (total impurities <0.1%), and cGMP-compliant manufacturing processes, meeting the high standards demanded by global pharmaceutical companies and healthcare institutions.
Pharmacological Effects
Direct thrombin inhibition: Potently inhibits both free and fibrin-bound thrombin (Factor IIa), blocking fibrinogen conversion to fibrin and suppressing platelet activation/aggregation.
Reversible and short-acting effects: Half-life ≈25 min (normal renal function); rapid restoration of coagulation post-discontinuation.
ATIII-independent mechanism: Efficacy unaffected by antithrombin III levels.
Mechanism of Action
Bivalirudin binds thrombin via dual-site interaction:
Catalytic site: Blocks substrate (e.g., fibrinogen) cleavage.
Anion-binding exosite I: Enhances affinity, stabilizing the inhibitor complex.
Self-limiting property: Thrombin partially cleaves bivalirudin's N-terminus, reducing over-anticoagulation risk.
Intended Use
|
Patient Population/Scenario |
Clinical Value |
|
PCI patients |
Heparin alternative, especially for HIT-suspected/confirmed cases; reduces bleeding risk. |
|
Acute Coronary Syndrome (ACS) |
Adjunct to antiplatelet therapy (aspirin/clopidogrel) in UA/NSTEMI. |
|
ECMO anticoagulation |
↓ Mortality (OR=0.74) and ↓ thrombotic events (OR=0.52) vs. heparin; ↑ weaning success. |
|
High-bleeding-risk patients |
↓ Intracranial hemorrhage (absolute risk reduction 4.9%) in elderly/renal impairment. |
Efficacy & Key Applications
PCI/ACS:
↓ Major bleeding by 28% vs. heparin ± GPI (P=0.001; HORIZONS-AMI trial).
Acute stent thrombosis risk marginally ↑ (P<0.0001), modifiable via prolonged infusion.
ECMO:
↓ Mortality by 26% (OR=0.74) and ↑ successful decannulation by 87% (OR=1.87).
Renal impairment: Safe with dose adjustment (avoid if CrCl <30 mL/min).
Clinical Advantages Summary
|
Parameter |
Bivalirudin |
Heparin |
|
Bleeding risk |
Significantly lower |
Higher |
|
HIT risk |
None (safe for HIT patients) |
Requires monitoring |
|
Anticoagulation control |
Short half-life; rapid reversal |
Variable response; protamine reversal |
|
Thrombin inhibition |
Free + fibrin-bound thrombin |
Free thrombin only |
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