Final editorial decision
The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 14-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. The 14-day reference requires 2–8 °C and adequate refrigerated physical suitability. Verify homogeneity/redispersibility and absence of irreversible separation; do not transfer this limit to room temperature. Apply the shortest supported limit, including the remaining BUD of any compounded base.
Required evidence
- Defined and approved supplier grade of anionic BP wax, with routine acceptance of the actual lot; accepted other ingredients and the exact reference formula/process.
- Justified finished-form category, defined container/storage, homogeneity and source-specific QC. For a preserved aqueous form, justify preservative suitability at the final pH and in the complete composition.
- For a compounded base, record its actual preparation date, release and remaining BUD. The new final mixture does not reset the base dating clock.
- Use a refrigerated default only with supported physical suitability at 2–8 °C: homogeneity/redispersibility and no irreversible separation. Do not transfer it to room temperature.
Closure criteria
- Close the research dependency on in-house wax by explicitly adopting the defined purchased pharmacopoeial grade. Incoming acceptance remains a routine requirement of actual compounding.
- Actual release requires the completed batch record, acceptable applicable QC and a signed BUD assessment applying the shortest supported limit.
- Do not apply a numerical default unless its category, compatible temperature and formulation suitability are supported. A new specific study is needed for extension or an unresolved physical/chemical concern, not merely to present a conditional default.
Scope
Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.
Sources and references
- USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
- VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300
- Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia compliance
- British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5
REFERENCE FORMULA
Reference formula
Reference basis: 1000 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Benzyl benzoate | 250 g | — |
| Emulsifying wax BP | 20 g | — |
| Freshly boiled and cooled purified water | q.s. ad 1000 mL | — |
Prerequisite formulations
Documentation
Preparation description
Emulsion: Benzyl Benzoate Application. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Specifications
Benzyl benzoate: 23.1-26.9% w/v [1]
Light
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidation
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubility
No quantitative hydrolytic stability limit is given for this formula. Retain the prescribed water amount and quality. [1]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [1]
pH and compatibility
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
Identity and weighing basis:
• Benzyl benzoate: 250 g.
• Emulsifying wax BP: 20 g.
• Freshly boiled and cooled purified water: q.s. ad 1000 mL.
The specified chemical forms/grades belong to the exact source formula.
Component of base CGR-BP-015: Sodium lauryl sulfate: JP describes a clear or opalescent solution of 1 g in 10 mL water. [1], [6], [7]
• Benzyl benzoate: 250 g.
• Emulsifying wax BP: 20 g.
• Freshly boiled and cooled purified water: q.s. ad 1000 mL.
The specified chemical forms/grades belong to the exact source formula.
Component of base CGR-BP-015: Sodium lauryl sulfate: JP describes a clear or opalescent solution of 1 g in 10 mL water. [1], [6], [7]
Staff protection
Risk assessment
Reference batch: 1000 mL. First ingredient: Benzyl benzoate, 250 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [9], [11], [13]
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [9], [11], [13]
Compounding conditions
BUD rationale
The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 14-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. The 14-day reference requires 2–8 °C and adequate refrigerated physical suitability. Verify homogeneity/redispersibility and absence of irreversible separation; do not transfer this limit to room temperature. Apply the shortest supported limit, including the remaining BUD of any compounded base. [12], [14], [15], [16]
Prerequisites
Fulfil CGR-BP-015 through procurement of the defined pharmacopoeial anionic wax grade. If intermediate CGR-BP-014 is used, record its actual release and available dating. Source composition and other source dependencies are retained. [12], [14], [15], [16]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
Compounding method
Melt the wax, mix in benzyl benzoate, then add the mixture to sufficient warm water for 1000 mL. Stir thoroughly until cold. [1]
Observations
The source defines final volume. This is not equivalent to 25% w/w. [1]
Container and packaging
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]
Quality control
HPLC C18 200 × 4.6 mm, 10 µm; water/acetonitrile 30:70, 1.5 mL/min, 230 nm, 20 µL injection. Sample 1 g/100 mL, further diluted 1:50. Benzyl benzoate BPCRS reference 0.0050% w/v. Determine mass per mL to report w/v.
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], [11]
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], [11]
Storage
Dispensing
Labelling
Benzyl Benzoate Application
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 2–8 °C, after confirming suitability for refrigeration.
Shake/redisperse well before use.
Temperature for this batch BUD: ____
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [4], [8], [13]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 2–8 °C, after confirming suitability for refrigeration.
Shake/redisperse well before use.
Temperature for this batch BUD: ____
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [4], [8], [13]
final_decision
The wax prerequisite is fulfilled by an accepted lot of supplier-qualified pharmacopoeial anionic wax matched to the reference composition. In-house wax manufacture is not necessary to implement this monograph. The 14-day figure remains a conditional general ceiling, not experimental stability or an assigned batch BUD. The 14-day reference requires 2–8 °C and adequate refrigerated physical suitability. Verify homogeneity/redispersibility and absence of irreversible separation; do not transfer this limit to room temperature. Apply the shortest supported limit, including the remaining BUD of any compounded base. [12], [14], [15], [16]
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- British Pharmacopoeia 2016 — Benzyl Benzoate Application2016PDF pp. 1–1; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- FN/2003/PA/004 ALMIDÓN DE TRIGORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Sodium Lauryl SulfateJP XVIII, 2021; English textPrinted p. 1718; Description; Containers and storageraw-material monograph2026-09-12
- British Pharmacopoeia 2016 — Emulsifying Wax2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQsUpdated 1 November 2023Questions 52, 54–56, 60–62; PDF pp. 11–14Primary clarification of aw classification, extension prerequisites and compounded-component BUDs; not automatic Greek legal adoption2026-10-14
- EMA — Excipients in the labelling and package leaflet, Annex Revision 5Published 5 December 2025EN and EL worksheets: arachis oil, wool fat, cetostearyl/cetyl alcohol, chlorocresolCurrent primary excipient warnings; used as a scientific labelling reference, without claiming MAH obligations automatically apply to a compounded prescription2026-10-14
- VVF manufacturer: Emulsifying WaxesProduct table: Vegarol EW 200; compare EW 100 and EW 300Targeted prerequisite / publication decision; not batch result2026-10-14
- Croda Pharma manufacturer: Crodex A pharmaProduct description and pharmacopoeia complianceTargeted prerequisite / publication decision; not batch result2026-10-14
- British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5Targeted prerequisite / publication decision; not batch result2026-10-14