Orthosiphon leaf 400 mg — herbal powder hard capsules · CGR-ES-114 (CGR-ES-114)

REFERENCE FORMULA

Reference formula

Reference basis: 1 capsule as reference unit; for N capsules: 400 × N mg herbal powder

Ingredient	Source quantity	Scaled quantity
Orthosiphon leaf powder	400 mg / capsule	—
Empty hard capsule; source suggests size 00	1 unit / capsule	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Each unit contains 400 mg of identified herbal powder, without extraction or added solvent. Herbal-drug mass is not equivalent to extract mass or isolated constituent mass. Record capsule-shell composition separately. ^{[1], [2], [3]}

Action and use

HMPC traditional use is adjunctive urinary flushing through increased urine output in minor urinary complaints, with adequate fluid intake. The older Spanish reference to mild renal insufficiency is not carried forward as an indication. HMPC powder doses are 500–750 mg per intake and 1000–1500 mg/day; the 400-mg unit does not exactly match that intake. No automatic capsule regimen or extract equivalence is generated. ^{[1], [3]}

Specifications

Accept raw material against RFE/Ph.Eur. monograph 1229 with species, plant-part and lot verification. Finished-unit controls include secure closure, absence of exterior powder, mass uniformity and disintegration requirements. Obtain numerical acceptance criteria from the current pharmacopoeia. ^{[2], [4], [5]}

Light

Protect raw material and capsules from light through opaque secondary packaging or a suitable light-protective container. A quantitative photostability study of this exact formulation/lot was not identified. ^{[1], [2], [5]}

Air and oxidation

Keep containers closed and minimise open powder handling. Tight packaging is a conservation measure; an oxygen specification or nitrogen-flushing requirement has not been established for these capsules. ^{[2], [5]}

Water and solubility

Add no water during filling. Wet equipment can promote clumping and impair the shell; document complete drying after cleaning. Water used for swallowing does not convert this capsule into a stored aqueous preparation. ^{[4], [5]}

Humidity

Preparation environment: relative humidity not above 60% and temperature 25±5 °C, subject to stricter drug/shell requirements. Protect the packed product from moisture. Room relative humidity is not a product water-activity measurement. ^{[1], [4]}

Temperature

Source storage is below 30 °C. Avoid extra heating, direct sunlight and prolonged hot milling. Refrigeration is not specified; opening a cold container may introduce condensation and requires separate assessment. ^{[1], [2], [5]}

pH and compatibility

No pH is specified for the dry capsule. A suspension pH, if selected as a test, requires a defined powder-to-water ratio and method; it is not automatic evidence of stability or clinical activity. ^{[1], [5]}

Other interactions

HMPC reports no interactions; nevertheless, increased fluid intake/diuresis requires review in kidney or cardiac disease and with concomitant treatments. Do not add empirically to diuretic therapy or describe it as treatment of bacterial infection. ^[3]

Ingredient-specific information

The raw-material monograph describes dried leaves and stem tips of Orthosiphon stamineus with at least 0.05% sinensetin on dry-drug basis. Current HMPC nomenclature is O. aristatus var. aristatus. The 400-mg powder is not a dry extract with a stated DER; verify origin, plant part and marker in the CoA. ^{[2], [3], [5]}

Staff protection

Use a controlled work area, limit airborne powder, wear gloves and protective clothing, and eye protection where powder splashing is foreseeable. The dust assessment determines extraction and suitable respiratory protection. Do not clean using compressed air or dry sweeping. ^{[4], [5]}

Risk assessment

Contraindications include hypersensitivity and conditions requiring reduced fluid intake, such as severe renal or cardiac disease. Use is not recommended under 18 or during pregnancy/lactation. “None known” adverse effects in HMPC does not establish absence of risk. Key laboratory risks are incorrect botanical identity, extract-for-powder substitution, dose error and airborne powder. ^{[2], [3], [5]}

Compounding conditions

Verify cleanliness, full dryness, material identity/expiry and an approved calculation. For N units, theoretical herbal-powder mass=400×N/1000 g. Record actual sieving losses; do not apply arbitrary active overfill. ^{[1], [4]}

BUD rationale

The source gives 3 months under its storage conditions. The register uses a conservative ceiling of 89 days, not exceeding 3 calendar months or the earliest ingredient expiry, below 30 °C and protected from light/moisture. This is an official formula validity period, not experimentally demonstrated stability of locally produced capsules. No study matching herbal drug, particle size, shell and container was found. Selection does not assume aw<0.60 or automatically apply the 180-day general ceiling. Extension or different packaging requires evidence for marker/fingerprint, disintegration, moisture and microbiological quality. Editorial convention: calendar-month source periods are retained as calendar periods; the calendar-period conversion ceiling is 28 days for one month or 89 days for three months; a separately selected shorter ceiling still governs. It is a conservative conversion, not a source quotation. ^{[1], [5], [6]}

Prerequisites

Use locally approved weighing, sieving, capsule-filling, cleaning, testing and labelling SOPs. This formula mandates no prepared excipient from the existing register. Adding diluent creates a separately documented variant with explicit quantity and controls. ^{[1], [4]}

Equipment

Calibrated balance suitable for batch size, 355-µm sieve, fully dry mortar/mixer, graduated cylinder for apparent bulk volume, spatula and capsule-filling device. Actual apparent density and capsule-shell specifications determine capacity. ^{[1], [4]}

Compounding method

1. Verify dry-drug identity and batch mass. 2. Break agglomerates, sieve through 355 µm and record recovery. 3. Measure apparent bulk volume and verify that the target charge fits source-suggested size 00. 4. Homogenise, fill to provide 400 mg drug per unit, and close. 5. Remove exterior powder, test and package. If another size or excipient is needed, document the change before execution. ^{[1], [4]}

Observations

The active material is whole herbal powder of the specified plant part. Do not substitute dry extract, essential oil or unspecified “equivalent” botanical material. Gross capsule mass includes the shell; assess net fill separately in uniformity work. ^{[1], [2], [3], [4]}

Container and packaging

The official formula permits blister packaging or a tightly closed bottle. Select a pharmaceutical container with documented moisture barrier and light protection; no particular polymer is mandated by the source. Use a desiccant only when shell-compatible, separated from capsules and appropriately labelled. ^{[1], [4], [5]}

Quality control

Verify drug authenticity and CoA through appropriate identity/marker confirmation. Finished-product controls: appearance, closure, unit count, net fill and mass uniformity under current RFE 2.9.5. For batches, the source procedure additionally specifies disintegration and microbiological testing. Shelf-life adoption also considers fingerprint/marker and moisture change. These tests have not been performed in this literature work. ^{[2], [4], [5]}

Storage

Below 30 °C, protected from light and moisture, with immediate reclosure after each use. Reject or investigate sticking units, soft/cracked shells or visible moisture; judge the botanical-specific odour against an approved reference. ^{[1], [2], [4]}

Dispensing

The prescriber must confirm capsule count because the 400-mg unit does not match the contemporary single-dose range. Confirm adequate fluid intake is possible and not medically restricted. Fever, blood in urine, spasms or dysuria require clinical assessment; do not continue self-treatment of persistent symptoms.

Seek assessment if symptoms persist longer than two weeks; fever, dysuria, spasms or haematuria require immediate advice. ^{[2], [3]}

Labelling

Orthosiphon leaf 400 mg/capsule. Oral use. Dose and duration: follow the responsible professional’s individual directions. Batch:____. Prepared:____. Use by:____. Below 30 °C; protect from light/moisture. Keep out of children’s reach. Declare full shell composition and any added excipients. Do not use when fluid restriction is required. Confirm the regimen before supply. ^{[1], [3], [4]}

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 scientific synthesis crediting AEMPS with supporting evidence. This is not an official translation, marketing authorisation or publisher endorsement. Stasinos Chr.Sikalias — compounding.gr.

Sources and references

AEMPS Formulario Nacional — FN/2003/POF/009 HOJA DE ORTOSIFÓN, CÁPSULAS DURAS DESource code FN/2003; current standalone official PDF retrieved 13 October 2026PDF pp.2–3; sections 3–12Exact master formula, process, storage, source validity period; older clinical details reassessed using reference 32026-10-14
AEMPS Formulario Nacional — FN/2003/PAF/010 ORTOSIFÓN, HOJA DESource code FN/2003; official standalone PDF retrieved 13 October 2026PDF p.2; identity, composition, raw-material specification and handlingBotanical raw-material identity and source-era specifications; current pharmacopoeial specification must be consulted before acceptance2026-10-14
EMA/HMPC — European Union/Community herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium22 September 2021; EMA/HMPC/486551/2020, revision 1PDF pp.3–7; preparation categories, sections 4.1–4.8Current adopted regulator monograph for specific plant part and preparation; not approval of this compounded product or product-specific stability evidence2026-10-13
AEMPS — PN/L/FF/001/00 Elaboración de cápsulas durasPN/L/FF/001/00; official standalone PDF retrieved 13 October 2026PDF pp.4–5; sections 4.3–4.6Capsule preparation, measured bulk-volume approach, environment, mass uniformity, disintegration and microbiological controls2026-10-13
EMA — Guideline on quality of herbal medicinal products/traditional herbal medicinal products, revision 318 January 2022; EMA/HMPC/CHMP/CVMP/201116/2005 Rev.3PDF pp.9–10 and 12–16; sections 5.1,7,8Identity, contaminants, justified specifications, chromatographic fingerprint and multi-component stability principles; numerical shelf life not supplied2026-10-13
USP Compounding Expert Committee — USP Compounding Webinar, NABP public handout14 September 2023; primary-author public educational handoutPDF pp.10–11, slides 19–22General aw-dependent BUD framework comparator; not full licensed USP795 text, Greek law, or measured stability/aw for this formulation2026-10-13
USP — General Chapter <795> Frequently Asked QuestionsNovember 1, 2023 FAQ; rechecked 14 October 2026Questions 52, 54–56, 61, 64–66General category/extension rules only; not exact-product stability evidence.2026-10-14