REFERENCE FORMULA
Reference formula
Reference basis: 1000 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Salicylic acid JP | 30 g | — |
| Glycerin JP | 50 mL | — |
| Ethanol JP | 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-JP-011 · Salicylic Acid Spirit JP 3% w/v
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
Clear, colourless liquid; relative density d20/20 approximately 0.86. [1]
Action and use
Specifications
Salicylic acid 2.7–3.3% w/v. JP <1.01> alcohol number, Method 2: at least 8.8. Relative density approximately 0.86. Do not relabel the alcohol number as % v/v without the official method. [1]
Compounding method
JP refers to the Spirits method. Practical implementation: dissolve salicylic acid in part of Ethanol JP, add glycerin and mix. Make to 1000 mL with Ethanol JP at a controlled volume-measurement temperature, mix and package promptly. Limit evaporation and ignition sources; do not add water beyond that in the specified ethanol. [1]
Quality control
Assay salicylic acid by the Fe(III) colour reaction and UV–Vis at 530 nm against a reference standard. Identification uses a 520–535 nm maximum in the coloured analytical solution. Determine alcohol number by JP <1.01>, Method 2. Use the full JP procedure for dilutions and reagents.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [5], [14]
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [5], [14]
pH and compatibility
pH 2.0 is the analytical buffer value, not a target for the cutaneous solution. The monograph gives no finished-product pH. [1]
Container and packaging
Tight container to limit solvent loss; select compatible glass and closure. [1]
Storage
Observations
Use the JP ethanol raw-material grade. Dilution changes solubility and the BUD category.
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], [16]
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], [16]
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
Humidity
Glycerol is hygroscopic; limit raw-material exposure to moisture. [2]
Temperature
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [1]
Other interactions
Ingredient-specific information
Glycerol: clear, colourless, viscous and strongly hygroscopic liquid. It mixes with water but is practically insoluble in fixed and essential oils.
Glycerin JP: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. [2], [5]
Glycerin JP: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. [2], [5]
Compounding conditions
Staff protection
Salicylic acid: avoid dust, inhalation and eye/mucosal contact; use eye protection.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [3], [6], [7]
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [3], [6], [7]
Risk assessment
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL. First ingredient: Salicylic acid JP, 30 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 JP q.s. ad 1000 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], [3], [4], [6], [7], [12], [14]
Reference batch: 1000 mL. First ingredient: Salicylic acid JP, 30 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 JP q.s. ad 1000 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], [3], [4], [6], [7], [12], [14]
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
Solvent system: 50 mL glycerol and JP ethanol to 1000 mL. Conservatively select the aqueous alcoholic category with antimicrobial contribution from the solvent, without claiming aw <0.6 or a longer nonaqueous allowance. Appropriate preservation of the exact final mixture remains a prerequisite. Do not transfer the period to a dilution.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
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], [9], [10], [11], [13], [15]
Solvent system: 50 mL glycerol and JP ethanol to 1000 mL. Conservatively select the aqueous alcoholic category with antimicrobial contribution from the solvent, without claiming aw <0.6 or a longer nonaqueous allowance. Appropriate preservation of the exact final mixture remains a prerequisite. Do not transfer the period to a dilution.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
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], [9], [10], [11], [13], [15]
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]
Labelling
Salicylic Acid Spirit JP 3% w/v
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: JP specifies a tight container; keep away from ignition sources because of the alcoholic solvent.
Temperature for this batch BUD: ____ [1]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: JP specifies a tight container; keep away from ignition sources because of the alcoholic solvent.
Temperature for this batch BUD: ____ [1]
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: Salicylic Acid Spirit JP 3% w/vJP XVIII, 2021; English textPrinted p. 1669; General Rules for Preparations: Spiritsmaster formula, description, tests and container2026-09-12
- FN/2003/PA/013 GLICEROLRetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- FN/2003/PA/033 SALICÍLICO, ÁCIDORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholRetrieved source editionFull cited procedureingredient facts2026-09-12
- FDA — Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolMay 2023, revision 1Recommendations; section on pharmacy compoundingraw material quality2026-09-12
- 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
- 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
- CDC — Chemical Disinfectants: Alcohol28 November 2023; 2008 guidelineAlcohol: Overview and Microbicidal activityAlcohol antimicrobial context; not a finished-product preservative challenge test2026-09-12
- 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