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Jingfang Baidu Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    • Product Name: Jingfang Baidu Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
    • Factroy Site: Yudu County, Ganzhou, Jiangxi, China
    • Price Inquiry: admin@ascent-chem.com
    • Manufacturer: Ascent Petrochem Holdings Co., Limited
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    Specifications
    HS Code 441475
    Product Name Jingfang Baidu Powder Veterinary Grade API
    Chinese Name 荆防败毒散(兽用级原料药)
    Api Type Standardized botanical extract powder for veterinary drug formulation
    Active Ingredients Schizonepeta extract, Saposhnikovia extract, and traditional Jingfang Baidu bioactive constituents
    Veterinary Grade Veterinary API
    Physical Form Fine brownish-yellow powder
    Odor Characteristic aromatic herbal odor
    Solubility Partially soluble in water; forms a homogeneous suspension when stirred
    Target Species Poultry, swine, cattle, sheep, goats, horses, and companion animals
    Indications Used for relieving exterior syndrome, dispelling wind-cold, eliminating dampness, and detoxification
    Pharmacological Actions Antipyretic, anti-inflammatory, antiviral, and immunomodulatory effects
    Available Dosage Forms Tablets, injections, capsules, powders, granules, premix, and solutions
    Recommended Processing Suitable as active ingredient for subsequent formulation into oral or parenteral veterinary dosage forms
    Storage Conditions Keep in sealed, cool, dry, and light-protected conditions
    Shelf Life 36 months from date of manufacture under proper storage
    Packaging Options 25 kg fiber drums or customized packaging
    Country Of Origin China
    Quality Standard Enterprise veterinary API specification with pharmacopoeia-aligned control methods
    Usage Note For further manufacturing use only; dosage depends on final formulation and target animal species

    As an accredited Jingfang Baidu 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 & Storage
    Packing Sealed, moisture-proof, tamper-evident packaging for veterinary use. Quantity: 1 kg per container. Ensures stability and safety.
    Container Loading (20′ FCL) One 20′ FCL container loaded with sealed drums/pails of Jingfang Baidu Powder, palletized, secured, and protected from moisture during transit.
    Shipping This veterinary-grade API is shipped in sealed, moisture-proof, light-resistant packaging to maintain stability. It requires cool, dry conditions and secure containment to prevent contamination. Each shipment includes a Certificate of Analysis, Material Safety Data Sheet, and export documentation. Worldwide delivery is available via temperature-controlled express, air, or sea freight, with applicable hazard classification labeling.
    Storage Store Jingfang Baidu Powder Veterinary Grade API in a tightly sealed, moisture-proof container in a cool, dry, well-ventilated area. Protect from direct sunlight, heat, and freezing. Keep away from incompatible substances and foodstuffs. Ensure container is clearly labeled and closed after each use. Maintain stable temperature and low humidity to preserve potency, efficacy, and shelf life.
    Shelf Life Shelf life is 24 months when stored sealed, dry, protected from light, and at controlled room temperature in original packaging.
    Application of Jingfang Baidu Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    Jingfang Baidu Powder Veterinary Grade API is introduced into post-weaning and grower-finisher swine rations as a dry premix at a final feed inclusion of 2.0–3.0 kg per metric ton when clinical respiratory signs overlap with diurnal barn temperature swings above 8°C and relative humidity above 65%. The extract is hygroscopic and is therefore pre-blended in a 500 kg horizontal ribbon mixer filled to 65–75% of working volume. The first dilution is made at 1:9 with finely milled rice hull or precipitated calcium carbonate having a bulk density of 0.55–0.65 g/mL. Mixing proceeds at paddle tip speed 2.0–3.5 m/s for 12–18 minutes. The batch is released only if the coefficient of variation for a salt tracer across 10 sampling points is ≤5.0%. In feed mills where conditioning before pelleting reaches 70–80°C for 30–45 seconds, marker retention of volatile oil constituents in the finished pellet can fall below 60% of the unprocessed powder. Thermal loss is mitigated by adding the premix post-pelleting as a top-dress or by limiting conditioner steam pressure to 1.5–2.0 bar when a post-pelleting liquid application system is unavailable. The terminal premix is packed in 20 kg multi-wall paper-poly bags with an inner 40 µm polyethylene liner and stored at 10–25°C and ≤60% RH. A validated HPLC marker assay per VICH GL1 principles is applied to confirm that the finished premix contains 95.0–105.0% of the declared marker content.

    What Causes Nipple Drinker Blocking When Jingfang Baidu Powder Is Metered Into Poultry Drinking Lines?

    At the medicator, the herbal extract is reconstituted as a 1:50 stock solution at 100–200 g/L, yielding a final drinking-water concentration of 2.0–4.0 g/L for broilers and layers. Reconstitution at 20–25°C for 15 minutes with mechanical agitation at 800–1200 rpm leaves insoluble lignified fiber fragments larger than 75 µm. Without an inline 100-mesh strainer, these particles accumulate at the nipple seat and reduce individual drinker flow below 30 mL/min within 48 hours. A two-stage filtration sequence of a 250 µm bag filter followed by a 100 µm stainless steel screen at the header tank is mandatory. Stock solution hold time is limited to 8 hours at 20–25°C; beyond that point, total aerobic microbial count can exceed 10³ CFU/mL in non-chlorinated water. Water hardness above 200 ppm as CaCO&sub3; promotes complexation between extract polyphenols and divalent cations, producing sediment. The solution pH is maintained between 6.0 and 7.2; above 8.2, alkaline hydrolysis of coumarin glycosides reduces marker content. Free chlorine must remain below 0.3 ppm because oxidative degradation of terpenoid components is rapid above this threshold. The finished medicated water is delivered through opaque 5 L high-density polyethylene jugs or direct injection; any residual stock solution is discarded after 12 hours. Dosing pump calibration is verified with a conductivity tracer at 1:50 before each new batch to prevent underdosing in antibiotic-free production programs.

    Injectable Solution Particle Loading and Endotoxin Specifications for Bovine Respiratory Adjunct Therapy

    For injectable presentation, Jingfang Baidu Powder extract is dissolved in Water for Injection at 10.0% w/v. The bulk solution is adjusted to pH 5.5–6.5 with 0.1 N hydrochloric acid or sodium hydroxide and then passed through a 0.45 µm polyethersulfone prefilter followed by a 0.22 µm sterilizing-grade filter at 20–25°C. Terminal steam sterilization at 121°C for 15 minutes is not specified because thermal exposure above 110°C reduces the peak area of volatile oil markers by more than 25% and generates visible flocculates in the 100 mL amber Type II glass vial. Aseptic filtration and filling under a nitrogen blanket are used instead. The 0.22 µm filter is integrity tested with a bubble point specification of ≥3.2 bar before and after filling. The formulation includes 0.2% w/v polysorbate 80 to prevent precipitation of non-polar extract fractions; without the surfactant, visible precipitation occurs below 4°C. Published stability data for this exact herbal injectable at commercial scale is limited; a pilot-scale media-fill and filter validation is required before line approval.

    AttributeRelease limitReference method
    Bacterial endotoxin<0.5 EU/mgUSP <85>
    SterilityNo growth after 14 daysUSP <71>
    Particulate matter ≥10 µm≤6000 per vialUSP <788>
    Particulate matter ≥25 µm≤600 per vialUSP <788>
    pH5.5–6.5USP <791>

    Tablet manufacturing requires the extract to be granulated before compression because the raw powder exhibits Carr compressibility above 30% and caking at 60% RH. Fluid-bed granulation is selected for batch sizes above 200 kg to limit wall adhesion. The intragranular phase contains 30.0% w/w Jingfang Baidu Powder extract, 25.0% w/w microcrystalline cellulose PH102, 20.0% w/w lactose monohydrate, 12.0% w/w pregelatinized starch, 3.0% w/w croscarmellose sodium, and 2.0% w/w povidone K30. Granulation is stopped at a loss-on-drying value of 2.0–3.0% at 85°C for 15 minutes. Final blending with 0.8% w/w magnesium stearate is limited to 5 minutes at 15 rpm to avoid overlubrication and delayed disintegration.

    Tablets are compressed on a rotary press to 600–800 mg fill weight, with hardness 70–90 N and friability ≤1.0% per USP <1216>. Disintegration in water at 37°C is ≤15 minutes per USP <701>. Because the extract is moisture-sensitive, tablets are packaged in PVC/PVDC/aluminium blister cavities. Unpackaged tablets exposed to 40°C and 75% RH lose more than 20% hardness within 48 hours. This operational boundary governs batch handling in facilities where tablet coaters or inspection lines operate outside humidity-controlled suites. The veterinary tablet is presented as a solid oral dosage form for neonatal calves and small ruminants where oral drenching is impractical.

    Capsule Fill Weight Uniformity and Powder Flow Function Parameters for Extract-Based Blends

    Hard gelatin capsule size 0 filling uses a dry-granulated intermediate rather than direct compression. The extract is first dry granulated by slugging and milling to a particle size of 0.5–0.8 mm. The final blend contains 5.0% w/w colloidal silicon dioxide and 2.0% w/w magnesium stearate to shift bulk density to 0.45–0.55 g/mL and tapped density to 0.55–0.65 g/mL. Carr compressibility is held below 20%. Dosator-type encapsulation machines operate at 60,000 capsules/hour; tamping pin penetration is 14–16 mm. Fill weight is 350 mg per capsule with a target acceptance value ≤15.0 per USP <905>. In production, fill weight is sampled every 15 minutes with 20 capsules per station.

    If relative humidity in the encapsulation suite exceeds 60%, gelatin shell cross-linking can delay disintegration to beyond 45 minutes; therefore, a desiccant pouch is inserted and shells are conditioned at 25°C and 50% RH for 24 hours before filling. The finished capsule is suitable for dogs or horses but not for feedlot cattle where esophageal adhesion of gelatin capsules has been reported. Capsules are packaged in 100-count high-density polyethylene bottles with induction-sealed closures and stored below 25°C.

    When Granule Density Falls Below Pneumatic Conveyance Thresholds in Feed Mills

    Dry roller compaction converts the herbal extract into free-flowing granules for oral top-dress and feed mill inclusion. The compactor is operated at roll pressure 8–12 MPa, roll gap 1.0–1.5 mm, and screen size 1.0 mm. Target granule bulk density is 0.60–0.70 g/mL and tapped density is 0.75–0.85 g/mL. If bulk density drops below 0.55 g/mL, dilute-phase pneumatic conveying lines exhibit elbow bridging and dust carry-over. Observed pressure drop increases of 0.8–1.2 kPa occur across a 3000 kg/h line when fines below 75 µm exceed 15% w/w. Friability of final granules is ≤1.0% after 100 revolutions in a Roche friabilator.

    Dissolution release of water-soluble markers in pH 6.8 phosphate buffer at 37°C reaches ≥80% within 30 minutes. Granules are packed in 20 kg paper-poly sacks with a dust extraction port at the filling station. Bulk density and particle size distribution are measured per USP <616> and USP <786>. The finished granule is intended for farm-scale top-dress application or direct addition to total mixed rations where separate micro-ingredient addition is not available.

    Oral drench solutions are compounded as a 20.0% w/v extract liquid in purified water with 0.15% w/v sodium benzoate and 0.10% w/v citric acid. Heating to 35–40°C for 20 minutes under propeller agitation at 500 rpm dissolves the water-extractable fraction. The mixture is then cooled to 15–20°C before passing through a 50 µm inline strainer. Filling is performed into 100 mL or 500 mL amber polyethylene terephthalate bottles with dosing pump caps. The solution is administered at 1.0 mL per 10 kg body weight twice daily for 3 consecutive days in pre-ruminant calves, lambs, and kids. Treatment beyond 5 days is not justified by current release data.

    Microbial quality is controlled according to USP <61> and USP <62>. Total aerobic microbial count must not exceed 10³ CFU/mL, yeast and mold must not exceed 10² CFU/mL, and Salmonella must be absent in 10 mL. The product is incompatible with ionophore oral suspensions because tannin-ion complexation reduces both active moieties. If hard water above 250 ppm as CaCO&sub3; is used for dilution, a visible haze forms at pH above 7.0; therefore, buffering with citric acid to pH 4.5–5.5 is required. The oral solution is stored at 10–25°C and protected from light to maintain marker stability over the 12-month shelf-life period.

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    Certification & Compliance
    More Introduction

    Jingfang Baidu Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied under the manufacturer’s model designation JFBD-VAPI-2405 as a multi-herb botanical processing-grade powder. The material is not a finished dosage form and is not sterile. It is intended for further manufacture in veterinary GMP facilities. The powder is a non-caking yellowish-brown to grayish-brown solid with a characteristic mixed botanical odor, packed in 25 kg sealed polyethylene-lined fiber drums. Published data for this specific configuration is limited; release limits below are representative and must be verified against the current manufacturer’s certificate of analysis, except where a standard code is cited.

    What Release Limits Govern Sieve Residue, Moisture, Heavy Metals, and Microbial Burden?

    Release criteria for the API are organized around dry powder handling, elemental safety, and nonsterile microbiological control. Sieve residue on 80 mesh is not more than 5.0% after 5 min sonic sifting. Loss on drying at 105°C is not more than 8.0%. Total ash is not more than 12.0%; acid-insoluble ash is not more than 4.0%. Bulk density measured by USP <616> Method I is 0.42 g/cm³ to 0.68 g/cm³. Heavy metals by ICP-MS after microwave digestion are controlled at not more than 10 mg/kg lead, 3 mg/kg arsenic, 1 mg/kg cadmium, and 0.5 mg/kg mercury. Residual solvent limits follow VICH GL18, with ethanol not more than 5000 ppm and methanol not more than 3000 ppm. Microbiological limits are those of a nonsterile botanical preparation: total aerobic microbial count not more than 104 CFU/g, total combined yeast and mold count not more than 102 CFU/g, Salmonella absent in 25 g by ISO 6579, and Escherichia coli absent in 1 g by ISO 16649-2.

    Release parameterLimitMethod
    Sieve residueNMT 5.0%80 mesh sonic sift
    Loss on dryingNMT 8.0%Drying at 105°C
    Total ashNMT 12.0%Ignition
    Acid-insoluble ashNMT 4.0%HCl-insoluble residue
    Bulk density0.42 g/cm³0.68 g/cm³USP <616> Method I
    LeadNMT 10 mg/kgICP-MS
    ArsenicNMT 3 mg/kgICP-MS
    CadmiumNMT 1 mg/kgICP-MS
    MercuryNMT 0.5 mg/kgICP-MS
    SalmonellaAbsentISO 6579
    Escherichia coliAbsentISO 16649-2

    On a 16-station B-tooling rotary tablet press, the API is blended with microcrystalline cellulose, sodium starch glycolate, and magnesium stearate in a V-blender for 20 min at 25 rpm unless direct compression is used as an initial process-screening route. Direct compression is restricted to API conditioned to RH below 60% and pre-sieved through 60 mesh; higher moisture produces upper-punch picking and edge lamination. Wet granulation with 5% w/v povidone K30 in a high-shear mixer, followed by fluid-bed drying at inlet air 60°C to final moisture 3.0% to 4.0%, provides better compressibility. Compression force of 8 kN to 12 kN commonly yields tablet tensile strength 1.2 MPa to 1.6 MPa at 10% w/w to 20% w/w API loading. Disintegration time in water at 37°C is 15 min to 25 min for uncoated cores. For capsule filling, the API is milled through 100 mesh and filled at 40% to 50% relative humidity to maintain moisture below 8.0% and prevent gelatin embrittlement.

    Injectable Solution Processing Requires a Clarified Aqueous Fraction

    For injectable solutions, raw botanical powder cannot be used directly. A clarified aqueous extract is prepared by boiling 100 kg of API in purified water at 100°C for 1.5 h, depth-filtering through 0.45 µm polypropylene, and vacuum concentrating at 55°C to 60°C to a relative density of 1.02 g/mL to 1.08 g/mL. The concentrate is chilled at 4°C for 24 h to sediment high-molecular-weight polysaccharides. The supernatant is passed through 0.22 µm PVDF and moist-heat sterilized at 121°C for 15 min. Endotoxin control is performed by USP <85> kinetic chromogenic assay with a limit not more than 0.5 EU/mL in the finished solution. The final pH is adjusted to 5.0 to 6.5; aggregation of flavonoid aglycones is observed at pH below 4.0. Low-endotoxin API lots should be reserved for this route; standard oral-grade lots are not interchangeable. Injectable solutions should be filled under nitrogen if the formulation contains more than 0.2% total flavonoid aglycones to reduce oxidative darkening.

    For oral powders and premixes, the API is mixed with a compatible carrier such as soluble starch, dextrose monohydrate, or corn cob meal using geometric dilution in a double-cone blender. Homogeneity is checked by sampling 10 points and assaying a marker compound; the coefficient of variation should remain below 5.0%. The product dusts heavily when transferred in low-humidity conditions, so 1.0% hydrogenated vegetable oil can be added as a dedusting and flow-control agent. In automatic auger filling, bridging is minimal when the powder is held at RH 50% to 60%; dry powder below 40% retains electrostatic charge and segregates the fine botanical fraction.

    When the API Is Selected for Premix Rather Than Granulated Oral Products

    Premix and granulated oral products impose different constraints on particle behavior. As a dry premix, the API benefits from carrier dilution and can maintain a mixing coefficient of variation below 5.0% if stepwise geometric blending is used and the carrier is close to the API bulk density. Granulation is chosen when the API is to be incorporated into pelleted feed or when dust containment is a processing bottleneck. Fluid-bed top-spray granulation with inlet air 55°C to 65°C, atomization pressure 1.5 bar, and binder delivery approximately 2.0 g/min produces granules of 0.5 mm to 1.0 mm, tapped density 0.55 g/cm³ to 0.75 g/cm³, and Hausner ratio below 1.35. The granule matrix swells before erosion in aqueous suspension, delaying marker release by 15 min to 30 min compared with raw powder.

    Compared with single-molecule veterinary APIs such as amoxicillin trihydrate or ivermectin, Jingfang Baidu Powder is a multi-component botanical matrix, not a crystalline chemical entity. Its specification is not expressed as a simple purity window but as a combination of TLC fingerprint, multi-marker assay, ash limits, and microbial limits. Consequently, tableting may require 3% to 5% binder rather than 1% lubricant alone. Against single-herb standardized extracts, the product retains a higher water-insoluble fiber and polysaccharide fraction, which supports oral suspension and granule preparation but restricts direct parenteral use.

    AttributeJingfang Baidu Powder Veterinary Grade APISingle-Molecule Synthetic APISingle-Herb Standardized Extract
    Matrix typeMulti-herb botanical powderCrystalline chemical entitySingle-herb fraction or extract
    Specification identityTLC fingerprint plus multi-marker assay and ash limitsSingle assay typically 98%102%Single or double marker with extract ratio
    Parenteral routeRequires clarified aqueous extractMay dissolve or suspend directlyOften requires further purification
    Tableting behaviorHygroscopic; binder at 3%5%Direct compression at 1% lubricantVariable; often spray-dried
    Microbial controlNonsterile botanical limitsLow bioburden if crystallineNonsterile botanical limits

    Storage stability of the unopened API is 24 months at 25°C and 60% RH in the original sealed fiber drum. After opening, the material should be used within 30 days when kept at 10°C to 25°C and protected from moisture. The powder is incompatible with strong oxidizing agents and with dry blending of high-acid organic acids such as citric acid monohydrate above approximately 1:1 molar ratio relative to the botanical acidic fraction, because local moisture uptake causes clumping and cake formation. Avoid combining with amine-based synthetic additives unless an active compatibility study is performed, since natural polyphenols in the API can undergo Schiff-base condensation during moist granulation. Such combinations should be evaluated in a forced-degradation study before full-scale granulation.

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