Patent Blue V coloured alcohol 60% v/v · CGR-FR-035 (CGR-FR-035)

REFERENCE FORMULA

Reference formula

Reference basis: 1000 mL

Ingredient	Source quantity	Scaled quantity
Ethanol 96% v/v	625.0 mL	—
Patent Blue V	1.5 mg	—
Purified water	q.s. ad 1000.0 mL	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Clear pale-blue liquid. Ethanol is the active component; Patent Blue V is a colourant at 1.5 mg/L. It is not an injectable or ophthalmic product. ^[1]

Action and use

The Formulaire national classifies it as a dermatological antiseptic/disinfectant, ATC D 08 AX 08. The formula supplies no contact time, organism-specific efficacy spectrum or surgical-antisepsis protocol; these cannot be inferred from 60% strength. ^[1]

Specifications

Nominal ethanol 60% v/v; source assay range 57–63% v/v. Patent Blue V 1.5 mg per 1000 mL. Clear blue appearance; colourant identity by TLC. Source TAMC and TYMC acceptance criteria are 1 CFU per 10 mL each. ^[1]

Light

The formula provides neither a specific photostability study nor an explicit light-protection requirement. Record initial colour and monitor changes in the selected package; colour change alone does not demonstrate ethanol loss. ^{[1], [2]}

Air and oxidation

The container must limit ethanol loss during repeated opening. Close promptly and assess closure tightness when selecting packaging. No antioxidant or inert gas is added to this formula. ^{[1], [2], [4]}

Water and solubility

Water makes the final volume up to 1000 mL; do not substitute an assumed exact 375 mL water charge. Ethanol/water mixing contracts. Uncontrolled dilution lowers strength and creates a different product. ^{[1], [4]}

Humidity

No relative-humidity limit is specified for the solution. Prevent uncontrolled wetting of the raw colourant and ingress of water into the container. Water content does not provide a numerical aw. ^{[1], [3]}

Temperature

Mix without an open flame; allow the mixture to return to the volumetric equipment reference temperature before final volume adjustment. The source specifies no numerical storage temperature or permissible excursion. ^{[1], [2], [4]}

pH and compatibility

No pH or buffer is specified. Do not add acid/base to adjust colour. Any pH monitoring requires a method appropriate for hydroalcoholic liquid and a separately justified acceptance limit. ^{[1], [2]}

Other interactions

Prevent admixture with strong oxidisers or unqualified disinfectants. Use the specified colourant, not methylene blue. Industrial denatured alcohol is not an automatic substitute for pharmacopoeial ethanol. ^{[1], [4]}

Ingredient-specific information

Ethanol 96% v/v:625.0 mL per 1000 mL batch. Patent Blue V:1.5 mg, introduced as 0.3 mL of a controlled 5 g/L aqueous stock. Purified water: to final volume. Do not equate grams and millilitres without density/alcoholometric data. ^[1]

Staff protection

Use goggles, ethanol-compatible gloves and protective clothing. Provide ventilation, remove ignition sources and control transfers. Never mouth-pipette the 0.3 mL stock aliquot. ^{[2], [4]}

Risk assessment

Main risks are flammable liquid, confusing 96% stock with 60% finished product, mixing the alternative gram/millilitre formulas, colourant microquantity error and ethanol loss. Neonates or damaged skin need specific clinical assessment because of local reactions and ethanol absorption; these indications are not assigned here. ^{[1], [2], [4], [5]}

Compounding conditions

Reference batch 1000 mL. For final volumeV mL, k=V/1000:96% ethanol=625 k mL and 5 g/L colourant stock=0.3 k mL. Scale only when the smallest volume can be measured reliably. Check pipette calibration and finished alcohol strength. ^{[1], [2]}

BUD rationale

The specific source gives no numerical BUD, and no study of this colourant/container combination was identified. Ethanol 60% does not prove aw<0.60, in-use alcohol retention or a complete preservation programme. Neither 90 nor 180 days is assigned automatically. Applying the 35-day preserved-aqueous default requires a justified category and compatible packaging/temperature. The operational duration remains unassigned pending approval of that evidence; the earliest relevant expiry always limits it. ^{[1], [3]}

Prerequisites

A controlled 5 g/L aqueous Patent Blue V stock is required for the recipe microquantity. No separate register code is assigned here. Record preparation, concentration, lot and approved stock use; its BUD is not invented. ^{[1], [2]}

Equipment

Ethanol-compatible mixing vessel, calibrated pipette suitable for 0.3 mL,1000 mL volumetric equipment, stirrer, thermometer and tight bottles. QC requires ethanol assay, TLC and membrane-filtration microbiology. ^{[1], [2]}

Compounding method

1. Verify the 5 g/L colourant stock and measure 0.3 mL.
2. Mix with 625.0 mL of 96% v/v ethanol.
3. Add purified water, mix and adjust to 1000 mL final volume at the reference temperature.
4. Homogenise, sample for QC and bottle while limiting evaporation. ^{[1], [2]}

Observations

The source separately gives a mass-based batch:96% v/v ethanol 555.0 g, colourant 1.5 mg and water to 1000.0 g. That is not this 1000 mL batch. Its 608.1 g of 90% ethanol alternative belongs to the mass formula and must not replace 625 mL without a new calculation. ^[1]

Container and packaging

Select a tight bottle and closure compatible with hydroalcoholic liquid and limiting evaporation. The specific source does not name a material; glass with a qualified closure is an editorial design choice, not an exclusive pharmacopoeial requirement. ^{[1], [2]}

Quality control

Check clarity, colour and final volume. Assay ethanol by Ph.Eur.2.9.10 against 57–63% v/v. Perform colourant TLC after evaporating 100 mL and reconstituting in 1 mL water against Patent V reference. TAMC/TYMC by membrane filtration:1 CFU/10 mL each. Record actual results separately; ethanol presence does not replace required testing. ^{[1], [2]}

Storage

Keep tightly closed in storage suitable for flammable liquids, away from heat and ignition. Exact temperature and use-by date must accompany the approved container/BUD system; the specific monograph supplies no numerical conditions. ^{[1], [2], [4]}

Dispensing

Cutaneous use only under a specified professional instruction. Avoid eyes and ingestion. This recipe does not establish use in infants, open wounds or mucosa. Assess final labelling for ethanol and the actual product characteristics. ^{[1], [5]}

Labelling

Patent Blue V coloured alcohol — ethanol 60% v/v
External cutaneous use only. Flammable. Do not swallow.
Close promptly; keep away from children and ignition.
Lot____ Quantity____ Prepared____
Use by____ Approved storage____ Directions____ ^{[1], [2], [4], [5]}

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 scientific compilation; not an official ANSM translation or endorsement.

Sources and references

ANSM — Alcool coloré bleu patenté V (60 pour cent V/V) (2010) (15/02/2012)2010p 1 Definition; p 1 Production; p 1 Characters; pp 1–2 Identification/Test/Assay; p 2 Therapeutic classExact master formula, preparation, specifications and stated storage2026-10-14
PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 2014Chapters 3–6; Annex 2Process records, facilities, contamination control and release; not a product stability study2026-10-13
USP expert presentation — Nonsterile Compounding: Beyond-use dates14 September 2023PDFpp 10–11, slides 19–22Public official expert explanation of USP 795 default categories; no exact-product experimental evidence2026-10-13
INRS — Éthanol, fiche toxicologique 48November 2019pp 1–3 and recommendationspp 7–9Ethanol identity, volatility, flammability and handling; pure-substance properties are not finished-product measurements2026-10-13
EMA/European Commission — Excipients in labelling and the package leaflet, annexRevision 5,5 December 2025English worksheet: ethanol rows 38–43; wool fat row 114Excipient labelling; not efficacy or stability of this compound2026-10-13
USP — General Chapter <795> Frequently Asked QuestionsNovember 1, 2023 FAQ; rechecked 14 October 2026Questions 52, 54–56, 61, 64–66General category/extension rules only; not exact-product stability evidence.2026-10-14