Salicylic oil 5% without ethanol PO004

Transparent yellow-green oily solution.

References: [1]

Hyperkeratotic scalp lesions in seborrhoeic dermatitis/psoriasis according to the source.

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Transparent yellow-green oily solution.

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Protect virgin castor oil from light.
Protect virgin olive oil from light.
For the finished product the source specifies:
Amber bottle, protect from light/moisture, <25°C.

References: [1] · [2] · [3]

Castor oil can undergo oxidative rancidity.
Virgin olive oil is oxidisable; store the raw material in a full, well-closed container.

References: [2] · [3]

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

References: [1]

For the finished product the source specifies:
Amber bottle, protect from light/moisture, <25°C.

References: [1]

Virgin castor oil raw material: ≤25°C in PA031. The formula separately specifies processing temperature.
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:
Amber bottle, protect from light/moisture, <25°C.

References: [1] · [2] · [3]

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

References: [1]

Salicylic acid: incompatibilities with alkalis, Fe/Pb salts and iodine. Above 2%, problems may occur in nonionic emulsions.

References: [4]

Salicylic acid: Salicylic acid: incompatibilities with alkalis, Fe/Pb salts and iodine. Above 2%, problems may occur in nonionic emulsions.
Virgin castor oil: Castor oil can undergo oxidative rancidity.
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.

References: [2] · [3] · [4]

Salicylic acid: avoid dust, inhalation and eye/mucosal contact; use eye protection.
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.

References: [4] · [5]

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.

References: [1]

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.

References: [1] · [6]

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, Mortar and pestle, Controlled heating and thermometer. Selection/qualification is defined locally.

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Triturate salicylic acid if necessary. Dissolve in castor oil in a water bath at about 50°C. Add olive oil, homogenise by stirring and cool.

References: [1] · [6]

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

References: [1]

Amber bottle, protect from light/moisture, <25°C.

References: [1]

Transparent yellow-green oily solution.
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.

References: [1] · [6] · [7]

Amber bottle, protect from light/moisture, <25°C.

References: [1]

Not for salicylate allergy or under 2 years. Avoid eyes/mucosa and occlusion without medical direction. The source directs night application and removal in the morning with mild shampoo. Check concurrent salicylates/keratolytics.

References: [1]

Salicylic oil 5% without ethanol PO004
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Εξωτερική χρήση / External use
Dose/directions: __________
Storage: Amber bottle, protect from light/moisture, <25°C.
Not for salicylate allergy or under 2 years. Avoid eyes/mucosa and occlusion without medical direction. The source directs night application and removal in the morning with mild shampoo. Check concurrent salicylates/keratolytics.

References: [1]