REFERENCE FORMULA
Reference formula
Reference basis: 1 καψάκιο / capsule; επιλέξτε μία ισχύ / select one strength
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Clarithromycin bulk API | 250 / 500 mg | — |
| Opaque gelatin shell, size 2 / 00 respectively | 1 τεμάχια / pieces | — |
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Hard capsules: Clarithromycin 250 / 500 mg capsules. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Macrolide antibiotic. [1]
Specifications
Mean assay 90–110% of nominal. Mass uniformity on 20 capsules and content uniformity on 10 in the control batch, using the full source procedure. [1]
Light
For the finished product the source specifies:
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [1]
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [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
For the finished product the source specifies:
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [1]
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [1]
Temperature
For the finished product the source specifies:
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [1]
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [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
Identity and weighing basis:
• Clarithromycin bulk API: 250 / 500 mg.
• Opaque gelatin shell, size 2 / 00 respectively: 1 τεμάχια / pieces.
The specified chemical forms/grades belong to the exact source formula. [1]
• Clarithromycin bulk API: 250 / 500 mg.
• Opaque gelatin shell, size 2 / 00 respectively: 1 τεμάχια / pieces.
The specified chemical forms/grades belong to the exact source formula. [1]
Staff protection
Risk assessment
Reference batch: 1 καψάκιο / capsule; επιλέξτε μία ισχύ / select one strength. First ingredient: Clarithromycin bulk API, 250 / 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.
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: Source period: 1 month.
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 28 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], [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 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 28 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], [4], [5], [7], [9]
Prerequisites
No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. [1]
Equipment
Balance, mortar/pestle, sieve, capsule filler for the specified shell size and mass/uniformity QC equipment. [1]
Compounding method
Calculate and weigh API for one strength and capsule count. Triturate, fill evenly, close and inspect capsules. No diluent is specified. Package after the required checks. [1]
Observations
Control powder exposure and cross-contamination. Source stresses separation from amoxicillin preparation. Match capsule strength and shell size. [1]
Container and packaging
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [1]
Quality control
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], [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
65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light. [1]
Dispensing
Dispense the exact prescribed strength. For liquids use a suitable graduated oral syringe; record dose and frequency from the prescription. [1]
Labelling
Clarithromycin 250 / 500 mg capsules
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light.
Temperature for this batch BUD: ____ [1]
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 65 mL HDPE without desiccant, or a suitable light-/moisture-protective source container. 15–25 °C, dry, protected from light.
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
- ANSM — Monographie de préparation magistrale (outside Formulaire national)v1 • 14/10/2024PDF pp. 1–7; αναλυτικά παραρτήματα / analytical annexesmaster formula2026-09-10
- 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> FAQs (official, updated 1 November 2023)Updated 1 November 2023; retrieved 14 October 2026Q52, Q61–64; use with the applicable full chapterWater-activity classification, component dating and BUD documentation; general professional framework, not a Greek legal adoption or formula-specific study2026-10-14