Weak Lugol Solution AEMPS 2025

Brown liquid with iodine odour. ^[1]

Oral iodine preparation for specific medical indications; it is not a universal thyroid-prophylaxis regimen. ^[1]

Brown liquid with iodine odour. ^[1]

Protect potassium iodide raw material from light. ^[2]

Iodine is volatile at ambient temperature. ^[3]

Iodine is poorly soluble in water; KI increases solubility.
Potassium iodide is very soluble in water and freely soluble in glycerol; it solubilises iodine. ^{[2], [3]}

No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. ^[1]

For the finished product the source specifies:
Amber glass bottle; <30 °C. ^[1]

No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. ^[1]

KI: incompatibilities with acids, metal salts, alkaloids, chloral hydrate and potassium chlorate. ^[2]

Identity and weighing basis:
• Iodine: 0.015 g.
• Potassium iodide: 0.030 g.
• Purified water: q.s. ad 100 mL.
The specified chemical forms/grades belong to the exact source formula. ^[1]

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [4], [5]}

Reference batch: 100 mL. First ingredient: Iodine, 0.015 g. Independently check chemical form, units and every scale conversion before weighing.
Check complete dissolution and crystallisation at the selected temperature. Calculate dose volume from the exact mg/mL, not the starting tablet or stock strength. Supply a suitable oral syringe.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: confirm final volume or mass at the reference temperature, intended clarity or dispersion, and specified container/closure. Do not equate grams and millilitres without a justified density. ^{[1], [8], [10]}

Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. ^{[1], [5]}

Period reported by source: 3 months.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected conservative general rule: up to 14 days at 2–8 °C for an aqueous form without adequately established preservation. Refrigeration must not cause precipitation, irreversible separation or other loss of suitability. If that condition fails, do not apply 14 days at room temperature; obtain specific short-use evidence.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. ^{[1], [6], [7], [9], [11]}

No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. ^[1]

Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. ^[1]

Triturate iodine and KI in glass mortar; dissolve in 1/10 water, make up volume, mix and paper-filter. ^[1]

Source 0.38 mg/mL denotes total iodine including iodide. Molecular iodine amount is 0.15 mg/mL. ^[1]

Amber glass bottle; <30 °C. ^[1]

Brown liquid with iodine odour.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. ^{[1], [10]}

Source-reported conditions/container: Amber glass bottle; <30 °C.
For the selected general ceiling: 2–8 °C, provided physical suitability and compatibility with the specific source are maintained. The 14-day rule does not apply at room temperature. ^{[1], [6], [7]}

Dispense the exact prescribed strength. For liquids use a suitable graduated oral syringe; record dose and frequency from the prescription. ^[1]

Weak Lugol Solution AEMPS 2025
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 2–8 °C, after confirming suitability for refrigeration.
Temperature for this batch BUD: ____ ^{[1], [6], [7]}

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.