| HS Code | 327515 |
| Product Name | Yinqiao Dougen Powder Veterinary Grade API |
| Veterinary Api Type | Herbal extract active pharmaceutical ingredient |
| Target Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Plant Origin | Derived from Lonicera japonica, Forsythia suspensa, and Sophora tonkinensis |
| Physical Description | Fine, dry, free-flowing powder |
| Color And Odor | Light yellowish-brown powder with characteristic aromatic herbal odor |
| Solubility Profile | Partially soluble in water; miscible with aqueous vehicles for veterinary formulations |
| Pharmacological Action | Antipyretic, antibacterial, antiviral, and immune-modulating properties |
| Storage Conditions | Store in a sealed, cool, dry place protected from sunlight and high temperature |
| Shelf Life | 24 months from manufacturing date when stored as recommended |
As an accredited Yinqiao Dougen 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 | 25 kg per drum, double polyethylene liner inside, fiber drum outside, labeled with veterinary grade Yinqiao Dougen Powder API details. |
| Container Loading (20′ FCL) | Loading one 20′ FCL of Yinqiao Dougen Powder veterinary grade API, packed in sealed drums for tablets, injections, capsules, and more. |
| Shipping | Ship via ground or air freight in sealed, UN-approved drums with desiccant. Label as veterinary API, non-hazardous if dry. Include MSDS, COA, and temperature-controlled handling (2–30°C). Protect from moisture, light, and cross-contamination. Delivery worldwide with track-and-trace and customs-compliant documentation. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature (20–25°C). Keep container tightly sealed to protect from moisture, light, and oxidation. Avoid exposure to high heat or freezing. Use original packaging until dispensing. Ensure proper labeling and segregation from food/feed. Follow veterinary-specific regulations. |
| Shelf Life | Shelf life: 24 months when stored in a cool, dry, sealed container away from light and moisture. |
Integration of Yinqiao Dougen Powder veterinary-grade API into drinking-water-administered granules for intensive poultry flocks begins with a pre-formulation moisture-control step. The incoming powder is conditioned for 4–6 h in a fluid-bed dryer at 50–55 °C inlet air with a dew point of ≤ 6 °C to bring loss on drying to ≤ 5.0%, because the polysaccharide and flavonoid fractions exhibit hygroscopicity above 60% relative humidity. The formulation batch is set at 25–35% w/w API, 10–15% w/w microcrystalline cellulose, 8–12% w/w lactose monohydrate, 1.5–3.0% w/w povidone K-30 as an aqueous binder, and 0.5–1.0% w/w sodium starch glycolate as a disintegrant. Granulation is performed on a top-spray fluid-bed granulator with a 10 kg working capacity at product temperature 38–42 °C, atomisation pressure 1.2–1.5 bar, binder spray rate 8–12 g/min, and post-spray drying to a final moisture of 2.5–4.0%. The granule fraction between 300 µm and 850 µm is retained for filling; bulk density is controlled to 0.45–0.60 g/mL to ensure consistent reconstitution in medicator dosing lines. Scale-up to 120 kg production fluid-bed units retains the same product temperature and inlet dew point, but atomisation rate is increased linearly with total air flow. Compliance for this route references Regulation (EU) 2019/6 for veterinary medicinal products, pharmacopoeial testing per USP <731> Loss on Drying, USP <616> Bulk Density and Tapped Density, and sieve analysis alignment with ISO 3310-1 test sieves. Terminal products are 100 g, 500 g, and 1 kg aluminium foil laminate pouches with an oxygen transmission rate < 1.0 cm³/m²·24 h·atm, intended for dilution in drinking-water systems at the dose specified in the authorised summary of product characteristics.
Segregation in a swine feed premix is typically traced to a mismatch between the bulk density of the supplied Yinqiao Dougen Powder and the mineral carrier, not to mixer inadequacy. The API is generally incorporated at 10–20% w/w of the premix, with the balance composed of calcium carbonate, wheat middlings, and silicon dioxide as a flow aid. The principal processing bottleneck appears when the supplied API bulk density of 0.35–0.50 g/mL is 20–30% lower than the mineral carrier; this creates convective segregation during bin discharge and raises the coefficient of variation above the acceptable limit of 5.0% as measured by blend uniformity testing. To correct the mismatch, the API is pre-milled through a pin disc mill to a D90 of ≤ 150 µm and then blended with a carrier fraction containing 60–70% w/w calcium carbonate at 180–250 µm particle size and 2.0–4.0% w/w precipitated silica. Mixing is executed in a 500 kg double-ribbon mixer at 12–18 rpm for 20–25 min; post-mix sampling at 10 points across the discharge path verifies a CV ≤ 5.0% before transfer to packaging. Compliance for this route is anchored to Regulation (EU) 2019/4 on medicated feed, GMP+ BA2 for feed safety assurance, and retention-sample testing per ISO 6496 for moisture and ash. Terminal products are swine feed premixes in 1 kg, 5 kg, 10 kg, and 25 kg barrier-lined sacks; complete feed incorporation rates are finalised only after assay of the active marker and confirmation of homogeneity in the final feed.
The use of Yinqiao Dougen Powder in injectable presentations requires a purified extract rather than an undissolved dry powder. The liquid formulation usually contains an extract equivalent to 0.5–2.0% w/v of the original API, with 0.9% w/v sodium chloride for isotonicity and pH adjustment to 5.5–7.0 using citrate or phosphate buffers. The critical process sequence is clarification through 0.45 µm polyethersulfone membrane filters, followed by 0.22 µm sterilising-grade polyethersulfone membrane filters under aseptic conditions; this is preferred when the active components show thermal sensitivity at 121 °C for 15 min. If terminal moist-heat sterilisation is used, the filled vials are autoclaved at 121 °C for 15 min, but only after thermal stability data confirm marker retention ≥ 95.0%. Published stability data for this specific botanical configuration are limited; therefore terminal sterilisation cannot be selected without product-specific validation. The solution must meet USP <787> or USP <788> particulate matter limits according to fill volume, USP <85> bacterial endotoxin thresholds, and EU GMP Annex 1 requirements for Grade A filling within a Grade B background. Incompatibility with phenol-based preservatives is noted for piglet formulations, as phenolic substances may precipitate polyphenolic fractions. Finished injectable products are filled into Type I borosilicate glass vials of 10 mL and 20 mL, sealed with bromobutyl rubber stoppers and aluminium flip-off seals.
Direct compression of high-dose botanical tablets places the greatest stress on ejection force and moisture stability. Yinqiao Dougen Powder can be formulated by direct compression when the API is pre-processed to a D90 of ≤ 125 µm and mixed with 40–50% w/w microcrystalline cellulose, 20–30% w/w lactose monohydrate, 2–5% w/w crospovidone, 0.5–1.0% w/w magnesium stearate, and 0.2–0.5% w/w colloidal silicon dioxide. The API content of the core tablet is 30–50% w/w, but direct compression is not appropriate for all batches because lot-to-lot variation in fibre content and moisture can raise ejection force and cause capping. Tablets are compressed on an eight-station rotary tablet press with 10 mm round concave tooling at a compression force of 12–18 kN, target hardness 50–80 N, friability ≤ 1.0% per USP <1216>, disintegration time ≤ 15 min in 0.1 N hydrochloric acid at 37 °C per USP <701>, and content uniformity per USP <905>. If direct compression fails, a pre-compression wet granulation step is introduced using a 5.0–8.0% w/w polyvinylpyrrolidone aqueous binder in a high-shear granulator; a subsequent film-coating step uses a 12% w/w aqueous coating suspension and pan air temperature 50–55 °C to achieve a weight gain of 2.0–3.0%. The final tablet presentations are 100 mg, 250 mg, and 500 mg strengths in PVC-aluminium blister packs, intended for oral administration in cats and dogs under veterinary prescription.
Before formulating oral liquid solutions for neonatal calves and piglets, the Yinqiao Dougen Powder is screened through an 80-mesh sieve to remove fibrous agglomerates, then hydrated in purified water for 30 min at 40–45 °C with continuous high-shear mixing at 1500–2000 rpm. The formulated liquid contains 2.0–5.0% w/v of the API, 10–15% v/v propylene glycol as a wetting co-solvent, 0.10–0.20% w/v sodium benzoate, 0.05–0.10% w/v potassium sorbate, and citric acid to adjust pH to 4.0–5.0. The pH target is critical because precipitation of polyphenolic fractions occurs above pH 6.5 when mineral water with high carbonate hardness is used without prior deionisation. After mixing, the liquid is passed through a 5 µm polypropylene depth filter and filled into 100 mL, 250 mL, 500 mL, and 1 L HDPE bottles with induction-sealed liners. If the API particle size is not reduced below 75 µm, settlement occurs in less than 24 h at 25 °C, which requires a label instruction to shake before use and limits compatibility with automated drench guns. Compliance is maintained through Ph. Eur. 5.1.4 for microbiological quality of non-sterile products, USP <51> Antimicrobial Effectiveness Testing, and the stability stress testing described in VICH GL3. Terminal product types are oral liquid solutions in 100 mL, 250 mL, 500 mL, and 1 L HDPE bottles with dosing pumps or drench-gun adaptors.
Water-soluble powders formulated from Yinqiao Dougen Powder for Venturi proportioner systems require a different particle design than fluid-bed granules. The powder is generally blended at 15–25% w/w API with 60–70% w/w dextrose monohydrate, 5–10% w/w citric acid, 2–4% w/w silica, and 1–2% w/w sodium lauryl sulfate as a wetting agent. The dispersion should form a clear-to-opalescent solution within 3 min in water at 10–20 °C; therefore the API is micronised to a D90 of ≤ 75 µm using a fluidised-bed opposed jet mill with classifier speed 4000–5000 rpm. Production blending is performed in a 200 L biconical mixer at 45% relative humidity and 60 rpm for 15 min; the finished powder is required to have moisture content ≤ 3.0%, tapped density 0.55–0.75 g/mL, and angle of repose ≤ 35° to avoid arching in the proportioner intake. Compliance references Regulation (EU) 2019/6, GMP for veterinary medicinal products, and Ph. Eur. 2.9.36 for powder flow. Terminal products are single-dose foil sachets of 100 g, 500 g, and 1 kg, plus 5 kg bulk bottles with measuring scoops for flock-level proportional dosing.
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Yinqiao Dougen Powder Veterinary Grade API is supplied as a non-sterile bulk active pharmaceutical ingredient under product code YQDG-API-2401. The material is a spray-dried or low-temperature vacuum-dried botanical powder intended as a shared raw material for tablets, injections, capsules, powders, granules, premix, and solutions. It is not a finished dose form, not depyrogenated, and not represented as sterile. The release specification is anchored to a multi-marker chromatographic fingerprint rather than a single assay; representative acceptance values include ≥5.0 mg/g chlorogenic acid and ≥2.0 mg/g phillyrin on a dried basis. Loss on drying is ≤5.0% by USP <731>, acid-insoluble ash is ≤2.0% by USP <561>, total aerobic microbial count is ≤10³ CFU/g by USP <2021>, and combined yeasts/molds are ≤10² CFU/g. Elemental impurities are controlled to ≤5.0 mg/kg lead, ≤2.0 mg/kg arsenic, ≤0.3 mg/kg cadmium, and ≤0.1 mg/kg mercury using USP <233> ICP-MS.
Model sub-designations are used by some manufacturers: YQDG-API-2401-M for micronized tablet and capsule work, and YQDG-API-2401-G for granulation and premix feed. These sub-designations are not pharmacopoeial identities; they describe particle-size reduction status and should be verified against the batch certificate of analysis.
Behavior diverges at the point of particle-size control. For direct compression tablets, the powder is often co-milled to a D90 of ≤150 µm and equilibrated to 2.5–4.0% moisture. On rotary tablet presses operating at 30–60 kN compression force, blends with a compressibility index of 22–30% show acceptable weight variation; values above 30% produce sticking and capping on formulations without adequate glidant. For capsule filling, the same base API is specified at D90 ≤180 µm because tamping-pin stations are sensitive to particles above 250 µm. The difference is process-driven: over-milling may reduce flow and increase electrostatic charging, while under-milling may cause segregation in the hopper.
Premix and powder applications prioritize homogeneity at low inclusion. A 5 kg API batch added to a 1,000 kg carrier requires carrier particle-size matching within ±20% of the API median diameter to limit percolation. On a 100 L V-blender, experimental runs typically reach relative standard deviation ≤5.0% after 15 min at 25 rpm when the API is pre-blended with 1:10 to 1:20 dilution. Without pre-blending, the same mixture may require 30–45 min and still show >10% RSD in later grab samples. Published data for this specific configuration is limited, but the general principle is documented in feed homogeneity guidance.
The following release limits are representative for the multi-dosage-form grade. They are not batch-specific certificates of analysis.
| Parameter | Limit | Test method |
|---|---|---|
| Loss on drying | ≤5.0% | USP <731> |
| Acid-insoluble ash | ≤2.0% | USP <561> |
| Lead | ≤5.0 mg/kg | USP <233> ICP-MS |
| Arsenic | ≤2.0 mg/kg | USP <233> ICP-MS |
| Cadmium | ≤0.3 mg/kg | USP <233> ICP-MS |
| Mercury | ≤0.1 mg/kg | USP <233> ICP-MS |
| Total aerobic microbial count | ≤10³ CFU/g | USP <2021> |
| Total combined yeasts/molds | ≤10² CFU/g | USP <2021> |
| Escherichia coli | Absent per 10 g | USP <2022> |
| Salmonella | Absent per 10 g | USP <2022> |
| Particle size D90 | ≤180 µm | ISO 13320:2020 |
| Bulk density | 0.38–0.52 g/mL | USP <616> |
| Tapped density | 0.52–0.75 g/mL | USP <616> |
For liquid dosage forms, additional specification points are applied downstream because the raw API is non-sterile. The table below summarizes controls that are typically required by formulation department protocols, not release limits of the bulk powder alone.
| Dosage form | Critical control parameter | Typical limit or setpoint | Method/equipment |
|---|---|---|---|
| Tablet | Compressibility index | 22–30% | USP <616> |
| Tablet | Moisture before compression | 2.5–4.0% | USP <731> |
| Capsule | Hausner ratio | 1.20–1.35 | USP <616> |
| Capsule | Particle size D90 | ≤180 µm | ISO 13320:2020 |
| Injectable solution | Bacterial endotoxins | <0.25 EU/mg | USP <85> |
| Injectable solution | Subvisible particulate matter | Pass after 0.22 µm filtration | USP <788> |
| Premix | Mix uniformity RSD | ≤5.0% | V-blender 25 rpm/15 min |
| Granules | Granule moisture | 2.5–3.5% | USP <731> |
| Oral solution | pH after reconstitution | 5.0–7.0 | pH meter |
Dry-powder handling behavior is governed by laser diffraction and tap-density measurements. The specification for D50 is maintained between 55 µm and 85 µm under ISO 13320:2020; the D10 is not less than 15 µm and the D90 is not more than 180 µm. Bulk density by USP <616> is typically 0.38–0.52 g/mL. Tapped density is typically 0.52–0.75 g/mL. The compressibility index calculated from these values determines whether additional glidant is necessary. At bulk moisture above 5.0%, powder cohesiveness increases and screen blinding occurs on 80-mesh and 100-mesh sieves; at below 2.5%, electrostatic repulsion reduces flow and increases dust. Conditioning at 40–50% relative humidity for 24 h before processing is therefore required when packaging line relative humidity is above 60%.
Milling history is a critical source of batch-to-batch variance. Air-jet milling reduces primary particle size but may create amorphous domains on the surface of botanical particles, raising hygroscopicity and changing dissolution behavior. A hammer mill with a 0.5 mm screen produces a broader distribution, whereas a pin mill at 6,000–8,000 rpm gives a narrower distribution at the cost of higher frictional heat. The resulting variation in tapped density can exceed 0.05 g/mL between milling campaigns, which is sufficient to alter capsule fill weight on high-speed dosing machines. Therefore, release testing should not rely on a single lot; process capability analysis for D90 and tapped density across 10–20 sequential batches is recommended before locking tablet tooling and capsule size.
The material is not supplied sterile, and injection applications require a dedicated downstream sequence. Endotoxin load must be verified before sterile filtration because a 0.22 µm polyethersulfone membrane does not remove endotoxins. A limit of <0.25 EU/mg or lower is usually imposed for parenteral formulations depending on target species and dose volume. The powder is reconstituted in water for injection, pH adjusted to 5.0–7.0, and protected from light during holding; degradation of marker compounds follows an oxidative pathway that accelerates above 40°C. Published data for this specific configuration is limited, so forced-degradation studies should establish marker-specific rate constants before registration. The final solution must meet USP <788> for subvisible particulate matter and USP <85> for endotoxin.
On stainless-steel mixing vessels with bottom-entering homogenizers operating at 3,000 rpm, the dispersed material forms a fine suspension. For true solutions, additional purification including ethanol precipitation, membrane clarification, and lyophilization may be required; the unprocessed powder contains alcohol-insoluble and water-insoluble plant matrix components that challenge clarity. Filters are selected for low polyphenol binding because phenolic acids and flavonoids can adsorb to nylon membranes and reduce filter throughput. The pH must be maintained below 8.0 during alkaline hydrolysis or buffer addition; higher pH conditions precipitate polyphenolic acids and produce filter-blocking aggregates. Terminal sterilization by autoclaving at 121°C for 15 min should be evaluated for marker loss, because multi-component botanical extracts can undergo Maillard-type reactions and color change under moist heat.
Premix uniformity depends on API particle size relative to the carrier and on the order of mixing. The API is pre-blended with a small portion of dried carrier or colloidal silicon dioxide before addition to the main mixer. In a single-step addition to a twin-shaft paddle mixer, field data show that active ingredient recovery can deviate by ±15% in the first 10 min; after 20 min the relative standard deviation drops below 5.0% when the total batch fill is 60–70% of mixer volume. Overloading above 70% fill reduces particle mobility and increases dead zones near the discharge gate. Granulated feed prepared on a fluidized-bed granulator at inlet air temperature 50–60°C and spray rate 15–25 g/min/kg yielded uniform distribution when the extract is dissolved in a 5% polyvinylpyrrolidone binder solution.
In low-inclusion premix, the major failure mode is not chemical degradation but segregation during transfer. If the premix is discharged into buckets or hoppers with a drop height above 1.5 m, fine API-enriched particles can separate from larger carrier particles. Pneumatic conveying with high air velocity above 25 m/s also leads to electrostatic adhesion to metal ducts. The use of grounded stainless-steel lines and low-velocity dense-phase conveying is therefore indicated. Sampling after transfer should follow ISO 6497:2002 or equivalent feed sampling practice, with 10 grab samples taken from different locations; acceptance is only meaningful when the analytical method shows a repeatability relative standard deviation below 3.0%, otherwise sampling error dominates the apparent homogeneity result.
The main separation is release-testing burden. Single-route powders are commonly released on appearance and sieve residue alone. The present grade is released with chromatography, elemental impurity, microbial, and powder-flow testing. Multi-component fingerprinting uses at least two marker peaks, which reduces the risk of substitution. The difference from synthetic single-entity APIs is equally material: the botanical matrix contains polysaccharides, tannins, and polyphenols that actively interact with gelatin capsules, magnesium stearate, and nylon filters; therefore, excipient compatibility studies are mandatory. The product should not be combined with strong alkali or high-concentration ammonium salts because such conditions precipitate polyphenolic acids and produce filter-blocking aggregates. Compared to single-marker standardized extracts, the dual-marker release specification lowers the probability that a batch enriched for a single chemical will pass acceptance.
Compared to crude Yinqiao Dougen powders intended only for direct feed, the veterinary grade described here has controlled residual moisture, microbial burden, heavy metals, and particle-size distribution. It may be used in wet granulation for tablets, dry-filled capsules, oral powders, and granular premix. The limits may not be sufficient for injectable products; the purchasing specification must state whether the powder will enter a parenteral process so that bacterial endotoxin testing, particulate matter, and appropriate packaging are added to the supply contract. The only difference that should be assumed without testing is that the raw material is non-sterile and requires downstream process validation before any claim of sterility or pyrogen control is made.
