Alibour water with copper sulfate 0.1%, zinc sulfate 0.4% and camphor 0.1% w/v · CGR-ES-102 (CGR-ES-102)

REFERENCE FORMULA

Reference formula

Reference basis: 100 mL τελικού διαλύματος / final solution

Ingredient	Source quantity	Scaled quantity
Copper sulfate pentahydrate	0.1 g	—
Zinc sulfate heptahydrate	0.4 g	—
Racemic camphor	0.1 g	—
Ethanol 96%	1 mL	—
Purified water	q.s. ad 100 mL	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Nonsterile clear very pale-blue liquid with camphor odour. Salt concentrations refer to copper pentahydrate and zinc heptahydrate, not elemental metals. Preparation includes a 24-hour holding period and filtration. ^[1]

Action and use

Traditional AEMPS cutaneous astringent/antiseptic. Historical references to infected dermatoses do not establish current first-line treatment or replacement of necessary antimicrobial therapy. Approve indication, site and duration for the individual patient. ^[1]

Specifications

Source: clarity, very pale-blue colour and characteristic camphor odour. No numerical pH, aw or assay limits are supplied. Check yield and sustained clarity after filtration; colour intensity is not a quantitative copper assay. ^{[1], [6]}

Light

Package in an opaque bottle as AEMPS specifies. Maintain equivalent protection after transfer; a clear container is not established as equivalent. ^[1]

Air and oxidation

Keep closed during the 24-hour hold and after each use to limit volatile loss and contamination. Camphor sublimes at room temperature [4] and ethanol is volatile [5]. No validated open-holding duration or inert gas is specified. ^{[1], [4], [5], [6]}

Water and solubility

Purified water is the main vehicle.1 mL 96% ethanol/100 mL does not demonstrate preservation. ICSC reports limited camphor water solubility [4]; check clarity after salt mixing and holding rather than assuming complete solubility at every temperature. ^{[1], [4]}

Humidity

Raw materials must retain their specified hydrate identity. Use verified CuSO₄·5 H₂O and ZnSO₄·7 H₂O, not anhydrous salts at the same weights. No relative-humidity limit is set for the finished liquid. ^{[1], [2], [3]}

Temperature

Source: below 30 °C. Do not impose refrigeration without evidence of camphor’s physical compatibility. Perform the 24-hour hold under recorded controlled conditions. Do not heat alcoholic camphor solution with a flame or unsuitable heat source. ^{[1], [4], [5]}

pH and compatibility

No final pH is specified. Record it with a suitable meter as a batch parameter where useful, but do not add an acid/alkali buffer. A pH change may alter metal-component solubility/speciation and requires separate assessment. ^{[1], [6]}

Other interactions

Do not mix other antiseptics or alkaline soaps into the bottle. Segregate raw materials according to their SDS incompatibilities. Collect copper/zinc waste through an appropriate route rather than pouring into drains [2,3]. ^{[1], [2], [3]}

Ingredient-specific information

Copper pentahydrate CAS 7758-99-8 and zinc heptahydrate CAS 7446-20-0 [2,3]. Use racemic camphor corresponding to RFE 0655; its safety card distinguishes isomers [4]. Use pharmacopoeial 96% ethanol, not denatured spirit. Verify 0.1/0.4/0.1 g weights against the balance’s minimum weighable quantity. ^{[1], [2], [3], [4]}

Staff protection

Control salt/camphor dust during weighing; use gloves and safety goggles. Raw copper sulfate can cause serious eye injury [2]. Select extraction for dust/vapour according to local assessment and remove ignition sources during ethanol handling [4,5]. ^{[2], [3], [4], [5]}

Risk assessment

Principal risks are wrong-route/child ingestion, camphor neurotoxicity, irritation and incorrect salt hydrates [1–4]. It is neither oral nor ophthalmic. The source advises against pregnancy/breastfeeding use and cautions in children. Holding/filtration requires process hygiene and mass/volume reconciliation without arbitrary loss replacement. ^{[1], [2], [3], [4], [6]}

Compounding conditions

For V mL:0.001 V g copper pentahydrate,0.004 V g zinc heptahydrate,0.001 V g camphor,0.01 V mL 96% ethanol and water to V. Use a compatible filter with documented retention/product losses. This is not labelled sterilising filtration. ^{[1], [6]}

BUD rationale

AEMPS gives 3 weeks, or 21 days, below 30 °C [1]. No matching primary physicochemical/microbiological study or aw/AET evidence was identified.21 days is a reference ceiling conditional on local adoption of exact composition, opaque container and controls. The 24-hour hold counts from preparation start. Ethanol does not establish preservation and an arbitrary 14-day refrigerated period is not imposed. Earlier expiry or loss of clarity prevails. ^{[1], [6]}

Prerequisites

No composite base is used. The exact hydrated salts, racemic camphor and 96% ethanol are required. Use SOPs for solutions, protected 24-hour holding, filtration, cleaning and metal-containing waste. ^{[1], [6]}

Equipment

Small-mass balance, two dissolving vessels, volumetric apparatus, closure for the 24-hour hold, compatible filter and opaque bottle. Segregated tools/cleaning limit copper and zinc carryover into subsequent preparations. ^{[1], [6]}

Compounding method

1. Dissolve both sulfate salts in approximately three quarters of the water. 2. Separately dissolve camphor in ethanol. 3. Combine and make to 100 mL with water. 4. Hold protected for 24 hours. 5. Filter, check clarity/yield and package. Do not add extra solvent to conceal precipitation. ^{[1], [6]}

Observations

The formula is by final 100 mL volume, not 100 g mass. It nominally supplies 1 mg/mL copper pentahydrate,4 mg/mL zinc heptahydrate and 1 mg/mL camphor before any process loss. These are neither elemental-metal concentrations nor ingestion doses. ^[1]

Container and packaging

Use an opaque tight bottle compatible with the solution and external use. Design packaging to prevent confusion with an oral solution, with prominent labelling and a suitable child-resistant closure. ^{[1], [6]}

Quality control

Verify hydrate identities/quantities, prefiltration final volume,24-hour hold, final yield, pale-blue colour and clarity. Investigate precipitate/API loss on the filter. Apply microbiological and assay controls under the approved plan; filtration does not demonstrate sterility. ^{[1], [6]}

Storage

Below 30 °C in an opaque tightly closed bottle. Do not refrigerate without established physical compatibility. Keep away from children and food. Quarantine turbidity/crystals rather than simply shaking. ^{[1], [4], [6]}

Dispensing

External use only after approval of the indication. No ingestion, eye use or informal dilution. Any dilution, site and duration must be specifically directed. Accidental ingestion requires urgent medical assessment with the label available. ^{[1], [4]}

Labelling

Alibour water — CUTANEOUS SOLUTION. Contains copper/zinc sulfates and camphor. External use only; DO NOT SWALLOW. Directions: __. Below 30 °C, tightly closed in opaque bottle. Keep away from children. Batch: __. Preparation started: __. Use by: __. compounding.gr. ^{[1], [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.

Sources and references

AEMPS — Formulario Nacional: AGUA DE ALIBOURFN/2006/PO/034; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
ILO/WHO — ICSC1416 Copper(II) sulfate pentahydrateNovember 2023Hazards, handling, storage, environmental effectsHydrated copper-salt occupational hazard; not a classification of finished diluted mixture2026-10-13
ILO/WHO — ICSC0349 Zinc sulfate heptahydrateOctober 2001; current cardHandling, physical properties, environmentExact hydrated zinc-salt hazard; not finished-product stability2026-10-13
ILO/WHO — ICSC1021 CamphorJuly 2003; current official card retrieved 2026Properties, handling and health effects; note on racemic formCamphor volatility/limited water solubility and ingestion/exposure hazards, not formulation stability2026-10-13
ILO/WHO — ICSC0044 Ethanol (anhydrous)May 2018Fire/explosion; handling; chemical incompatibilitiesRaw ethanol hazards; numerical anhydrous flash point is not assigned to finished mixtures2026-10-13
Ministerio de Sanidad — Guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalariaJune 2014; official AEMPS copyAnnexes 3–4, PDF pp.51–58Nonsterile preparation risk assessment, equipment, packaging and quality controls; not Greek legislation2026-10-13
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