Silver nitrate sticks 633 mg/g · CGR-FR-036 (CGR-FR-036)

REFERENCE FORMULA

Reference formula

Reference basis: 100 g

Ingredient	Source quantity	Scaled quantity
Silver nitrate	63.3 g	—
Potassium nitrate	36.7 g	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Hard elongated cylinders with rounded tips, white to pale grey. The source notes gradual darkening; colour cannot substitute for identity and content testing. ^[1]

Action and use

Source-classified cutaneous keratolytic/verrucide, ATC D 11 AF. Application is restricted to an identified local lesion by a suitably trained user; no universal frequency or treatment duration is supplied. ^[1]

Specifications

Nominal silver nitrate 633 mg/g; acceptance 60.1–66.4% w/w. Potassium nitrate constitutes 36.7% w/w of the starting mixture. Check shape, integrity and silver/nitrate/potassium identity reactions. ^[1]

Light

The source requires light protection. Keep sticks in protective packaging and replace after use. Raw-material photosensitivity does not establish a numerical product shelf-life. ^{[1], [4]}

Air and oxidation

No inert atmosphere is specified. Keep packaging closed to limit contamination and moisture; segregate from combustible or reducing materials. ^{[1], [4], [5]}

Water and solubility

The nitrate salts are water soluble. The source directs moistening immediately before application; water is not added in manufacturing the dry sticks. Keep wet used surfaces/residues separate from unused sticks. ^{[1], [4], [5]}

Humidity

No numerical humidity limit or measured aw is supplied. Protect dry sticks from wetting and inspect surface erosion, softening or crumbling. Absence of added water is not itself a water-activity measurement. ^{[1], [3]}

Temperature

Melt under controlled heating in a porcelain crucible. The mixture melting temperature is not stated; pure-salt melting points are not a validated mixture process. Avoid overheating and decomposition. ^{[1], [4], [5]}

pH and compatibility

No pH specification is assigned to the solid stick. Do not add acid/base. Solutions prepared for analytical testing are not products for dispensing. ^[1]

Other interactions

The salts are oxidants and require segregation from combustible/reducing materials. Avoid improvised organic mould lubricants. Qualify closure/lining compatibility rather than treating all plastics as equivalent. ^{[1], [4], [5]}

Ingredient-specific information

Silver nitrate AgNO 3, CAS 7761-88-8:63.3 g. Potassium nitrate KNO 3, CAS 7757-79-1:36.7 g. This is the 100 g charge ratio; record actual yield after casting and trimming without arbitrarily changing proportions. ^{[1], [4], [5]}

Staff protection

Use eye/face protection, suitable chemical gloves and protective clothing. Casting also requires thermal protection and safe crucible handling. Control dust and provide appropriate extraction during heating. ^{[2], [4], [5]}

Risk assessment

Manufacturing combines corrosive silver nitrate, oxidant salts and molten material. Qualify equipment and hot-material handling, prevent organic contamination and segregate silver waste. Clinical risks include burns to healthy skin/eyes, application at the wrong site and ingestion. The source restricts paediatric use to medical staff. ^{[1], [2], [4], [5]}

Compounding conditions

For initial chargeM g: AgNO 3=0.633 M g and KNO 3=0.367 M g. Independently verify identity and ratio. Do not add an arbitrary excess to compensate for losses. Record thermal profile, time, cast mass and yield locally. ^{[1], [2]}

BUD rationale

The monograph supplies no numerical period. No exact-mixture/container stability study or measured aw was identified. The 180-day default ceiling applies to justified nonaqueous forms with aw<0.60; it is not assigned solely because this is a solid stick. A storage period requires a documented category, light protection, integrity and moisture rationale. Numerical BUD and actual expiry remain unassigned here. ^{[1], [3]}

Prerequisites

No vehicle or manufacturing solvent is required. Both salts must meet pharmacopoeial quality. Any mould release agent or plastic holder requires separate compatibility assessment and is not a recipe ingredient. ^{[1], [2]}

Equipment

Balance, suitable dry mixing tools, porcelain crucible, controlled electric heater, suitable mould, tongs and thermal protection. Analytical equipment for titration and identity reactions. ^{[1], [2]}

Compounding method

1. Weigh 63.3 g silver nitrate and 36.7 g potassium nitrate; mix uniformly.
2. Melt in a porcelain crucible using a recorded local thermal procedure.
3. Cast carefully into a suitable mould.
4. Cool, demould and trim flash while controlling dust.
5. Check integrity/content and package with light protection. ^{[1], [2], [4], [5]}

Observations

This is not equivalent to commercial 75% sticks or another nitrate ratio. Number, length and mass per stick depend on the mould and are not specified. Do not invent a dose-per-centimetre conversion. ^[1]

Container and packaging

Use light-protective packaging that keeps the stick dry, intact and isolated from incompatible materials. The source names no container material; qualify it for an oxidant solid and safe application. ^{[1], [2], [4]}

Quality control

Identify silver, nitrate and potassium in solutionS (1 g to 50 mL water). For assay: dissolve 0.500 g powdered sample in 50 mL water, add 5 mL dilute nitric acid and 2 mL ferric ammonium sulfate solution; titrate with 0.1 M ammonium thiocyanate. Each 1 mL equals 17.00 mg AgNO 3. Acceptance 60.1–66.4% w/w. Assess analytical acid/titration hazards separately. ^{[1], [2]}

Storage

Protect from light, moisture and contact with combustible/reducing materials. The source gives no numerical storage temperature. Use a selected compatible closed container; colour change alone is not the sole release/rejection criterion. ^{[1], [4], [5]}

Dispensing

Moisten before use and protect healthy skin. Do not apply to mucosa. The source restricts paediatric use to medical staff. Supply lesion-specific instructions, avoid self-treatment of an uncertain diagnosis and arrange safe residue disposal. ^{[1], [4]}

Labelling

Silver nitrate sticks 633 mg/g
Potassium nitrate 367 mg/g (36.7% w/w).
External use only. Protect healthy skin. Avoid mucosa/eyes.
Moisten before application. Protect from light; keep dry.
Paediatric use only by medical staff.
Lot____ Quantity____ Prepared____ Use by____
Responsible professional instructions____ ^{[1], [2]}

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 — Bâtons au nitrate d'argent à 633 mg/g (2012) (15/02/2012)2012p 1 Definition; p 1 Production; pp 1–2 Identification/Assay; p 2 Conservation; p 2 PrecautionsExact 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
ILO/WHO — International Chemical Safety Card 1116, silver nitrateApril 2024Hazards, chemical dangers and environmentRaw silver-nitrate occupational and environmental hazards2026-10-13
ILO/WHO — International Chemical Safety Card 0184, potassium nitrateOctober 2001Hazards, chemical dangers and exposureRaw potassium-nitrate oxidant and dust hazards2026-10-13
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