REFERENCE FORMULA
Reference formula
Reference basis: 1000 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Macrogol 4000 | 500 g | — |
| Macrogol 400 | 500 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-003 · Macrogol 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 ointment with slight characteristic odour. [1]
Action and use
Compounding base. Check compatibility with the incorporated active. [1]
Specifications
White ointment; consult original identification test. [1]
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
No quantitative hydrolytic stability limit is given for this formula. Retain the prescribed water amount and quality. [1]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
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
Identity and weighing basis:
• Macrogol 4000: 500 g.
• Macrogol 400: 500 g.
The specified chemical forms/grades belong to the exact source formula. [1]
• Macrogol 4000: 500 g.
• Macrogol 400: 500 g.
The specified chemical forms/grades belong to the exact source formula. [1]
Staff protection
Risk assessment
Reference batch: 1000 g. First ingredient: Macrogol 4000, 500 g. Independently check chemical form, units and every scale conversion before weighing.
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
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], [6], [8]
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
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], [6], [8]
Compounding conditions
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], [5], [7], [9]
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], [5], [7], [9]
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]
Compounding method
Melt both macrogols in a 65 °C water bath; mix until set. [1]
Observations
Baseline 1:1. Source allows replacing <100 g of either macrogol with the other to adjust consistency; record a separate variant. JP XVIII: compare with JP XIX.
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], [10]
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], [10]
Container and packaging
Tight container according to JP XVIII. [1]
Quality control
Identification: dissolve 50 mg in 5 mL dilute HCl, add 1 mL barium chloride TS, shake and filter if necessary. Add 1 mL phosphomolybdic acid solution (1 in 10); a yellow-green precipitate forms. Test solutions are defined in JP.
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], [8]
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], [8]
Storage
Dispensing
Intermediate base for compounding. Adding an active requires reassessment of the final composition, pH, preservation and BUD. [1]
Labelling
Macrogol Ointment JP
Compounding base — not for direct administration
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tight container.
Temperature for this batch BUD: ____ [1]
Compounding base — not for direct administration
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tight container.
Temperature for this batch BUD: ____ [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
- Japanese Pharmacopoeia XVIII — Macrogol OintmentXVIII / 2021 • παλαιότερη / earlierPDF pp. 3–4 (έντυπη / printed 1286–1287)master formula2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- 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
- 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