| HS Code | 162177 |
| Product Name | Siwei Chuanxinlian Tablets Veterinary Grade API |
| Product Type | Herbal Veterinary Active Pharmaceutical Ingredient |
| Active Ingredient | Andrographolide |
| Botanical Source | Andrographis paniculata (Chuanxinlian) |
| Cas Number | 5508-58-7 |
| Molecular Formula | C20H30O5 |
| Molecular Weight | 350.45 g/mol |
| Purity | ≥98% (HPLC) |
| Appearance | White to off-white crystalline powder |
| Odour | Characteristic, slightly bitter |
| Solubility | Soluble in acetone, ethanol and methanol; slightly soluble in water |
| Melting Point | Approximately 230°C |
| Veterinary Indications | Anti-inflammatory and antibacterial for respiratory, gastrointestinal and urinary tract infections |
| Target Animal Species | Poultry, swine, cattle, sheep and goats |
| Dosage Forms Compatible | Tablets, injections, capsules, powders, granules, premix and solutions |
| Storage Conditions | Sealed, cool, dry and protected from light |
| Shelf Life | 24 months |
As an accredited Siwei Chuanxinlian Tablets 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 polyethylene-lined fiber drums, 25 kg net each, sealed, labeled, and moisture-proof for veterinary API use. |
| Container Loading (20′ FCL) | 20' FCL container loading for Siwei Chuanxinlian veterinary grade API, packed securely in drums/cartons, ventilated, dry, and segregated for safe transport. |
| Shipping | Shipped as a veterinary-grade active pharmaceutical ingredient in sealed, moisture-proof, light-resistant packaging. Full chain-of-custody documentation, Certificate of Analysis, and customs-compliant labeling included. Temperature-controlled transport is available upon request. Protect from direct sunlight and humidity during transit to preserve stability, potency, and safety for downstream formulation. |
| Storage | Store Siwei Chuanxinlian veterinary-grade API in a tightly sealed, labeled container in a cool, dry, well-ventilated area, protected from light and moisture. Avoid temperatures above 25°C and contact with incompatible substances or ignition sources. Keep away from food, feed, and animals. Ensure proper segregation and handling to preserve stability and prevent contamination during formulation. |
| Shelf Life | Shelf life is typically 24 months when stored properly in sealed, light-resistant containers under dry, cool conditions. |
To achieve batch-to-batch repeatability in tablet compression of Siwei Chuanxinlian Tablets Veterinary Grade API, the extract is first characterised for loss on drying, angle of repose, and hygroscopicity after open storage at 25 °C/60% RH for 24 h. A direct-compression route is generally not feasible when the extract’s Carr compressibility index exceeds 25% because the powder exhibits erratic die fill on a 45-station rotary tablet press operating at 80,000 tablets/hour. In such cases, wet granulation with 8–10% w/w aqueous polyvinylpyrrolidone K30 solution is performed in a 600 L high-shear granulator with impeller speed 200–300 rpm and chopper speed 1,000–1,500 rpm; the endpoint is recorded when wet-mass density reaches 0.62–0.68 g/cm³. Drying in a fluid-bed dryer with inlet temperature 55–60 °C reduces residual moisture to ≤3.0% LOD. The dried granules are milled through a 1.0 mm screen and blended with crospovidone 5.0% w/w and sodium stearyl fumarate 0.5% w/w. Compression at 15–20 kN produces 400 mg tablets with hardness 70–100 N, friability ≤1.0% after 4 min at 25 rpm per USP <1216>. Disintegration is tested in water at 37±2 °C using USP <701>, with a release target of ≤15 min. Content uniformity follows USP <905>, with acceptance value AV ≤15.0 across 10 tablets. The extract input is calculated from the certified andrographolide assay value rather than a fixed weight, and residual solvent testing under USP <467> is required whenever ethanol-based extraction was used upstream.
Injectable compounding from this veterinary-grade extract is constrained primarily by the thermolabile fraction of diterpene lactones in aqueous solution and by the particulate load in the raw input. Pre-formulation work should include a thermal degradation study at 121 °C, 115 °C, and 100 °C using a calibrated autoclave with temperature probes distributed across the batch; if the andrographolide peak area under the HPLC curve drops by more than 3.0% from the unprocessed bulk, terminal sterilization is not suitable and aseptic filtration is selected. For aseptic processing, the extract is hydrated in Water for Injection at 25–30 °C and pH-adjusted to 6.5–7.0 with 0.1 M phosphate buffer before addition of propylene glycol at ≤20% v/v as co-solvent. Clarification proceeds through a 0.45 µm polyethersulfone prefilter and a 0.22 µm polyvinylidene fluoride sterilizing filter at 20–25 °C with a differential pressure below 0.7 bar, followed by filling into USP Type I borosilicate vials under ISO 14644-1 Class 5 laminar airflow. Filter integrity is tested before and after use by bubble point or diffusion according to manufacturer limits. Endotoxin is controlled through depyrogenation at 250 °C for 30 min for glassware and validated rinsing for elastomeric closures; the final product must meet USP <85> for the total daily dose. Particulate matter is monitored per USP <788>; for a 100 mL fill, the limit for ≥10 µm particles is 6,000 per container and for ≥25 µm particles is 600 per container. Because published thermal degradation data for this specific multi-component herbal extract in all buffering systems is limited, each batch requires a pilot-scale terminal sterilization mapping study before routine production.
Hard gelatin capsule production with this API requires a dry granulate rather than the milled extract because the raw powder often has an angle of repose above 40°, which prevents consistent dosator fill at 60,000 capsules/hour on an intermittent-motion capsule filler. Roller compaction is preferred over wet granulation when the batch volume is below 200 kg to avoid thermal exposure; the extract is compacted at roll pressure 40–50 bar, roll speed 5–7 rpm, and screen-milled through 0.8 mm to produce granules with a D50 of 180–250 µm. The blend is prepared with lactose monohydrate 40% w/w, microcrystalline cellulose PH 102 30% w/w, and croscarmellose sodium 5% w/w; colloidal silicon dioxide 0.25% w/w and magnesium stearate 0.50% w/w are added for flow and lubrication. The final blend must show tapped density 0.45–0.65 g/mL and Carr index ≤25% per USP <1174>. Encapsulation is performed in a room controlled to 35–45% RH and 21±2 °C; hard gelatin shell moisture changes above 2.0% w/w cause either brittleness or stickiness on the dosing disc. In-process weight checks are taken every 15 min with a target fill weight variation ≤±5.0%, and the batch is rejected if the relative standard deviation of 20 capsules exceeds 3.0%. Dissolution testing in 900 mL water with 0.5% sodium lauryl sulfate at 37±0.5 °C and paddle speed 50 rpm uses USP <711>; sampling at 45 min should show not less than 70% of labeled andrographolide. The capsule output is packed in polyvinyl chloride/aluminium foil blisters with desiccant canisters when the packaging line is located in an area above 60% RH.
When granulating for drinking-water administration, wet-mass density controls the final dispersibility more than granule hardness. The extract is transferred into a 400 L bottom-drive high-shear granulator and sprayed with 12–15% w/w purified water containing 5.0% w/w povidone K30; impeller speed is 180–220 rpm and chopper speed is 1,200–1,500 rpm. The granulation endpoint is recorded with a heated moisture balance showing wet-mass moisture of 12.0–14.0%. After transfer to a fluid-bed dryer with inlet 55–60 °C and product bed temperature 40–45 °C, drying continues until LOD ≤3.0% to prevent caking in sachet packaging. The dried granules are screened through 650 µm and blended with sodium lauryl sulfate 0.10% w/w to reduce surface foaming in medicated drinking water. Dispersibility is tested by adding one 5 g sachet to 1000 mL tap water at 25 °C with stirring at 150 rpm; no visible agglomerates should remain after 2 min, and the 24 h sediment volume should be ≤10% of total fluid height. Uniformity of dosage units across 10 sachets per USP <905> must have an acceptance value ≤15.0. Packaging in four-side-sealed aluminium sachets with an internal desiccant layer is needed in climates where monthly RH exceeds 70%. Turbidity, pH, and forced degradation at 40 °C/75% RH for 3 months are monitored because water-dispersible veterinary granules can undergo hydrolysis at glycosidic linkages in the extract; published stability-indicating data for this exact extract in granular form is limited, so a bracketing stability design on moisture and temperature is operated.
Medicated feed premix operations for poultry and swine often use the API at low inclusion; the concentration in finished feed may range from 0.05% to 0.50% w/w. Because the extract is a heterogeneous powder with particle size distribution 50–250 µm, direct addition to a 2,000 kg ribbon mixer causes segregation and under-dosing. A geometric dilution sequence is therefore used in a 300 L ploughshare mixer with choppers running at 2,800 rpm for 2 min after each addition. The sequence starts with 1:1 extract:calcium carbonate, then doubles the diluent mass at each stage until the active fraction is 5.0% w/w in a ready-to-use premix. Carrier selection uses rice husk powder or ground corn cob retained between 300 µm and 850 µm; carrier moisture is below 12.0% per ISO 6496:1999. To control electrostatic dust, food-grade mineral oil is sprayed at 0.1–0.3% w/w into the carrier before adding the extract intermediate. Homogeneity is confirmed by sampling 10 locations in the blender at 5 min, 10 min, and 15 min using ISO 6497:2002; the batch meets specification if the coefficient of variation for andrographolide content is ≤5.0%. The final premix is packed in 25 kg multi-wall paper bags with a 0.10 mm polyethylene inner liner. Feed mills that subject the final feed to pelleting should verify retention of the marker compound at conditioner temperature 75–85 °C for 30 s; steam above 90 °C for over 60 s may produce assay loss not predicted by dry-powder stability data.
For oral drench production, a co-solvent system is used to avoid sedimentation in positive-displacement dosing lines. The extract is first dispersed in glycerin formal in a 500 L jacketed tank using a rotor-stator homogeniser at 4,500–5,500 rpm for 20 min; a typical extract-to-solvent ratio is 1:1 by weight. The main vehicle consists of 60% v/v purified water, 20% v/v propylene glycol, and 15% v/v glycerin, with pH adjusted to 6.5–7.0 using 0.1 N sodium hydroxide or 0.1 N citric acid. Viscosity is checked at 25 °C with a Brookfield rotational viscometer spindle 2 at 60 rpm; a batch is reworked if viscosity exceeds 50 mPa·s because peristaltic drench guns at farm level show delivery deviation above ±5.0%. The bulk is passed through a 25 µm inline sanitary strainer before filling into 500 mL or 1000 mL high-density polyethylene bottles with induction-sealed caps. Bottle-fill volume is based on density 1.05–1.10 g/mL measured at 20 °C. Storage stability is evaluated under ICH Q1A conditions at 40 °C/75% RH for 6 months and 25 °C/60% RH for 12 months; colour deepening may occur without assay change and should be baselined with colour patches. Label requirements include not below 5 °C to prevent precipitation and not above 35 °C in distribution. Shake-well instructions are omitted only if the solution shows no sediment after 30-day standing at room temperature.
| Dosage form | Critical control point | Measured parameter | Test method/equipment | Operational target |
|---|---|---|---|---|
| Tablet | Compression stage | Hardness | USP <1216> | 70–100 N |
| Injection | Sterile filtration | Differential pressure | Membrane filter integrity test | <0.7 bar |
| Capsule | Dosator filling | Fill weight variation | Analytical balance | ≤±5.0%; RSD ≤3.0% |
| Granules | Fluid-bed drying | Loss on drying | Moisture balance | ≤3.0% |
| Premix | Ribbon/ploughshare blending | Marker assay CV | ISO 6497:2002 | ≤5.0% |
| Oral solution | Bulk filling | Viscosity | Brookfield viscometer | ≤50 mPa·s |
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Siwei Chuanxinlian Tablets Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a standardized multicomponent botanical active pharmaceutical ingredient derived from the four-herb formula designated in the Chinese Veterinary Pharmacopoeia. The material is supplied as a dried extract powder with a defined diterpene lactone profile, not as a simple ground herb mixture. The same API lot can therefore be directed into tablet masses, capsule fills, injectable solutions after aseptic filtration, dry powders, granules, feed premixes, and oral solutions. No internationally harmonized model code exists for this botanical API. The manufacturer lot code and linked certificate of analysis serve as the batch identifier. Procurement specifications require the lot code to be associated with an ICH Q2(R1)-validated HPLC chromatogram and a marker content statement. The product is referenced to the compendial Siwei Chuanxinlian Tablets monograph, with additional checks for veterinary species use.
The purity-defining parameter is the sum of diterpene lactones. Tablet and injection grades are released at ≥ 90.0% total diterpene lactones and ≥ 80.0% andrographolide. Premix and oral-powder grades are released at 10.0–30.0% total diterpene lactones when feed inclusion rate and blend uniformity, rather than absolute purity, control the formulation. The dried powder is controlled to ≤ 5.0% moisture by Karl Fischer, with a tablet-grade particle-size limit of D90 ≤ 180 μm under ISO 13320:2020. Heavy metal limits are ≤ 20 mg/kg for lead, ≤ 2 mg/kg for cadmium, ≤ 2 mg/kg for arsenic, and ≤ 0.1 mg/kg for mercury. Residual solvents are controlled under ICH Q3C or VICH GL18; spray-dried lots using ethanol report ethanol at ≤ 0.5% (5,000 ppm). Injection-grade lots are released with bacterial endotoxin ≤ 0.5 EU/mg by Ph. Eur. 2.6.14.
| Parameter | Tablet/capsule grade | Injection grade | Premix/oral powder grade |
|---|---|---|---|
| Total diterpene lactones | ≥ 90.0% | ≥ 90.0% | 10.0–30.0% |
| Andrographolide | ≥ 80.0% | ≥ 80.0% | ≥ 10.0% |
| Loss on drying | ≤ 5.0% | ≤ 5.0% | ≤ 5.0% |
| Particle size D90 | ≤ 180 μm | ≤ 180 μm | ≤ 250 μm |
| Lead | ≤ 20 mg/kg | ≤ 20 mg/kg | ≤ 20 mg/kg |
| Cadmium / arsenic / mercury | ≤ 2 / 2 / 0.1 mg/kg | ≤ 2 / 2 / 0.1 mg/kg | ≤ 2 / 2 / 0.1 mg/kg |
| Bacterial endotoxin | Not specified | ≤ 0.5 EU/mg | Not specified |
| Ethanol residual | ≤ 0.5% | ≤ 0.5% | ≤ 0.5% |
Direct compression and dry granulation are used for tablet and capsule manufacture. The spray-dried API is hygroscopic above 60% relative humidity and should be stored at 18–25 °C in sealed polyethylene-lined fiber drums. A direct compression blend containing 20.0 wt% API, 75.0 wt% microcrystalline cellulose, 4.0 wt% croscarmellose sodium, and 1.0 wt% magnesium stearate is compressed on a 16-station rotary tablet press at 8–12 kN compression force. Acceptable friability below 1.0% is obtained when API moisture is held at 2.5–3.0%; capping and edge chipping increase above 3.5% moisture. Lubricant blending is limited to 5 min at 25 rpm in a V-type mixer; longer mixing reduces tablet crushing strength and raises disintegration time above 15 min under USP <701> conditions. Capsule filling uses a premix with 0.25–0.50% colloidal silicon dioxide, filled to deliver 50–200 mg API per capsule depending on target species.
Failure modes on a capsule filling line are mainly static and flow-related. The spray-dried API acquires electrostatic charge below 40% relative humidity, causing powder adhesion to dosator pins and variable fill weight. The capsule-filling suite is maintained at 45–55% RH, and the API is blended with 0.25–0.50% colloidal silicon dioxide. Fill weight variation is monitored over 30 min start-up intervals; acceptance is not more than 2 capsules outside ± 5.0% of target fill weight. For dry oral powders, the API is blended with anhydrous lactose and colloidal silicon dioxide and filled into single-dose sachets; content uniformity is assessed by HPLC and should meet USP <905> acceptance values. The powder should not be stored in open containers above 25 °C because moisture uptake above 5.0% causes caking.
Spray-dried lots are manufactured from a filtered water-ethanol extract using inlet air at 160–180 °C and outlet air at 75–85 °C. The resulting powder shows bulk density 0.40–0.55 g/mL before compaction. If wet granulation is unavoidable for high-dose tablets, a binder solution containing 5.0% povidone K30 is added at 10–15% of the dry blend mass. The wet mass is dried in a fluid-bed dryer at 45–50 °C to a final moisture of 2.5–3.0%. Drying above 55 °C reduces tablet hardness and increases disintegration time, indicating thermal degradation of the matrix rather than a marker-only loss. Roller compaction is performed at 3–5 kN/cm specific roll force with a 1.5–2.5 mm gap and a granulator screen of 0.8–1.25 mm; the resulting granules show Hausner ratio 1.2–1.4 and are transferred directly to the tablet press.
Granule production for oral administration uses either dry granulation or wet granulation. The dry-granulated material is preferred for sachets and powder admixtures because it disperses rapidly in water without a wetting agent. Granules are controlled to ≤ 5.0% loss on drying and 0.45–0.60 g/mL bulk density. If the granule is added to drinking water, a dispersion test should be performed: 1.0 g of granules in 100 mL water at 25 °C should pass through a 0.5 mm sieve within 3 min. Production-scale blending in a 600 L ribbon blender shows segregation when the API particle size exceeds D90 200 μm and when the mixer is loaded above 70% capacity. The light extract powder tends to migrate to the top of the blend. This is corrected by reducing the API particle size to D90 ≤ 180 μm and spraying 0.5–1.0% light mineral oil or soybean oil onto the carrier before addition. Blend uniformity samples from 10 locations should meet relative standard deviation below 5.0% by HPLC marker content.
Injection-grade lots are dissolved in water-for-injection at 20–30 °C with stirring. The solution is adjusted to pH 6.5–7.5 with 0.1 M sodium hydroxide or hydrochloric acid. Terminal sterilization at 121 °C for 15 min is acceptable only if stability data confirm andrographolide retention above 95.0%; otherwise, filtration through a 0.22 μm membrane under aseptic conditions is specified. The solution should not be compounded with strong oxidising preservatives or metal-ion-fortified isotonicity agents, because the conjugated lactone ring of andrographolide undergoes oxidative ring opening. Published data for this specific multicomponent API in injectable solution is limited; an in-use stability period of 24 h at 2–8 °C should be confirmed before field use.
For medicated feed premix and oral solution applications, the API is added to lactose monohydrate or corn starch carriers and mixed in a V-type mixer at 10 rpm for 20 min. Premix concentrations from 1.0–10.0 g/kg are common; higher concentrations require geometric dilution to keep the coefficient of variation below 5.0% by near-infrared blend uniformity. Oral solutions are prepared by first dispersing the API in a co-solvent system containing 10–20% ethanol and 0.5–1.0% polysorbate 80, then diluting with potable water. Precipitation is observed when the final solution pH falls below 5.0 or when ionic strength exceeds 0.9% sodium chloride equivalents. A 72 h in-use stability test is recommended because published water stability data for this botanical API remain limited.
The API is incompatible with strongly acidic carriers such as citric acid anhydrous or fumaric acid at more than 1.0% of the premix mass. Binary blends with these acids become sticky under accelerated storage at 40 °C / 75% RH for 4 weeks, and diterpene lactone content declines. The product should not be milled in a high-shear granulator with ferrous sulfate or copper sulfate mineral premixes; free metal ions catalyse oxidative ring opening and discoloration. If a vitamin-mineral premix is required, the API is kept in a separate layer or added after the mineral phase has been absorbed onto microcrystalline cellulose. Blends with bentonite or zeolite should be evaluated for reduced dissolution under USP <711> because the high surface area can bind the active constituents.
Batch-to-batch marker variance is controlled by sourcing material from a single harvest region and by blending before spray drying. The manufacturer certificate of analysis should include the HPLC chromatogram with relative retention times and peak-area ratios for the characteristic diterpene lactones. A near-infrared identity model validated with 20 batches is used in the warehouse to reject substandard lots before dispensing; the model is revalidated annually under ICH Q2(R1) and USP <1119>. This reduces the risk of misloading a premix-grade lot into an injection batch. Analytical methods for marker quantification should be capable of resolving andrographolide from neoandrographolide and dehydroandrographolide; peak purity is confirmed with a photodiode array detector at 225 nm.
Difference from single-marker Andrographis extract lies in standardisation strategy. Single-marker products are standardised only to andrographolide; this product is standardised to total diterpene lactones and requires the four-herb formulation fingerprint. Crude Chuanxinlian herb powder retains > 90% non-active plant matrix and cannot meet injectable endotoxin limits; it also shows higher batch-to-batch marker variance than the extract API. The veterinary-grade API is prepared with reduced residual plant matrix and controlled microbial load, but it is not automatically interchangeable with human botanical API unless the receiving jurisdiction applies mutual recognition. For food-producing species, the prescriber must verify withdrawal period data from the marketing authorization holder; no withdrawal period can be inferred from marker purity alone. The procurement model designation is a vendor code associated with marker content and intended dosage form, for example an injection-grade API at ≥ 90.0% total diterpene lactones; without the linked certificate of analysis, that code alone is insufficient for GMP release.
