Brown cutaneous solution with the characteristic odour described by the master. It contains 20 mg/mL iodine and 25 mg/mL potassium iodide on final volume. Potassium iodide enables iodine dissolution through complex formation in the aqueous stage. [1], [2]
Action and use
Cutaneous antiseptic, applied in the amount needed for the specified area under the source and clinical directions. It is not an oral iodine solution, thyroid treatment or ophthalmic preparation. [1], [2]
Specifications
Use iodine RFE 0031, source-compliant potassium iodide, purified water and ethanol 96%. Check complete dissolution, a homogeneous brown solution and final volume. The 99.5–100.5% range applies to raw iodine, not the finished 2% solution. [1], [2], [5]
Light
The master requires amber glass and protection from light. The solution’s own brown colour does not replace light-protective packaging. [1]
Air and oxidation
Iodine sublimes and ethanol evaporates; minimise open weighing/mixing time and use a tight seal. The master requires an airtight bottle but does not specify inert-gas blanketing. [1], [2], [3], [4]
Water and solubility
Water is a specific 25 mL charge used first to dissolve KI and then iodine. Adding iodine directly to water alone is not equivalent because of low aqueous solubility. Make up with ethanol 96%, not water. [1], [2]
Humidity
Keep raw materials clean and tightly closed. The general solutions procedure specifies relative humidity ≤60%; no finished-formula humidity study is supplied. [1], [5]
Temperature
No heating is specified. Store below 30 °C as stated by the source, away from ignition sources. Heating increases iodine/ethanol vapour exposure and is not a remedy for incomplete dissolution. [1], [3], [4]
pH and compatibility
No final pH is specified. No buffer is added; arbitrary neutralisation can change iodine species and activity. A pH value from another iodine formulation is not transferred. [1], [2], [3]
Other interactions
Iodine is a strong oxidiser, incompatible with reducing agents, ammonia and various metals. Ethanol is incompatible with strong oxidisers outside the documented specific formulation. Avoid metal contamination and empirical mixing with other antiseptics. [2], [3], [4]
Ingredient-specific information
Iodine I 2, CAS 7553-56-2, molecular mass 253.8: volatile crystals producing irritating vapour. Potassium iodide acts as a solubilising aid. Use undenatured pharmaceutical ethanol; rubbing alcohol containing unspecified denaturants is not equivalent. [1], [2], [3], [4]
Staff protection
Weigh iodine under local extraction with suitable gloves, coat and eye protection. Avoid metal weighing surfaces and vapour inhalation. Measure ethanol away from flames/sparks. Do not sniff close to the vessel as a quality check. [2], [3], [4]
Risk assessment
Assess previous reactions to the actual iodine preparation, thyroid disease and forthcoming thyroid testing. Avoid repeated/extensive use, occlusion, obstetric/neonatal use and regular use during pregnancy/lactation without clinical decision. Undissolved crystals increase local burn risk. [1], [2], [3]
Compounding conditions
For 100 mL: 2.00 g I 2, 2.50 g KI, 25 mL water and ethanol 96% to final volume. Independently check the two solids to avoid confusing iodine with potassium iodide. Set final volume after complete dissolution at working temperature. [1], [5]
BUD rationale
The source states three months in airtight amber glass below 30 °C. No complete exact-formula/container stability study or AET was identified. With documented local adoption, the ceiling is the earliest of 89 days, three calendar months and raw-material limits. Antiseptic action and ethanol alone are not preservative-efficacy evidence and do not establish aw. Editorial convention: calendar-month source periods are retained as calendar periods; the calendar-period conversion ceiling is 28 days for one month or 89 days for three months; a separately selected shorter ceiling still governs. It is a conservative conversion, not a source quotation. [1], [6]
Prerequisites
The solutions procedure and acceptance of all four raw materials are required. Lugol solution or another iodine monograph is not an intermediate dependency: differing I 2/KI and alcohol ratios are not interchangeable. [1], [2], [5]
Equipment
Suitable balance, nonmetal weighing surface, glass beaker/rod, 100 mL volume measure and amber glass bottle with a compatible airtight closure. Use a work station with vapour extraction. [1], [2], [3], [5]
Compounding method
1. Dissolve KI completely in the 25 mL purified water. 2. Add iodine and stir until no crystals remain. 3. Add undenatured ethanol 96% to a final 100 mL and mix. 4. Check and package promptly. [1], [2], [5]
Observations
The 25 mL water charge and ethanol q.s. ad do not establish exactly 75 mL ethanol or a final 72% v/v: dissolved solids and nonadditive volumes matter. Label the defined active composition rather than an assumed final alcohol strength. [1], [5]
Container and packaging
Amber glass bottle with an airtight closure compatible with iodine/alcohol. Avoid exposed metal components in contact with contents. Packaging must avoid confusion with oral iodine solutions. [1], [2], [3]
Quality control
Check identity and masses of I 2/KI, final volume, uniform colour and complete absence of crystals. Colour does not quantify available iodine. Analytical release requires an appropriate finished-product method, not supplied by this particular master. [1], [2], [5]
Storage
Store below 30 °C, protected from light, airtight and away from heat/ignition. Investigate colour change, crystals or closure leakage before use. [1], [3], [4]
Dispensing
Use externally on skin only, for the prescribed area and duration. Explain staining/irritation, avoidance of eyes/mucosa/ear, and no swallowing. Check thyroid history, pregnancy/lactation and neonatal exposure before dispensing. [1], [2]
Labelling
Iodine 2% w/v + potassium iodide 2.5% w/v alcoholic solution — cutaneous use only. Do not swallow. Avoid eyes/mucosa and extensive or prolonged use. Protect from light/ignition, tightly closed below 30 °C. Enter batch, quantity, preparation and authorised use-by dates during execution. [1], [4]
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 — ALCOHOL IODADO (FN/2003/PO/011)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–4; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
AEMPS — Iodo (FN/2003/PA/017)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
ILO/WHO International Chemical Safety Card 0167 — IodineApril 2004Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
ILO/WHO International Chemical Safety Card 0044 — Ethanol (anhydrous)May 2018Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
AEMPS — Elaboración de soluciones (PN/L/FF/007/00)Official FN procedure, version 00, accessed 2026-10-13Sections 5–6: environment, preparation, packaging, finished-product checksOfficial general dosage-form procedure; exact formula method takes precedence; batch-level tests are distinct from tests actually performed.2026-10-13
USP — Compounding Standards and Beyond-Use DatesNovember 2022 update, official USP fact sheet hosted by Mississippi Board of PharmacyNonsterile preparation BUD overview and category tableGeneral BUD framework; an AEMPS source period is not automatically a USP–NF monograph exception, and no measured water activity is implied.2026-10-13
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
