REFERENCE FORMULA
Reference formula
Reference basis: 1000 mL τελικού προϊόντος / final product
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Sulfur JP | 60 g | — |
| Camphor, d- or dl-, JP | 5 g | — |
| Hydroxypropylcellulose JP | 4 g | — |
| Calcium hydroxide — processing input for supernatant | 1 g | — |
| Ethanol JP | 4 mL | — |
| Water of JP-specified quality — see procedure | q.s. ad 1000 mL | — |
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Light-yellow suspension; some components separate on standing. [1]
Action and use
Cutaneous sulfur/camphor lotion. This JP monograph gives no clinical indication, age limit or dose for the complete mixture; these require prescription and patient assessment. [1]
Specifications
Nominal sulfur 6% w/v and camphor 0.5% w/v. Light-yellow, redispersible preparation with sulfur, camphor and calcium identification. No numerical pH, viscosity or assay limits are specified. [1]
Compounding method
1. Dissolve 4 g hydroxypropylcellulose in 200 mL of the specified water.
2. Dissolve 5 g d- or dl-camphor in 4 mL Ethanol JP. Triturate 60 g sulfur with this solution.
3. Incorporate the hydroxypropylcellulose solution gradually with trituration.
4. Separately mix 1 g calcium hydroxide with 500 mL water, stopper tightly, shake and allow to settle.
5. Add ONLY 300 mL of the clear supernatant to the main mixture. Do not transfer the sediment or the whole intermediate.
6. Add water to a final 1000 mL and shake thoroughly. [1]
2. Dissolve 5 g d- or dl-camphor in 4 mL Ethanol JP. Triturate 60 g sulfur with this solution.
3. Incorporate the hydroxypropylcellulose solution gradually with trituration.
4. Separately mix 1 g calcium hydroxide with 500 mL water, stopper tightly, shake and allow to settle.
5. Add ONLY 300 mL of the clear supernatant to the main mixture. Do not transfer the sediment or the whole intermediate.
6. Add water to a final 1000 mL and shake thoroughly. [1]
Quality control
After thorough shaking: identify sulfur in the separated precipitate, camphor after extraction and a 2,4-dinitrophenylhydrazine reaction, and calcium salts in the supernatant (JP <1.09>). Analytical organic solvents belong to testing, not the master formula. Check final volume and sediment redispersion.
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], [13]
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], [13]
Container and packaging
Tight bottle with sufficient headspace for shaking and a closure compatible with the formulation. [1]
Storage
Source-reported conditions/container: Tight container. JP supplies no specific temperature range or period; see BUD rationale.
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]
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]
Risk assessment
The 1 g calcium hydroxide is an input to make a supernatant, not an established amount in the finished product. Four mL ethanol per 1000 mL does not establish adequate antimicrobial preservation.
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL τελικού προϊόντος / final product. First ingredient: Sulfur JP, 60 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.
Volatile solvent in this formula: Ethanol JP 4 mL. Exclude ignition sources and minimise vapours/open evaporation. Check ventilation, electrical equipment and container compatibility with the specific solvent.
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. [1], [2], [4], [7], [8], [11], [13]
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL τελικού προϊόντος / final product. First ingredient: Sulfur JP, 60 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.
Volatile solvent in this formula: Ethanol JP 4 mL. Exclude ignition sources and minimise vapours/open evaporation. Check ventilation, electrical equipment and container compatibility with the specific solvent.
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. [1], [2], [4], [7], [8], [11], [13]
Observations
Record whether d- or dl-camphor is used. Do not calculate finished calcium hydroxide as 1 g/L: only part of the supernatant is transferred.
The reviewed source remains English JP XVIII. PMDA confirms JP XIX publication on 10 April 2026 and schedules English publication within one year. This work did not complete a comparison of the full final Japanese text of all relevant monographs; no JP XIX conformity is claimed. [1], [15]
The reviewed source remains English JP XVIII. PMDA confirms JP XIX publication on 10 April 2026 and schedules English publication within one year. This work did not complete a comparison of the full final Japanese text of all relevant monographs; no JP XIX conformity is claimed. [1], [15]
Light
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidation
Camphor is volatile; keep the raw material well closed.
Camphor is volatile; minimise open handling. [2]
Camphor is volatile; minimise open handling. [2]
Water and solubility
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
Limit unnecessary camphor heating because of volatility. [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
Ingredient-specific information
Racemic camphor: white, crystalline, friable and volatile material. For ointments, first dissolve in the oil or a small portion of base at low temperature.
Sulfur: raw-material water solubility is classified as practically insoluble by JP.
Hydroxypropylcellulose: white to yellowish powder forming a viscous liquid with water. Use the grade/viscosity specified by the formula. [2], [5], [6]
Sulfur: raw-material water solubility is classified as practically insoluble by JP.
Hydroxypropylcellulose: white to yellowish powder forming a viscous liquid with water. Use the grade/viscosity specified by the formula. [2], [5], [6]
Compounding conditions
Staff protection
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
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 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], [10], [12], [14]
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 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], [10], [12], [14]
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.
Calibrated pH meter and suitable check buffers. [1]
Calibrated pH meter and suitable check buffers. [1]
Labelling
Dispensing
Dispense with a clear route, strength and use-by date. Complete amount per application and frequency from the prescription. [1]
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
- MHLW — Japanese Pharmacopoeia XVIII: Sulfur and Camphor Lotion JPJP XVIII, 2021; English textPrinted pp. 1756–1757master formula, description, tests and container2026-09-12
- FN/2003/PA/002 ALCANFOR RACÉMICORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- FN/2003/PA/016 HIDRÓXIDO DE CALCIORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholRetrieved source editionFull cited procedureingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: SulfurJP XVIII, 2021; English textPrinted p. 1756; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: HydroxypropylcelluloseJP XVIII, 2021; English textPrinted p. 1123; Description; Containers and storageraw-material monograph2026-09-12
- PN/L/PG/002/00 INDUMENTARIARetrieved source editionFull cited procedureingredient facts2026-09-12
- 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
- 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> FAQs (official, updated 1 November 2023)Updated 1 November 2023; retrieved 14 October 2026Q52, Q61–64; use with the applicable full chapterWater-activity classification, component dating and BUD documentation; general professional framework, not a Greek legal adoption or formula-specific study2026-10-14
- PMDA — JP publication schedule / Frequently Asked QuestionsCurrent official schedule, retrieved 14 October 2026JP19 published 10 April 2026; English edition scheduled within one yearEdition status only; not a comparison of individual JP19 monographs2026-10-14