Acacia oral vehicle (potion gommeuse) Ph. Fr.

Viscous clear pale-yellow liquid, miscible with water. ^[1]

Mucilaginous vehicle for oral preparations. ^[1]

TAMC ≤10² CFU/g; TYMC ≤10¹ CFU/g; E. coli: absent / απουσία in 1 g or mL ^[1]

For the finished product the source specifies:
Protected from light, 2–8 °C. ^[1]

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

Component of base CGR-FR-027: Sucrose: JP classifies the corresponding pure raw material as very soluble in water. ^{[5], [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:
Protected from light, 2–8 °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]

Identity and weighing basis:
• Syrup Ph. Fr.: 30 g.
• Acacia: 10 g.
• Orange-flower water Ph. Fr.: 10 g.
The specified chemical forms/grades belong to the exact source formula.
Component of base CGR-FR-027: Sucrose: raw-material water solubility is classified as very soluble by JP. ^{[1], [5], [6]}

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [2], [3]}

Reference batch: 150 g. First ingredient: Syrup Ph. Fr., 30 g. Independently check chemical form, units and every scale conversion before weighing.
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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], [8], [10]}

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], [3]}

Period reported by source: Maximum 7 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], [4], [7], [9], [11]}

Simple syrup Ph. Fr.: CGR-FR-027
Orange-flower distilled water Ph. Fr. — qualified source-standard auxiliary ^[1]

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

Triturate powdered acacia with syrup. Gradually add water and orange-flower water; adjust and homogenise. ^[1]

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

Selection for local assessment: well-closed bottle compatible with the liquid. Check cleanliness, integrity, closure and material compatibility before filling. The specific monograph does not validate a particular commercial container. ^[1]

TAMC ≤10² CFU/g; TYMC ≤10¹ CFU/g; E. coli: absent / απουσία in 1 g or mL
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], [10]}

Source-reported conditions/container: Protected from light, 2–8 °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], [4], [7]}

Intermediate base for compounding. Adding an active requires reassessment of the final composition, pH, preservation and BUD. ^[1]

Acacia oral vehicle (potion gommeuse) Ph. Fr.
Compounding base — not for direct administration
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 2–8 °C, after confirming suitability for refrigeration.
Temperature for this batch BUD: ____ ^{[1], [4], [7]}

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.