Stasinos Chr. Sikalias · The science of compounding

Silver nitrate cutaneous solution 2% w/w

CGR-ES-072 · FN/2003/FMT/020 NITRATO DE PLATA, SOLUCIÓN AL 2% DE

For local reviewCGR-ES-072Spain · AEMPS

Documented bibliographic addition; requires local scientific approval before use as a master formulation record.

Dosage formSolution for external pharmaceutical use
Reference batch15 g
Monograph version5.0
Source packagev5

Source formula

IngredientSource quantity
Silver nitrate0.3 g
Purified waterq.s. ad 15 g

Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.

Description

Documented in source

Clear solution.

References: [1]

Use and action

Documented in source

Caustic for targeted destruction of pathological tissue, such as warts, according to AEMPS.

References: [1]

Specifications

Partial evidence

Clear solution. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided.

References: [1]

Light

Documented in source

The finished preparation is stored protected from light under the monograph.

References: [1]

Air

Partial evidence

Silver nitrate: protect from air and organic contamination.

References: [4]

Water and solubility

Partial evidence

Silver nitrate is very soluble in water.

References: [4]

Humidity

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Temperature

Partial evidence

Finished-product storage: Below 30°C; protect from light. Processing follows the method-specific temperatures.

References: [1]

pH and related incompatibilities

Not established

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Other incompatibilities

Partial evidence

Silver nitrate: incompatible with alkalis, acids and halogen salts, phosphates and tannins.

References: [4]

Ingredient-specific information

Partial evidence

Exact identities: Νιτρικός άργυρος / Silver nitrate; 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.

References: [1]

Compounding conditions

Documented in source

Laboratory environment under the referenced AEMPS procedure: 25±5°C and relative humidity ≤60%, unless the specific formulation requires otherwise. Room temperature differs from processing temperature.

References: [2]

Personal protective equipment

Partial evidence

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.

References: [3]

Risks and precautions

Documented in source

Caustic; may cause permanent staining/argyria. Ingestion can cause severe toxicity. Prevent staff eye and skin contact.

References: [1]

BUD rationale

Partial evidence

The specific monograph states 2 weeks under its specified conditions. This is a source period, not independently verified stability of the local batch. Match composition, preservative, container and storage, check applicable requirements and obtain responsible approval. The actual date remains blank.

References: [1]

Bases and dependencies

Documented in source

No separate compound base is required in the explicit formula.

References: [1]

Equipment

Editorial checklist

Balance with suitable resolution, mortar/spatula, suitable mixing vessels and final container. Add volumetric equipment for mL, a controlled water bath where melting is specified and a suitable filter where required. Analytical equipment follows the QC methods.

References: [2]

Preparation procedure

Documented in source

1. Weigh 0.3 g silver nitrate and purified water.
2. Dissolve with continuous stirring.
3. Make up to a final mass of 15 g with water and mix. The formula is mass-based, not volume-based.

References: [1] · [2]

Observations

Partial evidence

0.3 g/15 g = 2% w/w. This is not an ophthalmic preparation.

References: [1]

Packaging

Documented in source

Nonmetallic, alkalinity-free, hermetically closed light-resistant container, e.g. amber glass.

References: [1]

Labelling

editorial_specimen

Silver nitrate cutaneous solution 2% w/w
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 30°C; protect from light.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.

References: [1]

Quality control

Partial evidence

Under AEMPS: organoleptic properties and final mass and/or volume. For batches: colour RFE 2.2.2, clarity/opalescence RFE 2.2.1, relative density RFE 2.2.5, pH under PN/L/CP/001/00 and microbiological testing under RFE 5.1.4. This formula provides no numerical pH/density limits or specific active assay.

References: [1] · [2]

Storage

Documented in source

Below 30°C; protect from light.

References: [1]

Dispensing and directions

Documented in source

External use only, targeted to the lesion. The source gives one application/day with a suitable applicator. Protect surrounding healthy skin; avoid eyes and mucosa. Children, pregnancy and breastfeeding require medical assessment.

References: [1]

Sources and traceability

  1. FN/2003/FMT/020 NITRATO DE PLATA, SOLUCIÓN AL 2% DE

    FN/2003/FMT/020 · Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leaflet · A1 official formulary

    Review date reported in supplied metadata: 2026-09-10

  2. PN/L/FF/007/00 ELABORACIÓN DE SOLUCIONES

    PN/L/FF/007/00 · §4.3 environment; §4.4 method; §4.6 controls · A2 official technical guidance

    Review date reported in supplied metadata: 2026-09-10

  3. PN/L/PG/002/00 INDUMENTARIA

    PN/L/PG/002/00 · Clothing and protective equipment · A2 official technical guidance

    Review date reported in supplied metadata: 2026-09-10

  4. FN/2003/PA/026 NITRATO DE PLATA

    FN/2003/PA/026 · Raw-material properties, handling and incompatibilities · A1 official formulary

    Review date reported in supplied metadata: 2026-09-10

  5. AEMPS — Aviso legal

    Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence

    Review date reported in supplied metadata: 2026-09-10

  6. BOE — Real Decreto 1495/2011, artículos 7–10 y anexo

    Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence

    Review date reported in supplied metadata: 2026-09-10

Provenance and reuse

Source: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Formulario Nacional. Original Greek/English rendering and restructuring: Greek Formulary Sikalias, Stasinos Chr. Sikalias, compounding.gr. Reuse basis: AEMPS legal notice and RD 1495/2011, Articles 7–10/Annex. Composition and units retained; references, distinct editorial notes and blank batch fields added. AEMPS endorsement is not implied. Edition code appears in the reference; NIPO 134-20-002-3 / 090-22-245-5. The PDFs do not state an exact internal revision date. Access checked 10 September 2026.

SHA-256 of the supplied PDF: 75aa5f4fa430d47928bc1f09d305a02ff7dace6c74d0920dbf3320ee7d474d36