Tannic acid alcoholic solution 10% w/v

Clear yellowish to amber solution.

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Astringent cutaneous solution. The 2003 monograph describes pressure-ulcer prevention on intact skin. This records the source claim and does not establish contemporary clinical effectiveness.

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

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

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Ethanol generates vapour; limit time in open vessels. Evaporation can change composition (editorial process assessment).

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Ethanol is miscible with water. This does not establish that all dissolved actives remain soluble after dilution.
Tannic acid is very soluble in water. Solubility does not establish finished-solution stability.

References: [4] · [5]

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

References: [1]

Finished-product storage: Below 30°C, tightly closed and protected from light. Processing follows the method-specific temperatures.

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

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Ethanol is incompatible with strong oxidants.
Tannic acid is incompatible with alkaloids, metal salts, lime water, albumin, gelatin, mucilage, AgNO3, iodides and bromides.

References: [4] · [5]

Exact identities: Ταννικό οξύ / Tannic acid; Αιθανόλη 70% κατ’ όγκο / Ethanol 70% v/v. 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.

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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.

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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]

The source reports irritation and potential hepatic injury from systemic absorption after prolonged application to extensive or denuded areas. Flammable alcoholic solvent.
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.

References: [1] · [4]

The specific monograph states 3 months 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.

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No separate compound base is required in the explicit formula.

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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.

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1. Dissolve tannic acid in part of the 70% ethanol.
2. Filter as required by the source.
3. Make up to 100 mL with the same solvent under PN/L/FF/007/00 and mix.

References: [1] · [2]

Tannin is a mixture and requires appropriate pharmacopoeial quality. The strength means 10 g in a final 100 mL.

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Tightly closed amber glass bottle.

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Tannic acid alcoholic solution 10% w/v
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 30°C, tightly closed and protected from light.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Flammable. Keep away from flames. Do not swallow.
Specimen for pharmacist adaptation; not a final approved label.

References: [1] · [4]

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]

Below 30°C, tightly closed and protected from light.

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Use only on intact skin after clinical assessment of the indication. The historical source gives 2–4 applications/day. Avoid open wounds or extensive areas. Do not swallow.

References: [1]