Passionflower Supplement Manufacturer

Write six fields before anyone compares price. Those fields decide identity, serving math, fill, and the label.

“Vine” is commonly used commercially for the aerial herb, but the botanical specification should state P. incarnata aerial parts rather than relying on “vine” alone.

If origin will be declared on the finished label, include the origin specification in the RFQ and supplier documentation.

Public reference files and commercial files answer different questions:

The aerial herb’s chemistry is mainly C-glycosyl flavones. Vitexin is the usual named HPLC peak and the Ph. Eur. reference for total flavonoids. Isovitexin, orientin, and isoorientin sit on the same chromatogram as identity/profile peaks unless the PO names them as the claim analyte. Apigenin is not the default commercial marker for this aerial extract.

Commercial COAs often print 3.5% or 4% total flavonoids, sometimes expressed as vitexin, sometimes as a named vitexin peak. Those are different assays. 3.5% vs 4% is usually method, moisture basis, or supplier grade talk—not two pharmacopeial classes. Ph. Eur. ≥2.0% (dry extract, as vitexin) is a floor, not a retail “4%” grade.

A named ratio is a drug-extract ratio (DER) only when starting herb, finished extract, and solvent are on the file. Native extract ratio / native equivalent is a different number from DER. Do not convert 10:1 into 4% or 10% flavonoids.

Standardized botanical pathways: standard extracts.

“4%” is not a complete specification unless the analyte, analytical method, reference basis, and assay stage are defined.

Two “4% / 500 mg” prices are not a comparison until each quote is converted to marker milligrams per serving. Send both COAs; we map species, plant part, analyte, method, and assay stage before anyone pays for the wrong sample.

Extract weight × assay = marker amount per serving

Illustration only—not recommended intakes.

A and C both yield “10 mg” but not of the same compound. D cannot enter the table until a DER and an analyte exist. Incoming extract % is not finished-unit milligrams—blend, moisture, and gummy cook change the number that can be printed.

Compare Two COAs → Analyte, Method & Assay Stage

Release has to prove botanical identity, plant part, and—when a marker is on the file—the named assay method. Powder color does not close those rows.

Botanical identity testing verifies that the incoming material matches the specified botanical; marker assay quantifies the named chemical marker. HPLC flavonoid assay does not replace identity, and identity does not replace a printed marker milligram.

Incoming: identity (P. incarnata aerial), appearance, named assay, moisture, microbiology, heavy metals, pesticides and residual solvents as scoped, bulk density when fill weight depends on it.

In-process: blend uniformity (especially low-dose theanine or GABA), capsule fill or tablet weight, hardness/friability where applicable, gummy piece weight and water activity when that format is in scope.

Finished: agreed specification, microbiology, pack inspection, batch file. Hold/release when a result is outside spec. Third-party reports (SGS / Eurofins) when the RFQ asks. Methods: quality control.

Changing the extract supplier after approval restarts qualification.

We review relaxation, sleep-support, and other structure/function positioning against the destination market before artwork approval. For U.S. dietary-supplement labeling, FDA structure/function claims under 21 CFR 101.93 describe effects on body structure or function; they are not disease claims and they are not FDA approval of the finished bottle.

Usually discussable (verify locally): evening relaxation · calm · sleep-support · nervous-system support · bedtime wellness · occasional tension.

Daytime calm programs that sit in relaxation assortments: anxiety relief. Evening formulas and daytime formulas need two artworks.

Market-dependent before the BOM is frozen: GABA; melatonin; pediatric gummies; the word “anxiety” in some destinations.

The EMA Passiflorae herba file is a herbal-medicinal monograph (traditional use around mild mental stress and sleep; pregnancy and lactation not recommended for lack of reproductive-toxicity data). It is not a dietary-supplement claim deck and not a default formula.

Infant and pet products are out of scope.

Aerial extract is hygroscopic and aromatic. Packaging is selected against moisture, odor, dosage form, shelf-life target, and destination-market requirements.

Shelf life follows formulation, pack, storage, and stability data for that SKU.

OEM. You send a BOM or a confirmed spec. We confirm manufacturability, sample against that spec, then run commercial units.

ODM. You send channel, evening vs daytime direction, format, and a milligram direction. We propose a material route and formula card, confirm the aerial file, sample, then scale. A product concept is enough to start.

Typical timeline after specification, material, and artwork confirmation

Flavor work, dual HPLC, and finished flavonoid assay add time before the sample clock starts. An NDA is available before you send a BOM. A project manager is assigned when the specification is in review.

Example RFQ

Passiflora incarnata aerial extract, [total flavonoids or vitexin] [x]% HPLC, [250/500] mg per capsule, 60-count HPMC, destination [US/EU/…], evening relaxation or daytime calm, companions [none / theanine mg / Mg salt + elemental mg / GABA grade], artwork language to review, first PO quantity.

Bulk kilograms and finished retail units are different quotes.

Send any of the following: existing formula, supplier COA, target dosage, finished-product concept, required format, target market. Missing fields are acceptable—we identify specification gaps before quotation.