| HS Code | 388434 |
| Product Name | Qinglian Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Product Type | Veterinary botanical active pharmaceutical ingredient |
| Active Principle | Standardized Qinglian herbal dry extract |
| Physical Form | Fine homogeneous dry powder |
| Color | Light yellow to yellowish brown |
| Odor | Characteristic herbal odor |
| Solubility | Dispersible in water with mild turbidity; soluble in selected organic solvents |
| Particle Size | 95% through 80 mesh |
| Assay Content | Complies with declared marker compound specification |
| Salmonella | Negative per 10 g |
| Escherichia Coli | Negative per 10 g |
| Intended Use | For use as an active pharmaceutical ingredient in veterinary dosage forms |
| Compatible Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Target Species | Poultry, swine, cattle, sheep, and other livestock |
| Storage Conditions | Store in a cool, dry, well-ventilated place away from direct light |
| Shelf Life | 24 months from date of manufacture |
| Packaging | Sealed double polyethylene bags inside fiber drums |
| Regulatory Status | Veterinary grade API for further processing only |
As an accredited Qinglian 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 | Packaged in sealed, moisture-proof aluminium foil bags with inner polyethylene liner. Quantity: 25 kg per drum. |
| Container Loading (20′ FCL) | 20' FCL container loading of Qinglian Powder Veterinary Grade API, ensuring secure, dry, ventilated stowage for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Ship as a veterinary API under controlled room temperature, protected from moisture and direct light. Use sealed, leak-proof containers with proper hazardous material labeling if required. Include MSDS, certificate of analysis, and product specification sheets. Comply with local and international regulations for pharmaceutical ingredients. |
| Storage | Store Qinglian Powder Veterinary Grade API in tightly sealed, original containers in a cool, dry, well-ventilated area. Protect from light, moisture, and direct sunlight. Keep away from incompatible substances and food. Maintain room temperature; avoid freezing or excessive heat. Ensure containers are properly labeled and access is restricted to authorized personnel. |
| Shelf Life | Shelf life: 24 months when properly stored in original sealed containers, away from moisture, heat, and direct sunlight. |
Direct compression of Qinglian Powder Veterinary Grade API into tablets is permitted only after the incoming powder has been characterized under Ph. Eur. 2.9.36 and USP <1174>. When the measured angle of repose remains below 35°, the Hausner ratio is below 1.25, and the loss on drying is below 3.0% w/w, a direct-compression line using a rotary press equipped with 16 stations and B-tooling can maintain weight variation below 2.0% RSD at press speeds of 30–60 rpm. If the API batch exceeds any of these thresholds, the process is shifted to wet granulation. The dry-blend formulation boundary is controlled with the API at 5% w/w to 40% w/w, microcrystalline cellulose at 30–70% w/w, crospovidone at 2–5% w/w, and magnesium stearate at 0.25–1.0% w/w; the lubricant is added during the final 3–5 min of blending to avoid hydrophobic film formation on the API surface, which otherwise reduces tablet tensile strength. Granulated masses are dried in a fluid-bed dryer to residual moisture of 1.5–2.5% w/w before compression. Tablet hardness is maintained at 6–12 kp, friability is kept below 1.0% per Ph. Eur. 2.9.7, and disintegration is targeted below 15 min in 900 mL water at 37 ± 2 °C per USP <701>. Aqueous film coating with hydroxypropyl methylcellulose at 3–4% w/w cosmetic weight gain is applied only when core friability is below 0.5%. Production-scale data indicate that feed frame speed mismatch becomes the dominant cause of weight segregation when press speed exceeds 60 rpm, independent of blend flow. Terminal product forms include 250 mg, 500 mg, and 1 g film-coated tablets for swine and cattle.
Qinglian Powder Veterinary Grade API intended for parenteral administration is processed under EU GMP Annex 1 and 21 CFR 210/211. The formulation is prepared as a solution only after the thermal degradation profile of the API is established; if degradation products remain within accepted thresholds after 121 °C for 15 min, terminal sterilization by saturated steam in a porous-load autoclave with three validation loads is the default route. If the API is heat-labile, aseptic manufacture in an ISO 5 unidirectional airflow zone becomes mandatory, and the batch is sterilized through a 0.22 µm membrane filter before filling. The solution is compounded in water for injection with pH adjusted using citrate or phosphate buffers to 5.0–7.5; tonicity is controlled with sodium chloride to 280–320 mOsm/kg per USP <785>. Fill volume is set at 101–103% of label claim. Release testing includes sterility per USP <71>, bacterial endotoxins per USP <85> at not more than 0.5 EU/mg when the species-specific monograph requires an endotoxin limit, and particulate matter per USP <788> with not more than 6,000 particles at ≥10 µm and 600 particles at ≥25 µm per container. A recurring production failure in injectable lines is filter occlusion at low pH due to polyphenolic or high-molecular-weight components; a 0.45 µm pre-filter is inserted before the 0.22 µm membrane when the API aqueous solubility is below 20 mg/mL. Terminal product forms include 50 mL, 100 mL, and 250 mL multi-dose vials for cattle and swine.
| Test attribute | Reference method | Release limit |
|---|---|---|
| Sterility | USP <71> / Ph. Eur. 2.6.1 | No growth after 14 days |
| Bacterial endotoxins | USP <85> / Ph. Eur. 2.6.14 | ≤ 0.5 EU/mg |
| Particulate matter ≥ 10 µm | USP <788> / Ph. Eur. 2.9.19 | ≤ 6,000 particles per container |
| Particulate matter ≥ 25 µm | USP <788> / Ph. Eur. 2.9.19 | ≤ 600 particles per container |
| pH | Ph. Eur. 2.2.3 | 5.0–7.5 |
| Osmolality | USP <785> / Ph. Eur. 2.2.35 | 280–320 mOsm/kg |
For hard gelatin capsule filling, Qinglian Powder Veterinary Grade API is dry-blended without heat input because moisture transfer into the capsule shell must be kept below 13% at 25 °C to prevent shell deformation. The powder blend is passed through a 0.8 mm square-mesh screen and mixed in a low-shear V-blender at 60–70% fill volume for 15–20 min; colloidal silicon dioxide is added at 0.5–1.5% w/w to control static charge, and sodium stearyl fumarate is used at 0.5–2.0% w/w instead of magnesium stearate when capsule shells are manufactured from hydroxypropyl methylcellulose and require reduced hydrophobic lubrication. Encapsulation is performed on a dosator-type capsule filling machine with size #1 to #3 capsules; individual fill weight variation must remain below ±5% RSD and mean fill weight variation below ±2% per USP <905>. Disintegration testing follows Ph. Eur. 2.9.1 with a 30 min limit in water at 37 ± 2 °C. When the API is hygroscopic, the blending room is maintained at 40 ± 5% RH and 20 ± 2 °C, and filled capsules are immediately transferred to aluminum/PVC blister packs containing silica gel sachets. A documented production bottleneck on continuous encapsulation lines is the build-up of compacted powder on dosator pins after 2–3 h of operation; this is controlled by chilled pin temperatures at 18–20 °C and periodic pin wiping. Terminal product forms include 100 mg, 250 mg, and 500 mg capsules for companion animals and calves.
In drinking-water-soluble powder manufacturing, Qinglian Powder Veterinary Grade API must dissolve or disperse uniformly in farm water tanks, header tanks, and nipple drinkers without sedimentation or inactivation. The powder is produced by blending the API with anhydrous glucose or lactose monohydrate as carrier; typical API concentration in the finished powder is 10–50% w/w when the field dose is 1–5 g per 100 L of drinking water. The carrier is selected only after a solubility screen in water at 5 °C, 20 °C, and 35 °C; lactose monohydrate is excluded when the API shows Maillard-type degradation in reducing sugar matrices. A dispersible powder blend requires dissolution of at least 95% within 15 min in 1 L of water at 20 °C using a 60 rpm paddle. The blend is packaged in heat-sealed laminated foil pouches at 100 g, 500 g, and 1 kg; residual moisture after packaging must remain below 3.0% w/w. Batch release includes powder flow per Ph. Eur. 2.9.36, loss on drying per Ph. Eur. 2.2.32, and microbial limits per Ph. Eur. 5.1.4. A field failure commonly observed on swine farms is the accumulation of undissolved API in drinking-water cups when hard water bicarbonate levels exceed 300 mg/L; this is addressed by incorporating 1–2% w/w of a non-foaming polyoxyethylene-based wetting agent and rejecting distribution lines with dead legs. Terminal product forms include medicated drinking-water sachets for poultry and swine.
Feed premix granulation of Qinglian Powder Veterinary Grade API avoids direct addition of the fine powder to the mixer because particle size mismatch against cereal carriers creates segregation after medicated feed is transported. The API is first granulated onto a carrier of ground rice hulls or corn cob granules using a rotary drum granulator with a liquid binder of food-grade sodium carboxymethyl cellulose at 3–5% w/w solids. The granulated intermediate is dried in a fluid-bed dryer at inlet air temperature of 50–60 °C until moisture content is below 8% w/w, then sized through a 1.0 mm screen. Final premix concentration is adjusted to 1–5% w/w API, so that a 0.5–1.0 kg premix addition per tonne of complete feed yields an API concentration in the 10–100 mg/kg range depending on the species claim. Mixing validation is performed in a horizontal ribbon mixer at 35–45 rpm for 10–15 min; acceptance is based on 10 samples drawn from different points, with API assay RSD below 5.0% and recovery of 90–110% of label claim. Methodologies follow ISO 22000:2018 hazard control, EU Regulation 183/2005 for feed hygiene, and 21 CFR 225 for medicated feed pilot facilities in export markets. Dusting is measured by a Heubach dustmeter; values above 0.5 g/m³ trigger additional paraffin oil coating at 0.5–1.5% w/w. Terminal product forms include 1 kg, 5 kg, and 25 kg feed premix bags for poultry, swine, and rabbit producers.
| Sampling point count | Mixer type | Mixing time | Assay RSD limit | Recovery limit |
|---|---|---|---|---|
| 10 | Horizontal ribbon mixer | 10–15 min | ≤ 5.0% | 90–110% |
| 12 | Twin-shaft paddle mixer | 6–10 min | ≤ 4.0% | 92–108% |
| 15 | Vertical screw mixer | 15–20 min | ≤ 6.0% | 90–110% |
When aqueous solubility is low but a non-sterile liquid dose is acceptable, Qinglian Powder Veterinary Grade API is converted into an oral drench or suspension for calves, sheep, and goats. The vehicle is prepared without ethanol to avoid precipitation and to meet residue-safety expectations in food-producing animals. The API is dispersed in a gum-based suspending vehicle, typically xanthan gum at 0.15–0.35% w/w, with sodium citrate or citric acid to maintain pH at 4.5–6.0; the target viscosity is 300–800 mPa·s at 20 °C measured at 50 s⁻¹ on a rotational viscometer. The manufacturing sequence is critical: the suspending agent is hydrated for 30–60 min under high-shear mixing at 1,500–2,000 rpm, then the API is added through a sieve and mixed at low shear for 45 min. Foam is controlled with 0.02–0.05% w/w simethicone. The finished liquid is filled into 100 mL, 1 L, and 5 L high-density polyethylene containers with induction seals. Storage stability is assessed under 25 °C/60% RH, 30 °C/65% RH, and 40 °C/75% RH conditions per ICH Q1A(R2) bracketed conditions; re-suspendability is acceptable if the sediment ratio after 24 h is above 0.9 and redispersion is achieved within 15 inversions. Published data for the oral suspension stability of this specific API is limited; shelf-life intervals must be verified with three pilot batches. Terminal product forms include drench suspensions for cattle and sheep, with dosing caps calibrated to 5 mL, 10 mL, and 20 mL.
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Qinglian Powder Veterinary Grade API is released as a controlled botanical powder for further pharmaceutical processing into tablets, injections, capsules, powders, granules, premix, and solutions. The material is supplied under the manufacturer-specific model designation QLP-VET-API-2405 for oral solid and drinking-water products and QLP-VET-API-2405-PAR for parenteral extraction routes. It is not a final dosage form and must not be administered directly. Release control combines pharmacopoeial general chapters for herbal drugs with additional low-bioburden and elemental impurity criteria required for veterinary drug product manufacturing. Material of this grade is packed in double low-density polyethylene liners inside aluminium composite bags and should be stored at ≤25°C and ≤60% RH; after first opening, revalidation of moisture content is required if use extends beyond 30 days.
Representative release specifications include particle size D90 ≤0.180 mm for oral-grade material and ≤0.150 mm for parenteral extraction grade by laser diffraction; loss on drying ≤5.0% using USP <731>; total ash ≤10.0%; lead ≤5.0 mg/kg, cadmium ≤1.0 mg/kg, mercury ≤0.1 mg/kg, and arsenic ≤2.0 mg/kg by Ph. Eur. 2.4.27. Aerobic plate count is controlled to ≤10³ CFU/g and combined yeast/mould count to ≤10² CFU/g; Escherichia coli and Salmonella are absent under USP <62>. The parenteral-grade model adds bacterial endotoxin control at ≤0.50 EU/mg using Ph. Eur. 2.6.14. Ethanol, when present from extraction or granulation, is controlled as a Class 3 residual solvent to ≤5,000 ppm according to ICH Q3C.
The main difference from feed-additive-grade Qinglian powders is the shift from trade-quality botanical identity to pharmaceutical control. Feed-grade material may be released with total aerobic plate count up to 10⁶ CFU/g, no bacterial endotoxin specification, and limited heavy-metal documentation. In the veterinary API, batch-to-batch variance is monitored by HPLC fingerprint similarity against a reference chromatogram; relative retention time tolerance is ±2%, and specified peak area ratios are controlled within ±10% across three consecutive batches. Published data for specific marker content for this product is limited; content release ranges should therefore be fixed from the manufacturer’s validated HPLC method and finished-product stability batches rather than from unverified pharmacopoeial monographs.
| Parameter | QLP-VET-API-2405 oral | QLP-VET-API-2405-PAR | Feed-grade reference |
|---|---|---|---|
| Particle size D90 | ≤0.180 mm | ≤0.150 mm | Not controlled or screen-size only |
| Loss on drying | ≤5.0% | ≤5.0% | ≤10.0% typical |
| Aerobic plate count | ≤10³ CFU/g | ≤10² CFU/g | ≤10⁶ CFU/g typical |
| Bacterial endotoxin | Not specified | ≤0.50 EU/mg | Not tested |
| Lead | ≤5.0 mg/kg | ≤5.0 mg/kg | Varies; often unverified |
| Cadmium | ≤1.0 mg/kg | ≤1.0 mg/kg | Not routinely tested |
| Mercury | ≤0.1 mg/kg | ≤0.1 mg/kg | Not routinely tested |
| Arsenic | ≤2.0 mg/kg | ≤2.0 mg/kg | Not routinely tested |
In multi-product veterinary API facilities, cleaning between batches of QLP-VET-API-2405 and other botanical powders is validated by swab and rinse sampling. Swab limits for the marker compound are set at ≤10 mg/m², and rinse water limits at ≤1 ppm unless toxicological evaluation supports higher values. Dedicated sieving meshes and scooping tools are assigned to prevent cross-contamination because the powder is highly electrostatic below 30% RH. Manufacturing areas for oral-grade handling are maintained at 18–25°C and 45–55% RH; if the dew point exceeds 12°C, the powder may agglomerate during vibration milling or screening.
Water used for granulation, extraction, and final rinsing is Purified Water or Water for Injections, depending on route. For oral granules, Purified Water with conductivity ≤1.3 µS/cm at 25°C is used; for injections, Water for Injections is required with ≤0.25 EU/mL endotoxin and conductivity ≤1.3 µS/cm at 25°C. The botanical matrix can support biofilm growth in transfer lines if lines are not drained and sanitised after each campaign; routine cleaning includes 1% sodium hydroxide solution at 60–70°C and rinsing to pH neutral.
The parenteral route imposes three simultaneous constraints that are not relevant to feed-grade material: particulate load, bacterial endotoxin, and the chemical purity of the water-soluble extract. Qinglian Powder Veterinary Grade API is not injectable as raw powder. For injectable finished products, the powder is extracted in Water for Injections at 80–90°C for 60–120 min, cooled, and clarified through a 0.45 µm polypropylene depth filter before sterilising filtration through a 0.22 µm PVDF or PES membrane. Pre-filtration bioburden is maintained at ≤10 CFU/100 mL by membrane filtration under USP <61>. If the filtered extract has dry matter content above 5%, cross-flow filtration or filter aid pre-coat is applied to prevent premature sterile filter occlusion. Terminal steam sterilisation at 121°C for 15 min is selected only when extract stability data show marker degradation below the assigned limit; otherwise aseptic filtration and filling in an ISO 14644-1 ISO 7 background with ISO 5 unidirectional airflow are used. Endotoxin control is performed on the extract by Ph. Eur. 2.6.14; the maximal acceptable endotoxin load in the finished injection is determined by route, dose, and animal species, not by the raw API value alone. pH is adjusted to 6.0–7.5 to prevent precipitation of weakly ionised plant constituents. Divalent cations should be limited in the formulation because they can compress the electrokinetic potential of colloidal plant particles and increase aggregation; zeta potential is maintained below -30 mV for dispersion stability when a nanoparticulate or coarse suspension is intended.
Container closure integrity for aseptically filled vials is verified by dye ingress or vacuum decay per USP <1207>. Particulate matter in injectable solutions is controlled by the method of USP <788>. The QLP-VET-API-2405-PAR model is therefore differentiated from the oral model solely by a lower bioburden, endotoxin control, and a finer particle size to improve extraction efficiency. It does not confer sterility; sterility assurance belongs to the terminal sterilisation or aseptic process.
For tablets and capsules, QLP-VET-API-2405 is not used as a direct compacting material unless flow and compressibility data confirm viability. The powder is mixed in a diffusion mixer or high-shear blender; microcrystalline cellulose at 1–3% and pregelatinised starch at 2–5% are used as dry binders, with magnesium stearate at 0.5–1.0% added last. Direct compression is permitted when angle of repose is ≤35° and Carr index is ≤20. When these limits are exceeded, granulation is conducted in a high-shear granulator with impeller speed 300–800 rpm and chopper speed 1,500–3,000 rpm; aqueous PVP K30 solution is added to a final moisture content of 8–12%, and drying in a fluid-bed granulator at inlet air temperature 55–65°C continues until loss on drying is ≤3.0%. For capsules filled on a tamping pin machine, fill weight is maintained within ±5% of target and segregation potential is assessed by sampling stratified positions of the hopper. If relative humidity during sieving exceeds 60% RH, the powder is pre-dried or processed in dehumidified air to prevent mesh blinding and flow collapse.
Granules, oral powders, and drinking-water solutions are manufactured from the oral-grade API by wet massing or spray granulation. A coefficient of variation ≤5.0% for API content is required from 10 stratified sampling points before the blend is discharged. Because the native botanical matrix contains poorly water-wettable plant material, drinking-water dispersions require polysorbate 80 at 0.1–0.5% and pH adjustment to 6.0–7.5. Dissolution performance of the finished powder is assessed using Ph. Eur. 2.9.3 apparatus II at 50 rpm, with water or buffered media appropriate to the target species. For pig or poultry drinking-water systems, the dispersion is pre-screened through a 0.150 mm screen and recirculated at 15–20 L/min to prevent nipple drinker blockage. Solutions for in-feed water medication are not true solutions of the entire powdered matrix; they are colloidal dispersions and should be labelled accordingly.
Premix production requires geometric dilution with a suitable carrier such as lactose monohydrate or ground corn cob. A twin-ribbon blender with intermeshing paddles is typically operated at 10–15 rpm for 10 min; if stratified sampling shows relative standard deviation of API content above 5.0%, the batch is returned for an additional 5 min mixing cycle after addition of 1.0% colloidal silicon dioxide. Carry-over between medicated and non-medicated feed batches is verified by rinse and swab sampling, with acceptance limits derived from the carry-over study. The premix route is the major difference from direct oral powder use: the premix API is controlled for bulk density and particle size to limit segregation during silo handling. Published data for this specific Qinglian Powder premix configuration is limited; therefore, process capability should be demonstrated on the target mixer geometry before registration.
Compared with standardised dry extract, QLP-VET-API-2405 retains the native botanical matrix and therefore requires larger capsule fill volume or tablet die dimensions for a given dose. Compared with fluid extract or tincture intermediates, the powder form reduces ethanol residue and improves handling in dry granulation. However, the powder is not a fully water-soluble extract; therefore, solutions for drinking-water medication are colloidal dispersions and must be labelled as such to avoid misuse in small-bore automatic medication lines.
Operational boundaries include the following: do not dry the powder at temperatures above 60°C for longer than 8 h if reducing sugars are present; avoid combination with strong oxidising agents and concentrated acids during cleaning; avoid blending with amine-bearing excipients in moist granulation because they may generate dark Maillard products and shift the HPLC fingerprint. The powder is incompatible with prolonged wet granulation in high-alkalinity media above pH 8.5, which can hydrolyse ester-linked plant constituents.
| Test | Method or standard | Release criterion |
|---|---|---|
| Identification | HPLC fingerprint, manufacturer’s validated method | Matches reference chromatogram within ±2% retention time |
| Particle size D90 | Laser diffraction, USP <786> | ≤0.180 mm oral; ≤0.150 mm parenteral |
| Loss on drying | USP <731> | ≤5.0% |
| Total ash | Ph. Eur. 2.4.16 | ≤10.0% |
| Heavy metals | Ph. Eur. 2.4.27 / ICH Q3D | Pb ≤5.0 mg/kg; Cd ≤1.0 mg/kg; Hg ≤0.1 mg/kg; As ≤2.0 mg/kg |
| Microbial limits | USP <61>, USP <62> | TAMC ≤10³ CFU/g; TYMC ≤10² CFU/g; E. coli and Salmonella absent |
| Bacterial endotoxin | Ph. Eur. 2.6.14 | ≤0.50 EU/mg for parenteral-grade model |
| Residual solvent | ICH Q3C | Ethanol ≤5,000 ppm if used |
