Povidone-iodine 10% w/v in buffered vehicle, cutaneous solution · CGR-ES-097 (CGR-ES-097)

REFERENCE FORMULA

Reference formula

Reference basis: 100 mL τελικού διαλύματος / final solution

Ingredient	Source quantity	Scaled quantity
Povidone-iodine	10 g	—
Phosphate/citrate buffer pH 6.0, prepared as detailed in method	q.s. ad 100 mL	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Dark-brown opaque solution with a mild characteristic iodine odour [1]. The 10 g/100 mL amount specifies the povidone–iodine complex, not 10% free iodine. The free/bound iodine equilibrium cannot be inferred simply from complex mass [2]. ^{[1], [2]}

Action and use

Cutaneous antiseptic for limited appropriate use on intact skin or minor superficial lesions following clinical assessment [1,2]. This is not a sterile ophthalmic, intracavitary or general mucosal preparation. Extensive burns/chronic wounds require a separate specialist plan. ^{[1], [2]}

Specifications

Source: dark-brown opaque liquid, mild iodine odour and final pH 4.7 measured by pH meter [1]. pH 6.0 concerns the vehicle before API addition. No tolerance around 4.7, water activity, AET result or finished-product available-iodine limit is supplied; these are not invented. ^[1]

Light

Use amber glass and light protection as specified. Do not store the antiseptic in an open clear vessel. Inspect a representative sample promptly while keeping the main container closed. ^{[1], [3]}

Air and oxidation

The source requires tight closure. Minimise prolonged opening and repeated decanting to protect composition and limit contamination. An inert atmosphere or numerical oxygen limit is not established. ^{[1], [3]}

Water and solubility

Prepare aqueous reagent stocks using suitable purified water. Do not reduce concentration by informal dilution in the bottle. Dilution changes iodine equilibrium and does not automatically inherit the original formulation’s BUD or clinical use. ^{[1], [2]}

Humidity

No relative-humidity limit is given for the finished liquid. For solids, verify the exact hydrates and CoA/SDS storage conditions. Dehydrated phosphate or anhydrous citric acid cannot be weighed at the same masses without an approved equivalence calculation. ^{[1], [3]}

Temperature

Prepare without heating; the current cutaneous SmPC also advises against heating before application [2]. FN supplies no numerical storage temperature for this product; define local controlled storage when adopting the source, without inventing refrigeration or accelerated-stability allowances. ^{[1], [2]}

pH and compatibility

First verify the pH 6.0 buffer. After dissolving the complex, the reported final pH is 4.7. Use a pH meter because the strong colour interferes with strips. Do not add base to force the finished product to pH 6; investigate deviations by checking hydrates and concentrations. ^[1]

Other interactions

Do not co-apply or mix with alkalis, hydrogen peroxide, taurolidine, tannic acid or silver/mercury salts [2]. Organic burden may impair activity; colour is not a quantitative potency result. ^{[1], [2]}

Ingredient-specific information

Use povidone-iodine corresponding to RFE 1142 with verified identity/assay. Buffer stocks are Na₂HPO₄·12 H₂O 71.5 g/L and citric acid monohydrate 21 g/L, mixed 63.2:36.8 by volume. Water and reagents must be suitable for pharmaceutical preparation; the label “phosphate buffer” does not exclude its citrate component.

Official raw-material PA/030 defines the iodine/povidone complex with 9.0–12.0% available iodine on the dried-substance basis. The 10 g charge is the complex, not 10 g elemental iodine. The dry-basis specification requires the actual certificate and is not an assay result for the finished solution. ^{[1], [4]}

Staff protection

Weigh powder in a controlled area; use powder-free gloves, laboratory clothing and eye protection during dissolution/transfer. Select tools that limit dispersion and staining. The SDS for the actual povidone-iodine material, not elemental iodine, determines additional exposure controls [3]. ^{[1], [3]}

Risk assessment

Critical points are complex/free-iodine confusion, wrong phosphate hydrate, mistaking buffer pH 6 for finished pH 4.7 and microbial contamination. Clinical review covers thyroid disease, radioiodine, lithium, extensive absorption, infants, pregnancy/breastfeeding and hypersensitivity [2]. The current SmPC excludes children under 1 year; historical mucosal advice is not generalised. ^{[1], [2], [3]}

Compounding conditions

Prepare the two stocks separately at the stated concentrations. For 100 mL buffer, combine 63.2 mL phosphate stock with 36.8 mL citrate stock. Use buffer q.s. in the finished product: do not add 10 g API to 100 mL buffer and assume the final volume remains 100 mL. ^{[1], [3]}

BUD rationale

AEMPS states 3 months in a tightly closed light-protected container [1]. No primary study matching this exact buffer, glass bottle and process was identified. The 2-year commercial Betadine shelf life does not transfer [2]. The reference ceiling is 89 days and never later than 3 calendar months, conditional on approved local adoption of exact composition, temperature and controls; earlier material expiry prevails. This is not aw/AET evidence or a validated general 35-day preserved-product assignment. Do not automatically assign a date without a local temperature/suitability plan. 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], [2], [3]}

Prerequisites

Prepare the buffer within this procedure from the two specified stocks and verify pH 6.0. Do not substitute another “pH 6 buffer”, saline or commercial povidone-iodine product. Solution, pH-calibration and iodine-residue cleaning procedures are needed. ^{[1], [3]}

Equipment

Balance, suitable volumetric apparatus for 71.5/21 g/L stocks and 63.2:36.8 mixing, stirring vessel, calibrated pH meter and amber-glass dropper bottle. Verify electrode cleaning suitability for the strongly coloured vehicle. ^{[1], [3]}

Compounding method

1. Verify hydrates and prepare both stock solutions. 2. Mix 63.2 mL phosphate with 36.8 mL citrate stock and check pH 6.0. 3. Dissolve 10 g povidone-iodine in part of the buffer. 4. Make to final 100 mL with the same buffer and mix. 5. Record final pH 4.7/appearance, package and close tightly. ^{[1], [3]}

Observations

Nominal strength is 100 mg complex/mL. The stocks in 100 mL buffer supply 4.5188 g Na₂HPO₄·12 H₂O and 0.7728 g citric acid monohydrate; these are not automatically the quantities in 100 mL finished medicine because buffer is used q.s. ^[1]

Container and packaging

Use an amber-glass dropper bottle with tamper evidence and tight closure [1]. Verify closure/liner chemical compatibility. The different commercial product’s HDPE packaging is not supporting evidence for this sheet. ^{[1], [2], [3]}

Quality control

Independently check raw materials/weights, final volume, buffer pH and final pH by meter. Inspect appearance/leakage and use an approved available-iodine assay plan where required. Dark colour does not prove correct potency, sterility or absence of contamination. ^{[1], [2], [3]}

Storage

Keep tightly closed and protected from light at the temperature documented in the approved local record. Do not present a numerical range as an AEMPS specification when none is supplied. Store separately as an external preparation, away from children and incompatible antiseptics. ^{[1], [2], [3]}

Dispensing

Review thyroid/radioiodine history, age, pregnancy/breastfeeding, lithium and application area. External use only; avoid eyes, ears and mucosa. Stop and assess marked irritation/hypersensitivity. Do not present this as the same commercial product or a sterile surgical antiseptic. ^{[1], [2]}

Labelling

Povidone-iodine 10% w/v — CUTANEOUS SOLUTION. Not 10% free iodine. External use only; do not swallow. Area/frequency: __. Tightly closed, protect from light; temperature: __ [approved]. Batch: __. Prepared: __. Use by: __. Quantity: __. Keep out of children’s reach. compounding.gr. ^{[1], [2], [3]}

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: POVIDONA IODADA, SOLUCIÓN DEFN/2003/PO/023; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
AEMPS CIMA — Betadine 100 mg/mL solución cutánea, SmPCText revisionAugust 2022; retrieved 2026-10-13Sections 4.3–4.6,6.1–6.2Current topical-povidone-iodine hazards/incompatibilities; commercial excipients, container and 2-year shelf life do not transfer2026-10-13
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
AEMPS — Formulario Nacional, FN/2003/PA/030 Povidona iodadaCurrent standalone PDF retrieved 13 October 2026PDF p. 2, sections 3–5 and 10–11Raw-material identity, dry-basis available-iodine specification, solubility, light/closure protection and incompatibilities; not final-product BUD or clinical-dose authorisation2026-10-13
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