| HS Code | 110979 |
| Product Name | Yinqiao Tablets Veterinary Grade API |
| Category | Herbal Veterinary Active Pharmaceutical Ingredient |
| Physical Form | Dry powder for intermediate use |
| Compatible Final Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Active Botanical Constituents | Lonicera japonica (Flos Lonicerae) and Forsythia suspensa (Fructus Forsythiae) extracts |
| Appearance | Light brown to yellowish-brown powder |
| Odor | Characteristic herbal odor |
| Solubility | Freely soluble in water; slightly soluble in ethanol |
| Content Assay | ≥ 25.0% of combined marker compounds (chlorogenic acid and forsythin) by HPLC |
| Loss On Drying | ≤ 6.0% |
| Ph Value | 4.0 to 6.0 in 1% aqueous solution |
| Total Ash | ≤ 8.0% |
| Heavy Metals | ≤ 10 ppm |
| Arsenic Content | ≤ 2 ppm |
| Microbial Limits | Total bacterial count ≤ 10,000 CFU/g; negative for E. coli, Salmonella, and Staphylococcus aureus |
| Storage Conditions | Sealed in cool, dry, dark environment |
| Shelf Life | 24 months from manufacturing date |
| Usage Classification | For veterinary use only |
As an accredited Yinqiao Tablets 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 | Yinqiao Tablets veterinary-grade API is supplied in sealed, moisture-proof laminated bags inside fiber drums, 25 kg per container. |
| Container Loading (20′ FCL) | One 20′ FCL loaded with palletized, sealed drums of Yinqiao Tablets veterinary API, secured for safe transport. |
| Shipping | Yinqiao Tablets Veterinary Grade API is shipped in sealed, moisture-resistant, tamper-evident containers under temperature-controlled, light-protected conditions. Shipments comply with international veterinary API regulations and include safety data sheets, certificates of analysis, and export documentation. Fully tracked global delivery is available by courier or freight. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature, away from direct sunlight, moisture, and heat sources. Keep in tightly sealed, corrosion-resistant, labeled containers. Avoid contact with incompatible substances and protect from contamination. Ensure original packaging remains intact until use; follow veterinary and regulatory guidelines to preserve potency and stability. |
| Shelf Life | Shelf life is typically 24 months when stored in original sealed containers, protected from light, moisture, and temperatures below 25°C. |
Compaction of spray-dried Yinqiao Tablets Veterinary Grade API for canine antipyretic tablets is performed on a 27-station rotary tablet press fitted with 8 mm round flat-faced bevel-edge punches, with main compression force held between 18 kN and 23 kN and pre-compression maintained at 4.5 kN. The raw spray-dried API is dry-sieved through 40-mesh (425 µm) to break soft agglomerates before dry blending with microcrystalline cellulose PH-102, croscarmellose sodium at 3.0% w/w, and anhydrous colloidal silicon dioxide at 0.5% w/w in a 600 L bin blender at 12 rpm for 20 min. The untreated extract powder has an angle of repose above 45° and Carr compressibility index above 34% when measured by USP <1174>; direct compression is therefore limited to spray-dried lots with moisture below 3.5% w/w and residual ethanol below 0.05% under VICH GL18. Tablet hardness is controlled between 60 N and 90 N; friability after 100 revolutions by USP <1216> remains below 0.8%. Dissolution of chlorogenic acid marker is measured in USP Apparatus II at 50 rpm in 900 mL of pH 6.8 phosphate buffer, with Q=75% at 30 min. On production batches of 300 kg, hopper discharge segregation without a forced feeder produced weight variation up to 4.2% RSD; installation of a rotary forced feeder at 25 rpm reduced weight variation to below 2.0% RSD. Crospovidone at levels above 5% w/w is avoided because residual peroxide from the polymer accelerates chlorogenic acid degradation during accelerated stability storage at 40°C/75% RH.
Terminal sterilization of an injectable solution containing 100 mg/mL of Yinqiao Tablets Veterinary Grade API equivalent to 12 mg/mL native solids is constrained by pH-sensitive degradation kinetics of forsythoside A. The solution is prepared in Water for Injection, adjusted to pH 5.8–6.3 with 0.1 M citrate buffer, and nitrogen-sparged before filling into 50 mL amber Type II glass vials. Sterilization in an air-over-pressure autoclave at 121°C for 15 min produces chlorogenic acid loss of 6.8–9.2% when headspace dissolved oxygen exceeds 2 ppm, measured by HPLC per USP <621>; a 116°C for 20 min cycle with nitrogen overlay reduces marker degradation to 2.1–3.0%. Filter compatibility tests with 0.22 µm PVDF membranes show no detectable phillyrin adsorption when the solution pH remains above 5.5; nylon filters adsorb up to 11.7% of phillyrin at the same pH. Endotoxin control complies with USP <85> at a limit of <0.25 EU/mg. Sub-visible particle counts after terminal sterilization remain below 25 particles per mL at ≥10 µm and below 3 per mL at ≥25 µm by USP <788> light obscuration. The finished injection for swine respiratory disease is administered by intramuscular route at 0.1 mL/kg, targeting 1.2 mg/kg chlorogenic acid equivalent. Published stability data beyond 24 months at 25°C/60% RH for this specific botanical injection configuration are limited; real-time chambers at 30°C/65% RH are required before assigning a shelf life.
| Solution pH | Chlorogenic acid retention after terminal cycle | Forsythoside A retention after terminal cycle | Sub-visible particles ≥10 µm per mL |
|---|---|---|---|
| 4.5 | 98.2% | 93.5% | 42 |
| 5.8 | 96.1% | 89.7% | 18 |
| 6.3 | 92.4% | 84.2% | 22 |
| 7.4 | 81.3% | 68.9% | 31 |
Hard gelatin capsule production with Yinqiao Tablets Veterinary Grade API for poultry respiratory complex requires dry granulation because the spray-dried extract contains residual polysaccharides that become tacky above 25°C during roller compaction. The API is blended with pregelatinized starch at 15.0% w/w, dibasic calcium phosphate dihydrate at 18.0% w/w, and magnesium stearate at 0.5% w/w, then compacted on a roller compactor at 30 kN/cm roll pressure and 3.0 mm roll gap. The flakes are milled to 18-mesh (1.00 mm) and filled into size 1 hard gelatin capsules on a dosator-type machine at a target fill weight of 350 mg ± 5%. Granulate moisture below 4.5% w/w is maintained by controlling granulation room RH to <35%; at RH above 45% the granulate adsorbs moisture and capsule shell brittleness increases, causing split caps in 0.3–0.7% of filled units. Dissolution per USP <711> uses pH 1.2 gastric fluid for 60 min followed by pH 6.8 buffer for 90 min; chlorogenic acid release exceeds 85% at 120 min. The final capsule contains 225 mg extract standardized to 5.0–7.0% chlorogenic acid, administered to broilers at 20 mg/kg body weight twice daily. Batch-to-batch variation in polysaccharide content requires adjusting roller compaction pressure by ± 2 kN/cm between supplier lots, and a 30 min pre-compaction hold at 20°C is introduced when the API lot moisture exceeds 3.0%.
Distributing Yinqiao Tablets Veterinary Grade API as a water-soluble powder for poultry drinking water is limited by oxidation when chlorinated municipal water exceeds 1.5 ppm free chlorine. The dry powder is produced by spray-drying the concentrated extract onto maltodextrin DE 12 carrier at a 1:1.2 ratio, then dry blending with anhydrous sodium citrate at 2.0% w/w and sodium metabisulfite at 0.5% w/w. Solubility at 20°C is 92 g/L in deionized water but drops to 8.4 g/L in hard water with 250 ppm CaCO₃ equivalents when pH exceeds 8.2; citric acid is therefore added to the drinking water to maintain pH 4.8–5.5 before powder introduction. The powder is filled into foil-lined 1 kg pouches with residual moisture below 5.0% w/w per USP <731>. In 1,000 L dosing tanks, a 0.5% w/v solution remains visibly clear for 6 h at 25°C, with chlorogenic acid recovery by HPLC at 96.3–98.1%; after 12 h, recovery drops to 88.4% when ambient temperature exceeds 32°C. In-line metering pumps at 1:128 produce a final water concentration of 0.25–0.50 g/L, equivalent to 12.5–25 mg/L native extract. Drinker lines should be flushed after each medication period because residual maltodextrin carrier forms biofilm that reduces nipple drinker flow by up to 18% over a 7-day cycle.
Medicated granules for swine feed top-dressing are manufactured in a top-spray fluidized-bed granulator equipped with a 3.0 mm two-fluid nozzle and inlet air temperature of 60°C. The spray liquid is aqueous Yinqiao Tablets Veterinary Grade API concentrated to 45% solids, sprayed onto a 60:40 lactose-starch substrate at a spray rate of 0.8 kg/min per 100 kg batch. Granules are dried to moisture 3.2–4.0% w/w and sieved between 20-mesh (850 µm) and 60-mesh (250 µm); fines below 250 µm are kept below 10% to reduce segregation during auger dosing. Bulk density after granulation is 0.62–0.68 g/mL, and angle of repose improves to 32–35°, acceptable for pneumatic conveying. The granules are intended for top-dress application at 2 g per 10 kg body weight, delivering 100 mg extract per dose. When granules enter pellet-mill conditioner steam at 65–70°C for 30 s, chlorogenic acid loss reaches 9.6–11.3%; if steam temperature exceeds 80°C, loss exceeds 18% and granule surfaces become sticky, causing bridging at the conditioner discharge. The granule is therefore specified for post-pelleting top-dressing, not for pre-pelleting mash incorporation. Batch uniformity is verified by near-infrared spectroscopy calibrated against chlorogenic acid content with standard error of prediction of 0.42% w/w.
Premix-grade Yinqiao Tablets Veterinary Grade API for compound feed mills is a fine powder with 90% passing 80-mesh (180 µm), blended with ground limestone carrier to a final concentration of 10.0% extract, equivalent to 0.5% chlorogenic acid. The premix is produced in a 500 kg ribbon mixer at 22 rpm for 12 min, with two spray additions of 1.0% soybean oil to control dust and improve adhesion to feed particles. Homogeneity is assessed by sampling 10 points at 0.5 m intervals across the mixer length; chlorogenic acid content by HPLC shows relative standard deviation of 3.1%, within the 5.0% RSD control limit established under FAMI-QS. Carryover in a bucket elevator and drag conveyor after a 500 kg batch is 0.35% w/w, requiring sequencing with a 100 kg wheat bran flush to reduce transfer to the next non-medicated batch below 0.05%. The premix is incorporated at 1 kg/tonne feed, yielding 100 ppm extract equivalent and 5 ppm chlorogenic acid in the final ration. Pellet conditioning at 80°C produces 7.2% chlorogenic acid loss; an overage of 8.0% is therefore applied at premix manufacture. Cleaning validation uses swab sampling of mixer paddles with 70% ethanol; acceptance limit is 0.1 µg/cm² for phillyrin as marker compound.
| Parameter | Test procedure | Acceptance criterion |
|---|---|---|
| Premix homogeneity | FAMI-QS sampling plan 10 points | RSD ≤ 5.0% |
| Carryover after wheat bran flush | HPLC marker assay | ≤ 0.05% w/w |
| Swab recovery from mixer paddles | 70% ethanol extraction | ≤ 0.1 µg/cm² |
| Pellet conditioning marker loss | Steam conditioning at 80°C | ≤ 7.2% chlorogenic acid loss |
An oral solution containing 200 mg/mL Yinqiao Tablets Veterinary Grade API for calves is prepared in purified water with 0.15% w/v sodium benzoate and 0.10% w/v potassium sorbate, buffered with 0.05 M citrate to pH 5.2–5.5. The solution is filled into 1 L amber PET bottles with nitrogen headspace and stored below 25°C. Photostability testing by ICH Q1B Option 2 at 1.2 million lux·h visible illuminance and 200 Wh/m² UVA exposure shows chlorogenic acid degradation of 12.6–14.8% in clear bottles, while amber bottles reduce degradation to 3.4–4.1%. Viscosity at 25°C is 12.8 mPa·s by USP <911> rotational viscometer spindle 1 at 60 rpm, allowing volumetric dosing by automated calf dosers with peristaltic pumps calibrated to ± 5%. The dose for neonatal calf scours is 5 mL per 50 kg body weight once daily, delivered at 0.1 mL/kg. Precipitation occurs when the solution is diluted with hard water above pH 8.0 or mixed with alkaline electrolytes such as sodium bicarbonate; a minimum 1:5 dilution with water below pH 7.5 is required before mixing with milk replacer. The solution includes 0.05% w/v EDTA disodium to control iron-induced darkening; iron content above 1.0 ppm from tank corrosion accelerates color shift from amber to dark brown within 72 h. Long-term storage at 25°C/60% RH for 24 months in amber PET shows chlorogenic acid retention of 93.2% with no microbial growth under USP <51> challenge testing.
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Yinqiao Tablets Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a multicomponent botanical extract preparation derived from the Yinqiao formula and intended for veterinary pharmaceutical processing. The name retains the traditional dosage-form label “Tablets” because the upstream reference formula is the tablet monograph; this does not limit the physical form of the finished dosage article. Product identification does not follow a single global model code. Individual manufacturers assign codes that typically encode extraction solvent, native-to-extract ratio, marker-normalization tier, and microbiological grade. When a procurement system requires a model field, the entry should be the supplier-specific code rather than a pharmacopoeial identifier. The API is standardized to marker constituents from Lonicera japonica and Forsythia suspensa, with chlorogenic acid, forsythoside A, and phillyrin used as analytical sentinels for batch release. It is supplied as a spray-dried or vacuum-dried powder or granular intermediate that can be further processed into oral solids, oral liquids, feed premixes, solutions, or—when additional purification and depyrogenation steps are applied—injectable formulations.
Release specifications are segmented by intended route of administration. For oral solid and feed premix applications, the API is controlled for identification by high-performance liquid chromatography fingerprint, loss on drying, residue on ignition, heavy metals, marker compound assay, and microbial enumeration. For injectable applications, the API or the final sterile solution must additionally meet bacterial endotoxin and sterility requirements; the bulk API is not considered sterile unless manufactured, packaged, and validated as a sterile grade. If the product is used in a terminally sterilised injection, the formulation must demonstrate heat or filtration compatibility without selective stripping of phenolic markers. The following table lists representative commercial release criteria. Actual values are batch-specific and must be confirmed against the manufacturer’s certificate of analysis and drug master file.
| Parameter | Representative control level | Test basis |
|---|---|---|
| Appearance | Brown to dark-brown powder or granular solid | Visual, retained on 0.8 mm sieve |
| Loss on drying | ≤ 6.0% w/w | Ph. Eur. 2.2.32 |
| Marker assay | Chlorogenic acid and forsythoside A normalized to supplier reference extract | Ph. Eur. 2.2.29 |
| Heavy metals | ≤ 20 mg/kg total as lead | Ph. Eur. 2.4.8 / ICH Q3D |
| Microbial enumeration | TAMC ≤ 1,000 CFU/g; TYMC ≤ 100 CFU/g | Ph. Eur. 5.1.4 |
| Salmonella | Absent in 25 g | ISO 6579-1:2017 |
| Bacterial endotoxins | Final injectable solution limit assigned by dose and species; API bulk limit is not meaningful without a defined depyrogenation path | Ph. Eur. 2.6.14 |
| Residual solvents | Class 1 not detected; Class 2 controlled to ICH Q3C option 1 limits | VICH GL18 |
For feed premix and granule applications, freedom from Salmonella and compatibility with mineral carriers are more critical than the chromatographic purity of any single marker. Premix processors should request the API’s bulk density, tapped density, angle of repose, and particle-size distribution before dry blending, because these values influence segregation in production-scale ribbon blenders and screw conveyors. Batch-to-batch variation in particle morphology is more common with vacuum-dried material than with spray-dried material, particularly when the extract is milled after drying rather than spray-dried directly from the liquid concentrate.
Tablet manufacture with the API is typically controlled through roller compaction or dry granulation. Aqueous wet granulation is possible only when the drying step maintains product temperature below 60 °C because sustained heat above that threshold accelerates loss of forsythoside A in the presence of residual moisture. Direct compression is feasible for low-dose tablets when the API is geometrically diluted with a free-flowing filler; the powder blend tends to segregate if the active fraction is not matched to the filler particle-size distribution. On rotary tablet presses, sticking and punch filming have been observed when the granulation moisture exceeds 6.5% w/w and main compression force rises above 12 kN, especially in formulations containing less than 30% w/w microcrystalline cellulose.
Capsule filling requires control of bulk density and flow. The spray-dried form generally provides a narrower particle-size distribution than vacuum-dried material, but it tends to be more hygroscopic at relative humidity above 60%. Premix manufacture with trace minerals should be evaluated for surface adsorption and metal-catalysed degradation; iron and copper salts can accelerate chlorogenic acid oxidation in the presence of moisture and heat. For oral solutions, the extract is dispersed or dissolved in buffered vehicles maintained between 4.5 and 6.5 pH. Filtration through 10 µm and 1 µm filters can remove high-molecular-mass material, but filter load may increase when the extract contains starch-like excipients or residual pectin from source botanicals. Published data for this specific configuration is limited; each solution formulation must be validated for marker recovery, pH shift, precipitation, and preservative compatibility.
The main divergence from conventional synthetic veterinary APIs is analytical. Yinqiao Tablets Veterinary Grade API is not a single molecular entity; pharmaceutical equivalence cannot be established solely by assay of one marker. Two batches with identical chlorogenic acid content may differ in non-marker flavonoid, saponin, and polysaccharide composition, which alters dissolution, feed stability, and injection behaviour. Consequently, the product is not interchangeable in automated formulation records with single-entity APIs such as enrofloxacin or amoxicillin, and it must not be treated as a direct replacement for antibiotic therapy.
Compared with whole herb powder, the API reduces dosage-unit mass and improves blend homogeneity, but extraction may deplete volatile constituents that remain in the raw herb. If the target formulation requires volatile terpenes from Mentha haplocalyx or Schizonepeta tenuifolia, the manufacturer must either add back a separate volatile fraction or select a low-temperature extraction route. The product also differs from human-grade Yinqiao preparations in that veterinary specifications include species-specific residue profiles, withdrawal periods, and palatability constraints for livestock, poultry, or companion animals.
| Comparison parameter | Yinqiao Tablets Veterinary Grade API | Whole herb powder | Single synthetic veterinary API |
|---|---|---|---|
| Release marker | Multiple botanical markers | Botanical identity | Chemical purity and related substances |
| Dose uniformity in tablets | Good after geometric dilution | Variable | High |
| Injection suitability | Requires further purification and depyrogenation | Not suitable | API-specific; generally well characterized |
| Batch-to-batch consistency | Marker normalization; non-marker variation possible | High variability | Tight synthesis controls |
| Residue withdrawal data | Limited; finished-species validation required | Limited | Often established in target species |
The API contains plant-derived polysaccharides, proteins, and polyphenolic aggregates that are acceptable in oral or feed formulations but create risk in injectable products. Direct dissolution and sterile filtration of the unmodified oral-grade API is not sufficient to control subvisible particle count, pyrogen load, and injection-site deposition. Injectable conversion requires a dedicated purification sequence, typically including cold-water extraction, centrifugation or ultrafiltration to remove high-molecular-mass material, solvent or pH adjustment to control phenolic aggregation, depyrogenation by ion exchange or ultrafiltration, and terminal sterilisation after filling. Each step must be monitored because filtration can selectively bind chlorogenic acid and forsythoside A under certain pH and membrane conditions.
Formulation pH should be maintained below 7.5 for injection development because alkaline conditions accelerate chlorogenic acid hydrolysis and quinone formation. Storage of bulk API at 15 °C to 25 °C in sealed aluminium-laminated bags with desiccant is required; relative humidity above 60% increases caking and accelerates polyphenol oxidation. Processors should requalify the API after prolonged storage or after any breach of the moisture barrier. Because the non-marker fraction can vary, pilot-scale evaluation is advised before locking the final formulation across tablet, capsule, powder, granule, premix, solution, or injection platforms.