What is the purity standard for pharmaceutical diosmin hesperidin?

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Hesperidin

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What Are Diosmin and Hesperidin?

Diosmin is a semisynthetic flavonoid derived from citrus, produced by modifying Hesperidin extracted from the immature fruit of Citrus aurantium L. Hesperidin is the natural glycoside found in orange peel and other citrus sources. Both belong to the flavonoid family and are valued for their effects on blood vessel structure and tone.

In pharmaceutical practice, the two are almost always used together. The best-known combination is the 90:10 ratio — 90% Diosmin and 10% Hesperidin — which is the basis of micronized purified flavonoid fraction (MPFF) products used to manage chronic venous insufficiency, hemorrhoids, and varicose veins. A typical 500 mg tablet contains 450 mg of Diosmin and 50 mg of Hesperidin, while a 1,000 mg tablet contains 900 mg and 100 mg respectively.

Which Purity Standards Apply?

Pharmaceutical-grade Diosmin is defined by the major pharmacopoeias:

• European Pharmacopoeia (EP)
• British Pharmacopoeia (BP)
• United States Pharmacopeia (USP)
• Chinese Pharmacopoeia (ChP)

For most export-oriented pharmaceutical and nutraceutical applications, EP is the benchmark most commonly requested. EP-grade Diosmin is also frequently supplied in micronized form, because reducing particle size improves dissolution and bioavailability.

Key Purity Parameters for Pharmaceutical Diosmin

When you review a certificate of analysis (COA) for pharmaceutical Diosmin, these are the parameters that matter most:

1. Assay (content by HPLC, on anhydrous basis). The EP monograph requires 90.0% to 102.0% Diosmin, while the Chinese Pharmacopoeia for Diosmin tablets specifies 90.0% to 110.0% of the labeled amount. Anything below 90% does not meet pharmacopoeial grade.

2. Related substances (impurities). EP sets individual limits for each known impurity — for example, Hesperidin (impurity B) no more than 4.0%, isorhoifolin (impurity C) no more than 3.0%, linarin (impurity E) no more than 3.0%, diosmetin (impurity F) no more than 2.0%, and unspecified impurities no more than 0.4% each, with total impurities capped at 8.5%.

3. Heavy metals. Typically not more than 20 ppm total for EP-grade Diosmin; many suppliers tighten this to 10 ppm total with individual limits for lead, arsenic, mercury, and cadmium.

4. Water content. Not more than 6.0% for EP Diosmin; loss on drying for the 90:10 combination is usually specified at not more than 5.0%.

5. Sulphated ash. Not more than 0.2%.

6. Residual solvents. Methanol not more than 3,000 ppm, ethanol not more than 5,000 ppm, and pyridine not more than 200 ppm.

7. Particle size. For micronized grade, not less than 90% of particles below 5 microns.

8. Microbiological limits. Total plate count not more than 1,000 cfu/g, yeast and mold not more than 100 cfu/g, with E. coli and Salmonella negative.

The 90:10 Combination Standard

For the Diosmin + Hesperidin 90:10 blend used in MPFF-type products, the specification typically covers the same physical, chemical, and microbiological parameters, with the ratio itself verified by HPLC. A typical COA shows loss on drying not more than 5.0%, ash not more than 1.0%, total heavy metals not more than 10 ppm, and total plate count not more than 1,000 cfu/g.

How to Verify Purity When Sourcing

The COA is only as trustworthy as the laboratory behind it. When evaluating a supplier:

• Ask for a full COA showing assay, each related substance, heavy metals, residual solvents, particle size, and microbiological results.
• Confirm the analytical method (HPLC per the relevant pharmacopoeia) and the reference standard used.
• Request the pharmacopoeia edition the product is tested against (for example, the current EP edition).
• Verify that the manufacturing facility operates under cGMP and holds relevant certifications such as ISO 9001.
• For regulated markets, ask whether a Certificate of Suitability (CEP), DMF, or other regulatory documentation is available.

Choosing a Reliable Supplier

Purity is determined at the manufacturing stage. A source factory with controlled extraction, purification, and micronization processes — backed by a quality management system and complete testing equipment — is far more likely to deliver consistent, pharmacopoeia-compliant material than a trader without in-house production. Working with experienced plant extract suppliers who can supply diosmin hesperidin at pharmaceutical grade, with full documentation and stable supply, reduces the risk of batch-to-batch variation and compliance issues.

Conclusion

Pharmaceutical-grade Diosmin Hesperidin is defined by clear, measurable standards: an HPLC assay of 90.0% to 102.0%, strict individual and total impurity limits, controlled heavy metals, residual solvents, water, and microbiological quality, and — for micronized grades — a defined particle size distribution. Understanding these parameters lets you specify the right material, read a COA with confidence, and choose a supplier that can document compliance. For pharmaceutical and nutraceutical manufacturers looking for a dependable source of high-purity plant extracts for pharmaceuticals, working with a certified manufacturer is the surest path to quality.