Diosmin Capsules 500 mg

Hard capsules: Diosmin Capsules 500 mg. Additional appearance criteria are not established by the specific text reviewed. ^[1]

The source discusses symptomatic use in venous disorders and notes uncertainty about effectiveness. ^[1]

FTM 2010 general active-content range: 90–110% of declared amount unless specifically excepted (PDF p.15). Dosage-form requirements also apply. ^[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]

Component of base CGR-BE-002: D-Mannitol: JP classifies the corresponding pure raw material as freely soluble in water. ^{[5], [6]}

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:
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]

Identity and weighing basis:
• Diosmin: 30.0 g.
• Colloidal anhydrous silica: 0.30 g.
• Diluent A or B FTM: q.s. για / for 60 capsules No. 000 βλ. ποσότητα / see quantity.
The specified chemical forms/grades belong to the exact source formula.
Component of base CGR-BE-002: D-Mannitol: raw-material water solubility is classified as freely soluble by JP. ^{[1], [5], [6]}

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [2], [3]}

Reference batch: 60 καψάκια / capsules. First ingredient: Diosmin, 30.0 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], [8], [10]}

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], [3]}

Period reported by source: Historical validity: 2 months; in-use limit 2 months, within overall expiry.
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], [4], [7], [9], [11]}

Diluent A FTM — lactose: CGR-BE-001
Diluent B FTM — mannitol: CGR-BE-002 ^[1]

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

Triturate silica with about 1 g diosmin; progressively add remainder. Measure untapped volume, add selected diluent to calibrated volume for 60 No.000 capsules, homogenise and fill. ^[1]

Record choice of diluent A or B and resulting lactose content. ^[1]

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]

FTM 2010 general active-content range: 90–110% of declared amount unless specifically excepted (PDF p.15). Dosage-form requirements also apply.
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], [10]}

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]

Diosmin Capsules 500 mg
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 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.