REFERENCE FORMULA
Reference formula
Reference basis: 1000 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Hydrocortisone acetate JP | 5 g | — |
| Diphenhydramine base JP | 5 g | — |
| White petrolatum JP | q.s. ad 1000 g | — |
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-013 · Hydrocortisone Acetate 0.5% and Diphenhydramine Base 0.5% Ointment JP
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
White to pale-yellow ointment. [1]
Action and use
Specifications
Nominal hydrocortisone acetate 0.5% w/w and diphenhydramine base 0.5% w/w. White–pale-yellow appearance and positive identification. No numerical finished-product assay limits are specified. [1]
Compounding method
JP refers to the general Ointments method. Practical implementation: weigh hydrocortisone acetate and diphenhydramine base. Triturate hydrocortisone acetate with a small portion of petrolatum, incorporate diphenhydramine base and progressively add petrolatum to 1000 g. Homogenise cold with light protection, following PA015 handling information for the corticosteroid. Check uniformity and package. [1], [2]
Quality control
Identify hydrocortisone acetate using the JP colour/fluorescence reaction and diphenhydramine by bromophenol blue after extraction. TLC at 254 nm must show two spots matching the respective reference standards. Use JP p. 1115 for extraction, reagents and development. Also check homogeneity and absence of aggregates.
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
JP specifies a tight, light-resistant container. Select a tube/jar material compatible with the fatty base. [1]
Storage
Risk assessment
Two low-concentration actives require accurate weighing and uniform distribution. The first 5 g is the acetate ester; the second 5 g is free base. Do not substitute other chemical forms mass-for-mass.
Reference batch: 1000 g. First ingredient: Hydrocortisone acetate JP, 5 g. Independently check chemical form, units and every scale conversion before weighing.
Check uniform active distribution and absence of aggregates after cooling. Overheating, water ingress or a changed base alter the preparation; record actual yield and transfer losses.
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: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. [1], [11], [13]
Reference batch: 1000 g. First ingredient: Hydrocortisone acetate JP, 5 g. Independently check chemical form, units and every scale conversion before weighing.
Check uniform active distribution and absence of aggregates after cooling. Overheating, water ingress or a changed base alter the preparation; record actual yield and transfer losses.
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: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. [1], [11], [13]
Observations
Official source title: Hydrocortisone and Diphenhydramine Ointment. The working title and formula identify the exact chemical form of each active.
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
Air and oxidation
Diphenhydramine base: JP specifies an almost well-filled tight container protected from light. [4]
Water and solubility
White Petrolatum: JP classifies the corresponding pure raw material as practically insoluble in water.
Diphenhydramine: JP classifies the corresponding pure raw material as very slightly soluble in water.
Hydrocortisone Acetate: JP classifies the corresponding pure raw material as practically insoluble in water. [3], [4], [5]
Diphenhydramine: JP classifies the corresponding pure raw material as very slightly soluble in water.
Hydrocortisone Acetate: JP classifies the corresponding pure raw material as practically insoluble in water. [3], [4], [5]
Humidity
Hydrocortisone acetate: use low ambient humidity as specified in PA015. [2]
Temperature
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [1]
pH and compatibility
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
White Petrolatum: raw-material water solubility is classified as practically insoluble by JP.
Diphenhydramine: raw-material water solubility is classified as very slightly soluble by JP. Protect the raw material from light.
Hydrocortisone Acetate: raw-material water solubility is classified as practically insoluble by JP. [3], [4], [5]
Diphenhydramine: raw-material water solubility is classified as very slightly soluble by JP. Protect the raw material from light.
Hydrocortisone Acetate: raw-material water solubility is classified as practically insoluble by JP. [3], [4], [5]
Compounding conditions
For topical preparations, incorporate hydrocortisone acetate cold, dissolved or finely powdered, into the prepared base. [2]
Staff protection
BUD rationale
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.
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 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.
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. [1]
Labelling
Hydrocortisone Acetate 0.5% and Diphenhydramine Base 0.5% Ointment JP
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tight container, protected from light.
Temperature for this batch BUD: ____ [1]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tight container, protected from light.
Temperature for this batch BUD: ____ [1]
Dispensing
Emollient residues on clothing, dressings or bedding accelerate fabric ignition. Avoid smoking and naked flames during use. [8]
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: Hydrocortisone Acetate 0.5% and Diphenhydramine Base 0.5% Ointment JPJP XVIII, 2021; English textPrinted p. 1115: Hydrocortisone and Diphenhydramine Ointment; General Rules: Ointmentsmaster formula, description, tests and container2026-09-12
- FN/2003/PA/015 HIDROCORTISONA, ACETATO DERetrieved source editionSections 4, 6–10ingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: White PetrolatumJP XVIII, 2021; English textPrinted p. 1501; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: DiphenhydramineJP XVIII, 2021; English textPrinted p. 870; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Hydrocortisone AcetateJP XVIII, 2021; English textPrinted p. 1114; 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
- MHRA — Emollients and risk of severe and fatal burns: new resources available26 August 2020; updated 20 May 2021Fabric contamination and fire riskclinical safety2026-09-12
- 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