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Salicylated Alum Powder JP 3% w/w

Cutaneous powder · Japan

CGR-JP-012 · 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 g

IngredientSource quantityScaled quantity
Salicylic acid JP, finely powdered30g—
Dried aluminum potassium sulfate JP, very finely powdered640g—
Talc JP, very finely powderedq.s. ad 1000g—

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
White powder. [1]
Action and usePartial evidence
Cutaneous salicylic acid and dried alum powder. JP specifies no clinical indication or dosing schedule for the complete formula. [1]
SpecificationsDocumented in source
Salicylic acid content 2.7–3.3% w/w. UV–Vis and TLC identification as described by JP. Use the JP dried aluminum potassium sulfate grade. [1]
Compounding methodEditorial procedure for local review
JP refers to the general Powders method. Practical implementation: weigh materials, separately break aggregates to the specified fineness and preblend salicylic acid with a small amount of talc. Incorporate dried alum and remaining talc progressively to 1000 g by geometric dilution with dust containment. Check uniformity and package without adding water. [1]
Quality controlDocumented in source
Identify salicylate by a 520–535 nm maximum in the coloured solution and TLC matching the standard Rf and FeCl₃ response. Assay by Fe(III)/UV–Vis at 530 nm using the exact dilutions in JP p. 1670. In-process checks: white appearance, blend uniformity and final mass. 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], [10]
pH and compatibilityDocumented in source
pH 2.0 is an analytical-solution condition. No pH is assigned to the dry powder. [1]
Container and packagingDocumented in source
JP specifies a well-closed container; use a dry container with a closure limiting powder dispersion. [1]
StoragePartial evidence
Well-closed container. Prevent wetting and contamination during handling. For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [6]
Risk assessmentEditorial checklist
Use pharmacopoeial-grade talc. Do not substitute a hydrated alum or aluminum sulfate mass-for-mass for dried alum. Contain airborne powder. Reference batch: 1000 g. First ingredient: Salicylic acid JP, finely powdered, 30 g. Independently check chemical form, units and every scale conversion before weighing. Weighing, sieving and trituration can disperse inhalable powder. Contain at source, check contamination of nearby preparations and avoid blowing or dry sweeping during cleaning. 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. Release checkpoint: independently verify mg per unit, total unit count and smallest weighable quantity. Mass uniformity does not replace content uniformity when required. Document geometric dilution and prevention of powder segregation. [1], [8], [10]
ObservationsPartial evidence
The specified powder fineness is part of the formula. No unsupported numerical particle-size limits or mixing times are assigned. [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
Talc: JP classifies the corresponding pure raw material as practically insoluble in water. Salicylic acid is slightly soluble in water; raw-material melting range 158–161 °C. [2], [3]
HumidityNot specified in the reviewed source
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
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
Salicylic acid: incompatibilities with alkalis, Fe/Pb salts and iodine. Above 2%, problems may occur in nonionic emulsions. [2]
Ingredient-specific informationPartial evidence
Talc: raw-material water solubility is classified as practically insoluble by JP. [3]
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], [5]
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. [2], [4], [5]
BUD rationaleGeneral framework, subject to conditions
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability. Selected general rule: up to 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category. 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], [7], [9]
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, mortar/pestle, suitable sieve, mixing vessel and powder containment. [1]
LabellingEditorial specimen
Salicylated Alum Powder JP 3% w/w External use Quantity: ____ Batch: ____ Prepared: ____ Use by: ____ Patient / dose / frequency: ____ Storage: Well-closed container. Prevent wetting and contamination during handling. 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: Salicylated Alum Powder JP 3% w/wJP XVIII, 2021; English textPrinted pp. 1670–1671; General Rules for Preparations: Powdersmaster formula, description, tests and container2026-09-12
  2. FN/2003/PA/033 SALICÍLICO, ÁCIDORetrieved source editionSections 4, 6–10ingredient facts2026-09-12
  3. MHLW — Japanese Pharmacopoeia XVIII: TalcJP XVIII, 2021; English textPrinted p. 1772; Description; Containers and storageraw-material monograph2026-09-12
  4. PN/L/PG/002/00 INDUMENTARIARetrieved source editionFull cited procedureingredient facts2026-09-12
  5. ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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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