Viscous Lidocaine Hydrochloride 0.5% w/w

Transparent low-viscosity liquid. ^[1]

Topical mucosal anaesthesia. ^[1]

Transparent low-viscosity liquid. ^[1]

For the finished product the source specifies:
Tightly closed amber plastic container, protected from light.
Protect lidocaine hydrochloride from light. ^{[1], [2]}

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

Lidocaine hydrochloride is very soluble in water. ^[2]

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

No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. ^[1]

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

Lidocaine HCl adsorption to PVC depends on pH/temperature; assess the specific container material. ^[2]

Lidocaine hydrochloride: white crystalline powder. PVC adsorption depends on pH and temperature; PA020 specifies well-closed glass protected from light. ^[2]

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [3], [7]}

Reference batch: 100 g. First ingredient: Lidocaine hydrochloride, 0.50 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], [10], [12]}

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], [4]}

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 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], [8], [9], [11], [13]}

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 lidocaine in water; disperse carmellose, stand ≥24 hours and stir gently. ^[1]

No dosing or swallowing directions are supplied here. Mucosal use requires total-dose and systemic-absorption assessment. ^[1]

Tightly closed amber plastic container, protected from light. ^[1]

Transparent low-viscosity 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.
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], [4], [5], [6], [12]}

Source-reported conditions/container: Tightly closed amber plastic container, protected from light.
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], [8], [9]}

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

Viscous Lidocaine Hydrochloride 0.5% w/w
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], [8], [9]}

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.