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Salicylic Acid Spirit JP 3% w/v

Cutaneous alcoholic solution · Japan

CGR-JP-011 · Collection 8.0 · 12.09.2026Local adoption & batch approval
Local adoption & batch approval

Reference documentation. The actual use requires review, local adoption and batch approval.

MASTER FORMULA / v8.0

The source formula

Reference basis: 1000 mL

IngredientSource quantityScaled quantity
Salicylic acid JP30g—
Glycerin JP50mL—
Ethanol JPq.s. ad 1000mL—

q.s.: sufficient quantity · ad: to a final total. Ingredient identities and source quantities are retained exactly from v8. [1]

FORMULA SCALING / 9.0

Calculate proportional quantities.

Arithmetic scaling of the same formula. It does not change strength, dose, method or BUD.

Formula scaling

Prerequisite formulations

No separate prerequisite monograph is listed. Appropriate raw-material quality is still required.

Full documentation

Preparation descriptionDocumented in source
Clear, colourless liquid; relative density d20/20 approximately 0.86. [1]
Action and usePartial evidence
Cutaneous salicylic acid preparation; keratolysis is an ingredient action. JP does not specify a finished-product application regimen. [1], [3]
SpecificationsDocumented in source
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 methodEditorial procedure for local review
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 controlPartial evidence
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]
pH and compatibilityDocumented in source
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 packagingDocumented in source
Tight container to limit solvent loss; select compatible glass and closure. [1]
StoragePartial evidence
JP specifies a tight container; keep away from ignition sources because of the alcoholic solvent. For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [8]
ObservationsPartial evidence
Use the JP ethanol raw-material grade. Dilution changes solubility and the BUD category. [1]
LightNot specified in the reviewed source
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidationNot specified in the reviewed source
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubilityPartial evidence
Glycerol is miscible with water. This does not establish product microbiological stability. Salicylic acid is slightly soluble in water; raw-material melting range 158–161 °C. [2], [3]
HumidityPartial evidence
Glycerol is hygroscopic; limit raw-material exposure to moisture. [2]
TemperatureNot specified in the reviewed source
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [1]
Other interactionsPartial evidence
Glycerol: hazardous reaction with strong oxidising agents. Salicylic acid: incompatibilities with alkalis, Fe/Pb salts and iodine. Above 2%, problems may occur in nonionic emulsions. Ethanol is incompatible with strong oxidants. [2], [3], [4]
Ingredient-specific informationPartial evidence
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]
Compounding conditionsEditorial checklist
Use identified raw materials and clean compatible equipment. Retain the addition sequence, material forms and temperatures in the Procedure. Record actual conditions and deviations for each batch. [1], [7]
Staff protectionPartial evidence
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]
Risk assessmentEditorial checklist
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]
BUD rationaleGeneral framework, subject to conditions
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. [1], [9], [10], [11], [13]
PrerequisitesDocumented in source
No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. [1]
EquipmentEditorial checklist
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
LabellingEditorial specimen
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]
DispensingEditorial checklist
Dispense with a clear route, strength and use-by date. Complete amount per application and frequency from the prescription. [1]

Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.

Sources and references

  1. 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
  2. FN/2003/PA/013 GLICEROLRetrieved source editionSections 4, 6–10ingredient facts2026-09-12
  3. FN/2003/PA/033 SALICÍLICO, ÁCIDORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
  4. CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholRetrieved source editionFull cited procedureingredient facts2026-09-12
  5. 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
  6. PN/L/PG/002/00 INDUMENTARIARetrieved source editionFull cited procedureingredient facts2026-09-12
  7. ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
  8. 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
  9. 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
  10. 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
  11. CDC — Chemical Disinfectants: Alcohol28 November 2023; 2008 guidelineAlcohol: Overview and Microbicidal activityAlcohol antimicrobial context; not a finished-product preservative challenge test2026-09-12
  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
  13. 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
  14. 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
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