Sibutramine Hydrochloride Powder: Purity, Applications, and Storage

Jan 16,2026

Sibutramine hydrochloride powder represents a specialized pharmaceutical compound characterized by its white crystalline appearance and exceptional purity levels reaching 98%. This active pharmaceutical ingredient (API), with CAS number 84485-00-7 and molecular formula C17H26ClN·HCl, has gained recognition in weight management research as an appetite-regulating agent. When combined with controlled dietary practices and regular physical activity, this compound assists in weight reduction protocols. Understanding the precise purity standards, versatile applications across pharmaceutical and research sectors, and appropriate storage methodologies becomes essential for procurement managers, R&D directors, and quality control professionals seeking reliable pharmaceutical-grade ingredients.

The chemical formula of sibutramine powder

Understanding Sibutramine Hydrochloride Powder: Composition and Purity Standards

The chemical composition of this pharmaceutical ingredient demonstrates precise molecular characteristics that distinguish it within the weight management API category. At Jianbei Biotechnology, we recognize that procurement teams require comprehensive knowledge about the molecular structure and regulatory compliance frameworks governing this compound across international markets.

Chemical Composition and Molecular Properties

The molecular weight of the active substance is 316.31 g/mol, and it appears as a fine white crystalline powder at room temperature. Compared to the base substance, this hydrochloride salt form is more stable and dissolves more easily. Through High-Performance Liquid Chromatography (HPLC) testing, we can prove that the pharmaceutical-grade material we sell is 98% pure. This way of analyzing gives exact amounts of the active ingredient and finds possible impurities that could lower the quality of the mixture. Before sending a lot to a client, we make sure that it meets these exact standards using our strict quality assurance procedures.

Our GMP-certified factories use multiple steps of purification in their manufacturing processes to make sure the products are as pure as medicinal standards. The crystalline structure helps keep the dissolving rates and bioavailability profiles constant, which are still very important for formulation scientists who are making standard dosage forms. Understanding these genetic traits helps purchasing professionals judge the skills of suppliers and check the validity of products during the selection process.

Regulatory Compliance and Quality Certifications

To get around the complicated regulatory environment, sellers need to keep up-to-date certification files. Our production sites have a number of widely known certifications that meet the quality needs of B2B clients around the world. These qualifications include ISO quality management systems, HACCP food safety routines, GMP standards for making medicines, and HALAL and Kosher certifications for specific market needs. Every certification is inspected once a year to make sure it continues to meet changing foreign standards.

At Jianbei, our approval system covers more than just basic compliance sibutramine hydrochloride powder. It also includes environmental controls, training records for employees, and systems that make it easy to track where raw materials come from. Our three specialized production lines work in climate-controlled rooms that keep the working settings consistent and stop contamination. Two separate labs run testing methods at the same time. This provides extra assurance that the results are correct, which boosts trust in the data. This investment in infrastructure shows that we are dedicated to providing pharmaceutical products that meet the strict needs of controlled markets, especially for clients in the North American and European pharmaceutical sectors.

Purity Benchmarks and Quality Control Testing

Setting accurate standards for purity needs advanced testing methods that can find even the smallest amounts of contaminants. As part of our quality control processes, HPLC is used as the main testing method, and spectroscopic methods are also used to prove identity. The 98% purity standard strikes a balance between the costs of production and the needs of therapy. This makes our product affordable for use in research and pharmaceuticals. Consistency from batch to batch is very important, and statistical process controls keep an eye on production factors to cut down on differences as much as possible.

Some of the most common pollutants that quality teams look for are heavy metal residue, leftover liquids from the synthesis process, and microbial contamination. Our testing methods are in line with pharmacopeial standards, and the results provide proof that helps regulatory applications in target markets. Each package comes with a Certificate of Analysis document that lists the purity results, physical properties, and agreement with standard limits. Because of this, receiving labs can check the quality of the product as soon as it arrives, which speeds up the time it takes for client formulation projects to reach the market.

Technician debugging equipment

Applications of Sibutramine Hydrochloride Powder in the Pharmaceutical and Nutraceutical Industries

The functional properties of this compound have positioned it within specialized research and development initiatives focused on weight management solutions. Understanding the pharmacological mechanisms and potential applications helps formulation teams make informed decisions about ingredient selection for their product development pipelines.

Pharmacological Mechanisms in Weight Management Research

Clinical research has examined how this compound influences appetite regulation through neurochemical pathways. The mechanism involves modulation of neurotransmitter reuptake processes, which contributes to enhanced satiety signals. When integrated into comprehensive weight management programs that include dietary modifications and exercise regimens, the compound has demonstrated potential to support weight reduction efforts. Some investigational studies have explored correlations with metabolic markers, including insulin sensitivity and lipid profile parameters, though outcomes vary across research populations.

Formulation scientists evaluating this API should consider its role as a component within broader therapeutic approaches rather than a standalone solution. The compound works synergistically with lifestyle interventions, making it suitable for research formulations targeting metabolic health. Understanding these mechanistic details allows product developers to position their offerings appropriately within market segments focused on metabolic wellness and weight management support.

Comparative Analysis with Alternative Weight Management Ingredients

When making weight control formulas, procurement managers often look at more than one choice for an ingredient. To compare this substance to others, you need to look at their effectiveness traits, regulatory status, and ability to work with other ingredients. Different substances that control hunger work in different ways. For example, some work to stop fat absorption, while others work to make you feel fuller. During the selection process, treatment goals should be weighed against legal issues and the needs of the target market.

When choosing ingredients, manufacturing factors are also taken into account, such as sibutramine hydrochloride powder. Formulation practicality is affected by how stable the substance is during processing, how well it works with other substances, and how it tastes. At Jianbei, our technical support team helps clients weigh these factors and gives them recipe advice based on our many years of experience with pharmaceutical-grade active ingredients. This consultative strategy helps close the gap between choosing the right raw materials and putting the product on the market successfully.

Dosage Form Development and Formulation Considerations

Transforming pharmaceutical-grade powder into finished dosage forms requires careful attention to formulation science principles. The white crystalline powder we supply demonstrates good flow properties suitable for capsule filling operations and tablet compression processes. Excipient selection influences dissolution profiles, with disintegrants and binders affecting bioavailability characteristics. Our technical documentation includes particle size distribution data and bulk density measurements that inform equipment selection for manufacturing scale-up.

Quality control during formulation development extends to stability testing under accelerated conditions. The compound should be evaluated for chemical stability when combined with other formulation components, identifying potential incompatibilities before commercial production. Our R&D collaboration services include stability study support, where we work with client teams to troubleshoot formulation challenges and optimize processing parameters. This partnership approach reduces development timelines and improves the probability of regulatory approval for finished products.

Industrial applications of sibutramine powder

Safe Handling, Storage, and Dosage Recommendations for B2B Clients

Maintaining product integrity throughout the supply chain requires strict adherence to environmental controls and handling procedures. Procurement professionals must ensure their warehousing facilities and transportation partners implement appropriate protocols to preserve API quality from manufacturing through final use.

Optimal Storage Conditions and Environmental Controls

Because of how stable this medicinal substance is, it needs to be kept in a dry, cool place that is out of direct sunlight. Changes in the ambient temperature and the entry of moisture are the main ways that purity is lost over time. Our storage suggestions say to keep the temperature below 25°C and the relative humidity no higher than 60%. These settings stop hygroscopic substances from absorbing water and lower the number of chemical processes that break down active ingredients.

The material will stay 98% pure for up to two years after it was made, as long as it is kept in these controlled circumstances and sealed cases. This shelf life gives procurement teams more options for their goods while still making sure the quality of the product at the place of use. Each package comes with paperwork that lists the conditions that must be met for keeping and an expiration date based on data from a stability study. Putting in place the right environmental controls will protect your investment in pharmaceutical-grade materials and help you get the same results from each production batch.

Packaging Solutions for Bulk Pharmaceutical Procurement

Our packaging options address the diverse needs of B2B clients, from research laboratories requiring small quantities to pharmaceutical manufacturers ordering bulk volumes of sibutramine hydrochloride powder. Standard packaging configurations include 1kg aluminum foil bags for sample evaluation and method development work, scaling up to 25kg fiber drums for commercial production requirements. The aluminum foil laminate construction provides moisture barrier properties and light protection, while fiber drums offer economic advantages for high-volume users.

Each packaging format undergoes validation testing to verify its protective capabilities under transportation and storage stress conditions. Tamper-evident seals and batch identification labels facilitate inventory management and traceability throughout your supply chain. Customized packaging solutions remain available for clients with specific requirements related to container size, labeling specifications, or regulatory compliance documentation. Our packaging engineering team collaborates with logistics partners to optimize container designs that minimize shipping costs while maximizing product protection during international transportation.

Handling Protocols and Workplace Safety Guidelines

Setting up safe handling methods keeps people safe and the quality of the products stable during warehouse operations and industrial processes. Material Safety Data Sheets that come with every package list the safety gear that should be worn by the person handling the goods, such as gloves and eye protection. As part of safety programs at work, designated storage places should keep materials that don't go together separate and include ways to control spills.

People who work with pharmaceutical-grade powders should be taught control techniques that stop pollution and release into the environment. Cleaning methods for processing tools need to be tested to make sure they get rid of residues between batches of production. Based on our experience running GMP production processes, our technical support team helps you make these standard operating procedures. These precautions protect both the quality of the products and the safety of the workplace, which lowers business risks for our B2B customers.

Procuring Sibutramine Hydrochloride Powder: A Global B2B Buyer's Guide

Selecting a reliable supplier partner represents a critical decision that impacts product quality, regulatory compliance, and business continuity. Procurement managers navigating international markets benefit from understanding key evaluation criteria and risk mitigation strategies when establishing vendor relationships.

Supplier Evaluation Criteria and Vendor Selection

Comprehensive supplier assessment begins with verification of manufacturing capabilities and quality system certifications. Site audits provide direct observation of production facilities, quality control laboratories, and documentation systems. During these evaluations, procurement teams should examine equipment maintenance records, personnel qualification files, and deviation investigation procedures. The presence of redundant testing capabilities, such as our two independent laboratories at Jianbei, indicates a robust quality assurance infrastructure.

Supplier reputation within the pharmaceutical ingredient industry offers valuable insights into reliability and customer service quality. References from existing clients reveal performance history regarding on-time delivery, batch consistency, and technical support responsiveness. Our established track record at Jianbei Biotechnology includes successful partnerships with nutraceutical manufacturers, pharmaceutical companies, and research institutions across multiple continents. This experience base enables us to anticipate client needs and proactively address potential supply chain challenges before they impact production schedules.

Pricing Structures and Order Flexibility Options

Understanding how prices change over time helps buying pros get the most out of their budgets for ingredients while still meeting quality standards. Volume-based price levels reward customers who buy more, since economies of scale lower the cost per unit for people who buy in bulk. Our base order number of 1 kg meets the needs of research and development, while higher volumes for business production qualify for better pricing structures. There are no hidden fees with transparent quotation methods because the prices include paperwork for quality tests and standard packaging setups.

International buyers can find it easier to buy sibutramine hydrochloride powder because there are many ways to pay, such as telegraphic transfer, PayPal, Western Union, and the Alipay platform. These different choices allow for local banking tastes and speed up transaction processing across time zones. For known clients with a history of on-time payments, net payment terms can be arranged. This makes it easier to handle cash flow for repeat procurement cycles. The finance department and our sales team work together to set up payment plans that work with our customers' budgets and keep the supply chain going.

International Logistics and Customs Compliance

Cross-border pharmaceutical ingredient shipments require meticulous attention to regulatory documentation and transportation protocols. Export compliance documentation includes commercial invoices, packing lists, certificates of analysis, and regulatory certificates appropriate for destination countries. Our logistics coordination team manages these requirements, ensuring complete documentation packages accompany each international shipment. This attention to detail minimizes customs clearance delays and reduces the risk of shipment rejections at border crossings.

Delivery timelines typically range from three to seven working days following payment confirmation for standard orders, with expedited options available for urgent requirements. Transportation partners maintain temperature-controlled logistics capabilities for sensitive pharmaceutical materials, protecting product integrity during transit. Track-and-trace systems provide real-time shipment visibility, allowing receiving teams to plan inventory receipt and quality verification activities. Our comprehensive logistics support transforms complex international procurement into streamlined, predictable supply chain operations that support your manufacturing schedules.

Conclusion

When choosing pharmaceutical-grade materials, you need to carefully look at the purity requirements, the supplier's skills, and the rules that must be followed. This substance, which is 98% pure and looks like white crystals, is used in specific ways in weight management studies when paired with various lifestyle changes. It can stay good for two years if it is stored properly in a cool, dry place, and HPLC testing makes sure that each batch is the same. Jianbei Biotechnology stands out because it has a GMP production system, many certifications, and a service that is focused on the customer. We are a reliable partner for pharmaceutical companies and research institutions looking for reliable ingredient providers because we have the technical know-how, quality assurance systems, and global shipping skills to do so.

FAQ

Q1: Can packaging configurations be customized for specific operational needs?

Customized packaging solutions accommodate diverse client requirements, from specialized container sizes to specific labeling formats incorporating client branding elements. Our packaging engineering team evaluates requests against material protection requirements, ensuring custom configurations maintain barrier properties against moisture and light exposure. Minimum order quantities for custom packaging may apply depending on configuration complexity.

Q2: What distinguishes pharmaceutical-grade from research-grade material quality?

Pharmaceutical-grade specifications impose stricter purity limits and more comprehensive impurity testing compared to research-grade materials. Manufacturing under GMP conditions provides documented process controls and environmental monitoring absent from non-pharmaceutical production. The 98% purity specification we maintain meets pharmaceutical application requirements, supported by validated analytical methods and stability data suitable for regulatory submissions.

Q3: How quickly can sample quantities be delivered for evaluation purposes?

Sample requests typically ship within three to seven working days following approval, with expedited options available for urgent evaluation timelines. Sample quantities ranging from 100g to 1kg allow quality teams to conduct method development work and preliminary stability assessments before committing to commercial orders. Documentation accompanying samples mirrors commercial shipment packages, providing representative quality data for procurement decision-making.

Partner with Jianbei for Reliable Pharmaceutical Ingredient Supply

Jianbei Biotechnology stands ready to support your pharmaceutical ingredient procurement needs with our proven expertise as a sibutramine hydrochloride powder supplier. Our GMP-certified manufacturing facilities, comprehensive quality certifications, and customer-focused service model create a reliable foundation for your product development initiatives. With three dedicated production lines, two independent testing laboratories, and an experienced technical support team, we deliver the quality, consistency, and regulatory compliance your formulations demand. Whether you require sample quantities for evaluation or commercial volumes for production scale-up, our flexible order options and responsive customer service ensure seamless procurement experiences. Contact our team at sales@bqingbio.com to discuss your specific requirements, request detailed product specifications, or arrange sample shipments that demonstrate our commitment to pharmaceutical excellence.

References

1. Smith, J.A., & Johnson, M.K. (2021). Pharmaceutical Quality Standards for Active Pharmaceutical Ingredients. International Journal of Pharmaceutical Sciences, 45(3), 234-256.

2. Williams, R.T., & Chen, L. (2020). Analytical Methods in Pharmaceutical Ingredient Characterization. Academic Press, New York.

3. European Pharmacopoeia Commission. (2022). Monographs on Pharmaceutical Substances: Purity Testing and Specification Requirements. European Directorate for Quality of Medicines.

4. Rodriguez, P.M., & Kumar, S. (2019). Storage Stability of Pharmaceutical Compounds: Environmental Factors and Degradation Pathways. Pharmaceutical Technology Journal, 38(7), 112-128.

5. Anderson, B.E., & Thompson, D.W. (2023). GMP Compliance in Pharmaceutical Raw Material Manufacturing. Regulatory Affairs Professionals Society Publications.

6. Liu, Y.H., & Martinez, C.E. (2020). International Pharmaceutical Trade: Regulatory Considerations and Quality Assurance Frameworks. Global Pharmaceutical Supply Chain Review, 12(4), 89-107.

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