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Zinc Oxide Starch Powder JP 50% w/w

Cutaneous powder · Japan

CGR-JP-009 · 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
Zinc oxide JP500g—
Starch JPq.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 protective zinc oxide and starch powder. JP defines composition and quality, without a dosing regimen. [1], [2]
SpecificationsDocumented in source
Nominal ZnO content 500/1000 = 50% w/w. White powder with positive zinc and starch identification. This monograph does not specify a numerical finished-product assay range. [1]
Compounding methodEditorial procedure for local review
1. JP refers to the general Powders method. Practical implementation: verify the starch grade and botanical origin; weigh the materials. 2. Break aggregates by suitable trituration/sieving while containing dust. 3. Blend zinc oxide with progressively added starch to a homogeneous total of 1000 g. Do not add water. 4. Check appearance, final mass and uniformity; package. These mixing steps implement the general method and are not a separate validation study. [1]
Quality controlDocumented in source
Identify ZnO by ignition followed by a zinc-salt reaction on the residue. Identify starch in the washed residue by boiling with water, cooling and obtaining a dark blue-purple iodine response. Use JP p. 1930 for reagent quantities and conditions. In-process checks: appearance, aggregates, blend uniformity and mass balance. 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], [9]
Container and packagingDocumented in source
JP specifies a tight container. Use a dry container and a dispensing closure that limits airborne powder. [1]
StoragePartial evidence
Tight container as specified by JP. Avoid moisture and water addition; storage for a general BUD assignment is stated separately. For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [5]
Risk assessmentEditorial checklist
The fine powder requires airborne-particle control and prevention of cross-contamination. The monograph does not designate this product as sterile. Reference batch: 1000 g. First ingredient: Zinc oxide JP, 500 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], [7], [9]
ObservationsPartial evidence
50% is calculated composition, not an analytical acceptance range. Record starch identity in the raw-material record. [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
ZnO: practically insoluble in water and ethanol. [2]
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]
pH and compatibilityPartial evidence
ZnO dissolves in dilute mineral acids and forms soaps with fatty acids. [2]
Other interactionsNot specified in the reviewed source
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific informationPartial evidence
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts. [2]
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], [4]
Staff protectionPartial evidence
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], [4]
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], [6], [8]
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
Zinc Oxide Starch Powder JP 50% w/w External use Quantity: ____ Batch: ____ Prepared: ____ Use by: ____ Patient / dose / frequency: ____ Storage: Tight container as specified by JP. Avoid moisture and water addition; storage for a general BUD assignment is stated separately. 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: Zinc Oxide Starch Powder JP 50% w/wJP XVIII, 2021; English textPrinted p. 1930; General Rules for Preparations: Powdersmaster formula, description, tests and container2026-09-12
  2. FN/2003/PA/028 ÓXIDO DE ZINCRetrieved source editionSections 4, 6–10ingredient facts2026-09-12
  3. PN/L/PG/002/00 INDUMENTARIARetrieved source editionFull cited procedureingredient facts2026-09-12
  4. ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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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