| HS Code | 181588 |
| Product Name | Jinqiancao Powder Veterinary Grade API |
| Active Ingredient | Jinqiancao (Herba Lysimachiae / Desmodium styracifolium) extract |
| Product Type | Veterinary Active Pharmaceutical Ingredient (API) powder |
| Physical Form | Fine dry powder |
| Color | Brown to yellowish-brown powder |
| Solubility | Partially soluble in water; suitable for formulation after wetting or dispersion |
| Particle Size | Typically 80-120 mesh |
| Purity Assay | Standardized content of active marker compounds per veterinary pharmacopoeia |
| Compatible Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Indications | Promotes diuresis, relieves stranguria, supports urinary health, and helps manage urolithiasis in animals |
| Storage Conditions | Store in tight containers, protected from light, moisture, and heat |
| Shelf Life | 24 months when properly stored |
| Packaging | Sealed multi-layer bags or drums with inner lining |
| Regulatory Status | Veterinary grade API for non-breeding animal pharmaceutical formulations |
As an accredited Jinqiancao 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 25 kg fiber drums with double polyethylene liners, labeled for veterinary pharmaceutical manufacturing use. |
| Container Loading (20′ FCL) | 20′ FCL loading of Jinqiancao Powder veterinary API: packed in sealed drums, palletized, secured, container kept dry and ventilated. |
| Shipping | Shipping is arranged in sealed, moisture-proof packaging suitable for veterinary API powders. Shipments are dispatched via air or sea freight in compliance with international regulations. Products are protected against contamination and damage during transit, with temperature-controlled options available to maintain stability and potency throughout delivery. |
| Storage | Store Jinqiancao Powder Veterinary Grade API in a cool, dry, well-ventilated area at controlled room temperature, away from direct sunlight, moisture, and heat sources. Keep the container tightly sealed to prevent absorption of humidity and contamination. Protect from pests and incompatible substances. Use clean equipment; avoid cross-contamination. Follow manufacturer guidelines for shelf life and disposal. |
| Shelf Life | Shelf life is typically 36 months when stored in a cool, dry, well-ventilated area, protected from moisture and direct sunlight. |
In companion animal urolithiasis adjunct tablet manufacture, Jinqiancao Powder Veterinary Grade API is handled as a hygroscopic botanical API with a D90 of ≤ 150 µm, a moisture specification of ≤ 5.0%, and a total flavonoid content of ≥ 2.0% expressed as quercetin. The powder is not reliably direct-compressible because lamina and stem particles exhibit irregular platelet morphology, which creates die-fill variability when turret speed exceeds 35 rpm on a rotary tablet press. The process therefore requires wet granulation to convert the botanical matrix into a cohesive free-flowing granulate. For a 500 mg uncoated scored core, a documented batch sheet uses 150 mg Jinqiancao Powder Veterinary Grade API (30.0% w/w), 205 mg microcrystalline cellulose PH102, 75 mg lactose monohydrate, 40 mg povidone K30 applied as an 8.0% w/v binder solution, 25 mg crospovidone, and 5 mg magnesium stearate. If a 5:1 extract is substituted, the loading is reduced to 6.0–8.0% w/w to maintain marker equivalence, but compressibility must be revalidated because extract solids display a different yield-pressure curve than raw botanical powder. Compliance for tablet finished goods is anchored to USP <905> for uniformity of dosage units, USP <701> for disintegration, USP <561> for botanical article identity, and microbial limits according to EP 5.1.4 for non-sterile oral products; heavy metals are controlled to ≤ 10 ppm lead, ≤ 1 ppm arsenic, ≤ 0.5 ppm cadmium, and ≤ 0.5 ppm mercury using ISO 17294-2:2016 ICP-MS as the determinative method. Downstream production begins with 80-mesh sieving (180 µm), followed by dry blending in a V-blender at 15 rpm for 20 minutes, wet granulation with PVP K30 solution, fluid-bed drying at 55–60°C inlet air until loss-on-drying is ≤ 3.0%, twin-sieve milling through a 1.0 mm screen, final blending with crospovidone and magnesium stearate for 3 minutes, and compression at 8–15 kN to a hardness range of 6–10 kp. Friability is held to ≤ 1.0%, and disintegration is specified as ≤ 30 minutes in distilled water at 37 ± 2°C. Terminal product types include uncoated scored tablets, flavoured chewable tablets for canine dosing, and enteric-coated tablets where raw botanical fiber must be shielded from gastric mucosa.
For aqueous veterinary injectables derived from Jinqiancao Powder Veterinary Grade API, the powder alone does not meet injectable-grade specifications and must undergo aqueous extraction followed by sequential decontamination. Sterility is validated against USP <71>, bacterial endotoxins against USP <85> at a release limit of ≤ 0.5 EU/mg of extract solids, and particulate matter against USP <788> using both light obscuration and microscopic count protocols. For multi-dose vials, antimicrobial effectiveness testing follows USP <51>; benzyl alcohol at 1.0% v/v is the usual preservative candidate. The injection preparation is formulated as a 10 mL single-dose vial containing a clarified aqueous extract equivalent to 2.0 g crude Jinqiancao per 10 mL, or 0.2 g/mL crude-equivalent. If a 10:1 decontaminated extract is used, extract solids are incorporated at 5.0–8.0% w/v, sodium chloride is added to adjust osmolality to 280–320 mOsm/kg, and pH is adjusted with 0.1 M sodium hydroxide to 5.5–6.5. The terminal sterilization decision creates a process conflict: the flavonoid fraction degrades under autoclave loading, so aseptic filtration through a 0.22 µm PVDF membrane is preferred over terminal steam sterilization at 121°C for 15 minutes. If terminal sterilization is mandatory, antioxidant protection with 0.1% w/v sodium metabisulfite is required, although published data for this specific configuration is limited and must be generated batch-wise. Downstream production uses decoction at 90–100°C in purified water for 60 minutes, triple bag filtration at 25 µm, 5 µm, and 1 µm, activated charcoal treatment at 0.2% w/v for 20 minutes, ultrafiltration through a 10 kDa MWCO membrane, and sterilizing filtration. The operational boundary is incompatibility with divalent cation-containing diluents because soluble pectin fragments precipitate as calcium and magnesium complexes; rinsing with purified water is therefore required before administering other parenteral admixtures. Terminal product types include 10 mL single-dose vials for intramuscular administration and 50 mL multi-dose vials for oral-route off-label use in ruminant practice, though the multi-dose format requires preservative challenge data under USP <51>.
Poultry drinking-water premix systems impose the most restrictive dispersibility constraints on Jinqiancao Powder Veterinary Grade API because residual pectin and cellulose aggregates clog nipple drinkers and proportioner filters at flow rates below 1.0 L/min. The powder is therefore co-milled with dextrose monohydrate or lactose to a final D90 of ≤ 180 µm, and water dispersibility is verified by a 1.0% w/v suspension test with 10-minute stirring and 200-mesh sieve retention of ≤ 0.5%. A representative premix formula contains 200 g Jinqiancao Powder Veterinary Grade API per 1.0 kg premix (20.0% w/w), with 780 g lactose monohydrate and 20 g sodium hexametaphosphate as a hardness stabilizer. The in-use dilution is 1.0–2.0 g premix per litre of drinking water, equivalent to 200–400 mg Jinqiancao Powder Veterinary Grade API per litre. Compliance for poultry premix routes is referenced to EU Regulation 1831/2003 for feed additive authorization where applicable, EU Regulation (EU) 2019/6 for veterinary medicinal premixes, ISO 22000:2018 for feed safety management, and Codex CAC/RCP 54-2004 for good animal feeding practice. When the product is treated as a medicated premix, FDA 21 CFR Part 225 current good manufacturing practice for medicated feeds applies to US distribution. Production uses a ribbon mixer with working capacity of 500–1000 kg, pre-blending of Jinqiancao Powder Veterinary Grade API with 20% of the lactose for 10 minutes, main blending for 15 minutes at 20 rpm, and Alu-PE sachet filling at ≤ 35% RH to prevent hygroscopic caking. Water hardness above 300 mg/L CaCO₃ accelerates pectin flocculation; the sodium hexametaphosphate content is increased to 3.0% w/w of premix in those zones. Terminal product types include water-soluble powder sachets, stock solution bottles with a 24-hour use window, and effervescent granules that generate an oral solution at the farm.
| Dosage form | D90 specification | Moisture limit | Drying condition | Primary failure mode |
|---|---|---|---|---|
| Tablet core | ≤ 180 µm | ≤ 3.0% | 55–60°C fluid-bed | Die-fill variability above 35 rpm |
| Injectable solution | ≤ 25 µm post-ultrafiltration | lyophilized solids control | 56°C sustained only for aqueous buffer | Flavonoid degradation at 121°C |
| Drinking-water premix | ≤ 180 µm | ≤ 5.0% | low-humidity blending | Pectin flocculation at hardness > 300 mg/L CaCO₃ |
| Swine granule | 12–60 mesh | ≤ 5.0% | 50–55°C fluid-bed | Heat degradation above 80°C |
| Equine top-dressing | ≤ 2.0 mm | ≤ 8.0% | cooling to ≤ 30°C | Oxidative browning in molasses carrier |
| Capsule fill | ≤ 1.0 mm granulate | ≤ 4.0% | 50°C tray drying | Fill-weight drift above 60% RH |
When granulation improves swine palatability without exceeding heat degradation thresholds, the critical process variable is the inlet-air temperature in the fluid-bed dryer, not the binder quantity. Jinqiancao Powder Veterinary Grade API shows a total flavonoid loss of 8–12% after 20 minutes at 80°C dry heat, but loss is held below 3% when drying temperature is capped at 50–55°C and product-bed temperature is maintained at 38–42°C. A representative swine oral granule batch uses 300 g Jinqiancao Powder Veterinary Grade API per 1.0 kg granulate (30.0% w/w), 350 g corn starch, 200 g sucrose, 50 g sodium carboxymethyl starch, 30 g povidone K30 applied as a 10.0% w/v ethanolic binder, and 20 g magnesium stearate. If the granulate is subsequently mixed into complete swine feed, final feed inclusion is 5.0–10.0 kg Jinqiancao Powder Veterinary Grade API per metric ton, or 0.5–1.0% w/w. Compliance for swine granules is anchored to the Chinese Veterinary Pharmacopoeia 2020 granule general chapter for uniformity of mass and extractable matter, ISO 6497:2002 for feed sampling, and ISO 22000:2018 for feed safety management; when feed-grade premixes are produced, maximum residue limits for pesticides in the botanical input are verified under EU Regulation (EC) No 396/2005. The production process starts with 60-mesh sieving of Jinqiancao Powder Veterinary Grade API, introduction into a high-shear granulator with starch and sucrose, addition of binder solution over 5 minutes at an impeller speed of 200 rpm, wet massing for 3 minutes, extrusion through a 1.2 mm screen, spheronizing at 400 rpm, and fluid-bed drying at the low-temperature profile described above. Dried granules are sieved to 12–60 mesh; bulk density is maintained at 0.55–0.65 g/mL and angle of repose at ≤ 40° for consistent feed mixing. The operational boundary is thermal: pelleted feeds conditioned at 75–85°C should not contain unprotected Jinqiancao Powder Veterinary Grade API in the pre-extrusion blend; post-extrusion vacuum coating at ≤ 70°C with the granulated API is required to preserve marker flavonoids. Terminal product types include swine oral granules, drench powders, and top-dress feed premixes for post-weaning and grower-finisher rations.
For equine top-dressing powders, the limiting variable is not dissolution but the interaction of Jinqiancao Powder Veterinary Grade API with molasses-based carriers and the risk of batch-to-batch marker inconsistency when raw botanical lots are blended without standardization. A typical carrier base contains 180 g Jinqiancao Powder Veterinary Grade API per 1.0 kg base (18.0% w/w), with 520 g oat flour, 250 g molasses solids, and 50 g calcium carbonate as dusting control. The daily inclusion is 30–60 g of this base per 500 kg bodyweight, delivering 5.4–10.8 g Jinqiancao Powder Veterinary Grade API per animal; the ratio is adjusted against urinary pH so that the dietary cation-anion balance does not fall below −100 mEq/kg DM without veterinary supervision. Compliance is governed by the FEI Prohibited Substances List for sport horses, requiring documentary proof that the botanical batch is free from undeclared caffeine, ephedrine derivatives, and NSAIDs; analytical screening is performed by LC-MS/MS with limits of detection of ≤ 1.0 ng/mL in urine and ≤ 0.5 ng/mL in serum for the relevant prohibited substances. For European market entry, the carrier and premix must meet EU Regulation (EU) 2019/6 labelling requirements for veterinary medicinal in-feed products where a veterinary claim is made. Production uses a horizontal ribbon mixer with molasses heated to 70°C and sprayed at 0.5 L/min onto the dry blend; after cooling to ≤ 30°C, the mixture is screened through a 2.0 mm mesh and moisture is adjusted to ≤ 8.0% to prevent mold growth. The operational boundary is oxidative: the molasses carrier accelerates flavonoid oxidation during storage above 25°C; therefore, sealed bags with oxygen absorber inserts are required when shelf-life exceeds 12 months. Terminal product types include in-feed pellets for mature horses, top-dress powders for performance horses, and low-moisture lick blocks where saliva-activated dosing is preferred.
Capsule filling for companion animal cholagogue adjuncts requires low-moisture powder handling because Jinqiancao Powder Veterinary Grade API exhibits a water-vapour sorption inflection at approximately 60% RH; above this threshold, the powder becomes cohesive and fill-weight variability exceeds ±5.0% on a semi-automatic capsule machine. For a 350 mg size-0 capsule, a representative formula contains 120 mg Jinqiancao Powder Veterinary Grade API (34.3% w/w), 150 mg dicalcium phosphate dihydrate, 70 mg corn starch, 5 mg talc, and 5 mg magnesium stearate. If the powder lot moisture is above 4.0%, tray drying at 50°C for 4 hours is required before slugging or direct filling. Compliance is anchored to USP <905> for uniformity of dosage units, USP <701> for disintegration, USP <561> for botanical article identity, and microbial limits under EP 5.1.4; dissolution testing is performed according to USP <711> Apparatus 2 at 50 rpm with 900 mL of 0.1 M hydrochloric acid. The process step is dry granulation by slugging at 10–15 kN in a hydraulic press, followed by comminution through a 1.0 mm sieve, then capsule filling at ≤ 35% RH and 20–25°C with a dosator machine set at a fill depth of 12 mm. The operational boundary is incompatibility with hygroscopic alkaline excipients such as sodium bicarbonate, which raises local moisture activity and promotes flavonoid oxidative browning; the formulation therefore excludes carbonate-based effervescent couples. Terminal product types include size-0 two-piece gelatin capsules for canine hepatic support, HPMC capsules where porcine-free or cultural requirements apply, and enteric-coated capsules for delayed release in the proximal duodenum, where bile-facilitated dispersion is preferred.
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The veterinary-grade active pharmaceutical ingredient designated Jinqiancao Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a standardized herbal extract preparation derived from the aerial parts of Lysimachia christinae Hance. The product is supplied as a fine, hygroscopic, brownish-yellow to brownish-green powder intended solely for further pharmaceutical processing. Its procurement model commonly encodes particle size, assay basis, and target dosage-form quality; a non-sterile solid-oral grade may be designated JQC-V-80-NS, where 80 mesh refers to controlled sieving for dry blending, NS identifies a non-sterile grade, and water-soluble or injectable process grades carry WS or INJ suffixes. Because model coding is supplier-specific, the product code must be verified against the certificate of analysis before formulation work begins. The powder is not a sterile final-product API; injectable dosage forms require validated sterilization or aseptic processing downstream.
Release criteria are established under the current Chinese Veterinary Pharmacopoeia general chapters. Identification is confirmed by thin-layer chromatography against a reference herb, and high-performance liquid chromatography fingerprinting is used to verify batch identity. The assay marker is generally total flavonoids calculated as quercetin on a dried basis; the exact acceptance range must be fixed in the supplier certificate of analysis because published data for a single commercial product of this designation are limited. Physical release tests include loss on drying not more than 5.0% by CVP 0831 and total ash not more than 5.0% by CVP 2302. Heavy metals are controlled to not more than 10 mg/kg by CVP 0821, and arsenic is controlled to not more than 2 mg/kg by CVP 0822. Non-sterile solid oral and premix grades typically allow total aerobic microbial count not more than 10³ CFU/g, combined yeast and mold count not more than 10² CFU/g, and absence of Escherichia coli and Salmonella when tested by CVP 1105. Injectable grade powder is not sterile and must be processed under aseptic conditions; final injectable solutions should meet the current Chinese Veterinary Pharmacopoeia particulate matter and endotoxin requirements for the finished product.
| Quality attribute | Test method or reference | Representative acceptance limit |
|---|---|---|
| Appearance | Visual examination | Brownish-yellow to brownish-green fine powder |
| Identification | TLC / HPLC fingerprint | Corresponds to reference herb or extract |
| Assay | HPLC total flavonoids as quercetin | Supplier CoA specified |
| Loss on drying | CVP 0831 | ≤5.0% |
| Total ash | CVP 2302 | ≤5.0% |
| Heavy metals | CVP 0821 | ≤10 mg/kg |
| Arsenic | CVP 0822 | ≤2 mg/kg |
| Microbial limits | CVP 1105 | 10³ CFU/g TAMC; 10² CFU/g TYMC; pathogens absent |
| Particle size | Analytical sieving | ≥95% through 80 mesh |
| Tapped density | USP 616 | 0.35–0.65 g/cm³ |
Residual solvent limits are applied when ethanol or methanol is used during extraction. Ethanol is controlled as a Class 3 solvent under ICH Q3C; methanol, if present, is controlled to a supplier-specified limit. Pesticide residue limits follow GB 31650-2019 where applicable to edible-tissue residue safety, although for a plant-derived active pharmaceutical ingredient without an established maximum residue limit in food-producing species, the responsible veterinarian must derive a species-specific withdrawal interval from depletion data rather than assume a zero-day withdrawal.
Dry blending of this powder with excipients requires attention to moisture uptake and segregation. The 80 mesh sieve specification supports batch-to-batch consistency in low-dose tablets and premixes, but the powder alone often exhibits an angle of repose between 35° and 45° and a Carr index above 30, indicating poor flow. In direct compression, colloidal silicon dioxide at 0.5–1.0 wt% and magnesium stearate at 0.25–0.75 wt% are introduced by geometric dilution. Over-lubrication must be avoided because stearyl films can reduce tablet hardness and increase disintegration time. Tablets are typically compressed at 8–15 kN on a rotary press equipped with 9 mm round punches; friability should remain below 1.0% when measured by USP 1216.
For capsule filling, the milled blend is adjusted to a bulk density compatible with size 0 or size 1 hard gelatin or hydroxypropyl methylcellulose capsules. Lactose monohydrate or microcrystalline cellulose is used as filler; a low-dust granulation is preferred when capsule filling speeds exceed 60,000 capsules per hour because fine particles can interfere with dosing-disc vacuum. Premix manufacture is carried out in ribbon blenders or double-cone blenders with a corncob, limestone, or lactose carrier. Mixing time is validated by sampling at 10, 15, and 20 minutes; the target premix assay relative standard deviation is not more than 5%.
Assay loss during wet granulation is controlled primarily by granulation solvent composition and drying temperature. The total flavonoid markers in this material are heat-sensitive; fluid-bed dryer inlet air should not exceed 75°C, and product temperature should remain below 45°C. If tray drying is used, hot air at 60°C with periodic turning is preferred. Aqueous granulation may darken the mass and produce hard agglomerates if water is sprayed too quickly. An ethanol-water mixture of 30–50% v/v reduces water load and shortens the drying endpoint to a granule moisture content of ≤3.5%. In high-shear mixers, the binder solution should be added at a rate that avoids overwetting; production-scale batches using a 10 L bowl often require a spray rate below 20 g/min during the first three minutes of wet massing. Alkaline granulation media above pH 8 are incompatible because flavonoid degradation accelerates under basic conditions.
For oral solutions, the powder is dissolved or dispersed in purified water at 40°C under continuous stirring. The solution should be adjusted to pH 5.5–6.5; acidification below pH 4.0 can reduce clarity and may precipitate polyphenolic components. Sodium benzoate at 0.1–0.2% and disodium edetate at 0.05% are used as preservative and chelating agents. For injectable solutions, the concentrate is prepared in water for injection, clarified through a 0.45 µm filter, then sterile-filtered through a 0.22 µm polyvinylidene fluoride or polyethersulfone membrane. Membrane adsorption of polyphenols can reduce assay by 2–5% if the filter is not pre-flushed; filter compatibility must be validated because published data for this specific extract-filter combination are limited. Terminal sterilization at 121°C for 15 min may be used only after stability studies demonstrate acceptable assay retention; if heat stability is inadequate, aseptic filtration remains the standard route for injectable product.
| Attribute | Jinqiancao Powder veterinary-grade API | Unstandardized herbal powder | Human-grade extract |
|---|---|---|---|
| Marker standardization | HPLC total flavonoids on dried basis | None or botanical identity only | HPLC, but often without veterinary residue documentation |
| Microbial control | CVP 1105 non-sterile limits | May exceed 10⁴ CFU/g | Pharmacopoeial non-sterile limits |
| Heavy metals | ≤10 mg/kg | Variable | ≤20 mg/kg or tighter depending on market |
| Residue and withdrawal documentation | Veterinary CoA, TSE/BSE declaration, residual solvents | Usually absent | Human CoA; not suitable for food-producing species |
| Dosage-form suitability | Tablets / injections / capsules / powders / granules / premix / solutions | Limited to oral powders with dose variation | Limited to human-approved routes |
When compared with unstandardized herb powder, this veterinary-grade API reduces the risk of batch-to-batch potency variation and microbial contamination. The spray-dried or dehumidified extract format also improves solubility and dispersibility, which is critical for liquid oral products and injectable manufacturing. The principal distinction from human-grade extract is documentation: a veterinary-grade supply is expected to include a certificate of analysis, residual solvent data, heavy metal and pesticide data, and a TSE/BSE declaration. These documents support regulatory review for food-producing species. For companion-animal or equine use, the absence of a strict withdrawal interval may be acceptable; for swine, poultry, and ruminants, the withdrawal period must be established by the sponsor because published depletion data for this product in edible tissues are limited.
Processing incompatibilities include prolonged exposure to strong oxidizers, strong alkalis, and prolonged heat above 75°C. In feed premixes, post-mixing conditioning above 80°C during pelleting may reduce assay and should be validated before full-scale use. The powder should be stored in sealed double low-density polyethylene bags inside a high-density polyethylene drum at 15–25°C and relative humidity not more than 60%. If relative humidity exceeds 60% during dispensing, pre-drying at 40–50°C for 30–60 min is used to restore flow. In-use after opening is restricted to 30 days when the container is re-sealed under dry conditions; material reclaimed from dispensing must not be returned to the primary drum.
The product is not interchangeable with injectable-grade sterile APIs without additional purification, depyrogenation, and sterility assurance. For each finished dosage form, compatibility studies must be performed with the selected excipient system, because the multi-component flavonoid profile can interact with high-surface-area silicates, metal oxides, and certain preservatives. These limitations do not restrict general use; they define the operational window within which the product performs as a process-ready veterinary active pharmaceutical ingredient.
