Salicylic acid 5% and triamcinolone acetonide 0.1% cream

White cream with a firm consistency. ^[1]

AEMPS describes symptomatic treatment of psoriatic skin lesions. Salicylic acid is keratolytic; triamcinolone is an anti-inflammatory corticosteroid. ^[1]

White cream with a firm consistency. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided. ^[1]

The finished preparation is stored protected from light under the monograph. ^[1]

No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. ^[1]

Salicylic acid is slightly soluble in water and freely soluble in ethanol under PA033.
Propylene Glycol: JP classifies the corresponding pure raw material as miscible in water.
Salicylic acid is slightly soluble in water; raw-material melting range 158–161 °C. ^{[4], [6]}

Propylene glycol is hygroscopic; close its container promptly after measuring.
Propylene Glycol: the raw material is hygroscopic according to JP. ^{[5], [6]}

Finished-product storage: Protect from light; below 30°C. Processing follows the method-specific temperatures. ^[1]

No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. ^[1]

Salicylic acid: incompatibilities with alkalis, Fe/Pb salts and iodine. Above 2%, problems may occur in nonionic emulsions. ^[4]

Exact identities: Σαλικυλικό οξύ / Salicylic acid; Ακετονίδιο τριαμκινολόνης / Triamcinolone acetonide; Προπυλενογλυκόλη / Propylene glycol; Ανιονικό γαλάκτωμα O/W EX007 / Anionic O/W emulsion EX007. 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.
Propylene glycol (1,2-propanediol): colourless viscous water-miscible cosolvent and humectant. A small amount does not establish adequate preservation.
Propylene Glycol: raw-material water solubility is classified as miscible by JP.
Propylene glycol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. ^{[1], [5], [6], [7]}

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. ^[2]

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.
Salicylic acid: avoid dust, inhalation and eye/mucosal contact; use eye protection.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. ^{[3], [4], [8]}

Low-concentration corticosteroid: weighing accuracy and homogeneity are critical. The source reports systemic toxicity with large areas/high doses, especially in children and renal or hepatic impairment.
Propylene glycol: assess exposure from all medicines, especially in neonates, children under 5 and renal/hepatic impairment. For oral dosing: mg/kg/day = mg/mL × daily mL ÷ body weight in kg.
Reference batch: 100 g. First ingredient: Salicylic acid, 5 g. Independently check chemical form, units and every scale conversion before weighing.
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
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: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. ^{[1], [5], [11], [13]}

Period reported by source: 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.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. ^{[1], [9], [10], [12], [14]}

No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. ^[1]

Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. ^[1]

1. Prepare and check anionic emulsion EX007.
2. Finely triturate and mix both actives in a mortar.
3. Disperse in the minimum necessary propylene glycol to form a uniform paste.
4. Add the cooled base gradually while mixing with the pestle. Make up to a total mass of 100 g with base and homogenise. ^{[1], [2]}

The formula requires anionic base EX007. Do not arbitrarily substitute a nonionic cream, particularly with 5% salicylic acid. ^[1]

Opaque jar or plastic tube. ^[1]

Salicylic acid 5% and triamcinolone acetonide 0.1% cream
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Protect from light; below 30°C.
Temperature for this batch BUD: ____ ^[1]

Under AEMPS: organoleptic properties and final mass. Batch production additionally requires spreadability PN/L/CP/003/00, emulsion type PN/L/CP/002/00, pH for O/W under PN/L/CP/001/00 and microbiological testing under RFE 5.1.4. No formula-specific active-assay or pH limits are specified here; local release criteria are required.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [2], [7], [13]}

Protect from light; below 30°C. ^[1]

The source gives 1–3 applications/day to clean, dry affected skin. Do not use under age 2, with salicylate/corticosteroid allergy, on mucosa or eroded skin. No occlusion without medical direction. Avoid extensive/prolonged use and combination with other keratolytics. ^[1]

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.