Colloidal silver ointment · CGR-FR-037 (CGR-FR-037)

REFERENCE FORMULA

Reference formula

Reference basis: 100 g

Ingredient	Source quantity	Scaled quantity
Colloidal silver for external cutaneous use	15.0 g	—
Purified water	15.0 g	—
Wool fat	35.0 g	—
White soft paraffin	35.0 g	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Glossy very dark-brown semisolid ointment. It contains 15 g water per 100 g despite classification as a hydrophobic ointment; it is not an anhydrous base. ^[1]

Action and use

The French source classifies it as a silver-containing dermatological antiseptic/disinfectant, ATC D 08 AL. It does not establish a treatment duration, extensive-burn use or contemporary comparative effectiveness. Oral, ophthalmic and injectable uses are outside this formula. ^[1]

Specifications

External-use colloidal-silver raw material is charged at 15.0% w/w. The source sets a minimum 10.0% w/w content expressed as colloidal silver and provides an argentometric calculation. The raw-material charge is not automatically 15% elemental or nanoparticulate silver. Homogeneity requires absence of visible flakes/shiny lamellae. ^[1]

Light

The specific monograph requires glass but provides no photostability study or explicit mandatory light protection. Protective glass and colour monitoring are conservative local choices, not a measured photostability period. ^{[1], [2]}

Air and oxidation

Limit open mixing and close after each withdrawal to reduce contamination and water loss. No inert atmosphere or antioxidant is specified. Visible homogeneity is not evidence of chemical silver stability. ^{[1], [2]}

Water and solubility

The 15.0 g purified water first wets/disperses the colloidal silver. Do not omit it or substitute saline. Additional dilution or a changed aqueous phase requires reassessment of the colloidal system, microbiology and BUD. ^{[1], [2]}

Humidity

No relative-humidity or aw limit is given. A fatty continuous phase does not prove aw<0.60. Keep materials/product closed and prevent water ingress from wet tools or condensation. ^{[1], [3]}

Temperature

Do not exceed 30 °C during preparation. This process limit is not a proven storage-temperature limit. Refrigeration needs evaluation of consistency, separation, crystallisation and uniformity after return to use temperature. ^{[1], [2]}

pH and compatibility

No pH or buffer is specified. Measuring a dispersed aqueous phase requires an appropriate specific method; no fictitious ointment pH is assigned. Do not add acid or base. ^{[1], [2]}

Other interactions

Use the specified pharmacopoeial external-use colloidal-silver material. Consumer colloidal-silver liquids, nanosilver, silver salts and protein preparations with different specifications are not assumed equivalent. Compatibility concerns the complete formulation and container. ^[1]

Ingredient-specific information

External-use colloidal silver 15 g, purified water 15 g, wool fat 35 g and white soft paraffin 35 g. Lanolin can cause local skin reactions/contact dermatitis. Verify the exact silver raw material identity and certificate before quantitative interpretation. ^{[1], [4]}

Staff protection

Use laboratory clothing, eye protection and gloves for weighing/mixing. Contain the actual silver raw material and prevent transfer to tools/surfaces. Nitric-acid analytical digestion requires a separate fume-hood procedure and protection against acid fumes. ^{[1], [2]}

Risk assessment

Critical points are the wrong colloidal-silver grade, exceeding 30 °C, inadequate initial wetting, nonuniform dispersion and contamination during use. Screen for known lanolin allergy. Silver presence is not a preservative-efficacy test. Collect silver residues separately and prevent uncontrolled drain disposal. ^{[1], [2], [4], [5]}

Compounding conditions

The charge totals 100 g. ForM g batch use 0.15 M g silver material,0.15 M g water,0.35 M g wool fat and 0.35 M g petrolatum. Independently verify scaling and record actual yield; do not replace losses with water alone. ^{[1], [2]}

BUD rationale

The monograph supplies no use period, and no study of the same silver grade, aqueous/fatty base and glass container was identified. With 15% added water and unproven preservation, an anhydrous category is inappropriate. The 14-day unpreserved-aqueous default requires 2–8 °C and demonstrated physical suitability of this ointment; it is not 14 days at room temperature. Because refrigeration compatibility is unestablished in the sources, no operational numerical BUD is assigned. Specific evidence is required before dated storage/supply. ^{[1], [3]}

Prerequisites

No separately registered base is required. White soft paraffin, wool fat and colloidal silver must meet the source specifications. Do not substitute a hydrophilic base for wool fat or an oil for petrolatum. ^[1]

Equipment

Balance, glass vessels, suitable pestle/spatula, gentle controlled heating and thermometer. Two glass slides for homogeneity. Assay requires safely performed acid digestion and titration, not appearance alone. ^{[1], [2]}

Compounding method

1. Place 15 g water in glass equipment and add 15 g colloidal silver in portions without initial trituration.
2. Allow 5–10 minutes for wetting.
3. Gently prewarm 35 g wool fat and 35 g white soft paraffin without exceeding 30 °C.
4. Incorporate into the silver dispersion and triturate until homogeneous, maintaining≤ 30 °C.
5. Cool, test and transfer to the selected glass container. ^[1]

Observations

The 5–10 minute initial wetting period and gentle temperature are essential process elements. No sterilisation step is included. Express content according to the specific pharmacopoeial material, not as silver-nitrate equivalence. ^[1]

Container and packaging

Glass is selected in accordance with the monograph Conservation section. Use a compatible tight closure and a withdrawal method limiting finger/moisture contact. Qualify closure compatibility and repeated-use handling separately. The Preparation paragraph also prefers a lined metal tube, while Conservation states glass. This internal difference is recorded; glass is the selected reference option, and tube use requires an approved compatibility decision. ^{[1], [2]}

Quality control

Appearance/homogeneity: spread about 0.2 g between glass slides; no particles, flakes or shiny lamellae. Identify silver after acid treatment. Assay about 0.500 g after digestion with 3 mL nitric acid, adding 100 mL water, boiling/cooling and 1 mL ferric ammonium sulfate indicator; titrate with 0.1 M ammonium thiocyanate. Each 1 mL equals 10.79 mg Ag. Apply the complete method and specification basis, not the factor alone. ^{[1], [2]}

Storage

Store in well-closed glass. The source gives no numerical storage temperature or period. The required temperature must accompany a justified BUD; the≤ 30 °C manufacturing limit is not presented as a storage study. ^{[1], [3]}

Dispensing

Supply only for a specified cutaneous use following professional assessment. Check lanolin allergy and ingredient hypersensitivity. Frequency, treatment area and duration absent from the source are not invented here. Instruct clean withdrawal without wet tools. ^{[1], [4]}

Labelling

Colloidal silver ointment — cutaneous use
Contains 15% w/w of the specified colloidal-silver raw material and 35% lanolin.
Lanolin may cause a local skin reaction.
Do not swallow; avoid eyes. Close after withdrawal.
Lot____ Quantity____ Prepared____ Use by____
Approved storage____ Patient-specific directions____ ^{[1], [2], [4]}

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 — Pommade à l'argent colloïdal (2007) (15/02/2012)2007p 1 Definition; p 1 Preparation; pp 1–2 Identification/Test/Assay; p 1 Preparation versus p 2 Conservation; 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
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
WHO/IPCS — Silver and silver compounds: environmental aspectsCICAD 44;2002Environmental exposure and risk characterizationControl of silver-containing waste; does not establish topical efficacy or finished-mixture CLP class2026-10-13
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