| HS Code | 209417 |
| Product Name | Jiqiu Chong Powder Veterinary Grade API |
| Physical Form | Fine dry powder |
| Color | White to off-white or light yellow |
| Purity | Typically ≥98% |
| Solubility | Soluble in suitable pharmaceutical solvents; aqueous solubility depends on the final salt form |
| Storage Conditions | Store in a cool, dry, airtight container protected from light and moisture |
| Shelf Life | Generally 24 months under proper storage |
| Pharmacological Category | Antiprotozoal / anticoccidial veterinary active ingredient |
| Compatible Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Handling Precautions | Wear protective gloves, mask, and eye protection; avoid dust inhalation and skin contact |
| Stability | Stable under normal storage conditions; avoid high temperature and humidity |
| Use Class | Veterinary Grade API |
As an accredited Jiqiu Chong 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 inner polyethylene bags inside fiber drums, 25 kg net weight per drum. |
| Container Loading (20′ FCL) | A 20′ FCL container loaded with Jiqiu Chong Powder veterinary-grade API, properly packed in drums/pallets for secure transport. |
| Shipping | Shipping: This veterinary-grade API is packed in sealed, moisture-proof drums with tamper-evident seals. Shipments follow international hazardous material regulations, with proper labeling, SDS, and certificates of analysis. Courier options include air, sea, or express, ensuring temperature-controlled handling and full traceability to destination. |
| Storage | Store in a tightly sealed original container, away from moisture, direct sunlight, and heat. Keep in a cool, dry, well-ventilated area below 25°C. Avoid contact with incompatible substances. Ensure container remains closed when not in use. Use within the labeled shelf life and follow veterinary handling precautions. |
| Shelf Life | Shelf Life: 24 months from manufacture date when stored sealed in original container, below 25°C, protected from moisture and light. |
Jiqiu Chong Powder Veterinary Grade API is processed through seven downstream veterinary dosage-route applications. The incoming powder is first characterised by Ph. Eur. 2.9.34 bulk and tapped density, Ph. Eur. 2.9.12 sieve analysis, and loss on drying at 105°C to constant mass. Batches with d90 > 150 µm or Hausner ratio > 1.45 are pre-milled or blended with colloidal silicon dioxide at 0.2–1.0% w/w before dry processing. All process windows cited below are typical manufacturing-line ranges derived from veterinary pharmaceutical equipment classes; they are not batch-release specifications and require product-specific validation.
| Dosage presentation | Jiqiu Chong Powder load | Primary process equipment | Critical control point | Principal compliance anchor |
|---|---|---|---|---|
| Immediate-release tablet | 5–25% w/w direct; 10–30% w/w wet-granulated | Rotary tablet press, fluid-bed dryer, high-shear mixer | Hardness 60–90 N; friability <1.0% | Ph. Eur. 2.9.40, Ph. Eur. 2.9.7, Ph. Eur. 2.9.1 |
| Sterile injection | 0.1–10.0% w/v | Aseptic filling line, 0.22 µm PES filter | Filter integrity, endotoxin, sterility | 21 CFR 211.113(b), Ph. Eur. 5.1.1, Ph. Eur. 2.6.1 |
| Low-dose capsule | 1–20% w/w | Dosator capsule machine, V-blender | Content uniformity RSD ≤5.0% | Ph. Eur. 2.9.40, USP <905> |
| Water-soluble oral powder | 0.5–10.0% w/w | Ribbon blender, sifting line | Moisture ≤2.0%, wetting time ≤120 s | Ph. Eur. 2.9.34, Karl Fischer titration |
| Oral granule | 0.2–15.0% w/w | High-shear mixer, fluid-bed dryer, low-shear mill | Granule size 0.8–1.6 mm, Hausner ratio | Ph. Eur. 2.9.34, Ph. Eur. 2.9.12 |
| Medicated feed premix | 2–10% w/w premix; 0.1–5.0 kg/t final feed | Ribbon mixer, twin-shaft paddle mixer | Mixing CV ≤5.0%, carryover <1.0% | 21 CFR 225, 21 CFR 226, Regulation (EC) No. 1831/2003 |
| Oral solution | 0.1–5.0% w/v | Low-shear mixer, 5 µm depth filter, HDPE filling line | pH 5.0–7.0, preservative efficacy, precipitation | VICH GL3, Ph. Eur. 5.1.3 |
Under direct compression, the powder's particle-size distribution, bulk density, and deformation behaviour govern tablet tensile strength. Jiqiu Chong Powder is pre-blended with microcrystalline cellulose PH-102 at 45–65% w/w, lactose monohydrate at 15–25% w/w, crospovidone at 4–8% w/w, and magnesium stearate at 0.5–1.5% w/w. Direct compression is technically viable only when active loading remains below 25% w/w. Above this threshold, capping and weight variation increase because elastic recovery of the API progressively exceeds the compactability of the filler matrix. Rotary press parameters are set to precompression 5–8 kN, main compression 12–20 kN, and turret speed 40–60 rpm.
At loadings above 25% w/w, the process is changed to wet granulation. Povidone K30 is dissolved in purified water at 4–8% w/v and added to a high-shear mixer containing the API and fillers. Impeller speed 300–500 rpm and chopper speed 1500–2000 rpm are maintained for 3–5 min. The wet mass is dried in a fluid-bed dryer at inlet air 55–65°C and product temperature 32–38°C to loss on drying 1.5–2.5%. Dried granules are milled through a 1.0 mm screen, lubricated, and compressed. Release tests include hardness 60–90 N, friability <1.0% per Ph. Eur. 2.9.7, disintegration ≤15 min per Ph. Eur. 2.9.1, and content uniformity per Ph. Eur. 2.9.40 with acceptance value ≤15. The terminal article is an immediate-release veterinary tablet.
Aseptic filling of Jiqiu Chong Powder injection-grade solutions places the entire operation under 21 CFR 211.113(b) and Ph. Eur. 5.1.1. The formula is prepared at 0.1–10.0% w/v API in Water for Injections, buffered with phosphate or acetate to pH 6.0–7.4, and adjusted with sodium chloride to 280–320 mOsm/kg. If dissolved oxygen is above 1.0 mg/L, sodium metabisulfite is added at 0.1–0.3% w/v under a nitrogen blanket. The solution is clarified through a 0.45 µm depth or membrane filter and sterilized through a 0.22 µm polyethersulfone filter. Filter integrity is tested by bubble point before and after filling.
Published thermal degradation kinetics for this specific API in aqueous solution are limited. Therefore terminal steam sterilisation at 121°C for 15 min is accepted only after a formulation-specific D-value and z-value study demonstrates a sterility assurance level ≤10-6 and no degradation product above the qualification threshold in VICH GL18. Aseptic filling takes place in an ISO 14644-1 Class 5 zone with continuous particle monitoring. Batch release requires sterility per Ph. Eur. 2.6.1 and bacterial endotoxin per Ph. Eur. 2.6.14 at ≤2.0 EU/mL for parenteral use. The terminal product is a sterile veterinary injection.
Content uniformity, not dissolution, is usually the critical control point for capsule products when active load is below 5% w/w. Jiqiu Chong Powder is geometrically diluted with lactose monohydrate in 1:1 sequential steps until the active occupies 1–20% w/w of the blend. Dosator-type capsule machines require powder bed depth 10–25 mm and tamping force 50–150 N. Published data for this specific API in dosator format are limited; tamping-pin machines may require silanised excipients if cohesive lot variability is confirmed by Ph. Eur. 2.9.34. Blends are passed through a 0.425 mm sieve and mixed in a V-blender at 25 rpm for 15 min.
Mixing time is validated by sampling 10 locations and assaying API with relative standard deviation ≤5.0%. Capsule fill mass is controlled to ±5% of target. Content uniformity follows Ph. Eur. 2.9.40 or USP <905>. Dissolution testing uses Ph. Eur. 2.9.3 or USP <711> Apparatus 2 at 50–75 rpm in 900 mL buffer at 37°C ± 0.5°C. The terminal product is a low-dose veterinary capsule.
Drinking-water delivery formulations are manufactured as dispersible oral powders unless product-specific solubility data confirm dissolution at the intended use concentration. A typical water-soluble powder contains Jiqiu Chong Powder 0.5–10.0% w/w, dextrose monohydrate 60–90% w/w, anhydrous citric acid 0.5–2.0% w/w for pH adjustment, and colloidal silicon dioxide 0.2–0.5% w/w as anti-caking. If hydration testing indicates incomplete wetting within 120 s at 25°C, poloxamer 188 is added at 0.1–0.5% w/w. Production blending occurs in a ribbon blender at 15–20 rpm for 10–15 min.
The blended powder is discharged through a 0.315 mm sieve and immediately packed in heat-sealed aluminium-foil bags with moisture vapour transmission rate <0.1 g/m²/day. Final moisture is controlled at ≤2.0% by Karl Fischer titration to prevent hydrolysis and caking in tropical storage. The terminal product is a water-soluble oral powder for admixture to drinking water.
Before wet granulation, the dry premix contains Jiqiu Chong Powder 0.2–15.0% w/w, microcrystalline cellulose 10–30% w/w, lactose monohydrate 40–70% w/w, and croscarmellose sodium 2–5% w/w. Binder solution is povidone K30 at 3–6% w/v in purified water, added at 15–25 mL/min per 1 kg dry powder. Oversized granules above 1.6 mm are not acceptable for oral granule sachets because flow and reconstitution time deteriorate.
Wet granules are dried in a fluid-bed dryer with inlet air 60–75°C and product temperature 35–40°C until moisture is ≤2.0%. Dried granules are classified through 0.8 mm and 1.6 mm sieves; oversized material is milled at 1200 rpm using a low-shear mill. Flowability is measured by Ph. Eur. 2.9.34; if the Hausner ratio exceeds 1.35, fumed silica is added at 0.2–0.5% w/w and blended for 5 min. The terminal product is an oral granule sachet or bulk granule for reconstitution.
When feed mill incorporation is designed, the premix is not introduced directly at final feed concentration. Jiqiu Chong Powder is first blended into a Type B medicated feed premix at 2–10% w/w using a horizontal ribbon mixer. The carrier is ground corn or rice hulls with moisture ≤12% and bulk density 0.50–0.65 g/mL. Mixing time is established by tracer study to reach coefficient of variation ≤5.0% across 10 sampling points. This concentrated premix is then metered into final feed at 0.1–5.0 kg/tonne. Final feed mixing uses a twin-shaft paddle mixer for 4–6 min; sampling points include the mixer discharge and bagged feed.
Residue samples after flushing are analyzed by HPLC to confirm carryover below 1.0% of labeled active. Compliance falls under 21 CFR 225 and 21 CFR 226 for medicated feed, with EU monitoring under Regulation (EC) No. 1831/2003 for coccidiostats. The terminal product is Type C medicated feed or non-medicated flush feed.
Oral solution manufacturing begins with a co-solvent pre-slurry. Jiqiu Chong Powder is dispersed in propylene glycol 10–30% v/v under low-shear agitation at 200–400 rpm for 15 min; water is then added to a final API concentration of 0.1–5.0% w/v. Sodium benzoate is added at 0.1% w/v as preservative, and the pH is adjusted with citrate buffer to 5.0–7.0. The solution or fine suspension is clarified through a 5 µm polypropylene depth filter before filling.
High-density polyethylene bottles are filled with tamper-evident caps. Stability testing under VICH GL3 conditions at 40°C ± 2°C / 75% RH ± 5% RH for 6 months should demonstrate active loss ≤5.0% and no precipitation. Preservative efficacy is confirmed by Ph. Eur. 5.1.3. The terminal product is an oral solution for drinking-water or direct oral administration.
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Jiqiu Chong Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a non-sterile bulk active pharmaceutical ingredient powder released for further pharmaceutical processing across multiple veterinary dosage routes. The model designation identifies the unformulated powder, not a finished dosage form; the route terms specify the downstream manufacturing operations for which the powder’s physical and microbial quality attributes are controlled after additional route-specific handling. Each lot is accompanied by a certificate of analysis reporting identity, assay, related substances, water content, bulk and tapped density, particle-size distribution, and microbiological parameters. For parenteral applications, the powder is not sterile and not pyrogen-free as supplied; depyrogenation, terminal sterilisation, or aseptic formulation must be performed under the relevant veterinary marketing authorisation. Where no harmonised public monograph exists, the vendor specification and CoA remain the controlling documents.
Release testing is assembled from pharmacopoeial general chapters because veterinary APIs of this type are frequently controlled by a vendor specification rather than a single harmonised monograph. Identity is confirmed by infrared spectrum or HPLC retention time. Assay and related substances are determined by validated HPLC or titration. Loss on drying is measured by USP 731 or Ph. Eur. 2.2.32; residue on ignition by USP 281 or Ph. Eur. 2.4.14; elemental impurities by risk assessment under ICH Q3D, with methods referencing USP 232 and USP 233 where applicable. Bulk and tapped density follow USP 616 or Ph. Eur. 2.9.34. Particle-size distribution is measured by laser diffraction under USP 429 or Ph. Eur. 2.9.31. Microbial enumeration uses USP 61 and USP 62, or Ph. Eur. 2.6.12 and 2.6.13. Injectable-grade material adds bacterial endotoxin testing by USP 85 or Ph. Eur. 2.6.14, with limits calculated from maximum dose volume and target animal weight rather than assigned as a single default value. Residual solvents, when declared, follow USP 467 or Ph. Eur. 2.4.24.
| Test attribute | Referenced method | Representative acceptance criterion when declared | Route dependency |
|---|---|---|---|
| Appearance | Visual inspection | White to off-white powder | All routes |
| Identification | IR, HPLC retention time | Matches working standard or reference chromatogram | All routes |
| Loss on drying | USP 731, Ph. Eur. 2.2.32 | ≤ 0.5% common for dry oral and injection intermediates | Critical for capsules, dry blends, injections |
| Bulk density | USP 616, Ph. Eur. 2.9.34 | 0.30–0.70 g/mL typical; reported on CoA | Tablets, capsules, premix |
| Particle size distribution | USP 429, Ph. Eur. 2.9.31 | Route-specific: oral granules ≤ 250 µm; dry solutions ≤ 150 µm; injectable precursor often ≤ 20 µm | All routes; injection requires fine and controlled distribution |
| Total aerobic microbial count | USP 61, Ph. Eur. 2.6.12 | Non-sterile oral ≤ 1000 CFU/g; pre-sterilisation bioburden often ≤ 10 CFU/g | Oral versus parenteral |
| Bacterial endotoxin | USP 85, Ph. Eur. 2.6.14 | Calculated per dose; screening often ≤ 0.5 EU/mg for injectable development | Injection only |
| Elemental impurities | ICH Q3D, USP 232, USP 233 | Class 1 and 2A limits from finished product risk assessment | All routes |
Flow behaviour across manufacturing routes is controlled by bulk density and particle-size distribution rather than by chemical assay alone. In direct compression, powders with Carr compressibility index above 25% usually require forced feed frames on rotary presses; values below 15% are generally free-flowing. The powder should be measured under USP 1174 before hopper orifice diameter is selected. A powder near 0.35 g/mL bulk density may require vibration-assist at a 15 mm discharge orifice to avoid ratholing. In high-shear wet granulation using a vertical granulator with a 10 L bowl and chopper speed of 1500–3000 rpm, the endpoint should be determined by power draw or impeller torque rather than fixed time, because lot-to-lot particle-size shifts alter liquid uptake. For capsule filling on dosator systems, tapped density above 0.45 g/mL improves plug retention; for tamping-pin machines, low interparticle friction reduces weight variation.
Selection of the powder for injection formulations does not make the material injectable. Terminal sterilisation, aseptic processing, or sterile filtration of a reconstituted solution must be developed with pre-sterilisation bioburden and endotoxin limits established for the specific process. The acceptable pre-sterilisation bioburden is derived from D-value studies of the actual contaminant population and the required sterility assurance level; a customary screening limit is 10 CFU/100 mL or stricter. Endotoxin cannot be assumed to be removed by sterilisation; depyrogenation by dry heat or validated washing is required if the powder’s endotoxin content exceeds the final product limit. Oral dosage manufacturing may be conducted in unclassified or 1SO Class 8 areas, while injectable formulation requires transfer and dispensing in controlled environments with laminar flow protection at the point of use. Storage should not exceed 60% relative humidity for prolonged periods unless moisture-barrier packaging and desiccant are used, because water uptake changes powder flow and may accelerate hydrolysis.
For premix and solution manufacturing, dissolution rate and dispersibility in aqueous vehicles are more important than compaction properties. Particles at ≤ 150 µm generally wet faster than coarse granules, but very fine powder can form hydrated gel layers when dumped into a vortex. In a 1000 L mixing tank, addition through a venturi eductor or high-shear inline mixer at approximately 3000 rpm reduces fish-eye agglomerates; direct dumping into unaerated water may delay dissolution. Published data for this specific configuration is limited, so validation must be performed with the intended water temperature, water quality, and mixing intensity. Solutions intended for injection must be filtered through 0.22 µm membrane filters after complete dissolution unless terminal sterilisation is validated, and filter compatibility must be confirmed because active ingredients can adsorb to PVDF or nylon membranes.
The multi-route designation differs from a single-route oral premix powder because the same lot may be considered for oral and parenteral formulation only if the release specification includes the stricter route controls. A single-route oral premix powder may not be tested for endotoxin, may allow higher bioburden, and may be milled without control of sub-visible particulate matter. A micronised injectable grade is often controlled at ≤ 20 µm D90, low endotoxin, and cleaned packaging, but may be unsuitable for direct compression because high surface area increases sticking and reduces flow. This powder is not a sterile injectable API and is not a direct administration product; the multi-route claim requires that the CoA contain sufficient physical, chemical, and microbiological data for the formulator to assign route-specific acceptance limits.
| Property | Multi-route veterinary API powder | Single-route oral premix powder | Micronised injectable grade |
|---|---|---|---|
| Particle size | Reported D10, D50, D90; route-specific limits assigned | Often ≤ 500 µm; coarse granules acceptable | Typically ≤ 20 µm D90 |
| Microbial enumeration | Tested under USP 61, USP 62; limits set by route | Non-sterile oral limits; absence of specified pathogens | Low bioburden before sterile processing |
| Bacterial endotoxin | Tested when parenteral route is claimed | Usually not tested | Tested with dose-based limits |
| Packaging | Fibre drum with polyethylene liner; moisture protection | Similar bulk packaging | Cleaned low-density polyethylene bags; particulate control |
| Documentation | CoA, route-specific data, cleaning validation, residual solvent data | CoA for oral use only | CoA with endotoxin, particle size, and sterile processing support |
Storage and dispensing are controlled at 15–25 °C, with desiccant required when ambient moisture exceeds 60% relative humidity. The polyethylene liner should be resealed after each withdrawal; multiple openings are detected by loss-on-drying shift or by near-infrared moisture screening. Transfer from drums to intermediate bulk containers may occur in an unclassified area only for oral routes; for parenteral formulation, the powder must be transferred in a controlled environment appropriate to the process step. Avoid contact with strong oxidising agents and concentrated acids unless a specific solution preparation procedure has been qualified, because heat evolution may destabilise the active moiety. Compatibility with moisture-sensitive excipients should be evaluated by open-dish stress studies at 40 °C/75% relative humidity for 24 h, referencing ICH Q1A stress conditions where relevant.
