Iodine Tincture JP 6% with potassium iodide 4%

Dark reddish-brown liquid with a characteristic odour. Relative density d20/20 approximately 0.97.

References: [1]

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.

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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.

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Protect potassium iodide raw material from light.

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Iodine is volatile at ambient temperature.
Ethanol generates vapour; limit time in open vessels. Evaporation can change composition (editorial process assessment).

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Iodine is poorly soluble in water; KI increases solubility.
Ethanol is miscible with water. This does not establish that all dissolved actives remain soluble after dilution.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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KI: incompatibilities with acids, metal salts, alkaloids, chloral hydrate and potassium chlorate.
Ethanol is incompatible with strong oxidants.

References: [6] · [7]

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.

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JP provides no specific numerical room limits for this formula. Define a local SOP covering suitable clean conditions, temperature control and contamination prevention. This is an editorial checklist.

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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.

References: [4]

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.

References: [1] · [7]

The specific monograph provides no finished-product beyond-use period/BUD. No duration is assigned by assumption. Suitable stability evidence and responsible-pharmacist approval are required before release.

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No separate compound base is required in the explicit formula.

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Balance with suitable resolution, mortar/spatula, suitable mixing vessels and final container. Add volumetric equipment for mL, a controlled water bath where melting is specified and a suitable filter where required. Analytical equipment follows the QC methods.

References: [1] · [2]

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.

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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.

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JP requires a tight container. A light-resistant bottle is a conservative local choice based on KI information and requires compatibility assessment.

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Iodine Tincture JP 6% with potassium iodide 4%
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. 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.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Flammable. Keep away from flames. Do not swallow.
Specimen for pharmacist adaptation; not a final approved label.

References: [1] · [7]

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.

References: [1] · [2]

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.

References: [1] · [2] · [6] · [7]

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.

References: [1]