| HS Code | 568179 |
| Product Name | Changqing Qiu Chong Powder Veterinary Grade API |
| Api Type | Veterinary coccidiostat active pharmaceutical ingredient |
| Physical Form | Fine dry powder |
| Color | White to off-white |
| Veterinary Grade | Veterinary grade |
| Target Species | Poultry, livestock, and other food-producing animals as applicable |
| Therapeutic Activity | Antiprotozoal activity against Eimeria coccidia species |
| Mechanism Of Action | Interferes with coccidial oocyst development and intracellular stages |
| Solubility | Soluble in suitable organic solvents; aqueous solubility depends on the specific salt or free base form |
| Formulation Applicability | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Typical Assay Purity | ≥98% manufacturer-specified |
| Storage Condition | Store in airtight containers in a cool, dry, well-ventilated area |
| Shelf Life | Typically 24 months under recommended storage conditions |
| Packaging | Sealed multi-layer bags or drums |
| Standard | Meets veterinary API quality specifications |
As an accredited Changqing Qiu 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 | Changqing Qiu Chong Powder veterinary API is packed in sealed aluminum foil bags, 1 kg per bag, placed in cardboard drums. |
| Container Loading (20′ FCL) | 20′ FCL container loading for Changqing Qiu Chong Powder: drum-packed veterinary API, palletized, secured, with moisture-proof liners and proper ventilation. |
| Shipping | This veterinary-grade API powder is shipped in sealed, moisture-proof drums or multilayer bags with tamper-evident packaging. Transport requires cool, dry conditions, avoiding direct sunlight. Full documentation includes MSDS, certificate of analysis, and shipping marks. Shipments comply with international hazardous-goods regulations for air, sea, road, or rail freight. |
| Storage | Store in tightly sealed, original containers in a cool, dry, well-ventilated area, protected from direct sunlight, moisture, and high temperatures. Keep away from incompatible substances, food, and animal feed. Ensure container remains closed when not in use. Use before expiry date. Handle with appropriate protective equipment. |
| Shelf Life | Shelf life is 24 months when stored in original sealed containers, in a cool, dry place away from moisture and direct sunlight. |
During direct-compression and wet-granulation runs for companion-animal oral solid dosage forms, the hydrochloride salt is typically incorporated at 5–30% w/w in the tablet core, with common unit strengths of 25 mg, 50 mg, 100 mg, and 150 mg for dogs and cats. Blend uniformity is confirmed by USP <905> and Ph. Eur. 2.9.5; dissolution is tested by USP <711> Apparatus 2 at 50 rpm in 0.1 M hydrochloric acid with an acceptance limit of 80% released at 30 min. The manufacturing line for tablet strengths above 50 mg typically uses a top-spray fluid-bed granulator, in which a 5–10% w/w aqueous PVP K30 binder solution is sprayed at an inlet air temperature of 50–60 °C and a product temperature of 28–34 °C; the resulting granulate is dried to a loss-on-drying endpoint below 1.5% w/w because residual moisture above 2.0% w/w accelerates hydrolysis of the imidazothiazole ring and reduces tablet hardness stability in high-density polyethylene bottles stored at 60% relative humidity. The API release specification sets a particle-size distribution with D90 ≤ 250 µm by laser diffraction per ISO 13320:2020, and the API is pre-sieved through an 80-mesh screen before pre-blending. Compression is run on a 16-station rotary tablet press with 8–10 mm round tooling at 8–15 kN compression force, with in-process hardness controlled between 60 N and 100 N, friability below 0.5% w/w per USP <1216>, and disintegration below 10 min per Ph. Eur. 2.9.1. For chewable veterinary tablets, the API is pre-blended with spray-dried liver digest and sucrose at 10–20% w/w before direct compression; residual solvent levels are controlled under ICH Q3C(R8). Capsule filling for 50 mg and 100 mg strengths uses an intermittent-motion capsule filler and requires a Hausner ratio below 1.25 and a Carr index below 20 to maintain weight variation within ±5%. Terminal product types include uncoated tablets, hydroxypropyl methylcellulose film-coated tablets, meat-flavored chewable tablets, and hard gelatin capsules.
Sterile injectable manufacture for cattle and swine uses an aqueous solution of the hydrochloride salt at 5–10% w/v, equivalent to 50–100 mg/mL, because the salt’s high water solubility supports a clear solution only when pH is held between 3.5 and 5.0. Above pH 5.5, free-base precipitation and visible haze increase the risk of filter blinding and cause failure of the clarity test in Ph. Eur. 2.2.2. Multi-dose vials are compounded in stainless-steel tanks under a nitrogen overlay, with 0.1% w/v sodium metabisulfite as antioxidant and 1.0% v/v benzyl alcohol as preservative; oxygen-sensitive degradation is monitored by a stability-indicating HPLC method with a total degradation product limit of 0.5% w/w, derived from VICH GL18(R2). Equipment qualification and aseptic processing follow FDA 21 CFR 211.65 and EU GMP Annex 1. Sterile filtration is performed through a 0.22 µm PVDF or PES membrane in a Grade A isolator, followed by aseptic filling into depyrogenated Type II glass vials. Terminal sterilization by autoclaving at 121 °C for 15 min is generally avoided because the hydrolysis product increases under thermal stress; if a firm validates a terminal cycle, the final pH must remain 4.0–4.5 and the degradation product level must not exceed 0.2% w/w after release. Particulate matter is controlled by USP <788>, with limits of ≥ 10 µm particles not exceeding 6000 per container and ≥ 25 µm particles not exceeding 600 per container for a 100 mL multi-dose vial. On rotary piston filling lines, foaming at the fill nozzle can generate weight variation if fill speed exceeds 200 vials/min; therefore filling needles are maintained just below the liquid surface and the solution is degassed under vacuum at −0.08 MPa before filling. Terminal product types include 100 mL, 250 mL, and 500 mL multi-dose vials for cattle and swine, as well as 50 mL single-dose vials for sheep.
| Downstream scenario | Primary standard designation | Critical test method | Release criterion |
|---|---|---|---|
| Oral solid dosage forms | USP <905>, Ph. Eur. 2.9.5 | Content uniformity | Acceptance value ≤ 15 |
| Sterile injectable solutions | USP <788>, Ph. Eur. 2.6.1 | Particulate matter and sterility | ≥ 10 µm ≤ 6000; ≥ 25 µm ≤ 600; sterile |
| Feed premix | 21 CFR 225/226, ISO 6497:2002 | Mixer uniformity assay | Coefficient of variation < 5% |
| Drinking-water granules | VICH GL18(R2), Ph. Eur. 2.9.1 | Degradation products and dispersion time | Total degradation ≤ 0.5% w/w; dispersion < 5 min |
Medicated feed premix manufacture at feed mills operating under 21 CFR 225/226 requires a staged geometric dilution of the hydrochloride salt into an intermediate premix at 1–5% w/w active, followed by dilution to a complete feed concentration of 80–400 ppm (0.008–0.04% w/w) depending on the target species and regulatory registration. Mixer validation is conducted according to ISO 6497:2002, using a salt tracer or iron filings test in a 1000 L ribbon mixer with a working capacity of 70–80% and a mixing time of 12–20 min; the coefficient of variation for the active assay must remain below 5% across 10 sampling points. When the API has a median particle size below 50 µm, electrostatic adhesion to polypropylene bulk bags increases carryover and causes batch-to-batch assay drift; the preferred median particle size for premix blending is 100–180 µm, with D90 ≤ 250 µm by laser diffraction per ISO 13320:2020. Finished premixes are packed in 25 kg multi-wall bags with an inner polyethylene liner and stored below 30 °C and 60% relative humidity. Terminal product types include medicated complete feed, creep feed for swine, pelleted feed, crumbles for poultry, and top-dress meal.
Because the hydrochloride salt has high water solubility, drinking-water medication for poultry and swine can be prepared as a water-dispersible granule containing 10–20% w/w active, with lactose monohydrate as filler and an effervescent couple of citric acid and sodium bicarbonate at 10–20% w/w. The final in-use concentration is typically 0.05–0.1% w/v in drinking water, administered for 6–24 h under veterinary prescription; if water hardness exceeds 150 ppm calcium carbonate equivalents, the citric acid buffer maintains solution pH below 5.5 to prevent free-base precipitation. Granulation is run in a high-shear granulator at 200–400 L capacity, with a chopper speed of 1500–2500 rpm and an impeller speed of 150–250 rpm; the wet mass is discharged at a loss-on-drying of 3–5% w/w and dried in a fluid-bed dryer at 40–50 °C to a final moisture below 1.0% w/w. Stability-indicating data generated under VICH GL11 long-term conditions at 25 °C/60% RH and intermediate conditions at 30 °C/65% RH support a retest period of 24 months for the unopened granule. Dispersion time of the finished granule is measured by adding 20 g to 1 L of water at 20 °C with stirring; complete dispersion should occur within 5 min without visible sediment or surface scum. Packaging in moisture-barrier foil sachets is required above 60% relative humidity because the effervescent component reacts with absorbed moisture and causes sachet inflation and loss of effervescence. Terminal product types include 100 g and 1 kg foil sachets and 5 kg bulk packs for poultry and swine drinking-water administration.
Where oral drench and liquid feed-additive presentations are registered for ruminants and swine, the hydrochloride salt is dissolved in purified water at 1–10% w/v, often with 10–20% v/v ethanol or propylene glycol as co-solvent and stabiliser. The pH is adjusted with hydrochloric acid or citric acid to 4.0–5.0, and a preservative system such as methyl parahydroxybenzoate 0.1% w/v plus propyl parahydroxybenzoate 0.02% w/v is added for multi-dose containers. Bulk liquid is clarified through a 5 µm polypropylene filter before filling into amber high-density polyethylene drums or calibrated drench packs; the packaging operation is carried out under nitrogen sparging to reduce oxidative headspace degradation. Because the hydrochloride salt is susceptible to photodegradation in dilute solution, finished drench packages are wrapped in light-protective labels or cartons. Stability-indicating HPLC data generated under VICH GL11 long-term conditions 25 °C/60% RH and intermediate conditions 30 °C/65% RH support a retest period of 24 months for unopened oral solution; published data for this specific package configuration are limited, and firms should verify photostability per ICH Q1B. Terminal product types include oral drench solutions for cattle and sheep, pig doser solutions, and flexible pack solutions for swine.
In contrast to powder premixes, granulated presentations containing the hydrochloride salt at 5–20% w/w are produced to reduce dust generation and improve active assay uniformity in final feed on farms where mixing is performed in vertical mixers with short batch times. The granulation route uses a 120–200 mm roller compactor with a screen granulator, or a low-shear planetary mixer and extruder, to produce granules with a target particle size of 400–800 µm and a bulk density of 0.55–0.75 g/cm³. Because the active is water-soluble, wet granulation must be performed with a minimal aqueous binder at 5–10% w/w of dry mass and dried at 40–50 °C to a final moisture below 1.0% w/w; higher moisture during storage above 65% relative humidity causes caking and assay non-uniformity. Equipment and process controls follow 21 CFR 225.30 for mixer validation and 21 CFR 225.120 for bulk feed storage and distribution. Segregation testing is performed according to ISO 6497:2002 or an equivalent validated sampling plan; the granulated premix must maintain active assay within ±5% of label at the top, middle, and bottom of a 1000 L tote after 20 min of simulated transport vibration. Terminal product types include medicated feed granules, top-dress granules for swine, and intermediate bulk granules for licensed feed mills.
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Changqing Qiu Chong Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied as an unformulated active pharmaceutical ingredient for further processing by licensed veterinary pharmaceutical manufacturers. The material is released under the manufacturer’s specification code printed on the batch certificate; no single international model number or compendial designation applies to the named substance. Because this product is intended for multiple downstream presentations, the particle size distribution and bulk powder properties may be specified according to the intended dosage form. A micronized grade may be specified for poorly soluble actives in suspension or for content uniformity in low-dose solid oral forms; a non-micronized grade may be preferred for granulated premixes where dust generation must be minimised. The manufacturer’s specification code typically distinguishes these grades, and the code should be confirmed against the certificate of analysis before formulation work. The powder is intended for incorporation into registered veterinary medicinal products and is not a ready-to-administer feed additive or drinking-water product. Typical batch documentation includes assay on the dried basis, related substances, residual solvents, loss on drying, residue on ignition, heavy metals, microbial enumeration, and particle size data. Where the API is destined for injectable manufacture, the formulator must additionally control bacterial endotoxins, particulate matter, and sterility of the final product.
Published monographs specific to this named product are limited in major pharmacopoeias. Release testing is therefore aligned with general chapters applicable to veterinary active substances. The acceptance criteria below are representative of a veterinary-grade active substance intended for solid oral dosage forms; exact limits are fixed by the marketing authorization and the batch certificate.
| Attribute | Method or standard reference | Unit | Typical acceptance criterion |
|---|---|---|---|
| Assay on dried basis | HPLC, in-house validated method | % w/w | 98.0–102.0 |
| Loss on drying | Ph. Eur. 2.2.32 | % | Not more than 5.0 |
| Related substances | HPLC area normalization | % | Total impurities not more than 2.0; unspecified impurity not more than 0.5 |
| Residue on ignition | Ph. Eur. 2.4.14 | % | Not more than 0.2 |
| Heavy metals | USP ⟨231⟩ / Ph. Eur. 2.4.8 | ppm | Not more than 20 |
| Microbial enumeration | USP ⟨61⟩, USP ⟨62⟩ | CFU/g | TAMC not more than 10³; TYMC not more than 10²; absence of Escherichia coli and Salmonella |
For injectable use, additional tests are mandated: bacterial endotoxins per USP ⟨85⟩, subvisible particulates per USP ⟨788⟩, and sterility per USP ⟨71⟩. The exact endotoxin limit is derived from the dose and body weight of the target species, not from the API alone.
In tablet manufacturing, the API is first characterized for particle size distribution by laser diffraction and for bulk density and tapped density by USP ⟨616⟩. These measurements determine whether direct compression is feasible or whether granulation is required. Low-dose anticoccidial tablets are typically prepared by geometric dilution of the active powder with a carrier such as lactose monohydrate or microcrystalline cellulose in a bin blender. Blend uniformity is tested by assay of stratified samples; an RSD not more than 5.0% is a common acceptance limit for solid oral dosage forms under USP ⟨905⟩. If the angle of repose exceeds 40°, flow is considered poor and a glidant such as colloidal silicon dioxide at 0.2–0.5% w/w is introduced before capsule filling or compression. Capsule filling on dosator or tamping pin machines requires fill weight RSD not more than 2.0% to avoid content uniformity failures. Production bottlenecks observed on veterinary solid-dose lines include segregation during free-fall transfer into the press hopper and capping or lamination on rotary presses when dwell time is insufficient for the plastic deformation characteristics of the granulation. For standard rotary tablet presses operating at 40–80 rpm, compression force is typically adjusted within 5–15 kN until the friability is not more than 1.0% per USP ⟨1216⟩ and the disintegration or dissolution requirement of the target monograph is met. Formulation development usually includes a compatibility screen by storing binary mixtures of the API with candidate excipients at 40 °C/75% RH for 4 weeks and analysing for assay and related substances. This screen is common but does not replace formal stability studies under ICH Q1A or VICH GL3. Published data for this specific named API are limited; formulation-specific compatibility and stability studies must be performed.
The unformulated powder differs from commercial finished premixes and coated granules chiefly in potency, excipient load, and process control responsibility. A finished anticoccidial premix usually contains a carrier such as corn cob grit or mineral oil and is intended for direct feed addition; the API must instead be incorporated into a formulation by the manufacturer. The potency difference means the unformulated powder requires more rigorous containment and dust control during weighing and sifting. Coated granules may provide a diffusion barrier that modifies release rate in the gastrointestinal tract; the unformulated API does not possess such a barrier, so release kinetics in tablets or capsules must be engineered through matrix polymers, film coatings, or other formulation techniques. The powder cannot be substituted for a finished premix at the same inclusion rate without recalculating the active concentration on a dry matter basis and validating blend homogeneity in the final feed.
During feed premix and granule production, the API is generally first blended with a portion of the carrier before introduction into a ribbon blender or paddle mixer. Mixing time and fill level are selected to obtain a coefficient of variation not more than 5.0% across 10 stratified samples, which is a common limit for medicated feed premixes; the exact value must be confirmed under the product authorization. Liquid paraffin or vegetable oil at 1–2% w/w can be sprayed onto the mixture to reduce dust and improve adhesion to porous carriers, provided compatibility with the active moiety is demonstrated by stability-indicating assay. For granulated products, wet granulation in a high-shear granulator followed by fluid-bed drying is common. The inlet air temperature must remain below the thermal degradation threshold determined by forced degradation; published data for this named API are limited, so a minimum dataset under ICH Q1A and VICH GL3 is required. In continuous or melt-granulation trials, a twin-screw extruder with 40:1 L/D and segmented screws is available; however, thermal and shear history must not exceed the stability window defined by assay and related substances. A known production failure mode in medicated premix lines is post-blending segregation in free-fall transfer or steep cone bins; reducing cone half-angle to less than 30° and avoiding intermediate bulk containers with lengthy drop distances are common corrective measures.
Table 2 summarizes processing routes and the associated critical control parameters.
| Dosage presentation | Equipment class | Critical control parameter | Typical limit or standard |
|---|---|---|---|
| Tablet | Bin blender, rotary tablet press | Blend uniformity, compression force | RSD not more than 5.0%; friability not more than 1.0% per USP ⟨1216⟩ |
| Capsule | Dosator or tamping pin capsule filler | Fill weight uniformity | RSD not more than 2.0% |
| Injection | Stainless steel mixing vessel, sterilizing-grade filter | Pre-filtration bioburden, filter integrity | Not more than 10 CFU/100 mL before filtration; ASTM F838-20 |
| Oral solution | Multi-dose container | Preservative effectiveness | USP ⟨51⟩ category 1 or target product category |
| Premix | Ribbon blender, paddle mixer | Active uniformity after mixing | RSD not more than 5.0% across 10 samples |
| Granule | High-shear granulator, fluid-bed dryer | Drying inlet air temperature | Below API thermal degradation threshold; ICH Q1A, VICH GL3 |
For injectable products, the unformulated powder is first dissolved or suspended in a vehicle suitable for the intended route. If the active moiety is poorly soluble, a suspension is prepared with wetting agents and viscosity-modifying polymers, and sedimentation volume, redispersibility, and particle size are controlled. Solution formulations require clarity, pH, and tonicity adjustment before bioburden reduction. Sterilizing-grade membranes with a pore size of 0.22 µm are used for filtration; filter integrity is tested before and after use by bubble point or diffusion per ASTM F838-20. Terminal sterilization may be selected if the active substance is thermostable; otherwise aseptic filtration and filling are required. The pre-filtration bioburden limit of not more than 10 CFU/100 mL is a widely applied EU GMP Annex 1 guidance value; actual limits may differ by process validation. For injectable-grade use, bacterial endotoxins are tested per USP ⟨85⟩ and subvisible particulates per USP ⟨788⟩ or Ph. Eur. 2.9.19. The unformulated powder is not depyrogenated, so the formulator must either source a low-endotoxin batch or include a validated endotoxin control step. Oral solutions and drench products are less restrictive but, where multi-dose containers are used, preservative effectiveness is assessed by USP ⟨51⟩ or Ph. Eur. 5.1.3. For these dosage forms, chemical stability in aqueous media must be established, because the API may hydrolyse or oxidise after reconstitution; published data for this specific named API are limited.
Storage conditions before use are defined by the batch certificate and safety data sheet. At relative humidity above 60%, pre-drying may be required before dry granulation or capsule filling, because moisture uptake can reduce flow and accelerate hydrolysis or polymorphic transitions. Compatibility with amine-functional additives should be examined by differential scanning calorimetry or isothermal stress testing before formulation, because reactive amines can form adducts or discolour related veterinary actives; no inference should be applied to this named powder without experimental verification. Avoid uncontrolled contact with strong oxidizers, strong acids, and strong bases during development. A stability-indicating analytical method should be qualified by forced degradation that includes hydrolysis, oxidative challenge, photolysis, and thermal stress. For oxidative challenge, hydrogen peroxide concentrations from 0.1% to 3.0% are commonly used depending on degradation sensitivity. Published data for this exact named product are limited, and the results are required to define the allowable processing window and packaging configuration.
