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CGR-BP-033 / EDITION 10.0

Flexible Collodion

Cutaneous solution · United Kingdom · BP

2026-10-14Specialist setting only

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 10.0Record editorial review date: 2026-10-14

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Final editorial decision

Final evidence decision: no product-specific study was found establishing a numerical BUD for this exact in-house formulation and container. Prefer the exact required pharmacopoeial material from an approved supplier, with an acceptable lot CoA, dating and after-opening instructions. Different pharmacopoeial formulas and methylated laboratory variants are not automatically interchangeable. In-house production requires a volatile-compatible aw assessment and written method/matrix safety suitability. Low aw does not establish solvent retention, chemical stability, seal integrity or peroxide control. No arbitrary 180-day period is assigned. This is a completed reference monograph, not certification of a released batch.

Required evidence

  • Use qualified commercial Collodion BP against an approved specification. CGR-FR-006 is not an established automatic substitute.
  • Exact identity/composition of the required pharmacopoeial material, specification, actual lot CoA, supplier dating/instructions and a suitable tight container. Another pharmacopoeial formula or methylated laboratory variant is not presumed equivalent.
  • For the in-house final mixture, establish the aw category using a method resistant to volatile-solvent interference and written safety/suitability confirmation for ether and the actual matrix.
  • Suitable controls for ether/ethanol loss, closure integrity, appearance, applicable assays/residue and film formation. Apply fire and peroxide controls according to the material and supplier instructions.

Closure criteria

  • Procurement and routine acceptance of the exact required grade closes the material-selection question; it does not automatically establish new dating after mixing, modification or repacking.
  • Low aw resolves microbial-category uncertainty only. It does not establish solvent retention, chemical stability, closure integrity or adequate peroxide control.
  • Publish this monograph as a final specialist reference without a new numerical stock BUD. Actual use requires supported quality and a safe process. Same-session use does not replace identity, composition and safety requirements.

Scope

Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.

Sources and references

  1. USP General Chapter <795> FAQs, November 1 2023Questions 52, 60, 61, 62, 63; printed pp.11,14
  2. ANSM: Collodion, Formulaire national 1994pp.1–2, content limits; ethanol test; storage
  3. Addium/AQUALAB manufacturer: TDL2 volatile-sample water activity methodMeasurement principle, volatile samples, water-selective laser
  4. CDC/NIOSH Pocket Guide: Ethyl etherPhysical properties, incompatibilities and reactivities
  5. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5

REFERENCE FORMULA

Reference formula

Reference basis: 1000 mL

IngredientSource quantityScaled quantity
Colophony25 g—
Virgin castor oil25 g—
Collodion BPq.s. ad 1000 mL—

Prerequisite formulations

  • Κολλώδιο BP / Collodion BP

Documentation

Preparation description
Cutaneous solution: Flexible Collodion. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Skin protectant. [1]
Specifications
Composition and final quantity follow the formula table (1000 mL). The reviewed specific text gives no numerical assay, microbial-count or physicochemical acceptance range; no unsupported limit is assigned. [1]
Light
Protect virgin castor oil from light.
Light exposure contributes to ether peroxide formation. [2], [3]
Air and oxidation
Castor oil can undergo oxidative rancidity.
Ether can form explosive peroxides on exposure to air/light. [2], [3]
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
Virgin castor oil raw material: ≤25°C in PA031. The formula separately specifies processing temperature. [2]
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:
• Colophony: 25 g.
• Virgin castor oil: 25 g.
• Collodion BP: q.s. ad 1000 mL.
The specified chemical forms/grades belong to the exact source formula. [1]
Staff protection
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. [1], [4], [5]
Risk assessment
Ether/collodion: flammable vapour and peroxide hazard; appropriate solvent, ventilation and ignition controls are required.
Reference batch: 1000 mL. First ingredient: Colophony, 25 g. 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.
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], [9], [11]
Compounding conditions
Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. [1], [5]
BUD rationale
Final evidence decision: no product-specific study was found establishing a numerical BUD for this exact in-house formulation and container. Prefer the exact required pharmacopoeial material from an approved supplier, with an acceptable lot CoA, dating and after-opening instructions. Different pharmacopoeial formulas and methylated laboratory variants are not automatically interchangeable. In-house production requires a volatile-compatible aw assessment and written method/matrix safety suitability. Low aw does not establish solvent retention, chemical stability, seal integrity or peroxide control. No arbitrary 180-day period is assigned. This is a completed reference monograph, not certification of a released batch. [3], [13], [14], [15], [16]
Prerequisites

Collodion BP — qualified external pharmacopoeial material; supplier specification/CoA and released lot required [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
Mix until the colophony dissolves. Allow any deposit to settle, then decant the clear liquid. [1]
Observations
Use collodion of the specified source standard.
The matrix contains volatile organic solvents. The laboratory must demonstrate selective water-vapour measurement without interference or solvent loss and representative sampling. A binary ethanol–water table does not establish collodion aw. Passing aw does not replace evaporation and closure-function checks.
Laboratory aw is not compulsory for every preparation. Here the requirement remains specific to the complex volatile matrix and unverified category. Strong directly applicable published evidence may replace a new measurement; an instrument unsuitable for ether/ethanol cannot provide acceptable evidence. [1], [11], [12]
Container and packaging
Selection for local assessment: well-closed bottle compatible with the liquid. Check cleanliness, integrity, closure and material compatibility before filling. The specific monograph does not validate a particular commercial container. [1]
Quality control
The specific monograph supplies no separate assay. Check starting-material identity/quality and the general pharmacopoeial dosage-form requirements referenced by the source.
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], [11]
Storage

For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [6]
Dispensing
This entry does not generate a label or authorise patient dispensing. Consult its final decision and implementation criteria. [3], [13], [14], [15], [16]
Labelling
No dispensing label is issued by this entry. [3], [13], [14], [15], [16]
final_decision
Final evidence decision: no product-specific study was found establishing a numerical BUD for this exact in-house formulation and container. Prefer the exact required pharmacopoeial material from an approved supplier, with an acceptable lot CoA, dating and after-opening instructions. Different pharmacopoeial formulas and methylated laboratory variants are not automatically interchangeable. In-house production requires a volatile-compatible aw assessment and written method/matrix safety suitability. Low aw does not establish solvent retention, chemical stability, seal integrity or peroxide control. No arbitrary 180-day period is assigned. This is a completed reference monograph, not certification of a released batch. [3], [13], [14], [15], [16]

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. British Pharmacopoeia 2016 — Flexible Collodion2016PDF pp. 1–2; user-supplied BP extract; URL is publisher catalogue, not the licensed full monographmaster formula2026-09-10
  2. FN/2003/PA/031 RICINO, ACEITE VIRGEN DEΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
  3. CDC/NIOSH — Pocket Guide to Chemical Hazards: Ethyl etherΔιαθέσιμο κείμενο / Retrieved textOfficial referenceraw material or occupational2026-09-10
  4. PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
  5. ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. FDA — Water Activity (aw) in FoodsInspection Technical Guide 39, 16 April 1984; website copy accessed 2026-09-12Definition; sorption behaviour; measurement equipmentMetrological principles only. Food regulatory thresholds and old instrument recommendations are not pharmaceutical BUD rules2026-09-12
  13. USP — General Chapter <795> FAQsUpdated 1 November 2023Questions 52, 54–56, 60–62; PDF pp. 11–14Primary clarification of aw classification, extension prerequisites and compounded-component BUDs; not automatic Greek legal adoption2026-10-14
  14. ANSM: Collodion, Formulaire national 1994pp.1–2, content limits; ethanol test; storageTargeted prerequisite / publication decision; not batch result2026-10-14
  15. Addium/AQUALAB manufacturer: TDL2 volatile-sample water activity methodMeasurement principle, volatile samples, water-selective laserTargeted prerequisite / publication decision; not batch result2026-10-14
  16. British Pharmacopoeia: Content Usage Licence for Individual UsersSections1,4 and5Targeted prerequisite / publication decision; not batch result2026-10-14