Thymol water 0.1% PO008

Transparent liquid.

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Mouth/pharyngeal antisepsis in the main text.

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Transparent liquid.

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For the finished product the source specifies:
Airtight amber glass container, protected from light. No numerical temperature is given.

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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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Glycerol is miscible with water. This does not establish product microbiological stability.

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Glycerol is hygroscopic; limit raw-material exposure to moisture.

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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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Glycerol: hazardous reaction with strong oxidising agents.
Thymol: incompatible with oxidants/alkalis; proteins reduce antiseptic action.
Ethanol is incompatible with strong oxidants.

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Glycerol: Glycerol is hygroscopic; limit raw-material exposure to moisture.
Thymol: Thymol: incompatible with oxidants/alkalis; proteins reduce antiseptic action.
Ethanol 96%: Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
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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Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.

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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. Selection/qualification is defined locally.

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Dissolve thymol in ethanol, mix in glycerol, then add water.

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The leaflet lists a cutaneous route while indications/directions describe mouth and pharynx. Optional 1% polysorbate 20 is not incorporated into this base formula.

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Airtight amber glass container, protected from light. No numerical temperature is given.

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Transparent 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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Airtight amber glass container, protected from light. No numerical temperature is given.

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For rinsing, dilute with an equal quantity of water before use. Do not swallow. Clarify the route before dispensing because the leaflet conflicts.

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Thymol water 0.1% PO008
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Στοματοβλεννογόνια χρήση / Oromucosal use
Dose/directions: __________
Storage: Airtight amber glass container, protected from light. No numerical temperature is given.
For rinsing, dilute with an equal quantity of water before use. Do not swallow. Clarify the route before dispensing because the leaflet conflicts.
DRAFT — not a release label.

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