REFERENCE FORMULA
Reference formula
Reference basis: 1000 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Iodine | 60 g | — |
| Potassium iodide | 40 g | — |
| Ethanol 70% v/v | q.s. ad 1000 mL | — |
REFERENCE FORMULA SCALING
Proportional quantities of the same formula
Arithmetic aid. It does not change strength, dose, method or BUD and does not authorise compounding.
Theoretical calculation sheet
CGR-JP-008 · Iodine Tincture JP 6% with potassium iodide 4%
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Dark reddish-brown liquid with a characteristic odour. Relative density d20/20 approximately 0.97. [1]
Action and use
JP alcoholic iodine preparation. The monograph is a quality standard and does not provide a clinical indication, dose or evidence supporting 6% use in an individual patient. [1]
Specifications
Iodine 5.7–6.3% w/v and KI 3.8–4.2% w/v. Alcohol number ≥6.6 under JP 1.01, Method 2 with specified pretreatment. Dark reddish-brown liquid; d20/20 approximately 0.97. [1]
Light
Protect potassium iodide raw material from light. [5]
Air and oxidation
Ethanol generates vapour; limit time in open vessels. Evaporation can change composition (editorial process assessment).
Iodine is volatile at ambient temperature. [4]
Iodine is volatile at ambient temperature. [4]
Water and solubility
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [1]
pH and compatibility
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
Ingredient-specific information
Exact identities: Ιώδιο / Iodine; Ιωδιούχο κάλιο / Potassium iodide; Αιθανόλη 70% κατ’ όγκο / Ethanol 70% v/v. Use pharmacopoeial raw materials of the referenced edition, with CoA verification. Do not arbitrarily change salt, hydration state or strength. Record the actual q.s. amount in the batch. [1]
Compounding conditions
Staff protection
Clean protective clothing and head covering under AEMPS PN/L/PG/002/00. Use suitable gloves where contact is possible and respiratory/eye protection where powder handling requires it. Exact glove material, ventilation and respiratory protection must follow the SDS and local exposure assessment.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. [3], [7]
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. [3], [7]
Risk assessment
High iodine concentration and a flammable solvent require separate clinical and occupational exposure assessment. Do not equate this formula with dilute iodine tincture or povidone-iodine.
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL. First ingredient: Iodine, 60 g. Independently check chemical form, units and every scale conversion before weighing.
Verify chemical form and the w/w, w/v or v/v concentration basis against the formula. Do not equate g and mL without supported density. Check clarity/crystallisation and exact application route.
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.
Volatile solvent in this formula: Ethanol 70% v/v q.s. ad 1000 mL. Exclude ignition sources and minimise vapours/open evaporation. Check ventilation, electrical equipment and container compatibility with the specific solvent.
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], [3], [6], [7], [12], [14]
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL. First ingredient: Iodine, 60 g. Independently check chemical form, units and every scale conversion before weighing.
Verify chemical form and the w/w, w/v or v/v concentration basis against the formula. Do not equate g and mL without supported density. Check clarity/crystallisation and exact application route.
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.
Volatile solvent in this formula: Ethanol 70% v/v q.s. ad 1000 mL. Exclude ignition sources and minimise vapours/open evaporation. Check ventilation, electrical equipment and container compatibility with the specific solvent.
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], [3], [6], [7], [12], [14]
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
Solvent system: ethanol 70% v/v to 1000 mL. Conservatively select the aqueous alcoholic category with antimicrobial contribution from the solvent, without claiming aw <0.6 or a longer nonaqueous allowance. Appropriate preservation of the exact final mixture remains a prerequisite. Do not transfer the period to a dilution.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
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], [9], [10], [11], [13], [15]
Solvent system: ethanol 70% v/v to 1000 mL. Conservatively select the aqueous alcoholic category with antimicrobial contribution from the solvent, without claiming aw <0.6 or a longer nonaqueous allowance. Appropriate preservation of the exact final mixture remains a prerequisite. Do not transfer the period to a dilution.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
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], [9], [10], [11], [13], [15]
Prerequisites
No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. [1]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
Compounding method
1. Weigh iodine 60 g and KI 40 g.
2. Dissolve both ingredients in part of the 70% v/v ethanol according to the JP formula.
3. Make up to 1000 mL with the same solvent and mix. The specific order of addition, time and temperature are not specified in the individual monograph and must be finalised in the local SOP. [1], [2]
2. Dissolve both ingredients in part of the 70% v/v ethanol according to the JP formula.
3. Make up to 1000 mL with the same solvent and mix. The specific order of addition, time and temperature are not specified in the individual monograph and must be finalised in the local SOP. [1], [2]
Observations
Iodine strength is 6% w/v, not 6% w/w. The 70% refers to the added solvent and does not replace the finished-product alcohol-number test.
The reviewed source remains English JP XVIII. PMDA confirms JP XIX publication on 10 April 2026 and schedules English publication within one year. This work did not complete a comparison of the full final Japanese text of all relevant monographs; no JP XIX conformity is claimed. [1], [16]
The reviewed source remains English JP XVIII. PMDA confirms JP XIX publication on 10 April 2026 and schedules English publication within one year. This work did not complete a comparison of the full final Japanese text of all relevant monographs; no JP XIX conformity is claimed. [1], [16]
Container and packaging
Labelling
Iodine Tincture JP 6% with potassium iodide 4%
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Keep tightly closed. JP specifies no temperature or beyond-use period here. Light protection is separately based on raw-material information. Keep away from ignition sources.
Temperature for this batch BUD: ____ [1]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Keep tightly closed. JP specifies no temperature or beyond-use period here. Light protection is separately based on raw-material information. Keep away from ignition sources.
Temperature for this batch BUD: ____ [1]
Quality control
Identification: iodine gives a blue-to-purple starch reaction; processed sample gives potassium/iodide reactions under JP. Iodine assay: titrate a 5 mL aliquot with 0.1 mol/L sodium thiosulfate after the specified KI, water and HCl additions, using starch indicator. Each mL titrant equals 12.69 mg I. KI assay: titrate a separate 5 mL aliquot with 0.05 mol/L potassium iodate using the prescribed acidic two-phase method; KI(mg)=16.60×[a−b/2], where a=mL iodate and b=mL thiosulfate from the iodine assay. The 3.8–4.2% limit refers to the final solution, not the aliquot. Analytical chloroform/HCl handling requires a suitable laboratory.
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], [2], [14]
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], [2], [14]
Storage
Keep tightly closed. JP specifies no temperature or beyond-use period here. Light protection is separately based on raw-material information. Keep away from ignition sources.
For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [2], [5], [6], [8]
For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [2], [5], [6], [8]
Dispensing
No clinical dose is specified by the source. Dispensing requires the responsible pharmacist/clinician to confirm indication, route and concentration. Do not swallow; keep out of reach of children. [1]
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 adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- MHLW — JP XVIII: Iodine Tincture JP 6% with potassium iodide 4%2021JP XVIII (2021), printed p. 1170, Iodine Tincturespecific formulation2026-09-10
- MHLW — JP XVIII, General Rules for Preparations202111-4 Ointments and 11-2 Cutaneous liquids, printed p. 20; Other Preparations 3 Spirits, p. 22; General Noticesgeneral procedure2026-09-10
- PN/L/PG/002/00 INDUMENTARIAPN/L/PG/002/00Clothing and protective equipmentgeneral procedure2026-09-10
- FN/2003/PA/017 IODOFN/2003/PA/017Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PA/018 IODURO DE POTASIOFN/2003/PA/018Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholOfficial agency pageRaw-material properties, handling and incompatibilitiesspecific formulation2026-09-10
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- Allan MC, Mauer LJ. Dataset of water activity measurements of alcohol:water solutions using a Tunable Diode LaserData in Brief. 2017;12:364–369Table 1; ethanol/water at 25 °C; DOI 10.1016/j.dib.2017.04.017Full text read. Binary-mixture water activity; volume ratios before mixing, not finished medicinal-product shelf life2026-09-12
- CDC — Chemical Disinfectants: Alcohol28 November 2023; 2008 guidelineAlcohol: Overview and Microbicidal activityAlcohol antimicrobial context; not a finished-product preservative challenge test2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQs (official, updated 1 November 2023)Updated 1 November 2023; retrieved 14 October 2026Q52, Q61–64; use with the applicable full chapterWater-activity classification, component dating and BUD documentation; general professional framework, not a Greek legal adoption or formula-specific study2026-10-14
- PMDA — JP publication schedule / Frequently Asked QuestionsCurrent official schedule, retrieved 14 October 2026JP19 published 10 April 2026; English edition scheduled within one yearEdition status only; not a comparison of individual JP19 monographs2026-10-14