Puresterol® (Pueraria mirifica) Powdered Extract
Puresterol® is Bio-Botanica's patented, standardized extract of Pueraria mirifica root — U.S. Patent 7,658,955 — supplied here as a powdered extract on maltodextrin under Part ID 4523. It is standardized to a minimum of 300 mcg of miroestrol and 20 mg of isoflavonoids per 100 g, and is produced under our own patented process at our FDA-inspected cGMP facility in Hauppauge, New York. It is the only patented, specially processed compound of Pueraria mirifica available on the market today.
*These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.
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What Is Puresterol®?
Puresterol® is Bio-Botanica's patented, standardized extract of Pueraria mirifica root. The plant grows only in the rich soils of Thailand's high-altitude rainforests, where it has been used for centuries as a traditional rejuvenator and revitalizer. Bio-Botanica supplies Puresterol® in two formats; this record covers the powdered extract on maltodextrin, Part ID 4523.
Patented and Standardized
Puresterol® is protected under U.S. Patent 7,658,955 and is the only patented, specially processed compound of Pueraria mirifica available on the market today. It is standardized to a minimum of 300 mcg of miroestrol per 100 g and a minimum of 20 mg of isoflavonoids per 100 g, so formulators are dosing against a defined specification rather than a variable botanical. The patented process is what distinguishes Puresterol® from generic Pueraria mirifica material, and the specification for each lot is documented on the Spec Sheet/TDS and Certificate of Analysis.
Formulation Applications
The powdered format carries the extract on maltodextrin, giving a free-flowing dry input for capsules, tablets, stick packs, drink powders and dry blends where a liquid is impractical. It is intended for ingestible use — dietary supplement and food and beverage products. Pueraria mirifica is traditionally associated with women's health, framing intended for structure/function positioning only and not a consumer health claim. An alcohol-free liquid format (Part ID 5529) is available where a liquid input suits the process better.
Why Formulators Choose Bio-Botanica
Family-owned since 1972, Bio-Botanica manufactures Puresterol® at its FDA-inspected cGMP facility in Hauppauge, New York. Every lot passes identity, microbial, USP and heavy-metal testing in our onsite quality lab — HPLC, UPLC-MS/MS, GC/MS, LC/MS and ICP/MS — supported by third-party laboratories. We operate under NSF, cGMP and FSSC 22000 quality systems, and Kosher, Halal and Organic certification is available on request.
Common Buyer Questions
What is Puresterol®, and what species and plant part does it come from?
Puresterol® is Bio-Botanica's patented, standardized extract made from the root of Pueraria mirifica, a member of the Fabaceae family native to Thailand. This record covers the powdered format on maltodextrin, Part ID 4523.
What patent covers Puresterol®?
Puresterol® is covered by U.S. Patent 7,658,955. It is the only patented, specially processed compound of Pueraria mirifica available on the market today — which is the practical reason to specify Puresterol® rather than generic Pueraria mirifica extract.
What is Puresterol® standardized to?
Puresterol® is standardized to a minimum of 300 mcg of miroestrol per 100 g and a minimum of 20 mg of isoflavonoids per 100 g. The figures for your lot are documented on the Spec Sheet/TDS and the accompanying Certificate of Analysis.
What is the powder carried on?
The powdered format is carried on maltodextrin, which gives a free-flowing material suited to dry processing. The carrier and any processing details are documented on the Spec Sheet/TDS that accompanies samples.
What is the difference between the powdered and the liquid Puresterol®?
Both are the same patented, standardized extract. Part ID 4523 is a powder on maltodextrin for capsules, tablets, powders and dry blends; Part ID 5529 is an alcohol-free liquid for liquid supplements, shots and beverage concentrates. The choice is a format decision, not a potency one.
What applications and positioning does Puresterol® fit?
This format is intended for ingestible applications — dietary supplements and food and beverage. Pueraria mirifica is traditionally associated with women's health; that is structure/function framing for ingredient positioning only, not a consumer health claim. The traditional uses described are not validated in multiple, well-controlled clinical studies and have not been evaluated by the Food and Drug Administration.
Where does the Pueraria mirifica come from?
Pueraria mirifica grows only in the rich soils of the high-altitude rainforests of Thailand. Sourcing and country-of-origin details for a given lot are documented on the TDS that accompanies samples.
How is Puresterol® sold, and what about samples and MOQ?
Puresterol® is sold in bulk to formulators and brands, not as a finished consumer product, in pack sizes of 5 kg, 25 kg, 100 kg, 250 kg and 500 kg. Pricing is provided by formal quote against your chosen pack size and volume. Samples ship with a Spec Sheet/TDS, a representative Certificate of Analysis and a Safety Data Sheet.
How is Puresterol® manufactured and tested?
Puresterol® is manufactured under its patented process at Bio-Botanica's FDA-inspected cGMP facility in Hauppauge, New York. Testing runs from raw-material intake through finished product in our onsite quality lab using HPLC, UPLC-MS/MS, GC/MS, LC/MS and ICP/MS, covering identity, microbial, USP and heavy-metal testing, supported by third-party laboratories.
What certifications are available?
Bio-Botanica operates under NSF, cGMP and FSSC 22000 quality systems, and Kosher, Halal and Organic certification is available. Our Hauppauge, New York facility is FDA-inspected; certification specific to your order can be confirmed with our team.