Oxedrine

Oxedrine - Premium p-Synephrine for Pharmaceutical and Nutraceutical Applications

In 2011, Kang Biotech began producing pharmaceutical-grade Oxedrine (p-Synephrine, CAS 94-07-5) with 98% HPLC purity for the pharmaceutical, nutraceutical, and sports nutrition sectors. Ensuring consistent supply capacity, our 33,000 m² manufacturing facility in Hunan Province features 9 sophisticated production lines and over 20,000,000 m² of controlled bitter orange orchards. We meet ISO 9001, ISO 22000, HACCP, Halal, Kosher, and FAMI-QS certifications and maintain batch-to-batch consistency with 11 years of production experience and technical teams with 20 years of citrus extraction knowledge. We deliver to 40+ countries by express, air, and sea freight.

What is Oxedrine?

Citrus aurantium L. (bitter orange) produces sympathomimetic alkaloid p-synephrine. It targets alpha-1 and beta-3 adrenergic receptors as a selective agonist.

Unlike ephedrine, the product has reduced affinity for beta-1 and beta-2 receptors. Selectivity reduces cardiovascular stimulation without affecting function. The compound's chemical structure (C9H13NO2, 167.21 g/mol) allows for pharmaceutical and nutritional supplement production.

We use water and ethanol extraction of Rutaceae family plants like bitter orange peel and immature citrus fruit. The active p-synephrine isomer is preserved while pharmaceutical purity is maintained.

Technical Specifications and Properties

Our pharmaceutical-grade medication stays 99%+ potent for 36 months in cold, dry, light-protected circumstances. ICH-compliant accelerated testing protocols verify this stability.

Most stable is tartrate in somewhat acidic (pH 3.5-5.5) conditions. This allows liquid delivery, capsule, and tablet formulation versatility.

Quality Control and Testing Standards

Product quality affects regulatory compliance and market reputation. Following USP and EP monographs, we do extensive testing.

Our quality assurance method has five crucial inspections:

HPLC-DAD Assay indicates quantitative purity over 98% and identifies trace adulterants. This approach guarantees pharmaceutical formulation accuracy.

Chiral chromatography distinguishes p- and m-synephrine isomers. This testing ensures the bioactive form meets safety and effectiveness standards.

ICP-MS heavy metal screening meets worldwide toxicity criteria for pharmaceutical and food supplement applications with limits below 10ppm.

Gas Chromatography residual solvent testing eliminates Class 1 and 2 solvents. The compliance supports oral and specialized delivery systems.

ISO 17025-accredited Microbial Limit Testing validates TAMC/TYMC counts. All batches are quality-controlled from raw material selection to delivery.

Primary Application Scenarios

Nutraceutical and Dietary Supplements: Your thermogenic formulations benefit from our high-purity material. The compound supports metabolic rate enhancement and lipid oxidation in weight management products. Clinical studies demonstrate synergistic effects when combined with caffeine, without increasing cardiovascular strain.

Sports Nutrition Products: Athletes rely on formulations containing our material for energy support during intense training. The selective receptor activity provides functional benefits while maintaining a favorable safety profile compared to non-selective stimulants.

Pharmaceutical Applications: Healthcare facilities utilize the vasoconstrictive properties in managing hypotensive states and supporting blood pressure during medical procedures. The predictable pharmacokinetics enable precise dosing in clinical settings.

Topical Formulations: Personal care manufacturers incorporate the ingredient in nasal and ocular decongestant products. The localized vasoconstrictive action reduces mucosal edema without systemic rebound effects.

Manufacturing Advantages and Supply Capacity

Kang Biotech operates as a direct manufacturer with complete vertical integration. Our bitter orange plantations provide consistent raw material quality for Oxedrine, while our 9 production lines ensure scalable manufacturing capacity.

You receive batch-to-batch consistency through our mature production processes and technical expertise. Our joint research center with Hunan Institute of Agricultural Product Processing advances extraction technologies and customized ingredient solutions.

We maintain sufficient inventory for prompt shipping globally. Whether you require 1kg sample orders or commercial-scale quantities, our flexible logistics network supports FedEx express, air cargo, and ocean freight delivery.

Our OEM and ODM services accommodate custom specifications, purity levels, and packaging requirements. This flexibility helps you meet diverse regulatory standards across different markets.

Regulatory Compliance and Safety Profile

Your regulatory compliance depends on verified ingredient quality. Our manufacturing systems hold multiple international certifications including Halal, Kosher, FAMI-QS, and SC (China Food Production License).

The compound currently appears on the WADA monitoring program but remains non-prohibited in competition. We recommend monitoring annual regulatory updates for your specific market applications.

Safety studies confirm minimal impact on heart rate and central nervous system at standard dosages. This differentiation from ephedrine-based compounds provides formulation advantages for consumer-facing products.

Our technical documentation package includes Certificates of Analysis, stability data, and application guidance. This comprehensive support accelerates your product development timeline and regulatory submissions.

FAQ

Q: How does your material vary from synthetics?

A: Our Citrus aurantium L. extraction yields material. Botanical origins help regulatory approval in markets that value natural substances over synthetics.

Q: What tests show no m-synephrine contamination?

A: P- and m-synephrine isomers are definitively separated and quantified by chiral chromatography. Every batch is verified for  p-synephrine content over 98% purity.

Q: Does your material meet vegan and vegetarian standards?

A: The plant-extracted product we sell contains no animal products. Our Halal and Kosher certificates confirm religious dietary and ethical sourcing conformity.

Q: What documentation supports international shipping and customs clearance?

A: We supply Commercial Invoice, Certificate of Analysis, MSDS, Phytosanitary Certificate, and country-specific compliance documents for export. Our skilled logistics staff clears customs in 40+ countries.

Q: Do you provide product development formulation consulting?

A: Application consulting includes dose, stability, and ingredient compatibility by our technical experts. This support continues during product development and commercialization.

Contact Us

Partner with Kang Biotech for reliable supply of pharmaceutical-grade materials, including Oxedrine, backed by manufacturing  and technical expertise.

Email: sales02@kangbiotech.com.