USP Hesperidin

USP Hesperidin – Pharmaceutical-Grade Citrus Bioflavonoid from Kang Biotech

Kang Biotech has been making pharmaceutical-grade citrus extracts since 2011. They have more than 11 years of experience making them and more than 20 years of technical knowledge in citrus bioflavonoid extraction. Our USP Hesperidin strictly follows the rules set by the US Pharmacopeia monograph. It delivers 90.0% to 102.0% assay on anhydrous basis and goes thru strict quality control checks for heavy metals, residual solvents, and microbial limits. With more than 20,000,000 m² of controlled citrus farms and a 33,000 m² certified production center with 9 advanced production lines, we can guaranty consistent quality from batch to batch and a stable supply chain for the pharmaceutical and nutraceutical industries in more than 40 countries.

What Is USP Hesperidin?

Our product is a bioflavonoid glycoside that is mostly made from citrus fruits that are still not fully grown (Citrus aurantium L.). It meets the strict standards set by the US Pharmacopeia. It is a flavanone glycoside made up of hesperetin linked to the disaccharide rutinose, and its chemical formula is C28H34O15.

This pharmaceutical-grade ingredient solves important problems caused by differences in ingredients. By following the rules in the USP monograph, it addresses worries about heavy metal contamination, pesticide residues, and adding lower-quality extracts to make it more appealing. Manufacturers can be sure that circulatory and metabolic health products will be the same from batch to batch and work as well in clinical trials.

When it comes to purity, potency, and safety, our product is the gold standard. For high-stakes pharmaceutical uses where regulatory compliance and therapeutic dependability are musts, it offers a reliable raw material.

Technical Specifications

Key Properties and Technical Advantages

Our product is a fine, crystalline powder that is light yellow to pale yellow. It is very stable at high temperatures when processed as usual. Because of its specific range of spin and molecular structure, it works the same way in all formulas.

Even tho they naturally don't dissolve well in water, pharmaceutical-grade production often micronizes them to increase their surface area and bioavailability. Because of this change in processing, it can be used in a variety of delivery forms, such as pills, capsules, and functional drinks.

Tough identification tests, such as Infrared Absorption (USP <197K>), strict limits on related chemicals like Isocitrin, and full residue solvent testing set the quality standards. With these technical advantages, you can be sure that your formulations will meet the standards set by international regulators.

It comes naturally from citrus fruits and follows USP guidelines, which makes it ideal for clean-label products. You get an ingredient that comes from nature and is pure enough for medicinal use, with no added chemicals.

Quality Control and Testing

Our full quality control system makes sure that every batch meets the strict standards of the USP monograph. Before it gets to your facility, USP Hesperidin goes thru several levels of analytical testing.

The HPLC Assay proves the exact concentration of hesperidin, and the Limit of Related Compounds test makes sure that eriocitrin and other flavonoids stay within certain limits. This accuracy protects the therapeutic value of your product.

Heavy Metals testing with ICP-MS (USP <232>) is part of safety inspections. This makes sure that levels of Lead, Mercury, Cadmium, and Arsenic stay below what is considered safe. Gas Chromatography (USP <467>) tracking of residual solvents makes sure that no dangerous extraction chemicals are left over.

Microbial limits are very tight, and for E. coli and Salmonella, negative readings are needed. Total Aerobic Microbial Counts (TAMC) are kept at low levels, which means that oral dosage forms can be used.

We have ISO 9001, ISO 22000, HACCP, FAMI-QS, SC compliance, and Halal, Kosher, and FAMI-QS certifications. These qualifications show that we are dedicated to quality in food, nutraceutical, and medicinal settings.

Applications Across Industries

Hesperidin USP Standard is used in three very important, high-stakes situations where quality can't be ignored.

It is an important step in the process of making pharmaceutical APIs like Diosmin and Micronized Purified Flavonoid Fraction (MPFF). People all over the world use these derivatives to treat hemorrhoidal disease and chronic venous insufficiency. Your pharmaceutical products gain from the regular purity that is needed for them to work as medicine.

Our product is used in standardized nutraceuticals to make high-potency antioxidant supplements. Its clinical-grade purity makes sure that it works well with Vitamin C and other bioflavonoids. Because the chemical is pharmaceutical, it doesn't mess up metabolic processes, so it gives your customers what they want.

It is used as a gold standard in metabolic studies and clinical trials for clinical research uses. Flavonoid-based therapeutic interventions have been proven to work by researchers with results that can be repeated and meet the standards of international regulators. The reliability of the ingredients in your research gives it more weight.

Manufacturers of functional foods and drinks also use it to make formulas that help the heart. It is easy to make new formulations with because it is stable and works with a wide range of product combinations.

Manufacturing  and Customization

Growing fruit, research and development, production, and quality control are all part of Kang Biotech's combined industrial chain. Our 20,000,000+ m² of bitter orange farms in Lianyuan, Hunan Province, give us a steady flow of raw materials right from the source.

We have a variety of production methods, such as water extraction and ethanol extraction. Our OEM/ODM customization services can meet your exact needs when it comes to purity levels, specifications, and particle size.

The Hunan Institute of Agricultural Product Processing and Quality Safety and our Joint Research Center work together to support the development of new extraction technologies and functional ingredients. This research and development power lets you quickly adapt to your changing recipe needs.

It is possible to change the packaging to fit your brand and government rules. We can support more container sizes than just standard 25 kg drums, and we can label them to meet the needs of your market.

FAQ

Q: What distinguishes Hesperidin 90% from the product?

A: Both claim 90% purity, however the product must satisfy standard tests like IR identification, particular impurity limits, and residual solvent testing. Generic 90% mostly uses HPLC for assay without quality control.

Q: How will the product dissolve in liquids?

A: Water and ethanol poorly dissolve our substance. To ensure stability and bioavailability in liquid applications, cyclodextrins or suspensions are needed.

Q: Does the product include synthetic materials?

A: The product comes from Citrus aurantium L. (Bitter Orange). Identification tests in the USP monograph verify its botanical origin and natural extraction.

Q: How should the product be kept to prevent degradation?

A: Keep in light-resistant containers at room temperature. USP requirements ensure the substance stays stable when shielded from UV radiation and high humidity over its shelf life.

Q: Does the product fulfill 'Clean Label' standards?

A: Clean-label cardiovascular and immune health products that customers trust can include this natural citrus extract, which meets pharmacopeial purity criteria without synthetic ingredients.

Contact Us

Ready to secure pharmaceutical-grade USP Hesperidin for your formulations? Contact our technical team at sales02@kangbiotech.com for COA, samples, and customized solutions today.