Peru balsam ointment 6% w/w

Light-brown ointment with a characteristic odour. ^[1]

AEMPS records use for skin lesions, fissures, burns and wounds. This preparation is nonsterile; suitability for an individual lesion requires separate assessment. ^[1]

Light-brown ointment with a characteristic odour. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided. ^[1]

Protect virgin castor oil from light. ^[4]

Castor oil can undergo oxidative rancidity. ^[4]

White Petrolatum: JP classifies the corresponding pure raw material as practically insoluble in water. ^[5]

No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. ^[1]

Finished-product storage: Below 30°C. Processing follows the method-specific temperatures.
Virgin castor oil raw material: ≤25°C in PA031. The formula separately specifies processing temperature. ^{[1], [4]}

No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. ^[1]

No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. ^[1]

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.
White Petrolatum: raw-material water solubility is classified as practically insoluble by JP. ^{[1], [5]}

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. ^[2]

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.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[3], [6]}

Peru balsam may cause hypersensitivity, photodermatitis and phototoxic reactions according to the source. Assess staff exposure and allergy history.
Reference batch: 100 g. First ingredient: Peru balsam, 6 g. Independently check chemical form, units and every scale conversion before weighing.
Check uniform active distribution and absence of aggregates after cooling. Overheating, water ingress or a changed base alter the preparation; record actual yield and transfer losses.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
Release checkpoint: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. ^{[1], [2], [10], [12]}

Period reported by source: 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.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected general rule: up to 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted.
Register correction: at most 89 days as a conservative reference cap before any shorter expiry/component date. This edition converts one calendar month to 28 days and three calendar months to 89 days; weeks are converted to seven days. Original source units are retained. This is an editorial conversion policy, not a new stability result or automatic release. ^{[1], [8], [9], [11], [13]}

No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. ^[1]

Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. ^[1]

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. ^{[1], [2]}

The base contains 28% beeswax and differs from common softer balsam ointments. Do not change the base while retaining the same beyond-use period. ^[1]

Opaque jar. ^[1]

Peru balsam ointment 6% w/w
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Below 30°C.
Temperature for this batch BUD: ____ ^[1]

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.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. ^{[1], [2], [12]}

Below 30°C. ^[1]

The source gives 2–3 applications/day. Avoid extensive or prolonged application. Do not use with ingredient hypersensitivity. Stop if an allergic reaction develops.
Emollient residues on clothing, dressings or bedding accelerate fabric ignition. Avoid smoking and naked flames during use. ^{[1], [7]}

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.