Potassium permanganate 0.01% w/v (1 in 10,000) cutaneous solution · CGR-ES-095 (CGR-ES-095)

REFERENCE FORMULA

Reference formula

Reference basis: 1000 mL / 1000 mL

Ingredient	Source quantity	Scaled quantity
Potassium permanganate	0.10 g	—
Purified water	q.s. ad 1000 mL	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Clear purple solution as described by the source. A 100 mg charge in a final 1000 mL equals 0.1 mg/mL = 0.01% w/v = 1 in 10,000. It is not 1% or a concentrate for arbitrary further dilution. ^{[1], [4]}

Action and use

Restricted to cutaneous antiseptic/astringent use for weeping skin conditions under clinical direction. The later NHS alert supports topical 0.01% use and stringent ingestion prevention. Older references to gargles, mouthwashes or urogenital irrigation are not adopted. ^{[1], [4]}

Specifications

Use raw material RFE 0121 and purified water RFE 0008. Finished product: fully dissolved, clear purple solution without crystals or browning. The raw-material assay of 99.0–100.5% is not a finished 0.01% assay acceptance range. ^{[1], [2], [5]}

Light

Use amber glass and protect from light. The source requires discard if the solution turns brown, even before its maximum use period. ^[1]

Air and oxidation

Close after filling and use to limit contamination and water loss. Do not return used material to the container: organic residues react with the oxidiser. ^{[1], [2], [3]}

Water and solubility

Purified water is the sole vehicle. Organic contamination or reducing impurities consume permanganate and alter colour/activity. Do not add glycerol, ethanol or another organic excipient. ^{[1], [2], [3]}

Humidity

Keep the oxidising raw material in its original tightly closed container and contain dust. The general procedure specifies relative humidity ≤60%. No aw limit is given for the dilute aqueous product. ^{[3], [5], [6]}

Temperature

No heating is required; store below 30 °C. Raw-material solubility of 6.4 g/100 mL at 20 °C greatly exceeds the required charge; heating is not justified to bypass inadequate mixing. ^{[1], [3]}

pH and compatibility

No final pH or buffer is specified. Do not empirically acidify or alkalinise: changing the medium changes redox behaviour and creates a different formula. ^{[1], [2], [3]}

Other interactions

Strong oxidiser: incompatible with reducing agents, organic/combustible materials and metal powders. Separate the raw material from glycerol, ethanol and other flammables. Do not use an organic absorbent such as sawdust for a solid spill. ^{[2], [3]}

Ingredient-specific information

KMnO4, CAS 7722-64-7, deep-purple crystals with strong oxidising action. The charge is only 100 mg per litre; independent unit verification is critical. The source dissolves it first in about one third of the water, not in an organic cosolvent. ^{[1], [2], [3]}

Staff protection

Contain dust and wear gloves, coat and goggles; select face protection for solid handling/splash risk. The solid can cause severe eye/skin injury. Collect waste under a controlled procedure, not down the drain or mixed with organic reagents. ^[3]

Risk assessment

Prioritise ten-/hundred-fold concentration errors, undissolved crystals causing burns, and confusion with oral medicine. Even dilute solution is harmful if swallowed. Assess safe home use, lesion extent and renal disease; do not require the patient to handle crystals for this prescription. ^{[1], [3], [4]}

Compounding conditions

Independently verify 0.10 g = 100 mg per 1000 mL. The balance must have an acceptable minimum weighable quantity for 100 mg; a 100 mL batch needs 10 mg and is unsuitable without the required capability or a validated alternative process. Do not introduce an arbitrary stock solution. ^{[1], [5]}

BUD rationale

The source specifies 7 days in amber glass, protected from light below 30 °C. Retain this short source-specific limit rather than a longer general limit. Discard immediately if brown. No complete exact-formula stability study or preservative challenge test was identified; antiseptic activity does not equal AET. ^{[1], [6]}

Prerequisites

Dependencies are the solutions procedure, safe small-mass weighing, oxidiser segregation and written no-swallow patient information. No unspecified concentrate is required or authorised. ^{[1], [3], [4], [5]}

Equipment

Balance suitable for 100 mg, clean glassware free of organic residues, stirrer, filtration medium compatible with a dilute oxidiser, 1000 mL volume measure and amber glass bottle. ^{[1], [3], [5]}

Compounding method

1. Dissolve 100 mg KMnO4 in approximately one third of the total purified water. 2. Stir until fully dissolved without crystals. 3. Filter through a suitable medium. 4. Make up to a final 1000 mL with purified water and mix. 5. Check clarity/colour and package promptly. ^{[1], [5]}

Observations

This record uses the final 1000 mL stated in the method and patient leaflet. A 1000 g basis is not treated as an established equivalent. Colour intensity depends on optical path and cannot be the sole concentration check. ^{[1], [5]}

Container and packaging

Amber glass bottle with tight closure and prominent topical warning. Never use food/drink containers; store separately from oral medicines. Any application vessel must also be labelled, must not be a drinking cup and must be emptied safely. ^{[1], [4]}

Quality control

Independently check calculation/weight, final volume, complete dissolution, clarity and absence of browning. No validated assay for this finished dilution is supplied. Visual inspection cannot detect every concentration error or microbiological contamination. ^{[1], [5]}

Storage

Store below 30 °C, protected from light, tightly closed and separate from oral medicines, food and reducing/organic reagents. If brown, do not use or restore by adding more KMnO4. ^{[1], [3], [4]}

Dispensing

Dispense for a named patient with written cutaneous directions, defined area/duration and clear carer instruction. Do not gargle or drink. Ingestion requires immediate emergency medical/poison-centre help; dilute concentration does not remove the hazard. ^{[4], [1]}

Labelling

Potassium permanganate 0.01% w/v (0.1 mg/mL, 1 in 10,000) — CUTANEOUS USE ONLY. HARMFUL IF SWALLOWED. Ready dilution; use according to written directions. Store below 30 °C, protected from light. Discard if brown and no later than 7 days. Keep separate from oral medicines and away from children. Complete actual dates/batch/quantity 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 — PERMANGANATO DE POTASIO, SOLUCIÓN AL 1/10.000 DE (FN/2003/PO/019)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 — Permanganato de potasio (FN/2003/PA/029)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 0672 — Potassium permanganateNovember 2016Identity; 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
NHS England — Inadvertent oral administration of potassium permanganateNatPSA/2022/003/NHSPS, 5 April 2022pp. 1–2, alert and required actionsCurrent route, ingestion-prevention, storage and patient-information controls for topical potassium permanganate; not a stability study.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