REFERENCE FORMULA
Reference formula
Reference basis: 1000 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Ethanol JP, 95.1–96.9% v/v at 15°C | 830 mL | — |
| Purified water | q.s. ad 1000 mL | — |
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-007 · Ethanol for Disinfection 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
Clear, colourless, volatile, flammable liquid, miscible with water. [1]
Action and use
Ethanol preparation for disinfection as named by JP. This monograph does not prescribe a dose, contact time or efficacy against a specific microorganism. [1]
Specifications
Final ethanol 76.9–81.4% v/v at 15°C. Relative density d15/15: 0.86027–0.87264. Clear, colourless solution. Comply with prescribed purity tests. [1]
Light
The specific monograph requires light protection. [1]
Air and oxidation
Ethanol generates vapour; limit time in open vessels. Evaporation can change composition (editorial process assessment). [4]
Water and solubility
Miscible with water. Adding water changes strength; final volume adjustment and density verification are required. [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
Ethanol is incompatible with strong oxidants. [4]
Ingredient-specific information
Exact identities: Αιθανόλη JP, 95,1–96,9% v/v στους 15°C / Ethanol JP, 95.1–96.9% v/v at 15°C; Κεκαθαρμένο ύδωρ / Purified water. Use pharmacopoeial raw materials of the referenced edition, with CoA verification. Do not arbitrarily change salt, hydration state or strength. Record the actual q.s. amount in the batch. [1]
Compounding conditions
Staff protection
Clean protective clothing and head covering under AEMPS PN/L/PG/002/00. Use suitable gloves where contact is possible and respiratory/eye protection where powder handling requires it. Exact glove material, ventilation and respiratory protection must follow the SDS and local exposure assessment.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. [3], [5]
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. [3], [5]
Risk assessment
Flammable vapour. Assess ventilation, ignition sources and the amount of solvent handled by the laboratory.
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL. First ingredient: Ethanol JP, 95.1–96.9% v/v at 15°C, 830 mL. 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, 95.1–96.9% v/v at 15°C 830 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], [5], [10], [12]
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
Reference batch: 1000 mL. First ingredient: Ethanol JP, 95.1–96.9% v/v at 15°C, 830 mL. 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, 95.1–96.9% v/v at 15°C 830 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], [5], [10], [12]
BUD rationale
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
Solvent system: final ethanol 76.9–81.4% v/v according to JP. 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.
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], [7], [8], [9], [11], [13]
Solvent system: final ethanol 76.9–81.4% v/v according to JP. 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.
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], [7], [8], [9], [11], [13]
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
1. Verify JP-grade starting ethanol containing 95.1–96.9% v/v at 15°C.
2. Measure 830 mL and add purified water.
3. Mix and make up to a final volume of 1000 mL with water. Temperature equilibration before final volume adjustment is a local control for contraction/heating during mixing. Verify final strength by the official method. [1], [2]
2. Measure 830 mL and add purified water.
3. Mix and make up to a final volume of 1000 mL with water. Temperature equilibration before final volume adjustment is a local control for contraction/heating during mixing. Verify final strength by the official method. [1], [2]
Observations
830 mL of JP Ethanol does not mean 83% absolute ethanol. Do not substitute the same volume of anhydrous ethanol. The 24-month period in the adjacent Ethanol/Anhydrous Ethanol monograph is not transferred here.
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], [14]
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], [14]
Container and packaging
Tight, light-resistant container. [1]
Labelling
Ethanol for Disinfection JP
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Keep tightly closed and protected from light. Control ignition sources because of ethanol. The specific monograph gives no numerical storage temperature.
Temperature for this batch BUD: ____ [1]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Keep tightly closed and protected from light. Control ignition sources because of ethanol. The specific monograph gives no numerical storage temperature.
Temperature for this batch BUD: ____ [1]
Quality control
Use JP 2.56 relative density to verify concentration. Identification uses the two chemical reactions in the specific monograph. Purity follows Ethanol tests (clarity, acidity/alkalinity, volatile impurities by GC, evaporation residue), with a specific final-solution UV test: 5 cm cell, water blank; A240 ≤0.40, A250–260 ≤0.30, A270–340 ≤0.10 and a smooth curve over 235–340 nm. Execution requires the full referenced text.
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], [2], [12]
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], [2], [12]
Storage
Keep tightly closed and protected from light. Control ignition sources because of ethanol. The specific monograph gives no numerical storage temperature.
For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [4], [6]
For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [4], [6]
Dispensing
Label as a disinfectant preparation; not for drinking. Establish the permitted application and contact time separately. Do not infer marketing authorisation or a specific antimicrobial spectrum from this monograph alone. [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
- MHLW — JP XVIII: Ethanol for Disinfection JP2021JP XVIII (2021), printed pp. 966–967; starting Ethanol pp. 964–965specific formulation2026-09-10
- MHLW — JP XVIII, General Rules for Preparations202111-4 Ointments and 11-2 Cutaneous liquids, printed p. 20; Other Preparations 3 Spirits, p. 22; General Noticesgeneral procedure2026-09-10
- PN/L/PG/002/00 INDUMENTARIAPN/L/PG/002/00Clothing and protective equipmentgeneral procedure2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl alcoholWeb page reviewed 30 October 2019Physical properties: solubility and vapour pressure; CAS 64-17-5Properties of ethanol raw material; process implications are editorial, not finished-formula stability evidence2026-09-12
- 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
- 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
- CDC — Chemical Disinfectants: Alcohol28 November 2023; 2008 guidelineAlcohol: Overview and Microbicidal activityAlcohol antimicrobial context; not a finished-product preservative challenge test2026-09-12
- 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