Spironolactone capsules 25 mg FTM

Hard capsules: Spironolactone capsules 25 mg FTM. Additional appearance criteria are not established by the specific text reviewed. ^[1]

Potassium-sparing diuretic in selected cardiovascular regimens; potassium/renal monitoring is required. ^[1]

Composition and final quantity follow the formula table (20 capsules). The reviewed specific text gives no numerical assay, microbial-count or physicochemical acceptance range; no unsupported limit is assigned. ^[1]

Finished-product photostability is not specified. Any required container light protection is stated under Storage. ^[1]

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

Spironolactone: JP classifies the corresponding pure raw material as practically insoluble in water. ^[4]

No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. ^[1]

For the finished product the source specifies:
Suitable closed container, 15–25 °C. ^[1]

No pH is assigned to the dry dosage form. Any analytical-extract pH requires the specified method. ^[1]

No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. ^[1]

Spironolactone: raw-material water solubility is classified as practically insoluble by JP. ^[4]

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
For hazardous-active manipulation use appropriate ventilated containment, double tested chemotherapy gloves and an impervious disposable gown; hair/shoe covers and additional eye/face or respiratory protection follow exposure and the NIOSH table. A surgical mask does not substitute for respiratory protection. ^{[1], [3], [5], [8], [9]}

Spironolactone appears in the NIOSH List 2024, Table 2, PDF p. 32. The entry “developmental/reproductive toxicity only” is No; this does not mean absence of hazard.
Reference batch: 20 capsules. First ingredient: Spironolactone, 500 mg. Independently check chemical form, units and every scale conversion before weighing.
Mass uniformity alone does not prove content uniformity. Check geometric dilution, minimum weight, wall losses and capsule count/size. Keep strengths distinctly identified during filling and labelling.
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.
Spironolactone is in NIOSH 2024 Table 2. Trituration/mixing exposes staff to active powder and requires suitable ventilated containment, decontamination procedures and segregated residues. Assess staff reproductive risk and cross-contamination.
Release checkpoint: independently verify mg per unit, total unit count and smallest weighable quantity. Mass uniformity does not replace content uniformity when required. Document geometric dilution and prevention of powder segregation. ^{[1], [2], [8], [9], [11]}

Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. ^{[1], [5]}

Period reported by source: 2 months.
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 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category.
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 clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately.
v9 numerical correction: the source specifies 2 calendar months. This edition uses a conservative fixed reference ceiling of 59 days, avoiding extension beyond the shortest corresponding calendar span. This is an editorial conversion convention, not a source amendment or new experimental evidence. The 180-day category ceiling does not supersede the shorter source period. ^{[1], [6], [7], [10], [12]}

Diluent A FTM — lactose: CGR-BE-001 ^[1]

Balance, mortar/pestle, sieve, capsule filler for the specified shell size and mass/uniformity QC equipment. ^[1]

Place about 1 g diluent in the mortar. Add 500 mg active and mix. Determine fill volume from the calibrated capacity of 20 capsules without tamping. Add diluent, remix and fill. ^[1]

The final quantity is the master-formula basis. Record actual yield, losses and deviations in the batch record. ^[1]

Suitable closed container, 15–25 °C. ^[1]

Inspect appearance, uniformity/aggregates and final mass. No specific validated analytical method for the finished mixture was located in the source. These proposed in-process checks do not replace assay or microbiological testing when required.
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], [11]}

Suitable closed container, 15–25 °C. ^[1]

Dispense the exact prescribed strength. For liquids use a suitable graduated oral syringe; record dose and frequency from the prescription. ^[1]

Spironolactone capsules 25 mg FTM
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Suitable closed container, 15–25 °C.
Temperature for this batch BUD: ____ ^[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.