Hawthorn fluid extract · CGR-FR-040 (CGR-FR-040)

REFERENCE FORMULA

Reference formula

Reference basis: 1000 g πριν από την 48 ωρη παραμονή/τελική διήθηση· καταγράφεται η ανακτηθείσα μάζα /1000 g before 48 h settling/final filtration; record recovered mass

Ingredient	Source quantity	Scaled quantity
Hawthorn flowering tops	1000 g	—
Ethanol 45% v/v extraction solvent	q.s. as required	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Red-brown liquid;1 or 4 volumes of water cause turbidity and 9 volumes form a pale-brown precipitate. This is an extracted herbal preparation, not a solution of a purified active. ^[1]

Action and use

The 1:1 ratio and 45% v/v extraction solvent match the adopted HMPC fluid-extract category. Its traditional indication concerns temporary nervous cardiac complaints in adults after a doctor excludes serious disease. The separate stress/sleep indication for other preparations is not transferred. This is not treatment for heart failure or acute chest pain. ^{[1], [6]}

Specifications

Final ethanol 33–38% v/v; dry residue 14–20%. These apply to the finished extract, not the nominal extracting-solvent strength. The monograph-specific chromatographic identity is required. ^[1]

Light

The source requires light protection. Select light-protective glass; brief processing in clear equipment is not evidence of photostability. No permissible exposure duration is established. ^[1]

Air and oxidation

Close promptly after transfer. Evaporation changes solvent composition and concentration; assess closure integrity and mass loss when qualifying the container. Neither nitrogen blanketing nor an added antioxidant is specified. ^{[1], [2], [4]}

Water and solubility

Red-brown liquid;1 or 4 volumes of water cause turbidity and 9 volumes form a pale-brown precipitate. Dilution with water or an aqueous vehicle therefore creates a different preparation requiring reassessment of dispersion, dose uniformity and BUD. Do not correct evaporation losses by adding water without reassessing alcohol strength. ^{[1], [2]}

Humidity

The source gives no relative-humidity limit for the finished liquid. For the herbal starting material, apply its specific moisture/loss-on-drying specification and reject mouldy or unidentified material. Moisture content does not substitute for water activity. ^{[1], [3], [5]}

Temperature

Extraction uses the specified solvent; concentration is under reduced pressure at low temperature, with no numerical limit stated. A 48-hour cool settling period precedes filtration. A cool processing step is not evidence of long-term stability at 2–8 °C. Check precipitation or phase change at the selected temperature. ^{[1], [2]}

pH and compatibility

No numerical pH is specified. If monitored, use a method suitable for a hydroalcoholic herbal mixture and an approved internal specification. Do not adjust with acid/base to remove precipitation: this changes composition and extracted-constituent behaviour. ^{[1], [5]}

Other interactions

Avoid mixing with unqualified vehicles or other extracts. Assess fingerprint, alcohol strength and dry residue in this actual product. The source advises avoiding plastic containers; a plastic dropper bottle is not an established interchangeable option. ^{[1], [5]}

Ingredient-specific information

Starting hawthorn flowering tops: 1000 g for 1000 g finished product. Ethanol 45% v/v is an extraction solvent used as required, not a fixed additive mass. Exhausted plant residue is removed and is not included in the final mass. Document species, plant part and lot quality. ^{[1], [5]}

Staff protection

Use goggles, laboratory clothing and solvent-compatible gloves. Limit plant-dust generation and open transfers. Evaluate extraction/concentration equipment and ventilation for ethanol vapour and ignition sources. ^{[2], [4]}

Risk assessment

Critical failure modes: wrong species/part; confusing 45% extracting solvent with 33–38% final ethanol; incorrect 1:1 ratio; solvent loss; precipitation after dilution; and importing doses from a non-equivalent extract. Record identity, final mass, yield, alcohol assay and fingerprint before release. Numerical risk scoring belongs to the local assessment. In the adopted HMPC monograph, hypersensitivity is a contraindication and pregnancy/lactation use is not recommended because data are insufficient. Absence of reported interactions does not prove safety with cardiac medicines. ^{[1], [2], [5], [6]}

Compounding conditions

For scale factor k = (desired mass before settling/filtration)/1000 g, charge 1000×k g of herb. Reserve 800×k g of first percolate and adjust to 1000×k g before 48-hour settling and filtration; record recovered mass. Additional solvent is required for extraction; its amount is not calculated by subtracting the herb mass from final yield. Record lots, comminution method and actual recovery. ^{[1], [2]}

BUD rationale

The French monograph gives no use period, and no study was identified covering this exact formula, container and microbiological suitability. Final ethanol 33–38% v/v is neither a measured aw nor, alone, a preservative-efficacy test. Conservatively assess it as an aqueous product with unknown aw. The 35-day default for justified preserved aqueous products, or 14 days at 2–8 °C for unpreserved products, applies only after the corresponding category and physical compatibility are supported. No operational numerical BUD is assigned here. A recorded decision for this extraction/container is required, limited by the earliest relevant expiry. ^{[1], [3], [5]}

Prerequisites

No separately registered finished base is required. Pharmacopoeial herbal material, suitable-quality ethanol and a controlled preparation of the 45% v/v solvent are required. Data for another species, plant part or commercial extract do not transfer automatically. ^{[1], [5]}

Equipment

Balance, suitable cutter/mill, percolator, closed collection vessels, filter and glass bottles. Also a vacuum concentrator with solvent trap and controlled heating. For QC: TLC capability, ethanol assay and dry-residue determination. ^{[1], [2]}

Compounding method

1. Identify and comminute 1000 g of the specified herb.
2. Percolate with 45% v/v ethanol; reserve the first 800 g of percolate.
3. Continue to exhaustion. Concentrate the remainder under reduced pressure at low temperature to a soft extract.
4. Dissolve this in the reserved fraction; make up to 1000 g with the same extraction solvent.
5. Stand 48 hours in cool conditions, filter, test and package. Numerical low/cool temperatures and the exhaustion endpoint belong in the qualified local process. ^{[1], [2]}

Observations

The 1:1 ratio relates starting herb mass to finished extract mass; it is not purified-active strength. Dry residue, final ethanol and identity must all conform. Correct final mass alone is insufficient. Adjustment to 1000 g precedes 48-hour settling and filtration. Record actual filtered recovery; the source does not direct automatic post-filtration topping-up. ^{[1], [5]}

Container and packaging

Use light-protective glass with a tight, compatible closure. Avoid plastic containers as directed by the source. Record bottle/closure type and assess leakage, mass loss and visible change before adopting a storage period. ^{[1], [2]}

Quality control

TLC with chlorogenic acid, hyperoside and rutin references and assessment of the complete specified fingerprint. Determine dry residue 14–20% on 2.00 g after evaporation and 3 hours drying at 100–105 °C. Assay final ethanol 33–38% v/v. Methanol and 2-propanol testing is also specified. Apply the relevant general microbiological/herbal identity framework; no numerical limit absent from the specific source is invented. ^{[1], [5]}

Storage

Store well closed, light protected, in glass. The source gives no numerical storage temperature or duration. Record the temperature approved with the BUD on the label after assessing precipitation and alcohol retention; refrigeration is not imposed without qualification. ^{[1], [3]}

Dispensing

Supply only after adult clinical assessment and matching to this extract category. Symptoms persisting beyond 2 weeks, lower-limb oedema, breathlessness or chest pain require medical assessment; acute pain must not be managed with this preparation. Do not convert a dose to drops without calibration. ^{[1], [6]}

Labelling

Hawthorn fluid extract
Final ethanol: actual____% v/v (specification 33–38%).
Use only as specified by the responsible pharmacist. Protect from light; close tightly.
Route/dose____ Lot____ Quantity____
Prepared____ Use by____ Approved temperature____
Contains ethanol. Keep from children and ignition sources. ^{[1], [2], [4], [6]}

v9_controls

The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.

Independent Greek/English scientific compilation; not an official ANSM translation or endorsement.

Sources and references

ANSM — Extrait d'aubepine (fluide) (1989) (14/02/2012)1989p 1 opening recipe; p 1 opening procedure; pp 1–2 Characters/Identification/Test; 2 ConservationExact master formula, preparation, specifications and stated storage2026-10-14
PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 2014Chapters 3–6; Annex 2Process records, facilities, contamination control and release; not a product stability study2026-10-13
USP expert presentation — Nonsterile Compounding: Beyond-use dates14 September 2023PDFpp 10–11, slides 19–22Public official expert explanation of USP 795 default categories; no exact-product experimental evidence2026-10-13
INRS — Éthanol, fiche toxicologique 48November 2019pp 1–3 and recommendationspp 7–9Ethanol identity, volatility, flammability and handling; pure-substance properties are not finished-product measurements2026-10-13
EMA — Guideline on quality of herbal medicinal products/traditional herbal medicinal productsEMA/HMPC/CHMP/CVMP/201116/2005 Rev 3;18 January 2022Herbal-substance/preparation control, specifications and stability sectionsBotanical identity, fingerprints, extraction specifications and stability principles2026-10-13
EMA/HMPC — Crataegus spp., folium cum floreEMA/HMPC/159075/2014; adopted 2016§2 preparations;§4.1–4.9Exact herbal-preparation scope, traditional indications and clinical precautions;2025 draft is not substituted for this adopted text2026-10-13
USP — General Chapter <795> Frequently Asked QuestionsNovember 1, 2023 FAQ; rechecked 14 October 2026Questions 52, 54–56, 61, 64–66General category/extension rules only; not exact-product stability evidence.2026-10-14