Rosemary essential oil alcoholic solution 5% v/v

Clear, colourless liquid with the odour of rosemary essential oil.

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Topical rub for symptomatic relief of muscle and joint pain, as described by AEMPS.

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Clear, colourless liquid with the odour of rosemary essential oil. 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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Ethanol generates vapour; limit time in open vessels. Evaporation can change composition (editorial process assessment).

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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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Finished-product storage: Below 30°C; protect from light and moisture as stated in the leaflet. 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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Ethanol is incompatible with strong oxidants.

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Exact identities: Αιθέριο έλαιο δενδρολίβανου / Rosemary essential oil; Αιθανόλη 96% / Ethanol 96%. 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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Possible skin sensitisation/irritation and high alcohol content. Exact essential-oil identity is necessary.
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.

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The specific monograph states 3 months 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. Measure 5 mL pharmacopoeial-grade rosemary essential oil.
2. Dissolve in part of the 96% ethanol.
3. Make up to 100 mL with 96% ethanol and mix.

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Contains 5 mL essential oil, not 5 g herbal extract or tincture.

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Opaque, hermetically closed bottle.

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Rosemary essential oil alcoholic solution 5% v/v
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 30°C; protect from light and moisture as stated in the leaflet.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Flammable. Keep away from flames. Do not swallow.
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 and moisture as stated in the leaflet.

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Cutaneous use only; a small amount with gentle rubbing several times daily according to the source. Stop if irritation occurs. Do not use with ingredient hypersensitivity. The source provides no specific paediatric regimen.

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