| HS Code | 757669 |
| Product Name | Jililing Pills Veterinary Grade API |
| Api Name | Jililing |
| Grade | Veterinary Grade |
| Physical Form | Solid API suitable for processing into various dosage forms |
| Intended Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Appearance | White or almost white powder |
| Solubility | Soluble in designated pharmaceutical solvents based on formulation requirements |
| Application | Used as an active pharmaceutical ingredient for veterinary medicinal products |
| Compatibility | Compatible with common excipients used in tablets, capsules, granules, powders, premix, solutions, and injectable formulations |
| Target Animals | Livestock, poultry, and other veterinary species as directed |
| Storage Conditions | Store in a dry, cool, well-ventilated area protected from light and moisture |
| Shelf Life | 24 months from date of manufacture when stored under proper conditions |
| Packaging | Sealed and light-protected multi-layer packaging suitable for pharmaceutical raw materials |
| Quality Standard | Conforms to veterinary grade API specifications |
As an accredited Jililing Pills 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 | Jililing Pills Veterinary Grade API is supplied in sealed, moisture-proof drums, 25 kg per drum, ensuring purity, stability, and safe handling. |
| Container Loading (20′ FCL) | One 20-foot FCL container loaded with veterinary-grade Jililing Pills API, securely packed in drums/pails, palletized and sealed for transport. |
| Shipping | This veterinary-grade API, Jililing Pills, is shipped in sealed, tamper-evident containers with proper labeling. Packaging prevents contamination, moisture, and light damage. Export documents include SDS, certificate of analysis, and compliance with international veterinary drug regulations. Temperature-controlled logistics and cold-chain options are available on request. |
| Storage | Store in a tightly sealed, original container in a cool, dry, well-ventilated area away from direct sunlight, heat, and moisture. Protect from physical damage and contamination. Keep out of reach of children and animals. Follow manufacturer’s label and Safety Data Sheet for specific temperature ranges and expiry. |
| Shelf Life | For Jililing Pills Veterinary Grade API, shelf life is 24 months in original sealed packaging under cool, dry, dark storage. |
At incoming quality control, Jililing Pills Veterinary Grade API is released for downstream processing only after particle-size distribution, bulk density, and loss-on-drying data are matched to the target dosage form. Laser diffraction values are reported under ISO 13320:2020, and sieve analysis follows ASTM E11 using wire cloth with apertures from 75 µm to 500 µm. The milled grade used for tablet and capsule formulations typically requires a D90 of ≤ 150 µm, while the micronized grade intended for oral suspension or injectable suspension is controlled at a D90 of ≤ 15 µm to prevent sedimentation and inconsistent dose delivery. Loss on drying is measured under USP <731> and is kept below 1.0% for moisture-sensitive processing routes. Powder flow is characterized by USP <1174>, with compressibility index and Hausner ratio derived from USP <616>. If angle of repose exceeds 40° or compressibility index exceeds 25%, the lot is routed to wet granulation, dry granulation, or carrier deposition rather than direct compression. The following process windows are therefore assigned by downstream route.
Direct compression is retained only when the API compressibility index from USP <616> remains below 25% and the particle-size distribution D90 is ≤ 150 µm. On a rotary press equipped with plain B-tooling, tablets at target weight of 250 mg are compressed at 8 kN to 12 kN until breaking force measured by USP <1217> is between 40 N and 80 N. At relative humidity above 60%, the API can pick up a surface moisture film within 45 min, producing edge chipping and punch sticking. The process therefore requires conditioned air at 25 °C ± 2 °C and 35% RH ± 5%. Wet granulation is triggered when the direct-compression blend has a flow function coefficient below 4 or when API dose is below 5 mg per tablet because segregation risk becomes unacceptable. In a top-driven high-shear granulator, dry excipients—lactose monohydrate at 60–70 wt%, microcrystalline cellulose at 20–30 wt%, croscarmellose sodium at 2–4 wt%, and the API at the labelled concentration—are premixed at impeller speed 300 rpm for 3 min. Purified water is added at 8–12 wt% with a peristaltic pump over 90 s, then wet massing continues for 4–6 min at 400 rpm. Drying in a fluid-bed dryer with inlet air at 60 °C and product temperature 35 °C stops at a loss-on-drying endpoint of 1.5–2.5%. The dried granules are passed through a 1.0 mm oscillating granulator. A final lubricant addition of magnesium stearate at 0.5 wt% is blended for 3 min in a twin-shell V-blender at 15 rpm; over-lubrication above 1.0 wt% can depress tablet breaking force below 30 N and extend disintegration beyond 15 min under USP <701>. Tablet content uniformity is verified according to USP <905>, with acceptance value not exceeding 15.0 for the labelled dose.
Capsule filling introduces a different failure mode from tablet compression. The same API is diluted with pregelatinized starch or microcrystalline cellulose to a fill weight that matches the dosator chamber volume on a continuous capsule filler. Powder bed depth, tamping pin pressure, and dosator height are adjusted so that the tapped density at USP <616> remains between 0.55 g/mL and 0.75 g/mL. For size-0 hard gelatin capsules with a fill weight of 400 mg, the target weight variation is ±3.5% per shell, and in-process verification at 15-min intervals follows USP <905>. At relative humidity above 50%, the shell becomes pliable, the powder may bridge inside the dosator nozzle, and fill weight drift exceeds 5% within 20 min. A dry granulation or slugging step is therefore specified for powder blends with a Carr index above 28%. The slugged material is passed through a 0.8 mm mill and recompressed into slugs at 4–6 kN using a dry granulator; the resulting granules are then filled with a tamping pin machine at 40 rpm. Dissolution of the capsule product is monitored under USP <711> with 900 mL of 0.1 M hydrochloric acid at 37 °C and paddle speed 75 rpm; the Q value is set at 75% release in 45 min. If the API is moisture-labile, replacing gelatin with HPMC capsules is qualified at 25 °C/30% RH because HPMC shells lose brittleness at lower moisture but may require a small amount of fluidized-bed granulation to prevent electrostatic repulsion during high-speed filling.
If the API is administered through a proportioner dosing pump, the formulation must remain chemically stable and fully dissolved at the working concentration for 24 h under farm conditions. The pH is adjusted with citric acid or phosphate buffer so that solubility is at least 5 mg/mL in hard water at 25 °C; a solubility below 1 mg/mL shifts the design to a suspension formulation or a soluble powder with a carrier and wetting agent. In a plain stainless-steel dissolution tank, the API is mixed with sodium chloride at 0.9% when isotonicity is required, and with potassium sorbate at 0.1–0.2% as an antimicrobial preservative. The solution is filtered through a 10 µm polypropylene bag filter before filling into opaque high-density polyethylene bottles. Challenge testing follows Ph. Eur. 5.1.3 for non-sterile oral liquids; the pH drift is controlled within ±0.2 units under USP <791>. At a waterline flow of 20 L/min, the dosing pump must maintain a linearity error below 2% across the range 0.5–10 L/h. Light-stability testing under ICH Q1B may require amber packaging if total degradation exceeds 5% after 1 h at 1.2 million lux·h and 200 Wh/m². Settling studies for hard-water incompatibility use a graduated cylinder over 24 h; visible flocculation at 50 ppm calcium carbonate indicates a need for a chelating agent such as EDTA at 0.05 wt%.
Feed premix production starts with the API adsorbed onto a carrier such as ground corn cob, rice hull, or calcium carbonate with a particle-size range of 300–850 µm. The carrier is pre-dried to ≤ 8% moisture and mixed with mineral oil at 1–2 wt% in a horizontal paddle mixer for 2 min to reduce active dust. The API is then added at a ratio that achieves one of the standard inclusion rates, commonly 1–5 kg/tonne in complete feed or 10–20 kg/tonne in a supplement premix. Blend uniformity is tested by sampling 10 locations across the ribbon blender after 5 min; the coefficient of variation is required to remain below 5.0% under 21 CFR 225.58. Carryover is limited by sequencing the batch after a flush material with similar bulk density and by setting dust-collection differential pressure at 500–800 Pa; a change in pressure drop above 1,000 Pa indicates filter blockage and creates cross-contamination risk. The following table aligns the main dosage routes with the governing standard and the primary numerical boundary.
| Dosage route | Primary method | Standard designation | Typical numerical target |
|---|---|---|---|
| Tablet | Uniformity of dosage units | USP <905> | AV ≤ 15.0 |
| Capsule | Dissolution | USP <711> | Q ≥ 75% at 45 min |
| Drinking-water solution | pH stability | USP <791> | pH drift ≤ 0.2 over 24 h |
| Premix | Blend uniformity | 21 CFR 225.58 | CV ≤ 5.0% |
| Injection | Bacterial endotoxins | Ph. Eur. 2.6.14 | ≤ 0.5 EU/mg |
For pelleted feed, the medicated premix is added at the post-pelleting step when the API degradation threshold is below 75 °C because conditioning in a pellet mill at 80–85 °C can produce losses above 10%. The post-pelleting liquid spray route in a vacuum coater at 0.8 bar negative pressure and 60 °C reduces thermal exposure to 2 min. Batch sequencing is verified by flushing with 50 kg of unmedicated carrier and assaying residual API by a validated HPLC method with a limit of quantification of 0.05 mg/kg. Published data for the specific Jililing molecule in pelleted feed is limited; therefore the thermal degradation boundary must be confirmed on site before high-temperature pelleting is approved.
For an injectable solution, the API is dissolved in Water for Injection at 25 °C and adjusted to target pH with 0.1 M hydrochloric acid or sodium hydroxide. Osmolality is measured under USP <785> and adjusted with mannitol or dextrose to 280–320 mOsm/kg. The batch is filtered through a 0.45 µm prefilter and then through a 0.22 µm polyethersulfone membrane; filter integrity is confirmed by a bubble point test under ASTM F838 before and after filling. Terminal sterilization is chosen only if the API retains assay above 95% after an F0 of 8 min at 121 °C. If thermal degradation exceeds 5%, the process switches to aseptic filling in a Grade A laminar airflow station compliant with ISO 14644-1 and a Grade B background, and sterility assurance relies on filtration plus environmental monitoring rather than moist heat. The filled vials are stoppered with chlorobutyl rubber closures coated with a fluoropolymer film to control leachables. Bacterial endotoxin limits follow Ph. Eur. 2.6.14 with a typical limit of ≤ 0.5 EU/mg of API; for a 10 mL vial, the limit is calculated from the dose volume and may be tighter. Particulate matter is measured under USP <788>; counts must not exceed 6,000 particles per container at ≥ 10 µm and 600 at ≥ 25 µm. The API particle size for an injectable suspension is typically D90 ≤ 5 µm to avoid capillary obstruction and reduce tissue irritation.
Oral granules and sachet powders share excipient compatibility with tablets but require low-dust granule morphology for automated filling lines. A dry granulation route is selected when the API is moisture-sensitive; the powder is compacted at 6–8 kN and milled to granules between 200 µm and 800 µm. In a vertical sachet form-fill-seal machine running at 60 strokes per minute, granule size below 150 µm increases dust and causes electrostatic rejection of the sealing layer, while granules above 1.0 mm produce weight variation greater than ±5%. Flowability is measured with a ring shear tester; a flow function coefficient below 3 requires the addition of 0.2 wt% fumed silica. The oral powder is filled into aluminium-foil laminate sachets with a moisture barrier of ≤ 0.1 g/m²/day at 38 °C/90% RH. Reconstitution in 1 L of drinking water at 25 °C must achieve a uniform suspension with sedimentation ratio above 0.9 at 1 h. If the reconstituted granules are intended for oral suspension, content uniformity of the delivered dose is checked under USP <905> after redispersion. Published data for the specific Jililing configuration in sachet granules is limited; therefore the dust-control threshold and granule-size distribution should be confirmed on the target filling line before batch release.
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Jililing Pills Veterinary Grade API is a multi-compendial active pharmaceutical ingredient released under two stock-keeping models. The model designated JLP-VAPI-MIC is a micronized crystalline powder intended for tablets, hard capsules, oral powders, granules, premixes, and reconstitutable oral solutions. The model designated JLP-VAPI-LYO is a lyophilised low-endotoxin powder for injectable solutions and sterile-filtered liquid concentrates. Both models are derived from the same active substance, but they diverge in particle size distribution, residual moisture, bioburden, and primary packaging. The manufacturer assigns a single batch identity and maintains a route-specific release matrix rather than a single monolithic specification. Release documentation includes assay by HPLC, related substances under VICH GL11, residual solvents under VICH GL18, water by USP 921, and particle size distribution by ISO 13320:2020. For the lyophilised model, bacterial endotoxin by Ph. Eur. 2.6.14, subvisible particulate matter by USP 788, and sterility by Ph. Eur. 2.6.1 are appended when the final dosage form is claimed as sterile.
Release control is not defined by a single monograph value but by a tiered specification keyed to the final route. For all presentations, identification is performed by infrared absorption spectrophotometry according to Ph. Eur. 2.2.24, and assay is determined by a validated high-performance liquid chromatographic procedure. Related substances are evaluated under VICH GL11; the reporting threshold is 0.10% for unspecified impurities, the identification threshold is 0.50%, and the qualification threshold is 1.0% for total impurities. Residual solvents are controlled according to VICH GL18 Class 2 concentration limits; any Class 1 solvent must be absent at or above the limit stated in that guidance. Water content by Ph. Eur. 2.5.12 is set at ≤5.0% for the micronized oral grade and lower for the lyophilised injectable model, because moisture ingress shifts the degradation rate in solid dosage forms and may affect reconstitution clarity in parenteral solutions. The parenteral model adds a bacterial endotoxin specification of <0.5 EU/mg by Ph. Eur. 2.6.14, which is a typical safety threshold for intravenously administered veterinary products, but the final limit must be confirmed against the target species dose and the route of administration. Elemental impurities are monitored according to Ph. Eur. 5.20 or USP 232/233, where applicable. These controls create a boundary: a lot that passes oral-grade release cannot be diverted to injectable use unless the parenteral extended testing panel has also been completed and the storage container has remained intact.
Solid-state processing is the main source of batch-to-batch variance in tablets, capsules, powders, granules, and medicated premixes. The micronized model is produced under controlled milling with inert gas circulation to avoid heat-induced polymorphic shifts. Particle size distribution is determined by laser diffraction according to ISO 13320:2020; the release criterion is a d50 below 20 µm and a d90 below 50 µm for low-dose premixes, but the actual values are batch-specific and are reported on the certificate of analysis. Bulk density and tapped density are measured by USP 616 or Ph. Eur. 2.9.34; the compressibility index and Hausner ratio are calculated to assess flowability before direct compression. If the compressibility index exceeds 25%, the API may require dry granulation or addition of a glidant such as colloidal silicon dioxide at 0.5% to 1.0% w/w, but compatibility must be confirmed because high-shear blending can increase electrostatic charge and reduce content uniformity in low-dose tablets. Tablet blend uniformity is evaluated by Ph. Eur. 2.9.40 or USP 905 after sampling at defined blend locations; acceptance criterion is based on relative standard deviation, typically not more than 5.0% for uniform dosage units, but the registered specification controls the final limit. Dissolution testing of finished tablets follows USP 711 or Ph. Eur. 2.9.3 using the apparatus and medium selected during product development; no single dissolution condition is appropriate across all veterinary species because gastric pH and transit time vary substantially.
For hard capsule filling, the same micronized API is blended with lactose monohydrate or microcrystalline cellulose after pre-sieving through a 0.710 mm mesh to break soft agglomerates. Moisture is a critical border: when process area relative humidity exceeds 60%, the powder may bind on the capsule dosator and cause weight fluctuation; pre-drying at 40 °C to 45 °C for not more than 4 h is used where CofA water content is above the validated limit. These temperatures are equipment-independent but must be revalidated on the specific fluid-bed dryer or tray dryer used in production. Powder blends for oral sachets and granules are wet-granulated only when the API shows poor flow or low bulk density; otherwise a direct blending process with geometric dilution is preferred to limit thermal exposure. Granulation liquid addition rate is adjusted to maintain a granule moisture content below 3.0% after drying, as higher moisture accelerates hydrolysis in aluminium foil packaging and shifts the impurity profile during stability storage. Wet granulation with a high-shear granulator requires a defined liquid addition rate. When the API is granulated with purified water or a binder solution, the impeller tip speed is typically 5 m/s to 10 m/s in high-shear mixers, but this is equipment-specific. Over-granulation increases particle size and reduces dissolution rate; under-granulation lowers tablet hardness and increases friability. The endpoint is controlled by torque or power consumption rather than time alone. Drying is performed in a fluid-bed dryer with inlet air temperature 60 °C to 70 °C and product temperature not exceeding 40 °C; residual granule moisture should return to ≤3.0%. These conditions are typical for moisture-sensitive APIs but must be confirmed by forced degradation studies.
Parenteral processing imposes constraints that are not relevant for oral powders. The lyophilised model is reconstituted in Water for Injection under a unidirectional airflow cabinet; the resulting solution is filtered through a 0.22 µm low-protein-binding membrane before filling. The API must be free of visible particles after dissolution; clarity of solution is assessed by Ph. Eur. 2.2.1 or equivalent, and subvisible particulate matter in the final container is measured by USP 788. Where the final injection is terminally sterilised by moist heat at 121 °C for 15 min, thermal degradation products must be tracked in the stability programme; if the product is heat-labile, aseptic filtration with a 0.22 µm sterilising grade filter is used instead, and sterility is confirmed by Ph. Eur. 2.6.1. The API is not claimed to be intrinsically sterile unless the lyophilised model is gamma-irradiated or ethylene oxide treated under a validated cycle; such treatments must be pre-approved because residual ethylene oxide and its degradation products are restricted by VICH GL18. Dissolved oxygen level is reduced by nitrogen sparging to below 2 ppm before sealing to limit oxidative degradation in aqueous solutions; this is a standard headspace control for oxygen-sensitive veterinary actives, but published data for this specific configuration is limited. Injection solutions should be used within the validated in-use hold time after reconstitution; no multi-dose container should be preserved with benzyl alcohol unless the compatibility of the preservative with the API has been demonstrated by challenge testing according to Ph. Eur. 5.1.3 or USP 51. Solution pH is controlled using dilute hydrochloric acid or sodium hydroxide; the target pH is defined by solubility and stability studies, and the API should not be exposed to pH values below 2.0 or above 9.0 without data supporting chemical integrity. Buffering salts may crystallise after steam sterilisation; therefore phosphate-buffered solutions require visual inspection after cooling.
Premix homogeneity is a particular bottleneck on production-scale ribbon mixers with working capacities above 500 kg. When the API is added as a micronized fraction to a granular calcium carbonate or corncob carrier, segregation can occur during silo discharge if the carrier size distribution is too coarse. The blend is therefore discharged through a rotary valve into lined paper sacks rather than pneumatically conveyed over long distances. Sampling follows the registered sampling plan, usually not fewer than 10 locations per lot, and the assay acceptance is set by the registered premix specification. If the relative standard deviation exceeds 5.0%, the batch is remixed or reprocessed, but re-milling is not recommended because it can reduce carrier particle size and shift bulk density. The choice of carrier is not trivial: lactose-based carriers are preferred for oral powders due to high water solubility; calcium carbonate carriers suit mineral premixes but may raise pH in aqueous dilution and alter API solubility.
Most veterinary API powders are released for a single route: an oral premix, a feed additive, or a sterile injection. Jililing Pills Veterinary Grade API is differentiated by a dual specification envelope that applies bacterial endotoxin, particulate matter, and sterility tests to the lyophilised model while the micronized model carries powder-flow, particle size, and moisture controls for solid dosage forms. The operational consequence is supply-chain routing: a single active substance can be allocated to a tablet granulation, a capsule filling line, or a sterile solution filling suite without changing the chemical identity. That routing is limited by container-closure integrity. Once a bag or vial is opened in a non-sterile environment, the lot cannot be reassigned to aseptic processing; endotoxin and bioburden status are no longer valid without re-sampling and re-testing. In comparison with typical feed-grade APIs, the veterinary grade imposes a lower related-substance limit and a defined residual solvent profile, but it does not automatically meet human pharmacopoeial requirements. The user must still verify that the active substance is approved for the intended target species, indication, and country, because compendial compliance does not replace veterinary registration data.
| Presentation | Typical manufacturing step | Binding API characteristic | Reference method |
|---|---|---|---|
| Tablets | Direct compression or wet granulation | Particle size distribution, powder flow, bulk/tapped density | ISO 13320:2020; USP 616; USP 1174 |
| Capsules | Low-shear blending, dosator or tamping-pin filling | Water content, agglomerate tendency, flow | USP 921; Ph. Eur. 2.9.34 |
| Injections | Reconstitution, sterile filtration, aseptic filling | Bacterial endotoxin, particulate matter, clarity | Ph. Eur. 2.6.14; USP 788; Ph. Eur. 2.2.1 |
| Powders and granules | Geometric dilution, wet granulation, drying | Particle size distribution, moisture, blend uniformity | ISO 13320:2020; USP 921; Ph. Eur. 2.9.40 |
| Premixes | Step-down mixing with carriers | Bulk density, segregation tendency, assay distribution | USP 616; USP 905 |
| Solutions | Dissolution, filtration, fill | Clarity, pH, related substances | Ph. Eur. 2.2.1; Ph. Eur. 2.2.3; VICH GL11 |
Stability-related boundaries apply to both models. The API should be stored below 25 °C in sealed original containers; excursions to 30 °C for short transport intervals are acceptable only if the stability protocol has bracketed that condition. Direct sunlight and relative humidity above 60% should be avoided for the micronized model. The lyophilised model should be used immediately after reconstitution; unpreserved solutions held for more than 24 h at room temperature are not supported by the control strategy. Compatibility with amine-functional excipients should not be assumed; condensation or Maillard-type reactions may occur in reducing-sugar-containing granulations. No specific incompatibility can be asserted without a documented binary mixture study. These are operational boundaries derived from general veterinary GMP practice; specific shelf-life and in-use limits must be taken from the registered product dossier.
| Attribute | Reference standard | Limit basis |
|---|---|---|
| Related substances | VICH GL11 | Unspecified impurity ≤0.10%; total ≤1.0% |
| Residual solvents | VICH GL18 | Class 2 limits; Class 1 absent |
| Water | USP 921; Ph. Eur. 2.5.12 | Oral grade ≤5.0%; injectable grade lower |
| Bacterial endotoxin | Ph. Eur. 2.6.14; USP 85 | <0.5 EU/mg for parenteral model |
| Particulate matter | USP 788 | Final container limits apply |
| Sterility | Ph. Eur. 2.6.1; USP 71 | Where sterile presentation is claimed |
| Elemental impurities | Ph. Eur. 5.20; USP 232/233 | Route-specific daily exposure limits |
