Copper sulfate pentahydrate cutaneous solution 0.1% w/v

Clear, pale sky-blue liquid.

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Astringent and antiseptic. AEMPS describes cutaneous use for impetigo, exudative/crusted dermatitis and eruptions. Treatment selection requires clinical assessment.

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Clear, pale sky-blue liquid. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided.

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The finished preparation is stored protected from light under the monograph.

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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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Copper sulfate pentahydrate is freely soluble in water and practically insoluble in ethanol.

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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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Finished-product storage: Below 30°C; protect from light. Processing follows the method-specific temperatures.

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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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Copper sulfate pentahydrate is incompatible with reducing agents.

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Exact identities: Πενταϋδρικός θειικός χαλκός / Copper sulfate pentahydrate; Κεκαθαρμένο ύδωρ / Purified water. 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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Laboratory environment under the referenced AEMPS procedure: 25±5°C and relative humidity ≤60%, unless the specific formulation requires otherwise. Room temperature differs from processing temperature.

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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.

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Ingestion of the salt can cause severe gastrointestinal toxicity. The source associates copper accumulation with haemolysis and hepatic/renal injury.
Copper sulfate: concentrated solutions are corrosive; overexposure is associated with haemolysis, hepatic and renal injury.

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The specific monograph states 3 weeks under its specified conditions. This is a source period, not independently verified stability of the local batch. Match composition, preservative, container and storage, check applicable requirements and obtain responsible approval. The actual date remains blank.

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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.

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1. Weigh 0.1 g of the pentahydrate salt.
2. Dissolve in approximately 75 mL purified water.
3. Make up to a final volume of 100 mL with water and mix.

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The master formula is 0.1 g pentahydrate to 100 mL. The leaflet heading says “100 g” but repeats ad 100 mL. The explicit volume-based formula in §3.1 is retained. Do not substitute anhydrous salt without calculation.

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Amber or opaque bottle.

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Copper sulfate pentahydrate cutaneous solution 0.1% w/v
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 30°C; protect from light.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.

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Under AEMPS: organoleptic properties and final mass and/or volume. For batches: colour RFE 2.2.2, clarity/opalescence RFE 2.2.1, relative density RFE 2.2.5, pH under PN/L/CP/001/00 and microbiological testing under RFE 5.1.4. This formula provides no numerical pH/density limits or specific active assay.

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Below 30°C; protect from light.

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Cutaneous use only. The source gives 3–4 applications/day to a clean, dry area. Do not swallow or use as an emetic. Pregnancy and breastfeeding require medical assessment.

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