Camphor spirit 10% w/v

Colourless volatile liquid with a strong camphor odour.

References: [1]

Symptomatic cutaneous treatment of muscle/joint pain and itching according to AEMPS.

References: [1]

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

References: [1]

The finished preparation is stored protected from light under the monograph.

References: [1]

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

References: [4] · [5]

Ethanol is miscible with water. This does not establish that all dissolved actives remain soluble after dilution.

References: [5]

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Finished-product storage: Below 25°C, tightly closed and protected from light. Processing follows the method-specific temperatures.

References: [1]

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Ethanol is incompatible with strong oxidants.

References: [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.

References: [1]

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.

References: [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.

References: [3]

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.

References: [1] · [5]

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.

References: [1]

No separate compound base is required in the explicit formula.

References: [1]

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.

References: [2]

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.

References: [1] · [2]

Section 3.1 specifies 90% ethanol to 100 mL, but the leaflet lists 90 mL ethanol. These are not treated as equivalent. The explicit final quantity in the master formula is retained and the leaflet discrepancy is recorded.

References: [1]

Amber glass bottle.

References: [1]

Camphor spirit 10% w/v
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 25°C, tightly closed and protected from light.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Flammable. Keep away from flames. Do not swallow.
Specimen for pharmacist adaptation; not a final approved label.

References: [1] · [5]

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.

References: [1] · [2]

Below 25°C, tightly closed and protected from light.

References: [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.

References: [1]