REFERENCE FORMULA
Reference formula
Reference basis: 20 capsules
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Paracetamol, crystals | 5–10 g | — |
| Diluent A FTM | q.s. 20 capsules βλ. ποσότητα / see quantity | — |
Prerequisite formulations
Documentation
Preparation description
Hard capsules: Paracetamol capsules 250–500 mg FTM. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Analgesic and antipyretic. [1]
Specifications
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]
Light
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidation
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubility
No quantitative hydrolytic stability limit is given for this formula. Retain the prescribed water amount and quality. [1]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
For the finished product the source specifies:
Suitable closed container, 15–25 °C. [1]
Suitable closed container, 15–25 °C. [1]
pH and compatibility
No pH is assigned to the dry dosage form. Any analytical-extract pH requires the specified method. [1]
Other interactions
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
Use crystalline paracetamol: fine powder may not fit the specified capsule number/size. [1]
Staff protection
Risk assessment
Reference batch: 20 capsules. First ingredient: Paracetamol, crystals, 5–10 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], [6], [8]
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], [6], [8]
Compounding conditions
BUD rationale
Period reported by source: The source distinguishes 12-month validity from a 2-month use limit. The 12 months is not automatically adopted for local release.
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.
The historical 12-month validity and 2-month use limit are separate. This edition does not adopt 12 months: it retains a maximum reference ceiling of 180 days for the justified dry category and a separate conservative 59-day use limit, always within overall expiry. The pharmacist records when the use period starts; no extension after first supply is implied. [1], [4], [5], [7], [9]
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.
The historical 12-month validity and 2-month use limit are separate. This edition does not adopt 12 months: it retains a maximum reference ceiling of 180 days for the justified dry category and a separate conservative 59-day use limit, always within overall expiry. The pharmacist records when the use period starts; no extension after first supply is implied. [1], [4], [5], [7], [9]
Prerequisites
Diluent A FTM — lactose: CGR-BE-001 [1]
Equipment
Balance, mortar/pestle, sieve, capsule filler for the specified shell size and mass/uniformity QC equipment. [1]
Compounding method
Select one strength, 250–500 mg/capsule. Calibrate loose fill volume for 20 capsules without tapping. Geometrically mix active with the required diluent and fill. [1]
Observations
The source requires crystals. Fine powder is not equivalent for the described size 00/000 filling process. [1]
Container and packaging
Suitable closed container, 15–25 °C. [1]
Quality control
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], [8]
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], [8]
Storage
Suitable closed container, 15–25 °C. [1]
Dispensing
Dispense the exact prescribed strength. For liquids use a suitable graduated oral syringe; record dose and frequency from the prescription. [1]
Labelling
Paracetamol capsules 250–500 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]
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Suitable closed container, 15–25 °C.
Temperature for this batch BUD: ____ [1]
v9_controls
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.
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- Formulaire Thérapeutique Magistral, édition 2010 — H-I-1-a-12010PDF pp. 711–712master formula2026-10-14
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQsUpdated 1 November 2023Questions 52, 54–56, 60–62; PDF pp. 11–14Primary clarification of aw classification, extension prerequisites and compounded-component BUDs; not automatic Greek legal adoption2026-10-14