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In clinical diagnosis and treatment, there are many specific scenarios that require precise regulation of blood coagulation status. Among them, some operations have strong and strict requirements for inhibiting blood clot formation due to their own characteristics. Such operations often require strong adaptability, clear mechanism of action, controllable effect, and low stimulation of the body to provide auxiliary support. Bivalirudin Injection, with its unique characteristics of action, has become one of the preferred solutions in such scenarios.
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Bivalirudin COA
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| Certificate of Analysis | ||
| Compound name | Bivalirudin | |
| Grade | Pharmaceutical grade | |
| CAS No. | 128270-60-0 | |
| Quantity | 38g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090086 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.54% |
| Loss on drying | ≤1.0% | 0.42% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.98% |
| Single impurity | <0.8% | 0.52% |
| Total microbial count | ≤750cfu/g | 95 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 500ppm |
| Storage | Store in a sealed, dark, and dry place below -20°C | |
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| Chemical Formula | C98H138N24O33 |
| Exact Mass | 2178.99 |
| Molecular Weight | 2180.32 |
| m/z | 2179.99 (100.0%), 2178.99 (94.3%), 2180.99 (40.3%), 2182.00 (17.5%), 2180.99 (12.1%), 2180.99 (8.9%), 2179.98 (8.4%), 2181.99 (6.8%), 2180.99 (6.4%), 2181.99 (4.7%), 2183.00 (4.6%), 2183.00 (2.7%), 2181.00 (1.6%), 2179.99 (1.5%), 2180.99 (1.3%), 2179.99 (1.2%), 2184.00 (1.2%) |
| Elemental Analysis | C, 53.99; H, 6.38; N, 15.42; O, 24.22 |

Specifically, its standardized application in some peripheral vascular related operations and blood purification processes (mainly hemodialysis) not only precisely meets the core demand for effective inhibition of blood coagulation in such operations, but also ensures the stable performance of inhibition effects while considering the safety of the operation process and the patient's tolerance, effectively avoiding various adverse complications caused by improper inhibition of blood coagulation. To further clarify its application logic and value in the above scenarios, the following will focus on these two core scenarios and conduct specific analysis from multiple dimensions, focusing on their application details, adaptation points, and clinical core values.

Application in peripheral vascular related operations
In peripheral vascular related operations, the establishment of vascular pathways, treatment of diseased blood vessels, and other processes can easily induce blood clot aggregation, which can affect the effectiveness of the operation and even lead to poor prognosis. Therefore, it is necessary to use potent and mild blood clotting inhibitors to provide support. The selection of Bivalirudin Injection in such scenarios has clear targeting and advantages, which can be carried out from the following aspects:

Applicable operation types:
Not all peripheral vascular operations require the use of this preparation. Its core is suitable for scenarios with high coagulation tendency or high operational complexity, such as abdominal aortic aneurysm repair surgery, mesenteric vascular disease vascular reconstruction surgery, and lower limb arterial sclerosis and occlusion related vascular reconstruction surgery. In such operations, the range of vascular damage is large, the operation duration is relatively long, and the hidden danger of blood clot formation is significantly increased. Effective intervention to inhibit blood coagulation is needed to ensure smooth operation. In addition, for some intervention procedures related to peripheral venous thrombosis, this preparation can also be used as an adjuvant when the conventional blood coagulation inhibition regimen is ineffective.
The core logic of selection:
This is chosen for this type of operation, and its mode of action is in line with the operational requirements. Compared with traditional methods of inhibiting blood coagulation, it does not rely on the body's own coagulation regulating substances and can directly act on the key link of blood clot formation, achieving rapid, stable and strong inhibitory effects. It can effectively avoid problems such as vascular pathway blockage and aggravated thrombus in the lesion area caused by blood coagulation during the operation process, and reduce the adverse effects caused by excessive or insufficient inhibitory effects, while balancing effectiveness and safety.


Advantages of practical application:
In clinical practice, the use of this preparation for peripheral vascular operations can significantly reduce the incidence of bleeding complications at the operating site, especially the probability of local hematoma, compared to other blood coagulation inhibition schemes. At the same time, it can shorten the length of hospital observation after surgery and improve the recovery efficiency of patients. This advantage has been verified in multi center clinical observations, especially for patients who have poor tolerance or contraindications to traditional blood coagulation inhibition preparations.
Data information source:
Application in hemodialysis
As an important blood purification method in clinical practice, hemodialysis relies on the extracorporeal circulation system to remove metabolic waste from the blood.

Applicable dialysis scenarios
Its selection is mainly focused on two types of hemodialysis patients. One type is patients who have contraindications to the use of conventional blood clotting inhibitors, such as those who are allergic to traditional preparations and experience abnormal platelet count reduction after use. Bivalirudin Injection can be used as an alternative to ensure smooth dialysis; Another type is patients who experience repeated clotting in the dialysis process. These patients have a strong tendency to clot and conventional methods of inhibiting blood clotting are difficult to achieve ideal results. Choosing this preparation can achieve more potent and stable inhibitory effects, reducing the frequency of tube blockages.
Selected core advantages
The core advantage of using Bivalirudin Injection for hemodialysis lies in its controllability and safety of action. The duration of action of this preparation is relatively short. After discontinuation, the blood coagulation function can quickly recover to normal levels, effectively reducing the risk of bleeding caused by residual inhibition of blood coagulation after dialysis. It is especially suitable for patients who need to compress the puncture site for hemostasis after dialysis, reducing the difficulty of hemostasis and potential bleeding hazards. At the same time, its effectiveness is not significantly affected by the metabolic status of patients, and the dosage can be flexibly adjusted according to the duration of dialysis to adapt to individual differences in different patients.


Key points for practical application
When using this preparation in hemodialysis, the dosage should be adjusted according to the individual situation of the patient, especially for patients who rely on dialysis for a long time. Due to the special metabolic functions of the body, the infusion rate should be appropriately reduced to avoid adverse reactions caused by excessive dosage. At the same time, it is necessary to closely observe the patient's vital signs and the status of the tubing during dialysis, monitor blood coagulation related indicators in a timely manner, ensure that the inhibition of blood coagulation is within the ideal range, avoid tubing coagulation, and prevent abnormal bleeding caused by excessive inhibition.
Data information source:
Wang Yan, Li Juan Observation of clinical application of bivalirudin in hemodialysis patients [J]. Chinese Journal of Blood Purification, 2020, 19 (5): 345-347
Olmedo W, Villablanca P, Weinreich M, et al. Bivalirudin versus Heparin in Patients Undergoing Percutaneous Peripheral Interventions: A Systematic Review and Meta-analysis[J]. J Am Coll Cardiol, 2017, 70(18 Suppl): B298.
References
Zhang Min, Liu Yong Analysis of the application effect of bivalirudin peripheral vascular intervention therapy [J]. Chinese Journal of Practical Surgery, 2018, 38 (S1): 123-125
Tsu LV, Dager WE. Bivalirudin dosing adjustments for reduced renal function with or without hemodialysis in the management of heparin-induced thrombocytopenia[J]. Ann Pharmacother, 2011, 45(10): 1185-1192.
Liu Min, Zhao Jing The application value of bivalirudin in hemodialysis patients with hypercoagulability tendency [J]. Journal of Clinical Nephrology, 2021, 21 (7): 589-592
Vascular Surgery Group of the Surgery Branch of the Chinese Medical Association Guidelines for Diagnosis and Treatment of Lower Limb Arteriosclerosis Occlusion (Part 1) [J]. Chinese Journal of Vascular Surgery (Electronic Edition), 2015, 7 (3): 145-151
Kiser TH, et al. Safety, efficacy and dosing requirements of bivalirudin in patients with heparin-induced thrombocytopenia[J]. Pharmacotherapy, 2008, 28(9): 1115-1124.
FAQ
- What is the difference between bivalirudin and heparin?
Heparin is the primary choice for antithrombotic treatment. In contrast, bivalirudin is a new direct thrombin inhibitor that has been reported to have antiischemic properties and a lower risk of bleeding during PCI.
- How long does it last?
The half-life of Bivalirudin in patients with normal renal function is 25 minutes. In moderate and severe renal impairment, clearance is reduced by 21%, with corresponding half-lives of 34 and 57 minutes, respectively. In dialysis patients, clearance is diminished by 70% with a half-life of 3.5 hours.
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