Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of 99.9% pure lidocaine powder cas 137-58-6 in China. Welcome to wholesale bulk high quality 99.9% pure lidocaine powder cas 137-58-6 for sale here from our factory. Good service and reasonable price are available.
Lidocaine, chemically designated as N-diethylaminoacetyl-2,6-xylidine, is most frequently utilized in its hydrochloride monohydrate form: N-(2,6-dimethylphenyl)-2-(diethylamino)acetamide hydrochloride monohydrate. As a premier supplier of high-purity active pharmaceutical ingredients, Bloomtechz offers 99.9% pure Lidocaine powder, a potent local anesthetic with extensive pharmaceutical and clinical applications.
Beyond its well-documented chemical reactivity, the physical properties of Lidocaine are critical determinants of its performance during formulation and application. Notably, its relatively high aqueous solubility-reaching 6g/L-ensures excellent bioavailability and ease of integration into various aqueous-based preparations, a key parameter for optimizing therapeutic efficacy in final dosage forms.
|
Morphological |
powder |
|
Acidity coefficient (PKA) |
PKA 7.88 (H2O) (approximate) |
|
Solubility ethanol |
4 mg / ml |
|
Storage condition |
store at RT |
|
Flash point |
9 ℃ |
|
Color |
white to slightly yellow |
Lidocaine COA
 |
||
| Certificate of Analysis | ||
| Compound name | Lidocaine | |
| Grade | Pharmaceutical grade | |
| CAS No. | 137-58-6 | |
| Quantity | 18g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090055 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |
|
|
| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.65% |
| Loss on drying | ≤1.0% | 0.53% |
| 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% | 99.52% |
| Single impurity | <0.8% | 0.63% |
| Total microbial count | ≤750cfu/g | 551 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 532ppm |
| Storage | Store in a sealed, dark, and dry place below 2-8°C | |
|
|
||
Quality & Compliance
Bloomtechz supplies lidocaine base under a pharmaceutical-grade quality control framework, suitable for formulation development, regulatory filing support, reference standard preparation and compliant trade. Each batch is released with a full COA, and TDS, MSDS/SDS, stability summaries and analytical method summaries can be provided upon request.
Pharmacopoeial Alignment and Release Specifications
The in-house specification for Bloomtechz lidocaine base is aligned with key limits in USP, EP and ChP for lidocaine and related salt forms. Routine release testing covers appearance, identification, assay, related substances, residual solvents, heavy metals/elemental impurities, water content, loss on ignition/ residue on ignition and microbial limits. Where customers target a specific pharmacopoeial market, Bloomtechz can provide a corresponding limit comparison table at the order confirmation stage.
Related Substances and Genotoxic Impurity Control
Bloomtechz controls key intermediates and potential impurities arising from the lidocaine synthesis route, with particular attention to structurally alerting impurities such as 2,6-dimethylaniline.
Related substances are monitored using a stability-indicating HPLC method capable of evaluating peak-to-impurity separation. Impurity profile documentation can be supplied on request.
ICH Compliance Support
Residual solvents: Process solvents are assessed under the ICH Q3C framework. Routine data for common solvents such as ethanol can be provided.
Elemental impurities: Pb, As, Hg, Cd and other relevant elements are controlled under the ICH Q3D framework, with expanded elemental panels available when required.
Nitrosamine risk: Bloomtechz can conduct an N-nitrosamine risk assessment for the lidocaine process and provide a risk statement or testing data according to customer requirements.
Stability and Retest Period
Bloomtechz can provide long-term and accelerated stability data summaries based on ICH Q1A/Q1B conditions to support internal evaluation, formulation compatibility studies and regulatory documentation. The retest period, packaging integrity and light-protection requirements are clearly stated in the TDS.
Polymorphism, Particle Size and Formulation Fit
For tablet, suspension, transdermal and injectable applications, Bloomtechz can provide polymorph information, particle size distribution, bulk/tapped density and flowability data. Where customers have specific requirements for particle size, dissolution behavior or filterability, batch matching and process confirmation can be arranged before commercial production.
Analytical Support and Spectral Library
Each batch is tested for assay and related substances by HPLC. IR, NMR, MS and other identification spectra can be provided as needed. Bloomtechz supports method comparison, retain-sample retesting and coordination with third-party laboratories.
Packaging, Traceability and Audit Support
Products are packed in light-protected, moisture-resistant and sealed containers. Each batch number is traceable to raw material charging, production records and QC records. Bloomtechz supports customer quality questionnaires, document package review and remote/on-site audit cooperation where applicable, helping maintain a complete and verifiable supply-chain documentation trail.
Manufacturing Process and Pre-Production Forms
The production of pharmaceutical-grade Lidocaine is a complex, multi-step organic synthesis process that requires rigorous control to ensure purity and safety. The synthesis typically begins with 2,6-dimethylaniline (2,6-xylidine) and chloroacetyl chloride.
Before the final crystallization, Lidocaine exists in various intermediate forms. The initial reaction between 2,6-xylidine and chloroacetyl chloride yields α-chloro-2,6-dimethylacetanilide. This intermediate is a solid that must be purified before proceeding to the next step. The subsequent reaction involves the condensation of this intermediate with diethylamine. This step is critical, as incomplete reaction can lead to residual starting materials or side products.
The crude Lidocaine base is then converted into its hydrochloride salt by treatment with hydrochloric acid. This salt formation is crucial for enhancing water solubility. The resulting solution undergoes a series of purification steps, including activated carbon treatment to remove colored impurities and organic solvents for recrystallization. The crystallization process is carefully controlled to manage particle size, which influences flowability and compressibility-key factors for downstream tableting or capsule filling.
For Lidocaine intended for injectable or ophthalmic use, sterility is non-negotiable. While the API itself is produced under strict GMP (Good Manufacturing Practice) conditions to minimize bioburden, terminal sterilization of the powder is often achieved through aseptic filtration of the solution prior to final crystallization or lyophilization, rather than irradiation or heat which could degrade the molecule. The manufacturing environment must maintain ISO Class 5 (Class 100) cleanliness standards during the final isolation and packaging stages to prevent microbial contamination.
Applications and Clinical Utility
The versatility of Pure Lidocaine Powder allows for its incorporation into a wide array of pharmaceutical formulations. Its primary mechanism of action involves the blockade of voltage-gated sodium channels in neuronal membranes, thereby inhibiting the initiation and conduction of nerve impulses.
Pharmaceutical Formulations
Injectables: Used for infiltration anesthesia, nerve blocks, and epidural anesthesia. The high purity ensures that the solution is clear and free from particulate matter that could cause emboli.
Topical Agents: Found in gels, creams, ointments, and sprays for mucosal anesthesia (e.g., during endoscopy or intubation) and dermal analgesia (e.g., for minor burns or insect bites).
Transdermal Patches: Lidocaine patches are widely used for the management of post-herpetic neuralgia. The API must possess specific physicochemical properties to ensure consistent flux through the skin over a prolonged period.
Antiarrhythmic Agent: In intravenous form, Lidocaine is a Class IB antiarrhythmic drug used to treat ventricular arrhythmias, particularly those associated with acute myocardial infarction.
Industrial and Research Applications:Beyond direct human use, high-purity Lidocaine is utilized in veterinary medicine and as a reference standard in analytical laboratories for the calibration of HPLC and GC-MS instruments.
The discovery of lidocaine is an important milestone in the field of anesthesiology, and its development process embodies the wisdom of scientists and the spirit of medical exploration.
Early exploration and chemical fundamentals
The discovery of lidocaine originated from the study of the chemical structure of the alkaloid gramine. When scientists were synthesizing the isomer of isogarmine, they found that it has a local anesthetic effect. This discovery prompted researchers to further synthesize similar compounds, and eventually lidocaine was successfully synthesized by Nils Lofgren and Bengt Lundqvist from Stockholm University in Sweden in 1943. Lofgreen was still a doctoral student at that time, while Lundquist verified its anesthetic effect through autologous injection, laying the foundation for subsequent research.
Patents and commercialization processes
After the synthesis of lidocaine, Lundquist suggested conducting pharmacological tests at the Karolinska Institute and subsequently transferring the patent rights to the Swedish pharmaceutical company Astra AB. The company launched lidocaine to the market under the trade name "Xylocaine" in 1948, marking its official entry into clinical application. In the same year, Lofgreen completed his doctoral dissertation "Lidocaine: A New Synthetic Drug", further promoting the academic recognition of the drug.
Clinical advantages and wide application
Lidocaine has rapidly become one of the preferred drugs for local anesthesia due to its rapid onset and long-lasting effect. It is applicable to various scenarios such as infiltration anesthesia, block anesthesia and surface anesthesia, and has relatively low toxicity and high safety. Since 1949, lidocaine has been widely promoted on a large scale. It has not only been widely used in surgical operations but also gradually expanded into the field of arrhythmia treatment. In 1963, lidocaine was used to treat ventricular arrhythmias caused by acute myocardial infarction and became an important drug for the prevention and treatment of rapid ventricular arrhythmias.
Scientific breakthroughs and continuous impact
The discovery of it is a model of the interdisciplinary research between chemistry and medicine. It not only solves the addiction problem of traditional anesthetics such as cocaine, but also enhances the anesthetic efficacy and safety through structural optimization. To date, lidocaine remains a core drug in the field of local anesthesia. Its derivatives and improved dosage forms (such as aerosols and gels) keep emerging, further expanding the scope of clinical applications.
Summary
From the accidental discovery of the isomer of luteinine to the synthesis and commercialization of lidocaine, this process reflects the contingency and inevitability of scientific exploration. The birth of lidocaine not only promoted the development of anesthesiology, but also provided important inspirations for subsequent drug research and development. Its status as a classic local anesthetic remains difficult to be completely replaced to this day.
References
Challapalli, V., Tremont-Lukats, I. W., McNicol, E. D., Lau, J., & Carr, D. B. (2005). Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database of Systematic Reviews, 2005(4), CD003345.
European Medicines Agency. (2023). Guideline on the limits of genotoxic impurities (ICH M7(R2)). EMA.
Koo, C. H., Kim, J., Na, H. S., & Do, S. H. (2022). The effect of lidocaine patch for postoperative pain: A meta-analysis of randomized controlled trials. Journal of Clinical Anesthesia, 81, 110918.
Löfgren, N., & Lundqvist, B. (1946). The synthesis of local anesthetics of the xylidine type. Svensk Kemisk Tidskrift, 58, 149–156.
United States Pharmacopeial Convention. (2019). United States Pharmacopeia 42–National Formulary 37: Lidocaine hydrochloride monograph. USP.
Frequently Asked Questions
FAQ 1: What purity level does your Lidocaine powder meet, and can you provide a full Certificate of Analysis?
+
-
Our Pure Lidocaine Powder is manufactured to a strict 99.9% purity standard, fully compliant with USP, EP, and JP pharmacopoeial requirements. We provide a comprehensive Certificate of Analysis (COA) with every batch, detailing critical quality parameters including assay, related substances (with strict limits on genotoxic impurities like 2,6-dimethylaniline), residual solvents, heavy metals, and microbial limits. As a source manufacturer, our QC laboratory utilizes advanced HPLC and GC-MS instrumentation to ensure every parameter is rigorously validated before release.
FAQ 2: Do you offer custom packaging or bulk quantities for large-scale pharmaceutical manufacturing?
+
-
Yes, we specialize in scalable supply for both R&D and commercial production. Our standard packaging includes double-layered HDPE or aluminum foil bags sealed in fiber drums, but we offer fully customizable packaging solutions to meet your specific formulation and storage requirements, including vacuum-sealed options with desiccants for enhanced stability. Our mature production control systems allow us to accommodate bulk orders while maintaining strict batch-to-batch consistency and traceability.
FAQ 3: What are your standard lead times and logistics capabilities for international shipments?
+
-
As a direct source manufacturer, we maintain optimized inventory levels to ensure rapid fulfillment. Standard lead times typically range from 3-7 business days for stock items, with expedited options available for urgent requirements. We have established partnerships with major global freight forwarders and courier services, offering both standard and temperature-controlled shipping solutions to guarantee product integrity during transit. All necessary documentation, including COA, MSDS, and commercial invoices, is prepared meticulously to facilitate smooth customs clearance worldwide.
FAQ 4: How do you ensure the stability and sterility of Lidocaine intended for injectable or ophthalmic applications?
+
-
For high-grade applications requiring sterility, our manufacturing process adheres to strict GMP guidelines in ISO Class 5 cleanroom environments. Rather than using harsh terminal sterilization methods that could degrade the molecule, we employ aseptic filtration of the solution prior to final crystallization. Our rigorous stability testing protocols monitor for degradation products under various conditions, ensuring a typical shelf life of 3-5 years when stored in cool, dry conditions in our light-resistant, airtight packaging.
FAQ 5: What technical support do you provide for formulators integrating your Lidocaine into new dosage forms?
+
-
Our professional sales team provides one-on-one dedicated docking services, connecting you directly with our mature technical support specialists. Whether you are developing injectables, topical gels, transdermal patches, or novel liposomal formulations, we offer comprehensive guidance on solubility parameters, compatibility with excipients, and optimization of bioavailability. Our team is well-versed in regulatory requirements and can assist with documentation needed for your drug master file (DMF) submissions or regulatory audits.
Hot Tags: 99.9% pure lidocaine powder cas 137-58-6, suppliers, manufacturers, factory, wholesale, buy, price, bulk, for sale, raloxifene powder, 4 4 Diaminodiphenylsulfone CAS 80 08 0, 3 4 5 Trimethoxy trans stilbene, 99 9 pure lidocaine powder, 3-Dimethylaminophenol, Cyclophosphamide monohydrate powder