Peru balsam ointment 6% w/w

Light-brown ointment with a characteristic odour.

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AEMPS records use for skin lesions, fissures, burns and wounds. This preparation is nonsterile; suitability for an individual lesion requires separate assessment.

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Light-brown ointment with a characteristic odour. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided.

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Protect virgin castor oil from light.

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Castor oil can undergo oxidative rancidity.

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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.

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Finished-product storage: Below 30°C. 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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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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Exact identities: Βάλσαμο Περού / Peru balsam; Παρθένο καστορέλαιο / Virgin castor oil; Λευκός κηρός μελισσών / White beeswax; Λευκή βαζελίνη / White petrolatum. 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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Peru balsam may cause hypersensitivity, photodermatitis and phototoxic reactions according to the source. Assess staff exposure and allergy history.

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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. Melt beeswax and petrolatum in a 50–70°C water bath.
2. Mix Peru balsam with castor oil in a mortar.
3. Add this mixture to the melted base, stirring until ambient temperature. The theoretical petrolatum quantity is 60 g before any documented batch adjustments.

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The base contains 28% beeswax and differs from common softer balsam ointments. Do not change the base while retaining the same beyond-use period.

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Opaque jar.

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Peru balsam ointment 6% w/w
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 30°C.
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. Batch production additionally requires spreadability PN/L/CP/003/00 and microbiological testing under RFE 5.1.4. The source does not specify a formula-specific active assay. Uniform appearance alone does not establish content uniformity.

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Below 30°C.

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The source gives 2–3 applications/day. Avoid extensive or prolonged application. Do not use with ingredient hypersensitivity. Stop if an allergic reaction develops.

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