| HS Code | 303348 |
| Productname | Xiaochuang Powder Veterinary Grade API |
| Substancetype | Veterinary Active Pharmaceutical Ingredient (API) in powder form |
| Physicalform | Fine, free-flowing powder |
| Colour | White to off-white |
| Odour | Characteristic to the API or practically odourless |
| Solubility | Compatible with veterinary formulation vehicles for tablets, injections, capsules, powders, granules, premix, and solutions |
| Purityassay | ≥ 98.0% on anhydrous basis |
| Particlesizedistribution | Uniform powder suitable for tableting, encapsulation, and premix blending |
| Lossondrying | ≤ 5.0% w/w |
| Heavymetalslimit | ≤ 10 ppm |
| Residualsolvents | Meets applicable VICH/ICH limits |
| Microbiologicalpurity | Meets pharmacopoeial requirements; free from Salmonella, E. coli, and Staphylococcus aureus |
| Storageconditions | Store in tightly sealed, original containers in a cool, dry, well-ventilated area; protect from light and moisture |
| Shelflife | 24 months from date of manufacture under recommended storage conditions |
| Intendeddosageforms | Tablets, injections, capsules, powders, granules, premix, and solutions |
As an accredited Xiaochuang 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 double-lined sealed drums and moisture-proof bags to ensure stability, available in 1 kg, 5 kg, or 25 kg net quantities. |
| Container Loading (20′ FCL) | Container loading of 20′ FCL: packed in sealed drums, palletized, ventilated, secured for safe transport. |
| Shipping | This veterinary API is shipped in sealed, moisture-resistant containers to protect purity and stability. For domestic and international transport, we use secure, tamper-evident packaging with temperature-controlled options if required. All shipments comply with relevant regulations, with full documentation, traceability, and careful handling to prevent contamination or damage during transit. |
| Storage | Store in a cool, dry, well-ventilated area, away from direct sunlight, moisture, and incompatible substances. Keep the container tightly closed when not in use. Protect from extreme temperatures and physical damage. Ensure proper labeling and segregation to maintain product integrity, potency, and compliance with veterinary pharmaceutical regulations until use. |
| Shelf Life | Shelf life: 24 months when stored sealed in a cool, dry place, protected from light and moisture. |
Tablet manufacture with Xiaochuang Powder Veterinary Grade API begins with dispensed dry powder whose particle size distribution and bulk density govern die fill uniformity on high-speed rotary presses. The formulation addition ratio is calculated from the intended dose and total core mass; a 250 mg active dose in an 800 mg core corresponds to 31.25% w/w. Direct compression formulations generally maintain the API fraction between 1.0% w/w and 40.0% w/w, while low-dose high-shear wet granulation operates at 0.5% w/w to 25.0% w/w with a dry binder such as pregelatinized starch. Compliance under Regulation (EU) 2019/6 Annex I and FDA 21 CFR Part 210/211 requires completion of Ph. Eur. 2.9.8 and USP <1217> tablet breaking force measurements, Ph. Eur. 2.9.1 / USP <701> disintegration testing, USP <905> content uniformity, and friability testing per USP <1216>. The manufacturing sequence passes the API through a 20 mesh (0.85 mm) sieve to delump, followed by dry blending in a bin blender at 8–12 rpm for 15–20 min. For high-shear wet granulation, a GEA UltimaPro 300 or equivalent is operated at impeller 200–400 rpm and chopper 1500–3000 rpm, with purified water added at 8–15% w/w of batch. Drying in a fluid bed dryer with inlet air 55–65°C and product temperature 40–50°C reduces loss on drying to ≤2.0% w/w. The dried granulate is milled through a 0.8 mm Conidur screen at 1500 rpm and lubricated with magnesium stearate 0.25–1.0% w/w for 3–5 min. Compression on a rotary tablet press equipped with D tooling uses precompression 5–10 kN and main compression 8–25 kN to achieve tablet breaking force 50–120 N and friability ≤1.0% after 100 drops. Disintegration in purified water at 37±2°C is targeted at ≤15 min unless a published product monograph specifies otherwise. Terminal finished dosage types include uncoated and film-coated oral tablets for dogs, cats, swine, calves, sheep, and poultry, with film coating applied at 3.0% w/w weight gain where moisture protection is required.
Aqueous injectable solutions expose the API to aqueous stress, oxygen ingress, and bioburden accumulation; the principal control point is bacterial endotoxin load because downstream aseptic filtration does not remove lipopolysaccharide. The addition ratio for an injectable solution is expressed as mass per volume. A 100 mg/mL solution requires 100.0 g/L, equivalent to 10.0% w/v; a 50 mg/mL solution requires 5.0% w/v. Tonicity is adjusted to 280–320 mOsm/kg with sodium chloride 0.9% w/v or dextrose 5.0% w/v, and pH is maintained between 4.5 and 7.5 with dilute hydrochloric acid or sodium hydroxide. Release testing follows USP <1>, USP <71>, USP <85>, Ph. Eur. 2.6.1, and Ph. Eur. 2.6.14; sterile manufacture follows EU GMP Annex 1. Production begins in a 316L stainless steel jacketed vessel with Water for Injection at 20–30°C. The API is added under an overhead mixer at 300–600 rpm with nitrogen overlay if oxygen sensitivity is demonstrated. The bulk solution is prefiltered through a 0.45 μm polyethersulfone membrane and then sterilized through a 0.22 μm PVDF membrane with bubble point integrity testing before and after filling. Aseptic filling into Type I borosilicate glass vials of 10–250 mL occurs under Class A laminar airflow with rubber stopper insertion. Terminal heat sterilization is adopted only when pilot-scale thermal degradation data demonstrate assay loss within specification; published data for this specific configuration is limited, so aseptic filtration remains the default for manufacturing robustness. Terminal finished dosage types include sterile injectable solutions for cattle, sheep, swine, horses, and companion animals.
| Control point | Standard | Control range | Equipment/note |
|---|---|---|---|
| Bioburden pre-filtration | Ph. Eur. 2.6.12 | ≤ 10 CFU/100 mL | membrane filtration |
| Bacterial endotoxins | Ph. Eur. 2.6.14 / USP <85> | < 0.5 EU/mg API | Limulus amebocyte lysate test |
| Sterility | Ph. Eur. 2.6.1 / USP <71> | no growth after 14 days | aseptic membrane filtration |
| Particulate contamination | USP <788> | monograph limits by Method 1 | light obscuration |
| Filter integrity | bubble point per manufacturer | ≥ minimum bubble point | 0.22 μm PVDF |
Medicated premix production operates under FDA 21 CFR Part 225.1 for medicated feed manufacturers and Regulation (EU) 2019/6 Annex IV, with sampling and homogeneity verification under ISO 6497:2002. The addition ratio in the premix concentrate is generally within 0.05% w/w to 5.0% w/w active API, followed by downstream dilution at the feed mill at ratios between 1:10 and 1:100. A 10 kg active charge in 1000 kg premix corresponds to 1.0% w/w. Ribbon blending of the API with ground corn, calcium carbonate, and aerosil flow aid proceeds for 15–25 min at 50–70% fill volume; assay uniformity across 10 sampling points must yield coefficient of variation ≤5.0%. Carryover control between batches uses a flush batch of calcium carbonate or ground corn; FDA 21 CFR Part 225.102 requires sequential flushing with verification that active carryover is ≤1.0% of the previous batch. Where pelleted medicated feed is manufactured, the conditioned meal is exposed to steam at 70–85°C under 2–4 bar pressure for 30–60 s before passing through a die of 2.5–4.0 mm. Because published thermal stability data for Xiaochuang Powder Veterinary Grade API in pelleted feed is limited, process validation must include active recovery studies before and after pelleting. Cooling to within 5°C of ambient and moisture control to ≤12.0% w/w protect mass flow in bins and silos. Terminal finished dosage types include medicated premix, meal feed, and pelleted complete feed for poultry, swine, and cattle.
| Verification point | Reference standard | Control limit | Equipment/method |
|---|---|---|---|
| Mixing uniformity | ISO 6497:2002 | Coefficient of variation ≤ 5.0% | ribbon mixer sample thief |
| Moisture | ISO 6496:1999 | ≤ 12.0% w/w | forced-air oven |
| Carryover | FDA 21 CFR 225.102 | ≤ 1.0% of previous batch | flush batch assay |
| Conditioning temperature | process validation protocol | 70–85°C | steam conditioner with pressure 2–4 bar |
Capsule filling of low-dose Xiaochuang Powder Veterinary Grade API departs from tablet granulation because powder flow, floodability, and segregation resistance determine fill weight accuracy on automatic dosing-disc machines. The formulation addition ratio is derived from dose strength and capsule fill mass; a 50 mg API dose in a Size 1 capsule with 300 mg total fill mass corresponds to 16.7% w/w, and a 5 mg dose in a 250 mg fill mass corresponds to 2.0% w/w. Manufacturing compliance is anchored to USP <905> content uniformity, USP <711> dissolution, USP <1174> powder flow, FDA 21 CFR Part 210/211, and Regulation (EU) 2019/6. The API is sifted through a 30 mesh (0.59 mm) screen and blended in a V-cone blender at 15 rpm for 20 min with pregelatinized starch, lactose monohydrate, microcrystalline cellulose, and croscarmellose sodium. Sodium stearyl fumarate at 0.5–1.5% w/w is added for 3 min as the lubricant. Filling on a Bosch GKF 1500 or equivalent automatic capsule machine at 50,000–100,000 capsules/h is performed under ≤40% RH at 20–25°C. Fill weight is monitored every 15 min with rejection outside ±5.0% of target, and filled capsules pass through a metal detector. Dissolution testing follows USP <711> using Apparatus II at 50 rpm in 0.1 N HCl at 37±0.5°C; acceptance criteria are defined in product-specific monographs or in-house validation because a compendial dissolution monograph for this API is not universally established. Terminal finished dosage types include hard gelatin and HPMC capsules for companion animals, calves, foals, and small ruminants.
In drinking-water oral powder production, dispersion performance is determined by wetting time, electrolyte tolerance, and particle size distribution after sachet filling. The addition ratio is set by the target in-water concentration and product application rate; a target of 500 mg active per litre from a product applied at 1 g per litre requires an API fraction of 50.0% w/w in the dry granule, whereas a target of 250 mg active per litre at 1 g per litre requires 25.0% w/w. Regulatory requirements include Regulation (EU) 2019/6 and relevant pharmacopoeial general chapters for mass uniformity of oral powders, while batch release may include ISO 6496:1999 moisture testing. The downstream process uses top-spray fluid bed granulation with aqueous hydroxypropyl cellulose binder at 5.0–10.0% w/w of dry solids. Inlet air is maintained at 55–70°C, product temperature at 30–40°C, and atomization air pressure at 1.5–2.5 bar; drying continues to final loss on drying ≤2.0% w/w. Sieving to 20–80 mesh (0.18–0.85 mm) removes conglomerates, and the granulate is packed in aluminium foil laminate with desiccant. A rehydration test in 500 ppm hard water at 20°C must show wetting time ≤5 min without visible agglomeration. Terminal finished dosage types include water-soluble powders and oral granules for poultry, swine, and calves.
Oral drench solutions require tighter viscosity control than injectable solutions because dosing pumps, tube feeders, and container necks impose different fluid paths. The addition ratio for an oral drench commonly ranges from 5.0% w/v to 20.0% w/v active API; a 2 g active dose in a 20 mL drench corresponds to 10.0% w/v. Compliance is maintained under Regulation (EU) 2019/6, FDA 21 CFR Part 210/211, and applicable pharmacopoeial general chapters for liquid preparation uniformity; physicochemical testing includes pH according to USP <791>, density, and assay by validated HPLC. Manufacturing uses purified water at 25–35°C, with propylene glycol 10–30% v/v and glycerol 5–10% v/v as co-solvents. The API is dispersed under a propeller mixer at 300–600 rpm for 30 min; citric acid/sodium citrate buffer adjusts pH to 4.0–6.0 to control hydrolysis and deprotonation. The solution is filtered through a 10 μm polypropylene cartridge filter and filled into HDPE drench packs with tamper-evident caps. Published data for solubility in high-ionic-strength oral vehicles is limited; pilot solubility and preservative efficacy studies should accompany scale-up. Terminal finished dosage types include oral drench solutions for cattle, sheep, goats, and pigs.
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As a purified active pharmaceutical ingredient intended for multi-route veterinary formulation, Xiaochuang Powder Veterinary Grade API, designated Model XC-VAPI-200 in manufacturer technical documentation, is supplied as a free-flowing crystalline powder for incorporation into tablets, injections, capsules, oral powders, granules, premix, and solutions. The material is released under a certificate of analysis defining route-dependent specifications for assay, related substances, residual solvents, loss on drying, residue on ignition, heavy metals, microbial limits, and, where injectable presentation is required, bacterial endotoxins and sterility. Particle size distribution is determined by laser diffraction in accordance with ISO 13320-1:2020; published data for this specific configuration is limited, and particle size targets are assigned according to the intended manufacturing route. Identity is confirmed by infrared absorption spectrophotometry per Ph. Eur. 2.2.24 and by retention time agreement in high-performance liquid chromatography against a certified reference standard. Polymorphic form, residual solvent levels, and degradation product profile are controlled through validated analytical procedures applied to each batch.
For oral solid forms, release specifications depend on assay, related substances, loss on drying, residue on ignition, and microbial enumeration. Related substances are controlled under principles of VICH GL11, with identification, quantification, and qualification thresholds tied to daily exposure. A specified impurity reporting threshold of 0.05% is applied when the maximum daily dose exceeds 10 mg/kg body weight; the qualification threshold is 0.1% or 1.0 mg/day unless toxicological data justify a higher limit. Residual solvents follow VICH GL18(R2); class 1 solvents must be absent, class 2 solvents are limited by concentration and daily exposure, and class 3 solvents are controlled at not more than 5000 ppm. Loss on drying is measured by Ph. Eur. 2.2.32; residue on ignition by Ph. Eur. 2.4.14; microbial enumeration by Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13. For injections, bacterial endotoxins are determined by the kinetic chromogenic or gel-clot method of Ph. Eur. 2.6.14. The limit is calculated from the maximum endotoxin exposure of 5 EU/kg body weight per hour for parenteral veterinary products; a common release limit is below 0.50 EU/mg when the dose is 10 mg/kg or lower. Particulate contamination in injectable solutions is controlled by light obscuration per Ph. Eur. 2.9.19. Sterility is evaluated by membrane filtration per Ph. Eur. 2.6.1 after terminal sterilization or aseptic processing.
In tablet and capsule manufacture, processing behavior is governed by bulk density, particle morphology, and moisture sorption. Direct compression trials on a 300 L bin blender at 12 rpm with sampling after 25 min are used to assess blend uniformity; if the acceptance value exceeds 15.0, the process is converted to dry granulation. Roller compaction with a gap of 1.0 mm to 2.0 mm and roll pressure adjusted to compact porosity below 0.75 reduces segregation and improves flow. Tableting is performed on a Korsch XL 400 rotary press using 10 mm round tooling; ejection force, tablet hardness, and friability are recorded per Ph. Eur. 2.9.7 and Ph. Eur. 2.9.8. Capsule filling on a Bosch GKF 1500 at 75,000 capsules/h may require 0.5%–1.5% colloidal silicon dioxide to control electrostatic charging; the adjusted Carr index is used to verify flow before encapsulation. Moisture uptake is a critical constraint. If the API equilibrates above 30% relative humidity, caking may require a 60°C pre-drying step. Published data for this specific configuration is limited, so pilot-scale evaluations using the target excipient system are required.
Injectable solution development requires dissolution in Water for Injections and subsequent sterilization. The API is dissolved at 20°C to 25°C; pH adjustment is performed with dilute sodium hydroxide or hydrochloric acid. Oxidative degradation is assessed by sparging the solution with nitrogen and comparing degradation products by high-performance liquid chromatography. Filter compatibility is evaluated with polyethersulfone and polyvinylidene fluoride membranes at 0.22 µm; adsorption losses are quantified by filtrate recovery at three time points. If recovery falls below 95.0%, alternative membrane materials or pre-wetting protocols are used. Bacterial endotoxin load is reduced through depyrogenation only when thermal stability permits; dry heat exposure at 250°C for 30 min is a common depyrogenation cycle, but its applicability must be confirmed by degradation profile comparison. Terminal sterilization by moist heat at 121°C for 15 min may be used if the solution remains within specification for assay and related substances. The injection-grade release specification includes bacterial endotoxins, sterility, particulate matter, pH, and assay; all test methods are validated according to VICH GL1 and VICH GL2.
For oral powder and premix applications, constraints differ from solid dosage forms. A 1:10 dilution with lactose monohydrate in a ribbon blender is sampled at 10 points; the acceptance value is not more than 15.0 according to Ph. Eur. 2.9.40. If segregation occurs, the API is granulated using a high-shear granulator at impeller speeds of 200–400 rpm with purified water or starch paste; wet massing continues until a torque increase indicates densification. The wet granules are dried in a fluid-bed dryer with inlet air temperature of 60°C to 70°C until loss on drying is not more than 2.0%. Milling through a 1.0 mm screen yields granules for final blending with flow aids and fillers. Premix carriers such as corncob, limestone, or lactose require assessment of adsorption, homogeneity, and stability; carrier pH should be maintained between 5.0 and 8.0 unless forced degradation data justify a wider range.
Polymorphic form is monitored by X-ray powder diffraction per Ph. Eur. 2.9.33; a change in crystal habit can alter dissolution rate, solubility, and sedimentation behavior. In low-solubility compounds, micronization by jet milling with compressed nitrogen at 4 bar to 6 bar feed pressure produces a D90 below 20 µm, but surface energy increases and flowability decreases. The micronized powder is often incorporated into tablets via dry granulation or wet granulation because direct compression fails due to cohesive arching. For oral suspensions, the API is dispersed in aqueous vehicles containing wetting agents; redispersibility is tested by mechanical shaking and sedimentation volume. Zeta potential measurements guide electrostatic stabilization; values above +30 mV or below −30 mV are generally considered sufficient for physical stability. In injectable solutions, polymorphism is less relevant after complete dissolution, but crystalline residues must be excluded by filtration. Published data for this specific configuration is limited, and the relationship between crystal form and bioavailability should be confirmed by dissolution testing using Ph. Eur. 2.9.3 paddle apparatus at 50 rpm in the proposed medium.
Differences between Xiaochuang Powder Veterinary Grade API and technical-grade premix powders are summarized in the following matrix. The route-specific grade is controlled for active substance status, impurity profile, residual solvents, and microbial quality; technical-grade powders often lack full pharmacopoeial release data. The values are representative release targets and must be confirmed against the current certificate of analysis.
| Parameter | Technical-grade premix powder | XC-VAPI-200 oral solid grade | XC-VAPI-200 injection grade |
|---|---|---|---|
| Assay by HPLC | Label claim only; unspecified impurities not controlled | 98.0%–102.0% dried basis | 98.0%–102.0% dried basis |
| Total impurities | Not specified | ≤ 1.0%; specified impurities ≤ 0.5% | ≤ 1.0%; specified impurities ≤ 0.5% |
| Bacterial endotoxins | Not controlled | Not required unless used in injectable or mucosal route | < 0.50 EU/mg by Ph. Eur. 2.6.14 |
| Microbial limits | Not systematically released | TAMC ≤ 10³ CFU/g; TYMC ≤ 10² CFU/g | Sterility per Ph. Eur. 2.6.1 |
| Residual solvents | Not controlled | Class 2 limited per VICH GL18(R2) | Same as oral grade |
| Particle size D90 | Variable, often > 500 µm | ≤ 150 µm for direct compression; ≤ 20 µm for suspension | Dissolved; particulate matter controlled in solution |
| Polymorphic form | Not specified | Controlled by XRPD | Controlled by XRPD |
The substitution of a technical-grade powder with a compendial-grade API affects formulation economics, process capability, and regulatory documentation. Technical-grade powders are typically sourced for feed premix or oral powders where a label claim is the primary specification; they may contain process impurities above VICH GL11 thresholds and are not approved for parenteral use. Xiaochuang XC-VAPI-200 is released with full active substance documentation, including route-specific certificates of analysis, stability data, and declaration of residual solvents. The difference is measurable in injection preparation: technical-grade material would require additional purification, depyrogenation, and impurity qualification, while XC-VAPI-200 injection grade is controlled for endotoxin and sterility. For tablet and capsule manufacture, the increased control of particle size and polymorphic form reduces batch-to-batch variation in dissolution and content uniformity. Potential incompatibilities include amine-containing excipients that can react with electrophilic degradation products; forced degradation studies under heat, humidity, acid, base, oxidation, and photolysis should follow VICH GL5. If an incompatibility is identified, formulation adjustments use protective coatings, pH modifiers, or alternative fillers.
| Release test | Analytical method | Standard clause |
|---|---|---|
| Assay | HPLC with UV detection | Ph. Eur. 2.2.29 |
| Related substances | HPLC gradient | VICH GL11; Ph. Eur. 2.2.29 |
| Loss on drying | Halogen moisture analyzer | Ph. Eur. 2.2.32 |
| Residue on ignition | Muffle furnace at 600°C | Ph. Eur. 2.4.14 |
| Heavy metals | ICP-MS | Ph. Eur. 2.4.20 |
| Bacterial endotoxins | Kinetic chromogenic LAL | Ph. Eur. 2.6.14 |
| Sterility | Membrane filtration | Ph. Eur. 2.6.1 |
| Uniformity of dosage units | HPLC content per unit | Ph. Eur. 2.9.40 |
| Dissolution | Paddle apparatus 50 rpm | Ph. Eur. 2.9.3 |
| Particle size | Laser diffraction | ISO 13320-1:2020 |
For stability evaluation, long-term storage at 25°C/60% RH and accelerated storage at 40°C/75% RH are applied according to VICH GL3. Batches are placed in aluminum foil laminate overwrap to reduce moisture ingress; desiccant quantity is calculated from package moisture vapor transmission rate and API moisture sensitivity. For tropical zone registration, storage at 30°C/65% RH may be required under VICH GL45. The retest period is assigned only after at least three primary batches demonstrate all attributes within specification. If a product is reformulated from a technical-grade powder to the API grade, comparative dissolution profiles in at least three media are needed to justify equivalency. Published data for this specific configuration is limited; therefore, site-specific stability protocols should be finalized with the manufacturer dossier.
