Bupivacaine Powder Cas No.2180-92-9
Product source: Preparation by condensation reaction of piperidine ring and aromatic amine compounds through artificial chemical synthesis
Content specification: ≥ 99.0%
CAS NO：2180-92-9
Chemical molecule: C ₁₈ H ₂₈ N ₂ O (molecular formula)
Detection method: HPLC (USP/UP)
Mechanism of action: By blocking the sodium channels on the nerve cell membrane, it inhibits the generation and conduction of nerve impulses, thereby exerting local anesthetic effects. It belongs to amide-type long-acting local anesthetics.
Active ingredients: Bupivacaine
Product mesh size: 100-120 mesh
Product Description: White or off white crystalline powder
Product use: Bupivacaine Powder is mainly used in the field of local anesthesia in medicine
Product packaging: 1KG in aluminum foil bag; 25KG/drum
Product storage: Store in a dry and cool place, avoiding sunlight and high temperature
Shelf life: 24 months
Products Description
Xi'an Tihealth high-purity Bupivacaine Powder raw material
Bupivacaine Powder is a long-acting amide-type local anesthetic, widely used in clinical practice for regional and local anesthesia due to its potent and prolonged pain-blocking effects. First synthesized in the 1950s and approved for medical use in the 1960s, it belongs to the same class as lidocaine and ropivacaine but stands out for its extended duration of action-making it a preferred choice for procedures requiring long-lasting pain control. Chemically, it has a molecular formula of C18H28N2O, with a structure featuring an aromatic ring, an amide linkage, and a tertiary amine group-this amide structure contributes to its stability (resistant to hydrolysis) and low risk of allergic reactions compared to ester-type local anesthetics (e.g., procaine).
Products Advantages
Competitive advantage
The high-purity Bupivacaine Powder raw material products of Xi'an Tihealth Biotechnology Co., Ltd. provide safe and reliable raw material guarantees for the fields of medicine, cosmetics, etc. with the following core advantages that have been verified by authorities:
Quality and accuracy surpass industry limits
01
Full scenario compliance certification system
02
Cutting edge production technology ensures stability
03
Transparent traceability and zero error production
04
The terminal value of cost reduction and efficiency improvement
05
Tihealth Bupivacaine Powder defines quality with data--Make every gram of raw material withstand dual scrutiny from electron microscopy and global drug regulatory agencies.
Products COA
Certificate of Analysis
| Product Name | Bupivacaine Powder | Batch No. | TH20250305 |
|---|---|---|---|
| Production date | 2025-03-05 | Expiry Date | 2027-03-02 |
| Test Item | Result/Specification | Acceptance Criteria | Reference Standard |
| Appearance | White crystalline powder | - | EP 2.2.1 |
| Solubility (H₂O, 25°C) | ≥50mg/mL | - | EP 2.9.1 |
| pH (5% solution) | 4.5–5.5 | 4.0–6.5 | EP 2.2.3 |
| Crystal Form | Type I polymorph | Consistent | XRD (USP 〈941〉) |
| Assay (HPLC) | 99.97% | ≥99.95% | EP 2.2.29 |
| Largest Unknown Impurity | 0.018% | ≤0.10% | EP 2.2.46 |
| Total Impurities | 0.028% | ≤0.30% | EP 2.2.46 |
| Residual Solvent (DMF) | <1ppm (N.D.) | ≤880ppm (ICH Q3C) | GC-MS (EP 2.2.28) |
| Heavy Metals (Pb, As, etc.) | 0.8ppm | ≤1.0ppm | ICP-MS (EP 2.4.20) |
| Bacterial Endotoxins | <0.05 EU/mg | ≤0.083 EU/mg | EP 2.6.14 |
| Hemolysis Rate (0.6% sol.) | 0.55% | ≤0.6% (ChP ≤5%) | ChP 2020 |
| Micronucleus Test | Negative | Negative | OECD 474 |
| Sterility Test | Complies | - | EP 2.6.1 |
| Accelerated (40°C/6M) | Purity loss ≤0.05% | - | ICH Q1A(R2) |
| Long-term (25°C/24M) | Total impurities ≤0.35% | - | ICH Q1A(R2) |
| Transport Condition | -20°C Dedicated Cold Chain | Crystal structure protection | ISO 15378 |
| Certification | China GMP 2025, ISO 13485:2016 | - | FDA DMF No. 033779 |
| Traceability | Online audit via QR code | Real-time data access | TKYBIO Cloud Platform |
Products Function
A systematic summary of the health benefits of Bupivacaine Powder (including liposomal formulations) based on clinical research data, strictly based on authoritative literature and drug application evidence:
1, Long term analgesia, optimizing postoperative recovery
2, Significantly reduce opioid dependence and side effects
3, Improve perioperative safety
4, Accelerate recovery and improve long-term prognosis
Summary
The core clinical value of Bupivacaine Powder (especially liposomal formulations) lies in:
✅ Long acting analgesia (72 hour sustained release)
✅ Opioid reduction (dosage reduction of 61-78%)
✅ Safety improvement (nausea risk ↓ 46%, toxicity controllable)
✅ Accelerated rehabilitation (shortened hospitalization+optimized functional recovery)
Its benefits have become a key component of multimodal analgesia in scenarios such as peripheral nerve block, joint replacement, and oral surgery.
Products Application
The core applications of Tihealth high-purity Bupivacaine Powder cover:
✅ Surgical anesthesia
Nerve block/spinal anesthesia
✅ Postoperative analgesia
Ultra long acting needs such as joint replacement, thoracic surgery, etc.
✅Chronic pain
Cancer pain, Neuropathic pain
✅ High end cosmetics
Transdermal analgesics
Clinical Applications of Bupivacaine Powder Types
| Application Scenario | Bupivacaine Powder Type | Key Advantages |
|---|---|---|
| Post-arthroplasty analgesia | Liposomal Bupivacaine Powder | 72h sustained analgesia, ↓78% opioid use |
| Epidural anesthesia for labor | Standard Bupivacaine Powder | Motor-sensory dissociation, no labor delay |
| Topical skin anesthesia | Cosmetic-grade (HL-B01 batch) | Non-carcinogenic, safe transdermal absorption |
| Chronic neuropathic pain | Liposomal + standard mixture | Prolonged block interval (4–6 weeks) |
Production Packaging
Payment Methods
Delivery methods
Products FAQ
Q: What are the common side effects of using bupivacaine? Serious?
A: Common side effects include nausea, vomiting, constipation (with an incidence rate of about 10% to 15%), and a small number of people may experience fever or redness and swelling at the injection site. Most reactions are mild and can self alleviate without special treatment. Serious side effects, such as arrhythmia and difficulty breathing, are rare but require immediate medical attention.
Q: I heard that bupivacaine has cardiac toxicity, is it true?
A: Yes, the cardiac toxicity of bupivacaine is four times that of lidocaine, but the risk is significant only when used excessively or accidentally in blood vessels. Under clinical standard dosage (single dose ≤ 200mg), the blood drug concentration is far below the toxicity threshold, and the safety is controllable. Doctors will strictly monitor the dosage and provide emergency measures.
Q: How long can an injection of bupivacaine last? Is it stronger than regular anesthesia?
A: Regular bupivacaine: lasting 2-8 hours (such as anesthesia for tooth extraction and minor surgery);
Liposome preparation: Continuous analgesia for 72 hours through sustained-release technology (suitable for major surgeries such as joint replacement). The action time is 2-3 times that of lidocaine, which can reduce the need for repeated injections.
Q: Can it be used during pregnancy/lactation? Will it affect the fetus?
Available: 0.25% low concentration solution is recommended for delivery epidural anesthesia, with low placental permeability and validated safety;
Prohibited: 0.75% high concentration is prohibited during delivery (risk of cardiac arrest);
Breastfeeding period: A small amount of breast milk enters, but the risk is low and needs to be evaluated by a doctor.
Q: Can pediatric surgery be used? What about the elderly?
Children aged ≥ 12 years: Liposomal bupivacaine (dose 4mg/kg) can be used;
Elderly: Need to reduce dosage, as slow metabolism may lead to accumulation;
Attention should be paid to: use with caution for those with liver dysfunction, and use with caution for those with kidney dysfunction.
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