Chlorhexidine digluconate 0.1% w/v mouth rinse

Oromucosal preparation: Chlorhexidine digluconate 0.1% w/v mouth rinse. Additional appearance criteria are not established by the specific text reviewed.

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Oral antiseptic.

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pH 7.0 if adjustment is required by the method.

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For the finished product the source specifies:
Tight container, cool dry place, protected from light/heat.

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

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Chlorhexidine digluconate: heat/alkalinity promote decomposition.

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Chlorhexidine: check alkalinity and incompatibility with anionic ingredients.
Specification of this preparation, not a demonstrated stability range:
pH 7.0 if adjustment is required by the method.

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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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Chlorhexidine digluconate 20% w/v solution: Chlorhexidine digluconate: heat/alkalinity promote decomposition.
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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Chlorhexidine: prevent eye contact; use eye protection when handling.
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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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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No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
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, Calibrated pH meter. Selection/qualification is defined locally.

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Dilute stock in 50 mL water. Add aspartame and flavour, then polysorbate 20. Mix, add colour and make to volume. Adjust to pH 7.0 if required.

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Oromucosal use. Specify compatible flavour, colour and pH adjuster locally. Source notes anionic-detergent incompatibility. Contains aspartame.

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Tight container, cool dry place, protected from light/heat.

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pH 7.0 if adjustment is required by the method.

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Tight container, cool dry place, protected from light/heat.

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Mouth rinse; not an oral systemic medicine.

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Chlorhexidine digluconate 0.1% w/v mouth rinse
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Στοματοβλεννογόνια χρήση / Oromucosal use
Dose/directions: __________
Storage: Tight container, cool dry place, protected from light/heat.
Mouth rinse; not an oral systemic medicine.

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