Capsule diluent 1 EX013

White powder. ^[1]

Base or auxiliary excipient for further compounding. Its BUD is not adopted unchanged after adding an active. ^[1]

White powder. ^[1]

For the finished product the source specifies:
Opaque jar; protect from excessive heat, direct sunlight and moisture. ^[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]

For the finished product the source specifies:
Opaque jar; protect from excessive heat, direct sunlight and moisture. ^[1]

No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. ^[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:
• Microcrystalline cellulose: 98.05 g.
• Colloidal anhydrous silica: 1.95 g.
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], [2], [4]}

Reference batch: 100 g. First ingredient: Microcrystalline cellulose, 98.05 g. Independently check chemical form, units and every scale conversion before weighing.
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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: 6 months under the source conditions.
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. ^{[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 with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. ^[1]

Mix one third of the MCC with colloidal silica. Add and mix the second and final thirds successively. Use 15–30 min depending on quantity, in a tumbling mixer or, for small quantities only, a mortar. ^{[1], [3]}

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

Opaque jar; protect from excessive heat, direct sunlight and moisture. ^[1]

White powder.
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]}

Opaque jar; protect from excessive heat, direct sunlight and moisture. ^[1]

Intermediate base for compounding. Adding an active requires reassessment of the final composition, pH, preservation and BUD. ^[1]

Capsule diluent 1 EX013
Compounding base — not for direct administration
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Opaque jar; protect from excessive heat, direct sunlight and moisture.
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.