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. ^[1]

Oral antiseptic. ^[1]

pH 7.0 if adjustment is required by the method. ^[1]

For the finished product the source specifies:
Tight container, cool dry place, protected from light/heat. ^[1]

No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. ^[1]

No quantitative hydrolytic stability limit is given for this formula. Retain the prescribed water amount and quality. ^[1]

No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. ^[1]

Chlorhexidine digluconate: heat/alkalinity promote decomposition. ^[2]

Specification of this preparation, not a demonstrated stability range:
pH 7.0 if adjustment is required by the method.
Chlorhexidine: check alkalinity and incompatibility with anionic ingredients. ^{[1], [2]}

No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. ^[1]

Identity and weighing basis:
• Chlorhexidine digluconate 20% w/v solution: 0.5 mL.
• Compound flavour: q.s. —.
• Polysorbate 20: 1 mL.
The specified chemical forms/grades belong to the exact source formula. ^[1]

Chlorhexidine: prevent eye contact; use eye protection when handling.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[2], [3], [4]}

Reference batch: 100 mL. First ingredient: Chlorhexidine digluconate 20% w/v solution, 0.5 mL. Independently check chemical form, units and every scale conversion before weighing.
Clearly distinguish oromucosal use from swallowing. Check the prescribed dilution, ability to spit and total active/excipient exposure for the individual patient.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: confirm final volume or mass at the reference temperature, intended clarity or dispersion, and specified container/closure. Do not equate grams and millilitres without a justified density. ^{[1], [7], [9]}

Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. ^{[1], [4]}

No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
Final chlorhexidine digluconate is 0.1%, from 0.5 mL of 20% stock per 100 mL, with water and polysorbate 20. The antiseptic active alone does not establish mouth-rinse preservation; select the conservative aqueous, preservation-unestablished limit.
Selected conservative general rule: up to 14 days at 2–8 °C for an aqueous form without adequately established preservation. Refrigeration must not cause precipitation, irreversible separation or other loss of suitability. If that condition fails, do not apply 14 days at room temperature; obtain specific short-use evidence.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. ^{[1], [6], [8], [10]}

No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. ^[1]

Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities.
Calibrated pH meter and suitable check buffers. ^[1]

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. ^[1]

Oromucosal use. Specify compatible flavour, colour and pH adjuster locally. Source notes anionic-detergent incompatibility. Contains aspartame. ^[1]

Tight container, cool dry place, protected from light/heat. ^[1]

pH 7.0 if adjustment is required by the method.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. ^{[1], [9]}

Source-reported conditions/container: Tight container, cool dry place, protected from light/heat.
For the selected general ceiling: 2–8 °C, provided physical suitability and compatibility with the specific source are maintained. The 14-day rule does not apply at room temperature. ^{[1], [5], [6]}

Mouth rinse; not an oral systemic medicine. ^[1]

Chlorhexidine digluconate 0.1% w/v mouth rinse
Oromucosal use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 2–8 °C, after confirming suitability for refrigeration.
Temperature for this batch BUD: ____ ^{[1], [5], [6]}

The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.