Camphor spirit 10% w/v

Colourless volatile liquid with a strong camphor odour. ^[1]

Symptomatic cutaneous treatment of muscle/joint pain and itching according to AEMPS. ^[1]

Colourless volatile liquid with a strong camphor odour. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided. ^[1]

The finished preparation is stored protected from light under the monograph. ^[1]

Ethanol generates vapour; limit time in open vessels. Evaporation can change composition (editorial process assessment).
Camphor is volatile; keep the raw material well closed. ^[4]

Ethanol is miscible with water. This does not establish that all dissolved actives remain soluble after dilution.
Camphor: slightly soluble in water, readily soluble in fixed oils and very slightly soluble in glycerol. ^[4]

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 25°C, tightly closed and protected from light. Processing follows the method-specific temperatures.
Limit unnecessary camphor heating because of volatility. ^{[1], [4]}

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

Ethanol is incompatible with strong oxidants. ^[5]

Exact identities: Ρακεμική καμφορά / Racemic camphor; Αιθανόλη 90% κατ’ όγκο / Ethanol 90% v/v. 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.
Racemic camphor: white, crystalline, friable and volatile material. For ointments, first dissolve in the oil or a small portion of base at low temperature. ^{[1], [4]}

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]}

Camphor and a volatile flammable solvent. The source warns of serious respiratory risk from nasal application, particularly in children.
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 100 mL. 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.
Volatile solvent in this formula: Ethanol 90% v/v q.s. ad 100 mL. Exclude ignition sources and minimise vapours/open evaporation. Check ventilation, electrical equipment and container compatibility with the specific solvent.
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], [3], [4], [5], [6], [9], [11]}

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 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
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. ^{[1], [7], [8], [10], [12]}

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. Triturate camphor.
2. Dissolve it in part of the 90% ethanol and filter.
3. Make up to a final volume of 100 mL with the same solvent, following the master formula and PN/L/FF/007/00. ^{[1], [2]}

The calculation basis is a final 100 mL with 90% ethanol, as specified in the master formula. ^[1]

Amber glass bottle. ^[1]

Camphor spirit 10% w/v
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Below 25°C, tightly closed and protected from light.
Temperature for this batch BUD: ____ ^[1]

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.
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], [11]}

Below 25°C, tightly closed and protected from light. ^[1]

External use only; the source gives 3–4 gentle rubs/day. Do not use under age 2, near the nose, on mucosa, wounds or damaged skin. During breastfeeding avoid sites from which the infant could inhale vapour. Older children require medical direction. ^[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.