Hesperidin EP Standard

Hesperidin EP Standard – Pharmaceutical-Grade Citrus Bioflavonoid from Kang Biotech

Kang Biotech makes Hesperidin EP Standard, a pharmaceutical-grade flavanone glycoside from Citrus aurantium L. (bitter orange), according to Ph. Eur. monographs. Our technical team has over 20 years of citrus extraction knowledge and 11 years of manufacturing experience. We produce dry purity levels between 90.0% and 102.0%. Over 20,000,000 m² of controlled bitter orange plants in Lianyuan, Hunan Province support our 33,000 m² manufacturing facility with 9 sophisticated lines. Pharmaceutical and nutraceutical formulators benefit from batch-to-batch uniformity, traceability, and worldwide delivery from this integrated supply chain.

What Makes Hesperidin EP Standard Different from Standard Hesperidin?

We set the standard for bioflavonoids in citrus for pharmaceutical use. The chemical purity, impurity levels, and safety limits set by the European Pharmacopeia are all met.

The EP Standard requires a minimum assay of 90% with a full profile for related compounds like diosmin, linarin, and hesperetin. This is different from food-grade hesperidin, which can be anywhere from 10% to 98% pure. This makes sure that your compositions meet the strict rules of the EU and other markets.

EP-compliant hesperidin is extracted and cleaned using high-tech methods. For better absorption in pharmaceutical uses, we control the particle size distribution and offer forms that are micronized (D90 < 10μm).

Technical Specifications of Hesperidin EP Standard

Understanding the precise technical parameters helps you assess formulation compatibility and regulatory compliance.

Our product is produced through water or ethanol extraction followed by multi-stage purification to remove impurities and achieve pharmaceutical-grade quality.

Key Applications of Hesperidin EP Standard in Your Industry

Selecting the product gives doors to three vital sectors:

Pharmaceutical Manufacturing: It is the gold standard for vasoprotective APIs. In a 1:9 ratio with diosmin, it forms Micronized Purified Flavonoid Fraction (MPFF) to treat chronic venous insufficiency and hemorrhoidal illness.

Clinical Nutraceuticals: Antioxidant effectiveness and capillary permeability modulation necessitate EP-grade purity in high-end cardiovascular health supplements. Your clients expect this compliance for premium products.

Functional Food Formulations: EP-compliant hesperidin minimizes heavy metals and pesticide residues for bio-active fortification of metabolic syndrome-targeted drinks and snacks.

Rigorous Quality Control Ensures Regulatory Compliance

Hesperidin EP Standard quality assurance uses Ph. Eur.-compliant analytical techniques.

Isocitrus, linarin, and hesperetin limit tests and quantitative hesperidin measurement are performed using HPLC. These guarantee your products satisfy potency promises.

To verify molecular identification, each batch is compared to the Ph. Eur. reference standard using IR spectroscopy.

The Drying Control setting limits loss to < 5.0% to minimize microbiological development and chemical deterioration during storage and transportation.

We follow EP 2.4.27 and 2.8.13 for heavy metals and pesticide testing. Pharmaceutically safe lead, cadmium, and mercury levels.

Ethanol or methanol used in extraction is tested for ICH Q3C compliance by gas chromatography (GC).

Our facility is ISO 9001, ISO 22000, HACCP, Halal, Kosher, FAMI-QS, and SC certified. Your market-specific FDA and CE compliance paperwork is supported.

Why Choose Kang Biotech as Your Hesperidin EP Standard Supplier?

When it comes to citrus production, we're in charge. We can always get raw materials because Hunan Province has over 20,000,000 m² of plantations.

The Joint Research Center we share with the Hunan Institute of Agricultural Product Processing and Quality Safety works to improve extraction methods and custom ingredient solutions.

Flexible Customization: To meet the needs of your market, we offer OEM and ODM specs, micronization, custom packing, and private labels.

Global Delivery Network: We can handle small test orders (up to 1 kilogram) as well as large commercial shipments. We keep standard items in stock and can handle logistics in a variety of ways, including FedEx, air freight, and sea freight.

Professional Technical Support: Our experts can help you choose the right product, find the right technical documentation, help you figure out how to use it, and provide support after the sale.

Packaging and Delivery Options

Products are packed in 25 kg fiber drums with food-safe polyethylene bags inside. Custom packing choices are available based on what you need.

Our logistics team arranges for fast shipping, plane freight, or sea freight, depending on the size and location of your order. Adequate stock guaranties quick shipping around the world for important projects.

FAQ

Q: What distinguishes the product from food-grade hesperidin?

A: EP Standard demands 90%+ purity, flavonoids-specific impurity profiling, and tougher heavy metal and microbiological limitations than food-grade alternatives.

Q: Why is this optical rotation test needed?

A: It verifies the molecule's chiral purity and botanical origin, differentiating it from synthetic or contaminated versions.

Q: How should the product be kept to retain quality?

A: Protect it from light and store it in sealed containers at regulated room temperature to prevent oxidative deterioration.

Q: Does EP Standard encompass micronization?

A: The EP monograph defines chemical purity, however we provide a 'Micronized EP' version for compositions with limited bioavailability.

Q: Does the product meet USP standards?

A: EP standards have stricter impurity limits. Official cross-declaration requires independent testing, however most EP batches meet or exceed USP criteria.

Contact Us

Ready to integrate pharmaceutical-grade hesperidin into your formulations with Hesperidin EP Standard? Reach out to sales02@kangbiotech.com to start your partnership today.