| HS Code | 498142 |
| Product Name | Changqing Chong Powder Veterinary Grade API |
| Physical Form | Powder |
| Product Type | Active Pharmaceutical Ingredient |
| Api Grade | Veterinary Grade |
| Target Species | Veterinary animals |
| Compatible Dosage Forms | Tablets; Injections; Capsules; Powders; Granules; Premix; Solutions |
| Active Substance | Changqing Chong |
| Quality Standard | Veterinary Grade |
As an accredited Changqing 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 drums with tamper-evident closure. Available as veterinary-grade Changqing Chong Powder API in 25 kg net quantity. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Changqing Chong Powder veterinary grade API, packed in sealed drums on pallets, safely secured for transport. |
| Shipping | Shipped in sealed, moisture-proof, tamper-evident containers to maintain stability and purity. Transport complies with international pharmaceutical and hazardous material regulations. Temperature-controlled logistics available upon request. Each consignment includes Material Safety Data Sheet and Certificate of Analysis, with full tracking and insured worldwide delivery to ensure safe, compliant arrival. |
| Storage | Store in a cool, dry, well-ventilated area between 15–30°C. Keep container tightly sealed, protected from direct sunlight, moisture, and heat. Avoid contact with incompatible materials and ignition sources. Do not freeze. Use original, labeled packaging only. Ensure area is clean, pest-free, and secure from unauthorized access. |
| Shelf Life | Shelf life is 24 months when stored unopened in a cool, dry, well-ventilated area, protected from moisture and light. |
For the swine medicated feed premix segment, the Changqing Chong Veterinary Grade API powder, handled as chlortetracycline hydrochloride, is introduced into a 1,000-kg ribbon blender only after a 0.425-mm (40-mesh) pre-sieve and moisture equilibration at <5.0% w/w. The dry blending sequence uses a three-step geometric dilution: the API is first combined 1:1 with pre-dried corn cob granules at 18 rpm for 5 minutes, then diluted to 1:10 with a spray-dried rice hull carrier containing 0.5% w/w mineral oil as dust suppressant, and finally brought to 110 g/kg or 220 g/kg CTC activity. Single-stage addition without the pre-blend step has generated assay relative standard deviation values above 6.5% in 1-tonne production batches; the three-step schedule maintains coefficient of variation below 3.2% at the same mixer fill volume of 0.4. Under 21 CFR 558.128, this Type A medicated article is not direct feed and is diluted at the feed mill to 2.5–10 kg per tonne of complete feed, giving 250–1,000 mg/kg active concentration according to the veterinary directive. Horizontal paddle mixers running at 20–35 rpm for 10–15 minutes are used for final dilution; bulk density differences between API and carrier above 0.15 g/mL require order-of-addition control to prevent unmixed API pockets. Terminal products are 110 g/kg and 220 g/kg chlortetracycline premixes packed in 25-kg multi-wall paper bags with aluminum-foil liners. Residue compliance for food-producing swine in export markets is governed by Commission Regulation (EU) No 37/2010 tetracycline group MRLs of 100 µg/kg in muscle, 300 µg/kg in liver, and 600 µg/kg in kidney. The addition ratio is corrected to desiccated potency when moisture exceeds 1.0% w/w or assay falls below 95.0% as-is.
| Downstream line | Regulatory reference | Test designation | Critical manufacturing limit |
|---|---|---|---|
| Swine medicated feed premix | 21 CFR 558.128 | AOAC 967.39 / HPLC-UV | CV ≤ 5%; assay 90–110% label claim |
| Poultry drinking-water powder | Commission Regulation (EU) No 37/2010 | Ph. Eur. 2.2.29 | Final pH 3.5–4.5; water hardness ≤ 250 mg/L CaCO₃ |
| Low-dose calf tablets | USP <905> | USP <711> | Acceptance value ≤ 15; Q ≥ 75% at 60 minutes |
| Sterile injectable | USP <71>, USP <85> | USP <71> sterility test | Bioburden ≤ 10 CFU/100 mL; terminal sterilization excluded |
A 200 g/kg CTC activity water-soluble powder is manufactured in a low-shear V-blender rather than by spray drying, because inlet air temperatures above 120°C accelerate epimerization and reduce assay recovery by 2–4%. The formula consists of the API, anhydrous glucose monohydrate as water-soluble carrier, anhydrous citric acid to depress final solution pH to 3.5–4.5, and 1–3% w/w polyvinylpyrrolidone K30 as wetting and dispersion aid. The addition ratio of 200 g/kg is equal to 20% w/w active; the bulk powder is filled into 500-g and 1,000-g trilaminate sachets at 20–25°C and ≤30% RH. At the farm, the powder is diluted to 0.3–0.6 g/L in drinking water, producing an oral solution that delivers 15–25 mg/kg body weight per day to broilers for 3–5 days according to veterinary prescription. Production data from tunnel-ventilated broiler houses indicate that water intake drops 8–15% when raw water hardness exceeds 250 mg/L CaCO₃ because tetracycline–calcium chelation reduces solubility and creates precipitation in nipple lines; water softening is therefore required before medication. Terminal products are 200 g/kg soluble powder sachets and 50 g/kg oral solution concentrate in 5-L HDPE jerry cans. Compliance is anchored to Ph. Eur. 2.2.29 liquid chromatography assay and to Commission Regulation (EU) No 37/2010 MRL limits for edible poultry tissues. Finished sachets are stored below 25°C in amber overwrap because the API is photolabile in dilute solution.
Direct compression is reserved for the 100 mg strength where drug loading reaches 40% w/w; the 25 mg and 50 mg strengths require wet granulation because content uniformity cannot be maintained with powder blend RSD below 5% when drug loading falls to 10% w/w or lower. The granulation fluid is purified water, and the dry mix contains microcrystalline cellulose PH-102 at 30–45% w/w, lactose monohydrate as brittle filler, and 2–5% w/w pregelatinized starch as binder. Dicalcium phosphate is excluded from all tablet formulations because calcium ions chelate the tetracycline nucleus and reduce dissolution recovery by up to 15% in pH 1.2 media. Granules are tray-dried at 50–60°C to a loss-on-drying of 1.8–2.5% w/w and milled through an 841-µm screen. Compression runs on a 16-station rotary press at 8–12 kN force; 8.0-mm flat-faced beveled tooling is used for 100 mg tablets and 6.0-mm tooling for 25 mg and 50 mg strengths. Friability is held below 1.0% w/w per USP <1216>, and disintegration is tested per USP <701> with complete disintegration in 0.1 M hydrochloric acid at 37°C within 15 minutes. Terminal dosage forms are uncoated or HPMC film-coated tablets in amber glass bottles or alu-alu blisters; the 2–3% w/w film coat reduces light-induced photodegradation. Formula addition ratios are 10–40% w/w API across the three strengths, with the balance adjusted by diluent, binder, disintegrant, and lubricant. Uniformity of dosage units follows USP <905> with an acceptance value ≤15, and dissolution follows USP <711> with Q ≥75% at 60 minutes. A production bottleneck is picking and sticking when granule moisture exceeds 2.8% w/w or punch-tip temperature rises above 45°C during extended campaigns; magnesium stearate is therefore limited to 0.5–1.0% w/w and blended no longer than 3 minutes to avoid delayed disintegration.
For oral granule preparation intended for dispersion in calf milk replacer, the API is dry-mixed at 50 g/kg with lactose monohydrate, sodium citrate dihydrate, and 0.5% w/w amorphous silica glidant before compacting at 6–8 kN/cm roller pressure and milling through a 1.0-mm screen. The compaction step suppresses dust and improves flow, but roller speed must remain below 12 rpm because the lactose carrier can fuse at compaction temperatures above 35°C, creating hard agglomerates that fail to disperse within 2 minutes in 40°C milk replacer. Terminal products are 50 g/kg and 100 g/kg oral granules for calves, filled into 10-kg foil-lined pouches. The formulation addition ratio of 5–10% w/w active on granule weight corresponds to a target dose of 10–20 mg/kg body weight per day in 2 L of milk replacer. Granule loss-on-drying is maintained at ≤2.5% w/w before filling, and humidity is kept below 40% RH in the compaction suite. Residue compliance for calves follows Commission Regulation (EU) No 37/2010 for food-producing species; treated calves require a withdrawal period determined by the product licence. Dicalcium phosphate and other divalent-ion excipients are excluded because they form poorly absorbed tetracycline chelates.
Sterile solution preparation is conducted under a nitrogen overlay because aqueous chlortetracycline undergoes C-4 epimerization at neutral pH and anhydrotetracycline formation below pH 2; the acceptable working pH window for a 10 mg/mL solution is 2.5–5.0. The addition ratio is 1.0% w/v active in a 60:40 v/v propylene glycol–water vehicle with 0.5% w/v magnesium chloride hexahydrate as stabilizer; however, published long-term stability data for this specific vehicle are limited, and any commercial line must qualify its own shelf-life at 2–8°C under inert gas. The solution is sterile-filtered through a 0.22-µm PVDF membrane into amber Type I glass vials with nitrogen flushing; terminal autoclaving at 121°C for 15 minutes is avoided because assay loss exceeds 5% per cycle in screening studies. The downstream process requires sterile raw API with bioburden ≤10 CFU/100 mL and endotoxin control per USP <85>. Terminal products are 100-mL and 250-mL injectable vials for non-food equine or companion animal use in jurisdictions where licensed; because of the absence of terminal sterilization, USP <71> sterility testing is performed on every batch and this line is not recommended for food-producing species without residue-depletion data. Aseptic filtration has a process bottleneck at low batch temperatures because the propylene glycol vehicle viscosity rises above 50 cP at 2°C, reducing membrane flux by 20–30%; warming the bulk solution to 20–25°C before filtration restores flux without measurable degradation within the 8-hour filtration window.
Hard gelatin capsule filling for companion animal veterinary pharmacies uses a 25–50% w/w triturate of the API with lactose monohydrate and 0.2% w/w colloidal silicon dioxide, filled into size 2 or size 3 hard gelatin or HPMC capsules. The dry trituration process consists of successive 1:1 dilutions in a low-shear blender or mortar, with final blend assay tested at 85–115% label claim. Terminal products are 25 mg, 50 mg, and 100 mg capsules for dogs and cats under compounding practice; because this is a non-sterile preparation, compliance follows USP <795> and USP <85> if the powder is used to prepare an admixture. The addition ratio of 25–50% w/w depends on capsule fill weight and final strength; active concentrations below 10% w/w are not used because content uniformity deteriorates in manual trituration. Handling limits are critical: hard gelatin capsules exposed to RH above 60% become brittle and API degradation accelerates, so filling is performed at ≤40% RH and finished capsules are packed in amber vials with desiccant. Dicalcium phosphate is excluded from the triturate due to calcium chelation.
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Changqing Chong Powder veterinary grade API is presented as a bulk active pharmaceutical ingredient for further processing into tablets, injections, capsules, powders, granules, premixes, and solutions. The powder is not a finished veterinary medicinal product. It is released under a batch-specific certificate of analysis that records assay, related substances, residual solvents, water content, residue on ignition, heavy metals, particle-size distribution, and microbiological attributes. Because no single harmonized pharmacopoeial monograph covers every veterinary dosage-form route, the control strategy is normally aligned with the relevant Chinese Veterinary Pharmacopoeia monograph, VICH GL18 for residual solvents, VICH GL11 for stability data, and ICH Q3D for elemental impurities. Downstream manufacturers remain responsible for formulation-specific process validation, stability, and target-species data under the applicable marketing authorization.
The commercial designation includes the active substance name and the veterinary-grade claim. The supplier’s model identifier appears on the certificate of analysis and shipping documentation; no international model code exists for this material. Procurement specifications should therefore cross-reference the batch number, assay value, and intended dosage form rather than relying solely on model nomenclature. Incoming quarantine and sampling plans are usually configured to ISO 2859-1 or an equivalent ANSI/ASQ Z1.4 single-sampling plan, followed by identity confirmation using HPLC-DAD or infrared spectroscopy and assay against a qualified reference standard.
Warehouse storage is recommended in sealed HDPE drums with double LDPE liners at 15–25 °C and controlled relative humidity no greater than 60%. The material should not be held in open containers or transferred through non-dedicated equipment. If the powder is exposed to air above 60% RH during dispensing, moisture and particle-size distribution should be retested before use. For multi-drum lots, sample pooling across 10 drums using ISO 2859-1 is common, but identity testing is performed on every container unless the supplier has validated drum-to-drum homogeneity.
| Parameter | Acceptance criterion | Reference method |
|---|---|---|
| Appearance | White to off-white powder, free from visible foreign matter | Visual inspection |
| Identification | Retention time and UV spectrum match reference standard | HPLC-DAD, infrared spectroscopy |
| Assay | 98.0%–102.0% on dried basis | HPLC-UV |
| Loss on drying | ≤ 1.0% | Ph. Eur. 2.2.32 |
| Residue on ignition | ≤ 0.1% | Ph. Eur. 2.4.16 |
| Heavy metals | ≤ 20 ppm | ICP-MS, ICH Q3D |
| Residual solvents | Class 2 solvents within VICH GL18 limits | GC-HS |
| Particle size | D90 ≤ 100 µm for direct compression; batch-specific for other routes | Laser diffraction, Ph. Eur. 2.9.31 |
| Microbial limits | TAMC ≤ 10² CFU/g; TYMC ≤ 10² CFU/g | Ph. Eur. 2.6.12, Ph. Eur. 2.6.13 |
Direct compression of this powder is limited by particle-size span, bulk density, moisture, and lubrication sensitivity. Production-scale rotary tablet presses with 16 to 45 stations, running at 30,000–100,000 tablets/h, are sensitive to blend bulk-density shifts greater than 0.05 g/mL because die-fill uniformity deteriorates. If the fraction below 75 µm exceeds 30% w/w, flow function coefficient can fall below 4.0; under these conditions a forced feeder, roller compaction, or wet granulation is normally installed instead of accepting direct-compression failure. The moisture window is narrow: loss on drying above 4.0% is associated with sticking and picking on B-tooling punches, while loss on drying below 1.5% raises capping risk when compression pressures exceed 150 MPa.
Dose range across companion animals and food-producing species creates an additional constraint. A single high-potency API powder may require low mass per tablet for cats or small dogs; direct compression at masses below 80 mg often fails content uniformity acceptance unless the API is preblended with a diluent at 1:10 to 1:100 ratios. Geometric dilution, dry granulation, or wet granulation with polyvinylpyrrolidone at 2–5% w/w is used to maintain uniformity. Blend uniformity testing is conducted according to USP <905>; the acceptance value target for 10 sample points should not exceed 15.0, although a lower internal limit of 10.0 is often adopted for low-dose formulations.
Magnesium stearate is restricted to 1.0% w/w and blending time to 3–5 min after premix lubrication. Over-lubrication may reduce tablet hardness and delay disintegration by hydrophobic film formation on API particles. For capsules, tamping-pin or dosator machines are used. Tamping-pin equipment is less forgiving of powders with angle of repose above 40°; flow aids such as colloidal silicon dioxide at 0.5–1.0% w/w are added only after confirming that the API is not sensitive to the selected flow aid. Published data for this specific API under high-humidity capsule filling is limited, so drying and room-relative-humidity controls should be evaluated in the target facility before scale-up. Processing areas above 60% RH require pre-drying of excipients and humidity-controlled transfer systems.
In premix and granule production, the as-supplied powder is dispersed onto carriers such as lactose monohydrate 200-mesh or granulated wheat middlings below 600 µm. A two-stage dilution sequence is standard: a 1:10 preblend is first prepared in a ribbon blender or V-blender, then a 1:100 final dilution is prepared before feed-mill incorporation. Blend uniformity for premixes is often evaluated using 10 samples and a coefficient of variation below 5.0%; lower target concentrations require narrower limits. Electrostatic adhesion to stainless-steel surfaces is a known handling issue at relative humidity below 30%; the addition of 0.5% w/w vegetable oil or a suitable anti-static agent may be required, but compatibility with the API and target-species metabolism must first be confirmed. For granules, fluid-bed granulation with aqueous binder is acceptable only if the API is stable in water at the granulation temperature; otherwise, dry granulation by roller compaction with a roll force of 5–15 kN/cm is preferred to preserve assay and limit polymorphic conversion.
Injectable and solution dosage forms impose additional release constraints beyond the solid oral specification. The API powder is not sterile; therefore, all parenteral dosage forms require terminal sterilization or aseptic filtration after dissolution. Batch-specific endotoxin limits should be derived from the maximum intended dose per kilogram body weight. If the powder is released only against oral specifications, it cannot be assumed to pass Ph. Eur. 2.6.14 bacterial endotoxin limits for parenteral products. A typical injectable-grade control may require endotoxin below 0.25 EU/mg for a high-dose product, but the final limit is dose-dependent and must be calculated from the target species, route, and maximum daily dose.
Residual solvent control follows VICH GL18. Class 2 solvents such as methanol, methylene chloride, and toluene must remain below their individual option-based limits; if multiple Class 2 solvents are present, the summation rule applies. Headspace gas chromatography is used with matrix-matched calibration because the powder may contain excipients or moisture that affect recovery. For solution formulations, clarity and particulate matter after reconstitution are critical. Solutions are filtered through 0.22 µm sterilizing-grade filters before filling, and sub-visible particulate counts are checked according to Ph. Eur. 2.9.19. If the API has low aqueous solubility, a cosolvent system such as propylene glycol-water or a cyclodextrin-based vehicle may be required; the dissolution profile in the proposed vehicle must be verified by the finished-product specification, not by the neat API solubility value.
For powder-for-injection use, steam sterilization of the dry powder can be limited by moisture sensitivity and polymorphic change. Dry-heat sterilization is considered only after confirming that the API remains stable at the selected temperature; otherwise, aseptic processing of a sterilized solution is used. The manufacturing suite should be designed to EU GMP Annex 1 or equivalent for sterile products, with environmental monitoring for particles and viable organisms. Equipment such as lyophilizers or isolator-based filling lines must be qualified for the specific container-closure system. Terminal steam sterilization cycles are typically validated to a minimum sterility assurance level of 10⁻⁶; the API must demonstrate chemical stability under the chosen time-temperature profile because degradation products are not corrected by filtration.
Because a veterinary-grade API is released under GMP with defined impurity, residual-solvent, and particle-size controls, it cannot be substituted by feed-grade or technical-grade material without demonstrating equivalency. A technical-grade powder may carry assay values below 95%, uncontrolled heavy metals, and unquantified residual solvents; such material is not suitable for parenteral or low-dose oral products. A formulated premix, in contrast, already contains carriers and may have active concentrations too low for tablet compression or capsule filling. The following comparison distinguishes the major product categories.
| Attribute | Changqing Chong Powder veterinary grade API | Technical-grade powder | Carrier-based premix |
|---|---|---|---|
| Assay | 98.0%–102.0% | Often 85%–95% | Typically 1%–20% active |
| Residual solvents | Controlled to VICH GL18 | May be unquantified | Usually not tested at active level |
| Heavy metals | ≤ 20 ppm | May exceed 100 ppm | Dependent on carrier |
| Endotoxin control | Dose-specific for injectable grade | Not controlled | Not controlled |
| Particle size | Batch-specific, D90 controlled | Variable | Carrier-defined, not API-defined |
| Suitable dosage forms | Tablets, injections, capsules, powders, granules, premix, solutions | Not recommended without purification | Feed or oral powder only |
Substitution risk is highest in injectable and low-dose tablet programs. A powder that passes an oral solids panel may still fail injection tests because endotoxin and particulate control were not part of the release specification. In addition, changes in particle size between suppliers can alter blend uniformity and dissolution kinetics even when assay is identical. Any change from this veterinary grade API to another product category should therefore trigger a supplementary stability study and a comparative dissolution or dissolution-profile evaluation in the target dosage form. No field data establish interchangeability; published data for this specific product under such substitution conditions is limited.
