Sertraline 25 / 50 mg capsules

Hard capsules: Sertraline 25 / 50 mg capsules. Additional appearance criteria are not established by the specific text reviewed. ^[1]

Selective serotonin reuptake inhibitor. ^[1]

Mean fill mass 126–154 mg, nominal 140 mg. Mean assay 90–110%. Test mass on 20 capsules and content on 10 in the control batch; full criteria in the original. ^[1]

For the finished product the source specifies:
PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg. ^[1]

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

No quantitative hydrolytic stability limit is given for this formula. Retain the prescribed water amount and quality. ^[1]

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:
PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg. ^[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]

Identity and weighing basis:
• Sertraline hydrochloride, for 25 / 50 mg base strength: 8.394 / 16.788 g.
• Lactose Capsulac 60, respectively: 33.606 / 25.212 g.
• Opaque size 4 gelatin shells: 300 τεμάχια / pieces.
The specified chemical forms/grades belong to the exact source formula. ^[1]

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [3], [4]}

Reference batch: 300 καψάκια μίας ισχύος / 300 capsules of one strength. First ingredient: Sertraline hydrochloride, for 25 / 50 mg base strength, 8.394 / 16.788 g. 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.
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], [7], [9]}

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], [4]}

Period reported by source: Source period: 5 weeks.
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 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.
Register correction: at most 35 days as a conservative reference cap before any shorter expiry/component date. This edition converts one calendar month to 28 days and three calendar months to 89 days; weeks are converted to seven days. Original source units are retained. This is an editorial conversion policy, not a new stability result or automatic release. ^{[1], [5], [6], [8], [10]}

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

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

Select one of the two quantity columns. Mix micronised API and lactose using the studied source method: Topitec, 500 mL pot, 5 balls, 500 rpm for 10 min. Fill size 4 capsules evenly and test. Another mixer requires blend-uniformity qualification. ^[1]

Strengths are sertraline base; weigh hydrochloride: 27.98 / 55.96 mg per capsule. Do not freely exchange API or lactose grades; the note requires suitable dissolution and blend validation for alternatives. ^{[1], [2]}

Selection for local assessment: well-closed dry container suitable for the dosage form. Check cleanliness, integrity, closure and material compatibility before filling. The specific monograph does not validate a particular commercial container. ^[1]

Mass uniformity of 20 random units by Ph. Eur. 2.9.5 and content/unit tests in the specific analytical annex. Use the exact limits for the selected strength. The full annex is required for execution.
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], [9]}

PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg. ^[1]

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

Sertraline 25 / 50 mg capsules
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg.
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.