Camphorated oil 10% PO001

Yellowish translucent liquid. ^[1]

Symptomatic relief of myalgia/arthralgia according to the source. ^[1]

Yellowish translucent liquid. ^[1]

Protect virgin olive oil from light. ^[2]

Camphor is volatile; keep the raw material well closed.
Virgin olive oil is oxidisable; store the raw material in a full, well-closed container. ^{[2], [3]}

Camphor: slightly soluble in water, readily soluble in fixed oils and very slightly soluble in glycerol. ^[3]

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

For the finished product the source specifies:
Glass bottle, well closed, <25°C.
Limit unnecessary camphor heating because of volatility.
Virgin olive oil raw material: ≤25°C. This storage limit does not change the specific formula’s processing temperatures. ^{[1], [2], [3]}

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]

Racemic camphor: white, crystalline, friable and volatile material. For ointments, first dissolve in the oil or a small portion of base at low temperature. ^[3]

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [4], [7]}

Reference batch: 100 g. First ingredient: Racemic camphor, 10 g. Independently check chemical form, units and every scale conversion before weighing.
Verify chemical form and the w/w, w/v or v/v concentration basis against the formula. Do not equate g and mL without supported density. Check clarity/crystallisation and exact application route.
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.
Release checkpoint: confirm final volume or mass at the reference temperature, intended clarity or dispersion, and specified container/closure. Do not equate grams and millilitres without a justified density. ^{[1], [10], [12]}

The corresponding AEMPS SOP specifies room temperature 25 ± 5°C and relative humidity ≤60%, unless the particular formula requires otherwise. This is the work environment, not processing or storage temperature.
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment. ^{[1], [5]}

Period reported by source: 3 months under the source conditions.
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]

Dissolve camphor in virgin olive oil with gentle heating and stirring. The source gives no numerical temperature. ^{[1], [5]}

The final quantity is the master-formula basis. Record actual yield, losses and deviations in the batch record. ^[1]

Glass bottle, well closed, <25°C. ^[1]

Yellowish translucent liquid.
Additional tests from the referenced SOP:
Appearance and mass/volume. For batches: colour, clarity/opalescence, relative density, pH and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.
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], [5], [6], [12]}

Glass bottle, well closed, <25°C. ^[1]

Cutaneous use only. Not under 2 years or on the nose/mucosa/damaged skin. During breastfeeding, avoid sites from which the infant may inhale vapours. ^[1]

Camphorated oil 10% PO001
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Glass bottle, well closed, <25°C.
Temperature for this batch BUD: ____ ^[1]

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.