REFERENCE FORMULA
Reference formula
Reference basis: 1000 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Chloroxylenol | 50 g | — |
| Potassium hydroxide | 13.6 g | — |
| Oleic acid | 7.5 mL | — |
| Virgin castor oil | 63 g | — |
| Terpineol | 100 mL | — |
| Ethanol 96% v/v | 200 mL | — |
| Freshly boiled and cooled purified water | q.s. ad 1000 mL | — |
REFERENCE FORMULA SCALING
Proportional quantities of the same formula
Arithmetic aid. It does not change strength, dose, method or BUD and does not authorise compounding.
Theoretical calculation sheet
CGR-BP-038 · Chloroxylenol Solution
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Cutaneous solution: Chloroxylenol Solution. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Antiseptic according to the historical monograph. [1]
Specifications
Chloroxylenol 4.75–5.25% w/v; ethanol 16–21% v/v. [1]
Light
Protect virgin castor oil from light. [2]
Air and oxidation
Castor oil can undergo oxidative rancidity. [2]
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
Virgin castor oil raw material: ≤25°C in PA031. The formula separately specifies processing temperature. [2]
pH and compatibility
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
Ethanol is incompatible with strong oxidants. [3]
Ingredient-specific information
Identity and weighing basis:
• Chloroxylenol: 50 g.
• Potassium hydroxide: 13.6 g.
• Oleic acid: 7.5 mL.
The specified chemical forms/grades belong to the exact source formula. [1]
• Chloroxylenol: 50 g.
• Potassium hydroxide: 13.6 g.
• Oleic acid: 7.5 mL.
The specified chemical forms/grades belong to the exact source formula. [1]
Staff protection
Risk assessment
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL. First ingredient: Chloroxylenol, 50 g. Independently check chemical form, units and every scale conversion before weighing.
Verify chemical form and the w/w, w/v or v/v concentration basis against the formula. Do not equate g and mL without supported density. Check clarity/crystallisation and exact application route.
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.
Volatile solvent in this formula: Ethanol 96% v/v 200 mL. Exclude ignition sources and minimise vapours/open evaporation. Check ventilation, electrical equipment and container compatibility with the specific solvent.
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], [2], [3], [4], [5], [9], [11]
Reference batch: 1000 mL. First ingredient: Chloroxylenol, 50 g. Independently check chemical form, units and every scale conversion before weighing.
Verify chemical form and the w/w, w/v or v/v concentration basis against the formula. Do not equate g and mL without supported density. Check clarity/crystallisation and exact application route.
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.
Volatile solvent in this formula: Ethanol 96% v/v 200 mL. Exclude ignition sources and minimise vapours/open evaporation. Check ventilation, electrical equipment and container compatibility with the specific solvent.
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], [2], [3], [4], [5], [9], [11]
Compounding conditions
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
The pharmacopoeial final alcohol range is 16–21% v/v. Neither low aw nor whole-mixture preservation is established solely by chloroxylenol 5%. Select the aqueous, preservation-unestablished category; confirm clarity and refrigeration compatibility before assigning BUD.
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 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], [7], [8], [10], [12]
The pharmacopoeial final alcohol range is 16–21% v/v. Neither low aw nor whole-mixture preservation is established solely by chloroxylenol 5%. Select the aqueous, preservation-unestablished category; confirm clarity and refrigeration compatibility before assigning BUD.
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 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], [7], [8], [10], [12]
Prerequisites
No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. [1]
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
Dissolve KOH in 15 mL water; add castor oil dissolved in 63 mL ethanol. Stand 1 hour or until a sample stays clear with 19 volumes of water; add oleic acid. Combine terpineol with chloroxylenol dissolved in remaining ethanol; add to soap solution and make up volume. [1]
Observations
The final quantity is the master-formula basis. Record actual yield, losses and deviations in the batch record. [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
Gas chromatography with 4-chloro-o-cresol internal standard, chloroform extraction and chloroxylenol BPCRS reference. Column 1.5 m × 4 mm, 3% Carbowax 20M, 160°C.
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
Dispense with a clear route, strength and use-by date. Complete amount per application and frequency from the prescription. [1]
Labelling
v9_controls
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.
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 — Chloroxylenol Solution2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
- FN/2003/PA/031 RICINO, ACEITE VIRGEN DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholΔιαθέσιμο κείμενο / Retrieved textOfficial referenceraw material or occupational2026-09-10
- 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
- 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
- Allan MC, Mauer LJ. Dataset of water activity measurements of alcohol:water solutions using a Tunable Diode LaserData in Brief. 2017;12:364–369Table 1; ethanol/water at 25 °C; DOI 10.1016/j.dib.2017.04.017Full text read. Binary-mixture water activity; volume ratios before mixing, not finished medicinal-product shelf life2026-09-12
- 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