Artificial saliva AEMPS

Translucent, slightly viscous liquid. ^[1]

Saliva substitute for xerostomia. ^[1]

Translucent, slightly viscous liquid. ^[1]

Finished-product photostability is not specified. Any required container light protection is stated under Storage. ^[1]

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

Sodium Chloride: JP classifies the corresponding pure raw material as freely soluble in water. ^[6]

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

For the finished product the source specifies:
Well-closed bottle, <30 °C. ^[1]

No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. ^[1]

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

Sodium Chloride: raw-material water solubility is classified as freely soluble by JP.
Sorbitol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. ^{[6], [7]}

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. ^{[1], [2], [8]}

Reference batch: 1000 mL. First ingredient: Sodium carmellose, 10 g. 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], [11], [13]}

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. ^{[1], [3]}

Period reported by source: 15 days.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
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.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
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 clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately. ^{[1], [9], [10], [12], [14]}

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. ^[1]

Dissolve salts and sorbitol. Disperse carmellose without lumps, allow hydration and mix without entraining air. ^[1]

The final quantity is the master-formula basis. Record actual yield, losses and deviations in the batch record. ^[1]

Well-closed bottle, <30 °C. ^[1]

Translucent, slightly viscous liquid.
Additional tests from the referenced SOP:
Appearance and mass. For batches: spreadability, 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.
Spreadability PN/CP/003: fixed sample quantity between glass plates, with locally defined successive loads and times; measure two diameters and compare area against load. Temperature variation of ±0.5°C is suggested. The source gives no universal acceptance limit; establish it locally.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [3], [4], [5], [7], [13]}

Source-reported conditions/container: Well-closed bottle, <30 °C.
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], [9], [10]}

Dispense with a clear route, strength and use-by date. Complete amount per application and frequency from the prescription. ^[1]

Artificial saliva AEMPS
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], [9], [10]}

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.