Camphorated oil 10% PO001

Yellowish translucent liquid.

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Symptomatic relief of myalgia/arthralgia according to the source.

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Yellowish translucent liquid.

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Protect virgin olive oil from light.

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Camphor is volatile; keep the raw material well closed.
Virgin olive oil is oxidisable; store the raw material in a full, well-closed container.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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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.
For the finished product the source specifies:
Glass bottle, well closed, <25°C.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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Racemic camphor: Camphor is volatile; keep the raw material well closed.
Virgin olive oil: Virgin olive oil is oxidisable; store the raw material in a full, well-closed container.
These are selected facts for identified ingredients; relevant sensitivities and incompatibilities are detailed in the corresponding fields. This is not a complete SDS for every material.

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Complete formula-specific PPE is not specified. Select gloves, eye protection and exposure controls using the exact materials’ SDS and the local risk assessment.
Supplementary AEMPS framework: clean long-sleeved laboratory clothing, hair covering and dedicated footwear/overshoes. Powder handling requires suitable eye/respiratory protection; change gloves with activity or damage. Select the exact type/material using SDS and risk assessment.

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A complete formula-specific hazard classification is not established. Assess potency, dust/aerosol, allergens, solvents, microbial risk and cross-contamination using the actual materials and process. Absence of a flag does not establish absence of hazard.

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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.

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3 months under the source conditions.
The source period applies to its exact composition, method and packaging. It is not this batch’s expiry date and cannot be transferred to another vehicle/strength. Calculate the actual date in the blank batch record.

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No separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.

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Indicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Controlled heating and thermometer, Calibrated pH meter. Selection/qualification is defined locally.

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Dissolve camphor in virgin olive oil with gentle heating and stirring. The source gives no numerical temperature.

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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

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Glass bottle, well closed, <25°C.

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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.

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Glass bottle, well closed, <25°C.

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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.

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Camphorated oil 10% PO001
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Εξωτερική χρήση / External use
Dose/directions: __________
Storage: Glass bottle, well closed, <25°C.
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.

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