| HS Code | 574209 |
| Product Name | Honghua Powder Veterinary Grade API |
| Veterinary Api Type | Botanical active pharmaceutical ingredient for oral and parenteral veterinary use |
| Botanical Source | Dried flower of Carthamus tinctorius L. |
| Active Marker Compounds | Hydroxysafflor yellow A, Safflor yellow A, Carthamin |
| Appearance | Brownish-yellow to reddish-brown fine powder |
| Odour | Characteristic aromatic odour, no musty or rancid odour |
| Solubility | Soluble in water and dilute ethanol; practically insoluble in chloroform and ether |
| Pathogen Limits | Salmonella negative in 25 g; Escherichia coli negative in 10 g |
| Suitable Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Storage Conditions | Sealed, cool, dry place; protected from light |
| Shelf Life | 24 months |
As an accredited Honghua Powder 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 | Honghua Powder veterinary grade API is packaged in 25 kg sealed aluminum foil bags with inner polyethylene liner, per drum. |
| Container Loading (20′ FCL) | 20′ FCL container loading: Honghua Powder veterinary-grade API packed in sealed drums/bags, palletized, secured for safe, contamination-free transport. |
| Shipping | Shipping for Honghua Powder Veterinary Grade API: packaged in sealed, moisture-proof drums or bags, palletized for safe transport. Shipped via air or sea in temperature-controlled conditions to preserve stability. Fully compliant with international veterinary pharmaceutical regulations, with complete documentation, COAs, and stable lead times for global delivery. |
| Storage | Store Honghua Powder (veterinary grade API) in a cool, dry, well-ventilated area, protected from moisture, heat, and direct sunlight. Keep container tightly sealed after use, and avoid contact with incompatible materials or oxidizers. Use for veterinary purposes only; follow label storage recommendations and observe expiry date. |
| Shelf Life | Shelf life is 24 months when stored unopened in original container, below 25°C, protected from light and moisture. |
Direct compression of Honghua Powder Veterinary Grade API into uncoated, single-scored tablets for companion animal dosing is typically rejected at initial batch scale unless the milled extract is co-processed with spray-dried lactose monohydrate and microcrystalline cellulose at a ratio of 20–30 wt% API to 65–70 wt% filler-binder. The raw powder shows cohesive, moisture-sensitive flow behaviour; rotary tablet press trials with paddle force feeders have produced weight variation outside ±5.0% when direct compression is attempted below 15.0 wt% filler. Dry granulation by slugging or roller compaction is preferred when the API assay exceeds 10.0% w/w because the densified granules increase bulk density and reduce segregation. Pre-screening moisture is controlled by drying the API in a vacuum shelf dryer at 50°C for 2 h when water content exceeds 3.0%; prolonged drying above 60°C darkens the extract and reduces marker assay. In-process controls under 21 CFR 211.101 require stratified blend sampling at 10 locations and RSD below 5.0%. Disintegration is tested according to USP <701>; uncoated tablets containing hygroscopic botanical fractions should disintegrate within 15 min in water at 37°C. Compression force is maintained between 6 and 12 kN to limit capping without exceeding the plastic deformation threshold of the filler. The terminal dosage form is a scored tablet for oral administration to cats and dogs, with label content standardised to the declared marker compound rather than to total extract weight.
Parenteral conversion of Honghua Powder Veterinary Grade API requires the removal of colloidal polysaccharides, proteins, and residual plant cell debris before 0.22 µm membrane filtration. Published data for this specific API configuration is limited; however, process design for multi-component botanical extracts of this class follows a conservative filtration train. The bulk solution is first reconstituted in water for injection under high-shear mixing at 8,000–10,000 rpm for 15–20 min, then clarified by centrifugation at approximately 3,000×g for 10 min and passed through a 5.0 µm depth filter. A 0.45 µm PVDF prefilter protects the sterilising-grade 0.22 µm membrane, with a maximum pressure drop of 1.5 bar and a volumetric throughput limit of 50–100 L·m⁻² because higher loadings are not supported by published filter cartridge performance data for similar extracts. Terminal sterilisation is preferred over aseptic filtration when the chemical stability of the marker compound permits an autoclave cycle of 121°C for 15 min; lower-temperature cycles such as 115°C for 30 min may be validated if load qualification demonstrates a minimum F₀ of 8. Bacterial endotoxin limits follow USP <85>; if endotoxin recovery from the botanical matrix is problematic, tangential flow filtration using a 10 kDa nominal molecular weight cut-off may be integrated before final formulation. The finished injection is filled into amber Type I glass vials under nitrogen, sealed with butyl rubber stoppers, and labelled for intravenous or intramuscular injection in cattle, horses, or swine with osmolality adjusted to 280–320 mOsm·kg⁻¹.
Low-fill-weight capsule formulations containing Honghua Powder Veterinary Grade API are subject to particle segregation and assay non-uniformity when the active fraction is below 10 wt% of total fill weight. Automated dosator-type capsule fillers require free-flowing formulations; with botanical APIs, the blend is densified by roller compaction to a bulk density of 0.55–0.65 g·cm⁻³ and sieved to 0.5–1.0 mm before encapsulation. The standard formulation uses microcrystalline cellulose 60–70 wt%, lactose monohydrate 20–30 wt%, colloidal silicon dioxide 0.2–0.5 wt%, and magnesium stearate 0.25–0.50 wt% as a lubricant. Over-lubrication above 0.50 wt% can reduce capsule disintegration; under-lubrication causes intermittent sticking on tamping pins. On a production-scale intermittent-motion capsule machine operating at 60,000 capsules·h⁻¹, fill weight is monitored by automated weight sorting at ±5.0% of target. Blend uniformity follows USP <905>, with acceptance criteria tightened to RSD <4.0% for low-dose veterinary APIs. Gelatin shells are avoided if fill moisture exceeds 4.0% because shell crosslinking can delay dissolution. The final capsules are size 3 or 4 hard gelatin or HPMC shells, suitable for oral dosing of cats, small dogs, or exotic species, where dose flexibility and taste masking are achieved by enclosing the bitter botanical matrix.
Dry oral powders containing Honghua Powder Veterinary Grade API for in-feed or oral drench are manufactured by geometric dilution of the API with a dust-free carrier such as lactose monohydrate, glucose, or maltodextrin. The primary risk is not chemical degradation but electrostatic segregation and moisture uptake; the API is commonly milled to a particle-size distribution of D₉₀ <150 µm before blending. Layering the API onto the carrier using a low-shear tumble blender for 20–30 min at 10 rpm provides a coefficient of variation below 5.0% for a 2.0 wt% active content. Dust suppression is controlled by adding 0.3–0.5 wt% of a vegetable oil binder, but hydrophilic carriers can agglomerate if the oil addition exceeds 0.5 wt% because local moisture above 3.0% causes bridge formation. Batch-to-batch variance in residual moisture after blending can shift flow function coefficients by more than 20% when storage humidity exceeds 50% RH, a condition observed on unhumidified stainless steel blender platforms. The final powder is packaged in foil-lined sachets or tubs with desiccant; loss on drying should not exceed 3.0% at 105°C per USP <921>. The terminal product is used as a water-soluble oral powder or direct dietary supplement for cattle, horses, or poultry, with labelled assay expressed per gram of Honghua Powder Veterinary Grade API standardised to the selected marker compound.
Medicated premixes represent the highest-volume low-concentration application for Honghua Powder Veterinary Grade API; the main manufacturing conflict is achieving homogeneity at an inclusion rate of 0.5–5.0 kg per tonne of finished feed without exceeding the carrier’s absorption capacity. The premix is produced in a double-ribbon mixer at a fill level of 60–70%; the API is first premixed with 10 kg of calcium carbonate or wheat bran for 10 min, then added to 100 kg of carrier and mixed for 25–30 min. Mixing times above 40 min do not improve blend uniformity and may increase particle attrition and dust formation. The homogeneity target is a coefficient of variation <5.0% for the marker compound, verified by collecting 10 thief samples from different mixer zones after discharge. Carryover into subsequent batches is reduced by pre-coating the mixer walls with 5 kg of carrier before adding the API-containing mix and by a wash cycle with 25 kg of carrier after discharge. In feed mills, the premix is diluted at a rate of 1:100 to 1:500 into complete feed; segregation during pneumatic transfer is controlled by keeping the finished premix particle size between 300 and 800 µm. The terminal product is a free-flowing medicated premix for swine, broilers, or layers, intended for on-farm mixing where local regulations permit botanical APIs in medicated feed.
| Parameter | Representative target | Measurement or reference |
|---|---|---|
| API-to-carrier pre-blend ratio | 1:10 w/w | gravimetric |
| Main mixer fill level | 60–70% | volumetric |
| Mixing time | 25–30 min | chronometric |
| Homogeneity coefficient of variation | <5.0% | marker assay |
| Finished premix particle size | 300–800 µm | sieve analysis |
| Loss on drying | ≤3.0% | USP <921> |
For sachet filling lines that require a dust-free, densified intermediate, top-spray fluid-bed granulation of Honghua Powder Veterinary Grade API is selected over dry blending because it reduces electrostatic charge and standardises bulk density. A binder solution of povidone K30 at 5.0 wt% in water or hydroxypropyl methylcellulose at 3.0 wt% is sprayed onto the fluidised API-carrier mixture; inlet air temperature is set between 55 and 70°C, while product temperature is kept below 40°C to avoid thermal degradation of the marker fraction. Atomisation air pressure is maintained at 1.5–2.5 bar, and the spray rate is increased only after the bed reaches the target product temperature. Granulation endpoint is reached when the loss on drying falls below 3.0% and the granules pass through a 16-mesh screen with retention on a 40-mesh screen above 80%. The terminal product is an oral granule for reconstitution or direct administration to swine, calves, or horses, filled into single-dose sachets; resuspendability after reconstitution is checked by inversion after 30 s without visible clumping.
Honghua Powder Veterinary Grade API does not form a true solution in water at neutral pH; the aqueous solubility of the crude extract is limited by non-polar flavonoids and plant sterols. Oral liquid products are therefore formulated as stabilised suspensions or microdispersions using 0.8–1.2 wt% xanthan gum or 0.5–1.0 wt% hydroxyethylcellulose as a suspending agent. The aqueous phase is prepared with 5.0–10.0 vol% propylene glycol and 0.1 wt% potassium sorbate as a preservative; pH is adjusted to 5.5–6.5 with citrate buffer. Processing requires a high-shear rotor-stator at 10,000 rpm for 10–15 min to reduce particle size to 50–100 µm before mixing with the hydrated gum phase. Homogenisation temperature should remain below 35°C; high-shear dispersers can increase batch temperature by 10–15°C over 15 min. The finished liquid must be re-dispersible after 7 days of storage; sedimentation volume should exceed 0.9 after gentle inversion. Microbial limits follow USP <61> and <62>; the product is filled into amber PET or glass bottles and labelled with a "shake well before use" instruction. This dosage form is used for drenching cattle, horses, and sheep when flexible dosing by body weight is required.
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Honghua Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a dried, mechanically reduced powder derived from the flos of Carthamus tinctorius L. The material is supplied for downstream manufacture into multiple veterinary dosage forms, with controlled identity, marker content, particle size distribution, moisture, ash, elemental impurities, pesticide residues, and microbial quality. It is standardized as a multi-component botanical active pharmaceutical ingredient rather than as a single isolated constituent. The principal marker used for release is hydroxysafflor yellow A. The powder is not a sterile finished dosage form; therefore subsequent depyrogenation, sterile filtration, or terminal sterilization remains the responsibility of the injectable manufacturer.
Product code HH-VET-API-2025 designates the general oral-grade powder, while HH-VET-API-PAR is assigned to the parenteral processing grade when injectable or solution manufacture is required. Both grades are supplied as pale yellow-brown to orange-yellow powders with a characteristic odor. The oral grade is released against compendial identity, assay, moisture, total ash, acid-insoluble ash, heavy metals, and microbial limits. The parenteral grade additionally requires control of bioburden and bacterial endotoxins before downstream aseptic processing. Each batch is accompanied by a certificate of analysis stating the actual results, not merely the acceptance limits.
Storage and handling require sealed, light-resistant packaging at controlled room temperature between 15 °C and 25 °C. The flavonoid fraction, including hydroxysafflor yellow A, is susceptible to oxidative degradation under sustained light and elevated humidity. Containers should remain closed when relative humidity exceeds 60%. If bags are opened in a non-conditioned processing suite, the powder should be used within the shift or transferred to a desiccated hopper. Residual moisture uptake can increase adhesion to stainless steel surfaces, reduce flow, and alter compaction characteristics.
Unrefined safflower flos varies with field origin, harvest time, drying method, and storage conditions. The veterinary-grade API differs by applying pharmaceutical comminution to a defined particle size class, by releasing against marker content rather than crude weight, and by applying acceptance limits for elemental impurities and microbial burden. The product is screened for mycotoxins and pesticide residues when regional import requirements apply. This does not remove the need for incoming identity testing, but it reduces the probability of botanical misidentification, microbial contamination, and uncontrolled particle size that are common in field-grade safflower material.
| Parameter | Representative release limit | Method reference |
|---|---|---|
| Identification | Corresponds to reference standard by TLC or HPLC retention time | CVP 2020 or current compendial monograph |
| Assay of hydroxysafflor yellow A | ≥ 1.0% on dried basis | HPLC, octadecylsilane column, detection at 403 nm |
| Loss on drying | ≤ 13.0% for oral grade; injectable-grade limit is typically tighter | USP <731> or CVP oven-drying chapter |
| Total ash | ≤ 15.0% | CVP 2020 or equivalent |
| Acid-insoluble ash | ≤ 5.0% | CVP 2020 or equivalent |
| Particle size | D90 ≤ 150 µm for oral solid dosage; D90 ≤ 75 µm for parenteral extraction grade | Laser diffraction or sieve analysis |
| Heavy metals | Subject to ICH Q3D or regional veterinary limits | USP <232>, USP <233> |
| Microbial limits | TAMC ≤ 104 CFU/g; TYMC ≤ 102 CFU/g; absence of Escherichia coli and Salmonella | USP <2021>, USP <2022> |
The representative limits above are batch-release defaults for the oral powder grade. Injectable-grade lots require additional endotoxin and bioburden specifications because the oral-grade release profile does not address parenteral safety. When the receiving monograph imposes stricter limits, the stricter limit governs.
Tablet manufacture generally requires particle size reduction to a D90 of ≤ 150 µm for acceptable content uniformity. Capsule filling and injection-grade extraction may require a D90 of ≤ 75 µm where dissolution rate, extraction yield, or blend segregation are sensitive to particle size. Powder flow is measured by Carr index and Hausner ratio according to USP <616>. Botanical powders of this class frequently exhibit Carr indices above 25%, indicating fair-to-passable flow. Direct compression therefore usually requires granulation rather than simple dry blending.
Wet granulation may use binder addition rates between 2% w/w and 5% w/w of dry powder mass, followed by drying to a final loss on drying of 2.0% to 4.0%. Drying product temperature should not exceed 60 °C to limit marker loss unless supporting stability data for the specific lot demonstrate acceptable degradation at higher temperature. On an instrumented rotary tablet press fitted with B tooling and a 10 mm round flat-faced punch, compactibility curves should be generated before locking compression force. Typical main compression forces may fall between 8 kN and 18 kN for a target tensile strength of 1.5 MPa to 2.5 MPa, but these values are batch-dependent and must be confirmed against hardness, friability, and disintegration requirements. Ejection forces above 1.5 kN typically require external lubrication with magnesium stearate at 0.25% to 0.75% w/w or an alternative lubricant system after chemical compatibility is verified.
Capsule manufacturing on dosator or tamping pin equipment requires powder bed depth and powder head pressure to be fixed after angle-of-repose and avalanche-energy measurements. Angle of repose above 45° indicates the need for wet granulation or a flow aid. If colloidal silicon dioxide is used, addition levels of 0.5% to 1.0% w/w may reduce particle agglomeration, but the effect on hydroxy safflor yellow A recovery should be confirmed by HPLC because some siliceous carriers can adsorb polyphenolic constituents. Fill weight variation is assessed according to USP <905> or the corresponding veterinary compendial chapter.
For oral bulk powders and granules, particle size through 80 mesh (180 µm) is common. Granules for sachet filling are typically sized to 20 mesh to 60 mesh (840 µm to 250 µm) to permit free flow and uniform fill. The powder should not be milled below the required particle size without thermal monitoring, because excessive milling can generate fines, increase surface area, and accelerate oxidative degradation of flavonoids during subsequent storage.
For the injectable and solution route, the dry powder is not injected as a particulate. The formulation path begins with aqueous extraction or co-solvent dissolution, followed by clarification, depyrogenation, and filtration. Bacterial endotoxin burden must be measured by USP <85> or EP 2.6.14. The acceptance limit is not fixed for all species or doses; it is derived from the maximum intended dose and animal body weight according to compendial endotoxin limit calculations. Because polyphenolic constituents can adsorb to nylon and some polyethersulfone membranes, filter compatibility studies should be performed with the target 0.22 µm or 0.10 µm membrane disc before scale-up. Adsorption losses on nylon membranes may exceed 10% of the marker without pre-treatment; selection of PES or PVDF must therefore be based on measured recovery rather than vendor rating alone.
Injectable-grade material requires incoming bioburden control and endotoxin testing before downstream aseptic processing. A typical in-process expectation is to limit bioburden to no more than 102 CFU/g before dissolution and to perform microbial reduction by depth filtration or heat treatment only where thermal stability permits. The resulting liquid must meet particulate matter limits according to USP <788> or EP 2.9.19, and the finished injectable must meet sterility testing according to USP <71> or the relevant veterinary compendial method. Holding times between dissolution and sterile filtration should be minimized, protected from light, and temperature-controlled below 25 °C unless stability data support extended processing.
Solubility of the dry powder in purely aqueous media is limited. If a true solution is required, pH adjustment or co-solvent systems are used. Exposure to pH above 8.5 at temperatures above 40 °C may accelerate oxidation of hydroxysafflor yellow A. Process validation should therefore include marker recovery at each pH and hold stage, not merely at final assay. Filterability testing using a 47 mm disc holder at constant pressure of 0.5 bar may be used to estimate throughput before membrane plugging. The reported Vmax value applies only to the specific extraction batch and membrane lot; adsorption and plugging can shift with minor changes in polysaccharide content or particle fines.
| Processing criterion | Oral/tablet/capsule powder | Injectable-grade extraction powder |
|---|---|---|
| Loss on drying | ≤ 13.0% | ≤ 5.0% or justified by solubility and handling |
| Particle size D90 | ≤ 150 µm | ≤ 75 µm |
| Bacterial endotoxins | Not specified for oral use | Limit derived from dose, species, and route |
| Microbial quality | TAMC ≤ 104 CFU/g | TAMC ≤ 102 CFU/g before bioburden reduction |
| Elemental impurities | ICH Q3D oral limit | ICH Q3D parenteral limit |
| Finished-product sterility | Not required | Required by aseptic processing or terminal sterilization |
Premix manufacturing requires staged geometric dilution in a ribbon mixer or tumble blender. The API is first blended with a carrier such as dextrose, lactose monohydrate, or calcium carbonate having a similar particle size range to prevent segregation. The resulting intermediate premix is then extended with the full carrier quantity. Mixer fill level should not exceed 70% of rated gross volume, and mixing time is established by coefficient of variation of the marker across 10 sampling points. Uniformity is generally considered acceptable when the coefficient of variation is ≤ 5.0%, but the target may be tighter for low-dose premixes or where regional veterinary regulations impose stricter limits.
Electrostatic charge and adhesion to stainless steel surfaces can reduce yield. In low-humidity processing environments below 30% RH, equipment should be grounded and the powder may require an antistatic excipient such as colloidal silicon dioxide at a level justified by blend uniformity data. For granulated oral dosage forms, fluid-bed granulation with inlet air at 50 °C to 60 °C and product temperature below 45 °C is preferred when heat-labile marker retention is required. The use of an organic binder in a hydroalcoholic granulation must be evaluated against residual solvent limits according to USP <467> or the corresponding veterinary compendial method.
In comparison with single-entity synthetic pharmaceutical ingredients, Honghua Powder is a multi-analyte matrix. Its acceptance is based on marker assay plus fingerprint rather than absolute compositional purity, and its behavior in granulation, compression, or filtration cannot be predicted from the active marker alone. In comparison with field-grade safflower meal, the veterinary API has tighter microbial and elemental impurity limits and is not intended for direct feeding without the required dilution or dosage form conversion. It also differs from isolated hydroxysafflor yellow A reference material because the full powder contains waxes, polysaccharides, and minor phenolics that influence hygroscopicity, flow, and compatibility with excipients.
Published data for this exact multi-dosage botanical grade in peer-reviewed process literature is limited. Therefore scale-up trials on equipment equivalent to the target commercial train, with actual safety factors for drying, compression, filtration, and hold time, are required before locking the formulation for any of the seven listed routes. Each target dosage form imposes its own limits for residual moisture, particle size, endotoxin, and terminal processing, and these limits must be qualified against the specific batch certificate rather than assumed from a general monograph.
