| HS Code | 565406 |
| Product Name | Oryzae Fructus Germinatus Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Botanical Source | Germinated seeds of Oryza sativa L. (rice sprout) |
| Used Part | Germinated fruit/seed with sprout |
| Active Ingredients | Amylase, protease, lipase, maltose, dextrin, glucose, vitamins, and organic acids |
| Physical Form | Fine, free-flowing powder; dry solid for further pharmaceutical compounding |
| Solubility | Partially soluble in water; forms a colloidal or suspendable mixture depending on dosage form |
| Heavy Metals | Compliant with veterinary grade limits for lead, arsenic, cadmium, and mercury |
| Microbial Limits | Total aerobic microbial count <10,000 CFU/g; yeast/mold <1,000 CFU/g; free from Salmonella and E. coli |
| Ph Value | 4.0 - 6.5 (1% aqueous suspension at 25°C) |
| Bulk Density | 0.35 - 0.55 g/mL |
| Ash Content | Total ash <= 5.0% w/w; acid insoluble ash <= 1.0% w/w |
| Storage Conditions | Store in airtight, moisture-proof containers in a cool, dry, dark place at or below 25°C |
| Shelf Life | 24 months from date of manufacture when stored under recommended conditions |
As an accredited Oryzae Fructus Germinatus 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 25 kg fiber drums with double polyethylene liners, ensuring stability, safety, and purity of Oryzae Fructus Germinatus Veterinary Grade API. |
| Container Loading (20′ FCL) | 20′ FCL loaded with palletized, sealed drums of Oryzae Fructus Germinatus veterinary API, secured dry, ventilated, and contamination-free. |
| Shipping | Ship as a fine botanical veterinary API in sealed, moisture-proof double polybags inside durable drums or cartons. Protect from direct sunlight, humidity, and heat. Include Safety Data Sheet, certificate of analysis, and product label. Not considered hazardous; however, use clean, dry transport with proper segregation for pharmaceutical raw materials. |
| Storage | Store in a cool, dry, well-ventilated area, away from direct sunlight and heat sources. Keep container tightly closed to protect from moisture and contamination. Avoid exposure to strong acids, bases, and oxidizing agents. Ensure compliance with veterinary-grade handling requirements to maintain stability and efficacy. |
| Shelf Life | Shelf life is typically 24 months when stored in airtight containers, protected from light, moisture, and heat. |
Oryzae Fructus Germinatus veterinary-grade API is a hygroscopic botanical powder whose downstream handling is governed by residual moisture, particle-size distribution, and thermal sensitivity. The formulation data below are organised by production route rather than by species, because the critical control points shift with dosage form. The API is pre-dried at 45–50°C in a forced-air or vacuum dryer when ambient relative humidity exceeds 60%, and the milled material is not exposed to temperatures above 40°C during hammer milling.
Direct-compression oral tablets for weaned piglet digestive support are produced with Oryzae Fructus Germinatus as the major botanical component, because the material contributes both starch matrix compressibility and enzyme-bearing fractions. The API addition ratio is maintained at 20–35% w/w of the 250 mg core, equivalent to 50–87.5 mg per tablet; compression studies indicate that increasing the ratio above 35% w/w raises ejection force and capping incidence on rotary presses. Before blending, the API is milled through a 0.5 mm screen to a particle size distribution with D90 ≤ 180 µm and pre-dried at 45–50°C when ambient RH exceeds 60% to keep moisture below 8.0%. Blending is performed in a V-shell blender at 60% fill volume, 15 rpm, for 20 min; magnesium stearate is limited to 0.5% w/w because higher concentrations can extend disintegration beyond 15 min in 0.1 M HCl at 37°C. Compression uses 8 mm round concave tooling with precompression at 6 kN and main compression at 18 kN, yielding tablet hardness of 60–90 N and friability ≤0.8% per Ph. Eur. 2.9.7. Tablet weight is checked every 15 min; if hardness falls below 60 N, main compression is raised in 2 kN increments, but forces above 25 kN are not used because the starch fraction can undergo plastic deformation and increase tablet relaxation. The finished tablets are tested for uniformity of dosage units per USP <905> and manufactured against the Chinese Pharmacopoeia 2020 Edition monograph for Oryzae Fructus Germinatus. Terminal product types include 50 mg and 100 mg oral digestive tablets in cold-form aluminium/PVC blister packs for creep-feed transition in swine operations.
Water-soluble powder concentrates used in automated drinking lines are designed for rapid reconstitution and 8 h stability in hard water at 15–20°C. Oryzae Fructus Germinatus is incorporated at 30–45% w/w of the dry concentrate, and the in-line drinking water dose is 0.5–2.0 g/L. The powder blend is produced by screening the API through a 40-mesh screen and mixing in a low-shear ribbon blender at 25 rpm for 15 min; citric acid monohydrate at 1.0% w/w and colloidal silica at 0.3% w/w are added to maintain pH 4.5–5.5 and reduce moisture adsorption. Filling is conducted at 21–25°C and ≤30% relative humidity, because the API readily absorbs water and can exceed the 8.0% volatile-matter limit set by ISO 6496:1999. Reconstitution performance is tested by adding a 10 g aliquot to 1 L of water at 20°C under 200 rpm stirring; complete dispersion within 60 s is treated as the release criterion. Bulk density is controlled at 0.55–0.75 g/mL, and tapped density per Ph. Eur. 2.9.34 is used to set sachet fill depth. The finished powder must avoid combination with strongly alkaline electrolytes above pH 7.5, which reduces enzyme stability. Terminal product types include 100 g foil sachets, 1 kg foil pouches, and 5 kg water-soluble premix pails for broiler and nursery-pig water medication programmes.
Oral drench and paste formulations for pre-ruminant calves and transition cows require a controlled yield stress to remain in the oral cavity but still pass through piston syringe nozzles at farm temperatures. Oryzae Fructus Germinatus is dispersed at 5–12% w/w; above 12% w/w the plastic viscosity exceeds 4,000 mPa·s and causes nozzle plugging during cold-weather dosing. The manufacturing process first hydrates sodium carboxymethylcellulose at 0.5–1.0% w/w in purified water heated to 65°C, then cools the polymer solution to 25–30°C before adding the API and preservative under high-shear dispersion at 1,500 rpm for 10 min. The batch is vacuum-degassed at -0.08 MPa for 20 min to remove entrapped air that would otherwise cause fill-volume variation in 30 mL syringes. Viscosity is measured at 20°C by rotational viscometer per Ph. Eur. 2.2.10 and held in the 2,000–4,000 mPa·s range; pH is buffered to 4.5–6.0 with citrate to limit microbial proliferation. Fill weight for 30 mL syringes is controlled at 30 g ± 1.5 g, and syringe piston air pressure is set at 2.5–3.5 bar. Terminal product types include 30 mL and 60 mL oral paste syringes for calves, 100 mL multi-dose dial-a-dose syringes, and 1 L drench bottles for veterinary prescription use.
For companion-animal capsule manufacture, Oryzae Fructus Germinatus is incorporated at 50–70% w/w of a target 300 mg fill weight, corresponding to 150–210 mg per capsule. The powder is pre-dried in a vacuum shelf dryer at 45°C for 8 h when loss on drying exceeds 10%, then milled through a 0.5 mm screen and blended with dicalcium phosphate, pregelatinised starch, and 0.5% w/w magnesium stearate in a bin blender at 12 rpm for 18 min. Capsule filling on a dosator-type machine uses size 1 HPMC capsules with powder bed depth maintained at 90–110 mm and filling speed capped at 120,000 capsules/h; this speed cap is necessary because the hygroscopic API increases stickiness and weight variation above that threshold. Encapsulation is performed at 30–35% relative humidity, because HPMC shell moisture above 8% increases shell brittleness and splitting. Uniformity of mass is checked per USP <905>, content uniformity per Ph. Eur. 2.9.6, and disintegration time is controlled at ≤30 min in 0.1 M HCl at 37°C. Terminal product types include 250 mg two-piece HPMC hard capsules packed in HDPE bottles with molecular-sieve desiccant for companion-animal digestive support programmes.
| Dosage form | API addition ratio | Critical process measurement | Terminal product type | Primary compliance anchor |
|---|---|---|---|---|
| Oral tablet | 20–35% w/w core | hardness 60–90 N; friability ≤0.8% | 50 mg, 100 mg piglet tablets | Ph. Eur. 2.9.7; USP <905> |
| Water-soluble powder | 30–45% w/w concentrate; 0.5–2.0 g/L final water | reconstitution ≤60 s; LOD ≤8.0% | 100 g, 1 kg sachets | ISO 6496:1999; Ph. Eur. 2.9.34 |
| Oral drench | 5–12% w/w | viscosity 2,000–4,000 mPa·s at 20°C | 30 mL, 60 mL paste syringes | Ph. Eur. 2.2.10 |
| Companion-animal capsule | 50–70% w/w of 300 mg fill | weight variation ≤5% RSD; disintegration ≤30 min | 250 mg HPMC capsules | USP <905>; Ph. Eur. 2.9.6 |
| Feed premix | 5–15% w/w in premix; 1–5 kg/tonne complete feed | CV ≤5%; Hausner ratio ≤1.25 | 20 kg multi-wall bags | ISO 6497:2002; Reg (EC) No 183/2005 |
| Injectable solution | 1.0–5.0% w/v dry extract equivalent | 0.22 µm sterilising filtration; BET limits | 10 mL, 20 mL vials | USP <85>; Ph. Eur. 2.6.14 |
Premix and granular feed applications predilute Oryzae Fructus Germinatus in feed-grade glucose at a ratio of 1:9 before homogenous incorporation into a vitamin-mineral carrier. The final complete-feed addition rate is 1–5 kg/tonne, while the intermediate premix contains 5–15% w/w API. Geometric dilution is performed in a double-ribbon mixer at 20 rpm for 15 min after each dilution stage; blend uniformity is checked at 10 sampling points per ISO 6497:2002 with a coefficient of variation ≤5%. For granular premixes, the diluted powder is dry-compacted on a roller compactor at roll force 8–12 kN/cm and milled through a 1.0 mm screen to achieve a Hausner ratio ≤1.25. Dust extraction velocity at the hopper is limited to 0.5–0.8 m/s to avoid fines carryover and segregation. The ingredient is not added to mashes or pellets before extrusion at barrel temperatures above 85°C, because thermal exposure above this threshold reduces enzyme activity and alters starch digestibility. Terminal product types include 20 kg multi-wall paper bags with polyethylene inner liner, 5 kg premix pails, and granular premix for post-pelleting coating or meal inclusion.
Injectable solutions are prepared from purified aqueous extract rather than the raw powder, because crude botanical solids introduce unacceptable particle burden and endotoxin variability. The addition ratio in the finished injectable is 1.0–5.0% w/v as dry extract equivalent; published data for this specific configuration is limited, and dose-range confirmation must be generated for each formulation. The production route uses cold-water extraction at 20–25°C for 2 h, followed by disk-stack clarification at 8,000–10,000 rpm, depth filtration through 0.45 µm, and sterilising-grade PES membrane filtration through 0.22 µm. Membrane filter capacity is sized at 50–100 L/m² for the clarified extract; differential pressure above 1.5 bar indicates filter blocking and triggers post-filtration integrity testing per ASTM F838-20. Terminal sterilisation at 121°C for 15 min is acceptable only if solution stability studies confirm no precipitate formation and no marker reduction ≥10%; otherwise aseptic filtration under ISO 7 conditions is substituted. The finished injection must meet USP <85> bacterial endotoxin limits, USP <788> particulate matter limits, and Ph. Eur. 2.6.14; multi-dose vials require additional preservative efficacy testing per USP <51>. Terminal product types include 10 mL and 20 mL multi-dose vials for veterinary hospital administration.
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Model OFG-VET-API-01 is a veterinary-grade active pharmaceutical ingredient prepared from the dried germinated caryopsis of Oryza sativa L. (Poaceae). The material is supplied as a pale yellow to beige powder with a farinaceous odour and is controlled for residual moisture, total ash, heavy metals, microbial load, particle-size distribution, and enzyme-labile starch rather than for a single marker component. It is intended for incorporation into tablets, injections, capsules, powders, granules, premixes, and solutions under current Good Manufacturing Practice for veterinary medicinal products. The API is not a food-grade malted rice or a feed flavouring; its release dossier includes the Latin botanical name, batch number, net weight, country of origin, and the statement “veterinary use only.”
Incoming lots are quarantined until identity testing matches the retained reference lot by morphological microscopy, starch granule iodine reaction, and thin-layer chromatographic profiling against the ChP 2020 Part I monograph for Oryzae Fructus Germinatus. Because cultivar, planting season, and germination time alter the starch and reducing-sugar profile, the supplier specification includes an amylolytic activity window expressed as grams of soluble carbohydrate released per 100 g of dry material under fixed buffer conditions. There is no single universal pharmacopoeial unit for veterinary-grade activity across all registrations; therefore, the buyer dossier must state whether activity is measured by the dinitrosalicylic acid reducing-sugar method or by a starch-iodine colorimetric method. Inter-laboratory bias should be controlled by using the method reference from the supplier validation dossier.
The released API is defined by a specification set that reflects the downstream process. For tablets and capsules, particle-size distribution and bulk flow are as important as starch content. For injections, bacterial endotoxin and heavy-metal burden are more critical than tapped density. A representative buyer specification is provided below; the numerical acceptance limits are not universal and must be fixed in the purchasing dossier for the target species and dosage form.
| Control parameter | Method/reference | Technical relevance |
|---|---|---|
| Botanical identity | ChP 2020 Part I, microscopy, TLC | Prevents substitution with ungerminated rice flour or malted barley |
| Loss on drying | ChP 2020 0832, representative limit ≤ 10.0% | Controls caking, capsule fill weight, and microbial stability |
| Total ash | ChP 2020 2302, representative limit ≤ 4.0% | Detects silica and soil residues from post-harvest handling |
| Acid-insoluble ash | ChP 2020 2302, representative limit ≤ 0.5% | Limits non-physiological mineral contamination |
| Heavy metals | ChP 2020 2321, representative limits Pb ≤ 5.0 mg/kg, Cd ≤ 0.5 mg/kg, As ≤ 2.0 mg/kg, Hg ≤ 0.1 mg/kg | Required for food-producing species and parenteral use |
| Microbial enumeration | ChP 2020 1105 / 1106, total aerobic count ≤ 10³ CFU/g, yeasts/moulds ≤ 10² CFU/g | Prevents bioburden in oral and premix dosage forms |
| Particle-size distribution | ISO 13320 or sieve method, D90 ≤ 180 μm for capsule and premix grades | Controls segregation, dusting, and die fill |
| Bulk/tapped density | USP 616, bulk 0.40–0.60 g/mL, tapped 0.55–0.75 g/mL | Determines dosator performance and mixer capacity |
| Bacterial endotoxin | ChP 2020 1143, < 0.5 EU/mg for injection grade | Mandatory if the API is used in parenteral solutions |
Particle-size reduction is a documented source of process conflict. Milling to D90 ≤ 75 μm improves content uniformity in low-dose premixes but raises the hygroscopic surface area. On production-scale capsule lines with dosator feed, excessive fines below 75 μm cause stationary powder beds to densify and weight variation to rise beyond ±3% relative standard deviation. In tablet manufacturing, fine fractions can increase tensile strength but also increase sticking when residual moisture exceeds 5%. Therefore, the particle-size target is deliberately widened for capsule and tablet grades, while premix grades are matched to the carrier particle size to avoid stratification.
Injection-grade use imposes constraints absent from oral dosage forms. The crude powder contains starch granules, residual cell-wall fragments, and thermolabile α-amylase; it cannot be sterilized by autoclaving without losing enzyme activity and inducing starch gelatinization. For solution or suspension injections, the formulator typically prepares a depyrogenated aqueous extract at 40–50 °C for 20–30 min, followed by filtration through a 0.22 μm polyethersulfone membrane and aseptic filling. Terminal moist-heat sterilization above 60 °C is not assigned to the crude API because starch granule swelling increases viscosity beyond the filling range and denatures the enzyme fraction.
Bacterial endotoxin control is batch-critical because plant-derived materials can carry high intrinsic endotoxin loads. The API supplier’s endotoxin release value is therefore not a substitute for post-extraction depyrogenation. In one production-scale failure mode reported for starch-based botanical extract solutions, residual endotoxin after sterile filtration remained above the product specification because the holding tank was not depyrogenated and the filter membrane was not validated for endotoxin retention under low-ionic-strength conditions. The control strategy must therefore include pre-washing, high-temperature depyrogenation of product-contact surfaces, and endotoxin challenge tests on the final filter train.
For a parenteral emulsion or suspension, the insoluble starch fraction must be controlled. Particles larger than 10 μm are reduced by high-pressure homogenization at 800–1000 bar; however, published data for this specific configuration is limited. The formulator must verify that homogenization does not liberate reducing sugars at a rate that alters osmolality beyond the species-specific limit. Injection-grade development therefore requires a stricter extract specification and a narrower thermal window than oral powder or capsule development.
Wet granulation in a high-shear mixer is applied when the API load exceeds direct-compression capacity. In a 65 L bowl using starch paste or polyvinylpyrrolidone as binder, binder addition at 0.5 kg/min and impeller speed of 150 rpm produces granules with D50 250–350 μm, suitable for sachet filling. Overwetting above 12% w/w can cause dryer surging and hard agglomerates; underwetting below 6% w/w creates dusty granules with poor die fill. The dried granule is milled through a 1.0 mm screen before final blending.
For low-inclusion premixes, the API is commonly co-milled with lactose monohydrate, dextrose, or maltodextrin. Co-milling through a 0.5 mm screen in a pin mill reduces segregation but increases the fraction below 75 μm; this fine fraction raises hygroscopicity and creates dust losses during transfer. In a premix containing mineral carriers, particles below 75 μm can adhere to mixer walls and reduce batch homogeneity below 5% coefficient of variation after 10 min of mixing. Homogeneity is evaluated by assay of the marker component or by validated tracer studies, with acceptance typically set at ≤ 5% relative standard deviation for the active component.
For oral solutions, the API requires a wetting agent because of its waxy starch coating. A dispersion step in 0.5–1.0% polysorbate solution prevents clumping before addition to the bulk aqueous phase. If the solution is intended for drinking-water delivery, particles larger than 75 μm must be removed to prevent clogging of nipple drinkers. For solution stability, the formulation is buffered to avoid starch hydrolysis and browning: a pH above 8.0 in the presence of amine-rich stabilizers accelerates starch degradation and colour formation. A pH target of 4.5–6.5 is typically selected for liquid oral forms.
Tablet formulations generally use direct compression when the API fraction is below 20% w/w; higher loads require wet granulation with 2–5% w/w polyvinylpyrrolidone binder. The API has limited compactibility because of high starch and low fibre content. Lubrication with 0.5% magnesium stearate for 3 min is sufficient; prolonged blending reduces tablet hardness by coating the particles. Capsule filling with dosator nozzles requires tapped density between 0.45 and 0.65 g/cm³; material outside this range tends to produce weight variation during high-speed filling.
Oryzae Fructus Germinatus is frequently compared with Hordei Fructus Germinatus and with ungerminated rice powder. The principal operational difference is the enzyme profile: germinated barley generally exhibits stronger β-amylase activity, whereas germinated rice has a higher α-glucosidase-to-β-amylase ratio. The starch system of germinated rice is partially hydrolyzed into dextrins and reducing sugars; ungerminated rice remains largely native starch. These differences alter binder behaviour, disintegrant demand, and in vitro carbohydrate availability in the target animal.
| Attribute | Oryzae Fructus Germinatus | Hordei Fructus Germinatus | Ungerminated Oryzae Fructus |
|---|---|---|---|
| Botanical source | Oryza sativa L. | Hordeum vulgare L. | Oryza sativa L. |
| Germination status | Controlled germination and low-temperature drying | Controlled germination and kilning | None |
| Dominant carbohydrate | Partially hydrolyzed starch, dextrins, reducing sugars | Partially hydrolyzed starch, maltose, β-glucans | Native starch |
| Enzyme profile | α-amylase, α-glucosidase, limited β-amylase | α-amylase, β-amylase, phytase | Negligible |
| Dosage-form fit | Oral powder, soft extract, premix, solution | Oral powder, capsule, liquid feed | Capsule diluent, tablet filler |
| Moisture sorption | Moderate to high after milling | Moderate | Low to moderate |
| Main process risk | Enzyme inactivation above 60 °C, caking | β-glucan viscosity in liquid feeds | Retrogradation of unmodified starch |
Operational boundaries include pre-drying at 50 °C if moisture exceeds 10% before dry milling. The API should not be dry-blended with strong oxidizing agents or iodine-based disinfectants because starch-iodine complex formation and oxidation can alter release behaviour. Avoid combination with alkaline granulating fluids above pH 8.0 and amine-rich additives that accelerate starch hydrolysis and browning. In medicated feed premixes, the material functions as a botanical active raw material within a licensed veterinary formulation, not as a sole nutritional source. Published data for each species-specific pharmacokinetic application remains limited, and the formulator must verify target animal safety and batch-to-batch process capability before commercial manufacture.
