| HS Code | 626289 |
| Botanical Name | Nelumbo nucifera |
| Plant Part Used | Rhizome Node (Nodus) |
| Grade | Veterinary Grade API |
| Active Constituents | Alkaloids (e.g., liensinine, isoliensinine), flavonoids, and phenolic compounds |
| Appearance | Brownish-yellow to light brown powder or crystalline form |
| Solubility | Sparingly soluble in water; soluble in ethanol and dilute acids |
| Heavy Metals Profile | Total heavy metals: ≤20 ppm; Lead ≤5 ppm; Arsenic ≤2 ppm; Mercury ≤1 ppm |
| Microbial Limits | Total viable aerobic count ≤1000 CFU/g; Yeast/Mold ≤100 CFU/g; Absence of Salmonella and E. coli |
| Particle Size | Nominal mesh size: 80-100% through #60 sieve (for powders/granules) |
| Ph Range | 4.5-6.5 (in 1% aqueous dispersion) |
| Suggested Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Storage Conditions | Store in tightly sealed containers, protected from light and moisture, below 25°C |
| Shelf Life | 24 months from date of manufacture when stored as directed |
As an accredited Nelumbinis Rhizomatis Nodus Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Packaged in sealed, light-protected double-layer bags inside fiber drums, 25 kg net weight, with tamper-evident closure and certificate of analysis. |
| Container Loading (20′ FCL) | 20′ FCL container loading: Nelumbinis Rhizomatis Nodus veterinary-grade API, palletized and secured, for safe shipment in various dosage forms. |
| Shipping | Shipments of Nelumbinis Rhizomatis Nodus Veterinary Grade API are dispatched in sealed, moisture-proof containers with tamper-evident seals. Temperature-controlled logistics maintain stability during transit. Full compliance documentation, MSDS, and batch certificates accompany each consignment. Proper labeling ensures safe handling and timely delivery for pharmaceutical manufacturing. |
| Storage | Store in a tightly sealed container in a cool, dry, well-ventilated area at controlled room temperature, protected from light and moisture. Avoid exposure to excessive heat or freezing. Keep away from strong oxidizers and incompatible materials. Ensure container is clearly labeled and securely closed after each use to preserve potency and stability. |
| Shelf Life | Shelf life is 24 months from manufacturing date when stored airtight in a cool, dry place, protected from light and moisture. |
In high-density farrow-to-finish swine production, subclinical gastric ulceration and stress-related hemorrhagic enteropathy are managed with water-soluble oral powders and granules in which Nelumbinis Rhizomatis Nodus Veterinary Grade API serves as the astringent/hemostatic fraction. The dry extract is dry-mixed with a maltodextrin or anhydrous glucose carrier, passed through a 60-mesh stainless-steel screen, and then wet-granulated in a high-shear granulator using a 30% ethanol-water binder at 40–50 °C; this solvent fraction limits over-wetting of the tannin-rich extract. Loss on drying is held between 3.0% and 5.0% w/w because moisture above 5.5% has been associated with caking and darkened granule surfaces in 25 °C / 60% RH packaging trials. The addition ratio is not a fixed compendial number; formulators start from the 9–15 g crude drug reference in the ChP 2020 Nelumbinis Rhizomatis Nodus monograph and back-calculate through extract yield and allometric body-weight scaling to the target swine dose. Compliance for oral powders and granules is tied to CVP 2020 general chapter requirements for solid oral veterinary preparations, veterinary GMP, and ISO 22000:2018 when the product is used on farms with feed-safety certification. Terminal product types include 100 g, 500 g, and 1 kg water-soluble powders, 5% and 10% w/w premix-compatible granules, and 1 g unit-dose sachets for individual piglet administration.
Sterile veterinary injectables containing Nelumbinis Rhizomatis Nodus require a refined extract grade rather than crude dry powder because crude high-molecular-weight tannin-polysaccharide complexes can foul polyethersulfone membranes before throughput reaches 50 L/m² under constant pressure. A workable sequence begins with reconstitution in Water for Injection, pH adjustment to 5.5–6.5, and activated-carbon clarification at 0.05–0.1% w/v; the clarified liquor is then passed through a 0.45 µm polypropylene prefilter followed by a 0.22 µm PVDF or PES membrane. If thermal stability testing confirms less than 5% marker degradation, terminal sterilization at 121 °C for 15 min is preferred; otherwise aseptic filtration and filling in an ISO 14644-1:2015 Class 5 environment is mandatory under EU GMP Annex 1 2022. Addition ratio is expressed as total extract solids in the finished solution, commonly 0.5–2.0% w/v, but published data for this specific configuration is limited and every batch must be set against the marker compound assay. Compliance requirements include sterility testing per Ph. Eur. 2.6.1, bacterial endotoxin testing per Ph. Eur. 2.6.14, and sub-visible particulate evaluation per Ph. Eur. 2.9.19. Terminal product types are 10 mL and 20 mL injectable solutions for intramuscular or intravenous use in cattle and swine. Iron salts and amine-based solubilizers must not be combined with this extract in solution because polyphenol chelation can generate precipitates and reduce active-fraction availability.
Medicated premix production lines that carry this API into swine and poultry rations operate with a stepwise dilution protocol because the extract’s bulk density and particle-size distribution differ substantially from corn-cob, rice-hull, or calcium-carbonate carriers. The premix is built from the small to the large: the full API charge is first blended with an equal portion of carrier in a 50 L bin blender for 5 min, then this mixture is extended 1:10 to 1:100 through a horizontal ribbon mixer equipped with spray nozzles for liquid binder addition only when the formula contains hygroscopic fractions. Blend uniformity is accepted only when the coefficient of variation for a marker or tracer is below 5.0%, measured at 10 sampling points after 8–12 min mixing at 18–25 rpm. Addition ratio in the finished feed is back-calculated from the target mg API per kg body weight, not from a fixed premix percentage; typical premix strengths lie between 5% and 20% w/w API, with final feed dilution commonly in the range of 1–3 kg/t where bird or pig intake data support that level. Compliance is governed by EU 2019/4 for medicated feed, veterinary GMP for intermediate products, and ISO 22000:2018 for feed-safety management. Molasses-based carriers should be avoided at ambient humidity above 60% RH because they accelerate extract caking and create flush-out problems in mill bins. Terminal product types include 5 kg and 25 kg premix bags, 0.5% and 1.0% final feed premixes, and custom premix granules for on-farm dosing systems.
Hard gelatin or HPMC capsules for adult cattle and calves are filled with a dry extract blend under controlled relative humidity because the extract’s moisture sorption changes fill weight and capsule shell dimensions. The capsule fill is often composed of 10–30% w/w API, microcrystalline cellulose as filler, and sodium starch glycolate as disintegrant; magnesium stearate is held at 0.5–1.0% w/w to avoid excessive lubrication and brittle compacts. Filling runs are performed at 40–50% RH and 20–25 °C; below 35% RH gelatin shells can lose elasticity and crack, while above 55% RH they soften and stick on dosing disks. Disintegration must meet Ph. Eur. 2.9.1, but in adult bovine rumen fluid the release rate is modulated by pH 6.0–7.0 and by the extract’s tannin fraction binding to feed proteins; this is not a defect, but it means capsule dissolution and in vivo release must be distinguished in bioavailability work. Compliance also references CVP 2020 general chapter requirements for capsules and veterinary GMP. Addition ratio is set from the active marker content of the extract batch, not from a fixed monograph percentage; published data for this specific configuration is limited. Terminal product types include Size 1 and Size 0 hard gelatin capsules, HPMC capsules for halal or vegetarian supply chains, and large-size oral boluses containing 1–5 g of formulated blend for adult bovines.
| Dosage form | Core compliance standard | Critical process parameter | Typical control window |
|---|---|---|---|
| Water-soluble powder / granule | CVP 2020 / veterinary GMP / ISO 22000:2018 | Loss on drying | 3.0–5.0% w/w |
| Injectable solution | Ph. Eur. 2.6.1 / Ph. Eur. 2.6.14 / EU GMP Annex 1 2022 | Endotoxin burden | < 0.5 EU/mL |
| Medicated premix | EU 2019/4 / ISO 22000:2018 | Blend uniformity CV | < 5.0% |
| Hard capsule / bolus | Ph. Eur. 2.9.1 / CVP 2020 | Filling humidity | 40–50% RH |
| Direct-compression tablet | Ph. Eur. 2.9.5 / Ph. Eur. 2.9.1 | Main compression force | 15–25 kN |
| Aqueous oral solution | Ph. Eur. 5.1.4 / Ph. Eur. 5.1.3 | Fill temperature | 20–25 °C |
Direct compression of Nelumbinis Rhizomatis Nodus dry extract is feasible when the API is spray-dried with a high-glass-transition carrier such as maltodextrin, but the process window tightens rapidly when the suite drops below 20% RH because low moisture increases electrostatic charging and can cause die fill variation. Tablets are typically formulated with 10–25% w/w API, 50–60% w/w microcrystalline cellulose, 2–5% w/w crospovidone as disintegrant, and 0.5–1.0% w/w magnesium stearate. Compression is run on a rotary tablet press at 15–25 kN main compression force; capping and lamination have been observed above 25 kN when the feed-frame residence time is extended. Weight uniformity is tested per Ph. Eur. 2.9.5, disintegration is tested per Ph. Eur. 2.9.1, and accelerated stability protocols follow VICH GL18(R2) at 25 °C/60% RH and 40 °C/75% RH; dissolution methodology must be developed specifically for the tannin-containing extract because standard sink conditions may under-report release if protein-binding media are omitted. Addition ratio is adjusted for each extract lot against marker assay, with a pre-drying step required at ambient humidity above 60% RH before blending. Terminal product types include 100 mg and 250 mg tablets for companion animals, and 500 mg tablets for small ruminants. Ferrous sulfate and other iron-containing excipients are incompatible in direct-compression formulations because polyphenol-iron complexes discolor tablets and create black specks.
Aqueous oral solutions are the most straightforward commercial form but the most sensitive to preservative failure if the extract’s polyphenolic fraction binds sorbate or benzoate before the solution reaches the filling line. The extract is dissolved in warm purified water at 40–50 °C, cooled to 20–25 °C, adjusted to pH 4.5–5.5, and preserved with 0.1–0.2% w/w sodium benzoate or 0.05–0.15% w/w potassium sorbate; container compatibility testing follows Ph. Eur. 5.1.4 for the microbiological quality of non-sterile oral preparations. The cooled solution is passed through a 0.45 µm filter before transfer to a stainless-steel holding tank; filling is performed below 25 °C to avoid headspace condensation and cap-area mold growth. Addition ratio of the API is ordinarily 1.0–3.0% w/v total extract solids, but the exact level must be derived from the extract’s marker assay and the target daily volume for swine, poultry, or companion animals. Published data for this specific configuration is limited, so preservative efficacy testing per Ph. Eur. 5.1.3 should be run on every new formulation. Terminal product types include 500 mL and 1 L HDPE bottles with tamper-evident dosing pumps, 5 L jerry cans for farm use, and 250 mL companion-animal bottles. Do not use sorbic acid in solutions intended for cats because feline sorbate sensitivity has been documented in peer-reviewed toxicology literature.
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Nelumbinis Rhizomatis Nodus Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is the dried, comminuted node of Nelumbo nucifera Gaertn. (Nymphaeaceae), supplied as a botanical active pharmaceutical ingredient for veterinary dosage form manufacture. The article is assigned model series NRN-VG; the numerical suffix denotes nominal sieve aperture under ASTM E11-20. NRN-VG-80, NRN-VG-100, and NRN-VG-200 are offered with nominal apertures of 177 µm, 149 µm, and 74 µm respectively. Unlike purified single-molecule veterinary APIs, this material is a multicomponent matrix in which water-extractable polysaccharides, polyphenolic substances, and acid-insoluble ash jointly determine solubility, viscosity, and tablet compression response. Because no harmonised monograph for this node is published in Ph. Eur. 11.0 or USP-NF 2024, conformity is assessed against general pharmacopoeial methods and, where applicable, the Chinese Pharmacopoeia 2020 monograph for Nelumbinis Rhizomatis Nodus.
Direct use of the milled node in injectable formulations is not permissible without extraction, clarification, and sterilisation. The raw botanical carries surface-adherent microbial bioburden, insoluble fibre, and endotoxin. Aqueous extracts intended for parenteral application are passed through depth filtration followed by membrane filtration with nominal pore size 0.22 µm. Sterility of the finished injection is verified according to USP <71>; bacterial endotoxin is evaluated by Limulus amebocyte lysate testing, with the finished product limit fixed in the marketing authorisation rather than in the API certificate. Particulate matter in the final injection is controlled under USP <788> or Ph. Eur. 2.9.19. Terminal sterilisation by autoclaving at 121 °C for 15 min is not assumed to be marker-stable; pH drift and extract precipitation must be quantified before release.
Polyphenol-protein complexes and hydrated polysaccharide fractions can foul membrane filters during sterile filtration. Production-scale extractors equipped with low-shear axial impellers have shown foam formation and filter blinding at high plant material loading, although published data for this specific configuration is limited. A prefiltration stage using 0.45 µm depth media is therefore applied before final membrane filtration. Cold extraction below 40 °C may reduce some oxidative discoloration, but it also reduces extractable solids and can prolong hold time. The extract is not inherently sterile; aseptic processing or terminal sterilisation is required, and the choice of method must be justified by finished product stability data generated under veterinary stability protocols.
For tablet and capsule dosage forms, the fine-milled grade is generally preferred over the coarse botanical because the coarse fraction exhibits low bulk density and cohesive flow. Wet granulation with aqueous binder systems increases granule density and reduces dust; residual moisture is confirmed by loss on drying according to USP <731> or Ph. Eur. 2.2.32. Direct compression has been limited to low-dose formulations where the botanical fraction does not dominate the blend. The API is not freely soluble in aqueous media at 20–25 °C; dissolution from tablets and capsules therefore depends on disintegration, matrix erosion, and extraction rather than true solution kinetics. Sieve uniformity is determined by analytical sieving per USP <786> or Ph. Eur. 2.9.38. Rotary tablet press capping has been associated with fibrous particles oriented during prior dry blending; pre-granulation is used when capping is observed.
Comminution is performed by impact milling with classification rather than knife milling; this reduces fibrous tails that can create die-fill irregularities. The particle-size specification is not a single-point value. Cumulative retention on the nominal sieve and fines below 45 µm are controlled because excessive fines increase electrostatic adhesion, reduce flow, and raise lubricant demand. Sorption hysteresis is assessed by dynamic vapour sorption; processing at relative humidity above 60% should be preceded by moisture isotherm evaluation because published data for this specific botanical node are limited. Aqueous extract viscosity is shear-dependent. At low shear, polysaccharide hydration can produce pseudoplastic behaviour that reduces filter throughput and impedes mixing; at high shear, viscosity falls sharply. In solution and suspension manufacture, hydration sequence and mixer speed therefore affect batch-to-batch reproducibility.
| Model designation | Nominal sieve aperture | Typical processing route | Test standard |
|---|---|---|---|
| NRN-VG-80 | 177 µm | coarse aqueous extraction, percolation, granulation after comminution | ASTM E11-20, USP <786> |
| NRN-VG-100 | 149 µm | dry blending, wet granulation, capsule filling, premix dilution | ASTM E11-20, USP <786> |
| NRN-VG-200 | 74 µm | low-dose direct compression, suspension concentrates, injectable extract feedstock | ASTM E11-20, USP <786> |
Binary excipient compatibility is not inferred from the bulk API specification. The node contains ionisable polyphenolic species and mineral constituents; co-processing with citric acid monohydrate, tartaric acid, or phosphate buffers can shift the aqueous extract pH and alter the solubility of extractable components. Direct compression blends containing acidulants require screening by differential scanning calorimetry, Fourier-transform infrared spectroscopy, and accelerated stability storage under VICH GL3 conditions. Aluminium lake colourants and certain amine-functional excipients may form insoluble complexes or induce discoloration; no compatibility claim is made without binary compatibility testing. Tablet hardness, disintegration per USP <701>, and dissolution per USP <711> must be generated on the finished product. The botanical particle can also be abrasive; pre-lubrication is used when tooling wear is observed on rotary tablet presses.
For premix manufacture, the API is incorporated by geometric dilution into feed-grade carriers after pre-blending the NRN-VG-100 grade to minimise segregation. Homogeneity is verified by sampling validated locations in a ribbon blender or ploughshare mixer; high drop heights in transfer lines can stratify the blend because the botanical bulk density differs from mineral carriers. Fluidised-bed spray granulation with an aqueous binder reduces dust and improves dispersibility in drinking water, but granule porosity and pore-size distribution should be confirmed when dose uniformity is critical. The milled node does not form a true solution in drinking water; undisintegrated particles can settle, therefore suspension vehicles require suspending agents and pH control.
Botanical identity is established by macroscopic and microscopic examination, thin-layer chromatography against authenticated reference material, and high-performance liquid chromatography fingerprinting with diode-array detection when required. The absence of a harmonised veterinary monograph for this node means quantitative acceptance criteria must be defined in the finished product dossier. The certificate of analysis records loss on drying, total ash, acid-insoluble ash, heavy metals by USP <233> or Ph. Eur. 2.4.27, pesticide residues by methods described in USP <561>, and microbial limits by USP <61> and USP <62>. Batch-to-batch variation in polysaccharide and polyphenol content is controlled by comparison with a botanical reference extract; published data for single-marker standardisation in veterinary applications is limited. The user should not extrapolate data from purified alkaloid fractions to the whole node because the matrix modifies dissolution, stability, and excretion.
| Parameter | General method / standard | Application |
|---|---|---|
| Particle size distribution | USP <786>, Ph. Eur. 2.9.38 | model grade control |
| Loss on drying | USP <731>, Ph. Eur. 2.2.32 | granulation and capsule fill |
| Total ash / acid-insoluble ash | USP <561>, Ph. Eur. 2.4.16 | identity and purity |
| Heavy metals | USP <233>, Ph. Eur. 2.4.27 | safety limit |
| Microbial enumeration | USP <61>, Ph. Eur. 2.6.12 | non-sterile upstream |
| Specified organisms | USP <62>, Ph. Eur. 2.6.13 | non-sterile upstream |
| Sterility, if claimed | USP <71> | injection |
| Bacterial endotoxins, if injectable | Ph. Eur. 2.6.14, USP <85> | injection |
| Stability evaluation | VICH GL3 | finished product |
Compared with purified haemostatic veterinary APIs such as tranexamic acid or etamsylate, this botanical article is not defined by a single molecular weight or narrow solubility profile. The unextracted node contains water-insoluble fibre and mineral residue that increase formulation burden but preserve the native multicomponent composition. Compared with standardised extract products that are spray-dried onto maltodextrin carriers, NRN-VG is supplied as the unextracted botanical matrix; this permits decoction-type processing or direct incorporation into solid dosage forms but requires additional filtration for parenteral use. The veterinary grade is not interchangeable with food-grade lotus node powder because the veterinary grade applies microbial enumeration, heavy metal, and specified organism testing under the methods listed above and is intended for GMP processing before administration. The model suffix is not a potency claim; it defines a particle-size fraction only, and potency must be established by the finished product dossier.
For oral or topical solution preparation, aqueous decoction is performed before compounding. The extraction ratio, hold time, and temperature must be fixed because polysaccharide hydration is time-dependent. The resulting liquid is not considered stable without preservative challenge testing; oral solutions are screened according to pharmacopoeial preservative efficacy procedures, and pH is adjusted after cooling. Use of alkaline buffers above pH 9 is avoided because polyphenolic oxidation may accelerate and colour change may occur. Hydroalcoholic extraction can improve filtration and solubilise less polar constituents, but the solvent ratio must be validated because residual alcohol in a solid dosage form may affect granulation and dissolution.
