| HS Code | 126190 |
| Product Name | Andrographis Herba Powder Veterinary Grade API |
| Botanical Source | Andrographis paniculata |
| Family | Acanthaceae |
| Active Marker | Andrographolide |
| Appearance | Brownish yellow to dark brown free-flowing powder |
| Odor | Slight characteristic herbal odor |
| Taste | Very bitter |
| Solubility | Sparingly soluble in water; soluble in methanol, ethanol, and dimethyl sulfoxide |
| Ph Value | 4.0 to 7.0 in 1% aqueous suspension |
| Storage | Store in well-closed containers in a cool, dry place |
| Shelf Life | 24 months when properly stored |
As an accredited Andrographis Herba 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 double polythene bags inside 25kg fiber drums, with tamper-evident closure, labeled per veterinary grade API specifications. |
| Container Loading (20′ FCL) | 20′ FCL loading: Andrographis Herba Powder veterinary grade API packed in sealed drums/bags, palletized and secured for safe transport. |
| Shipping | Andrographis Herba Powder ships as a veterinary-grade API in sealed, moisture-proof drums or bags. Transport in temperature-controlled, dry conditions, away from direct sunlight and contaminants. Include Material Safety Data Sheet, certificate of analysis, and shipping documentation. Protect during handling to preserve stability and prevent cross-contamination. |
| Storage | Store in tightly sealed, original containers in a cool, dry, well-ventilated area below 25°C. Protect from direct sunlight, moisture, and strong odors. Avoid exposure to excessive heat or humidity. Keep away from incompatible substances and food. Ensure container remains sealed when not in use. Proper storage maintains potency and stability for pharmaceutical manufacturing. |
| Shelf Life | Shelf life: 24 months in original sealed container, stored cool, dry, and away from direct sunlight. |
For oral solid dose tablets intended for piglets and poultry, the as-received API is rarely suitable for direct compression. Assayed total andrographolide, quantified as the sum of andrographolide and 14-deoxy-11,12-didehydroandrographolide by HPLC with UV detection at 226 nm, typically ranges from 10.0% w/w to 30.0% w/w depending on extraction solvent and leaf source. The powder forms cohesive agglomerates at moisture levels above 5.0%, which causes sticking to upper punch faces on a rotary tablet press. A conical mill fitted with a 0.8 mm rasping screen and operated at 2,000 rpm reduces particle size to a D90 of 150 µm to 200 µm; particle size is verified by laser diffraction according to USP <429>. The moisture specification is set at ≤ 4.0% by loss on drying per USP <731> and water activity below 0.60 because residual polysaccharides in the extract increase hygroscopic bridging. Tablets containing 24.0 wt% API are blended with microcrystalline cellulose PH-102 (72.0 wt%), crospovidone (2.0 wt%), colloidal silicon dioxide (1.0 wt%), and magnesium stearate (1.0 wt%). The mixture is blended in a bin tumbler for 15 min at 25 rpm and compressed on a 16-station rotary press at 12 kN to 18 kN compression force. Target tablet hardness is 60 N to 80 N; friability must remain below 1.0% according to USP <1216>. Disintegration tested at 37 °C in purified water must be ≤ 15 min per USP <701>. Content uniformity follows USP <905> with acceptance value ≤ 15.0. Compression speed above 40 rpm may produce lamination and capping because the extract contains terpenoid lactones with low plastic deformation, and the residual fibrous fraction inhibits clean shear. The finished tablets are coated with a hydroxypropyl methylcellulose film at 3.0% weight gain to mask bitterness and improve moisture protection. The terminal product is a 500 mg oval tablet packed in HDPE bottles or PVC/aluminum blisters with a desiccant sachet.
Parenteral dosage forms based on Andrographis Herba Powder veterinary grade demand a different input specification from oral grades. Total aerobic microbial count in the API should not exceed 10³ CFU/g, with absence of Staphylococcus aureus and Pseudomonas aeruginosa in 1 g according to Ph. Eur. 2.6.13. Bacterial endotoxins are controlled in the finished solution to ≤ 0.5 EU/mg of andrographolide because pyrogenic polysaccharides co-extracted from leaf biomass are not acceptable by the parenteral route. Andrographolide itself is poorly water-soluble; reported aqueous solubility is below 0.1 mg/mL at 25 °C, although the exact value shifts with the co-extracted diterpene matrix. A typical 50 mL multi-dose vial formulation contains andrographolide at 20 mg/mL, propylene glycol 30% v/v, ethanol 96% 10% v/v, sodium metabisulfite 0.1% w/v, and water for injection q.s. The pH is adjusted to 6.5 to 7.0 with citrate buffer. Above pH 7.5, hydrolysis of the lactone ring accelerates and marker compound assay loss becomes measurable within a single batch; below pH 5.0, the free acid form may precipitate in the vial. The bulk solution is filtered through a 0.45 µm polyethersulfone prefilter and then a 0.22 µm PVDF sterilizing filter. Terminal sterilization at 121 °C for 15 min is acceptable only if thermal stability studies confirm andrographolide assay loss of less than 5.0%; sterilizer validation requires F0 ≥ 8 min at the slowest-heating point. Finished vials are tested for pH, osmolality between 280 mOsm/kg and 320 mOsm/kg, visible particles per Ph. Eur. 2.9.20, sub-visible particulate matter per Ph. Eur. 2.9.19, and sterility per Ph. Eur. 2.6.1. The terminal product is a clear amber glass vial with nitrogen headspace to reduce oxidative degradation of the conjugated diene system, stored below 25 °C and protected from light.
Filling capsules with Andrographis Herba Powder veterinary grade for companion animal practice usually begins with dry granulation rather than direct filling because the raw extract has poor flow, a Hausner ratio frequently above 1.35, and Carr index values between 25% and 35%. Powder flow is assessed before filling according to USP <1174>; bulk and tapped densities are determined per USP <616>. A rollerdensified intermediate can carry 98.0 wt% API with 1.5 wt% fumed silica and 0.5 wt% sodium stearyl fumarate; the mixture is compacted at 40 bar hydraulic pressure on a roller compactor, milled through a 1.0 mm screen, and passed over a 0.5 mm safety sieve. Capsule filling is performed on an intermittent-motion dosator machine with size 0 or size 1 gelatin or hypromellose capsules. Target fill weight is 250 mg for a size 0 capsule; fill weight acceptance is ± 5.0% of target. Content uniformity follows Ph. Eur. 2.9.40 with acceptance value ≤ 15.0. The terminal product is a hard capsule for oral administration to dogs or horses, packed in cold-seal aluminum foil with a desiccant sachet when the extract moisture level exceeds 3.5% after densification. This configuration is preferred over loose powders because it reduces operator exposure to bitter diterpene dust and eliminates a separate reconstitution step in the clinic. Free-flowable powders for feed top dressing follow a similar rollerdensification sequence but omit the capsule shell; in that case the densified intermediate is blended with coarse dextrose to a final concentration of 10.0 wt% and packed into 100 g or 500 g polyethylene terephthalate jars under nitrogen flush.
In feed mills, Andrographis Herba Powder veterinary grade is rarely added as a raw herb powder because segregation occurs during pneumatic conveying and auger transport. Wet granulation produces a dust-free premix granule with a target bulk density of 0.55 g/cm³ to 0.65 g/cm³, matching typical compound feed carriers and reducing separation after mixing. The formula consists of API at 15.0 wt%, lactose monohydrate 72.5 wt%, microcrystalline cellulose 10.0 wt%, povidone K-30 2.0 wt%, and silicon dioxide 0.5 wt%. Purified water is sprayed onto the dry blend in a top-spray fluid bed granulator; inlet air temperature is held at 65 °C, product temperature between 38 °C and 42 °C, and spray rate at 0.5 kg/min for a 50 kg batch. The binder addition window is deliberately restricted to 6.5% to 8.0% w/w of dry mass. Below 6.5%, granules fracture during bagging and create dust that reduces mixer cleanability; above 8.0%, granules become hard and resist disintegration in the animal’s digestive tract, delaying release of the marker diterpene lactone. After granulation, the material is dried to loss-on-drying ≤ 2.0% and sieved to retain particles between 0.4 mm and 1.0 mm. Homogeneity is checked by sampling from 20 points in a 500 kg ribbon mixer; the coefficient of variation for andrographolide content must be ≤ 5.0%. Regulatory compliance follows European feed hygiene rules under Regulation (EC) No 183/2005, and the product is classified as a feed material or additive only where national registration status allows. Terminal packaging is 25 kg multi-walled paper sacks with a polyethylene liner carrying the batch analysis certificate.
Drinking water formulation of Andrographis Herba Powder veterinary grade is constrained by the low water solubility of free diterpene lactones and by the variable pH and hardness of farm water. A liquid concentrate is manufactured by dispersing the API in a wetting vehicle composed of propylene glycol at 20.0% v/v and Polysorbate 80 at 0.5% w/v in purified water. The concentrate is adjusted to pH 5.5 to 6.5 with citric acid/sodium citrate buffer. At field dilution of 1:500 to 1:1000, the target drinking water andrographolide concentration is 25 ppm to 50 ppm. At pH above 7.5, precipitation is visible as a haze within 2 h; therefore, acidification of the water line to 0.05% v/v with organic acid blends is recommended when alkalinity exceeds 200 ppm CaCO₃. Stock solution in HDPE containers has a shelf life of 12 months at 25 °C, but once diluted it should be used within 24 h to prevent biofilm development and microbial accumulation. Compatibility with chlorine dioxide at 0.3 ppm residual is acceptable; contact with chlorine bleach above 5 ppm free chlorine is avoided because oxidative cleavage of the α,β-unsaturated lactone reduces assay values. Work is performed in a closed stainless steel mixing vessel with a high-shear rotor-stator at 3,500 rpm for 20 min. The terminal product is a 1 L or 5 L high-density polyethylene bottle with a measuring cap for poultry and swine buildings.
Lactose monohydrate loses flowability in packaging halls where relative humidity exceeds 60% when Andrographis Herba Powder is prepared as an oral drench powder, causing caking and reduced fill accuracy. Anhydrous calcium sulfate at 40.0 wt% of the final powder is a more suitable carrier because it has low hygroscopicity and does not initiate Maillard reactions with residual flavonoids. A representative oral powder contains API at 20.0 wt%, anhydrous calcium sulfate 40.0 wt%, maltodextrin DE 10–12 38.0 wt%, and xanthan gum 2.0 wt%. The API is first mixed with maltodextrin for 10 min, then combined with calcium sulfate and xanthan gum in a double-cone blender for 15 min at 20 rpm. Before inclusion in a drench bottle, the powder is sifted through a 0.425 mm sieve per Ph. Eur. 2.9.12. For drench reconstitution, 20 g powder is suspended in 100 mL potable water immediately before administration; xanthan gum delays sedimentation, yielding a suspension that remains visually homogeneous for 30 min. Homogeneity acceptance on the dry powder follows the same ≤ 5.0% coefficient of variation criterion as premixes. Moisture limit is ≤ 2.0% by Karl Fischer titration according to USP <921> because calcium sulfate dihydrate can release water of crystallization at elevated temperature; the blend is therefore dried at 45 °C for 6 h before packaging. Terminal product is a 100 g or 500 g aluminum-lined sachet or polyethylene bottle with a child-resistant cap for farm dosing.
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Andrographis Herba Powder Veterinary Grade API is a comminuted preparation of the aerial parts of Andrographis paniculata (Burm. f.) Nees, intended for incorporation into tablets, capsules, oral powders, granules, premixes, solutions, and injectable suspensions where regional veterinary drug approvals permit botanical APIs. The material is processed by drying, coarse milling, fine milling, particle-size classification, metal detection, and final blending. Representative particle-size models are designated by sieve cut: 80 mesh, 120 mesh, 200 mesh, and 325 mesh. Laser diffraction per ISO 13320:2020 reports D10, D50, and D90 values for each model. Bulk packaging is typically 25 kg net in double polyethylene liners within a fibre drum, with desiccant placed between the liners for moisture protection. The default powder is non-sterile; an injectable-grade lot is micronized, vacuum-dried, and controlled for bacterial endotoxins by Ph. Eur. 2.6.14 and, where applicable, sterility by Ph. Eur. 2.6.1. Compared with a concentrated standardized extract, the full botanical matrix is present; assay values are lower per unit mass, and the material contains cell wall polysaccharides, ash, chlorophyll, and insoluble fibre that must be considered in downstream formulation.
Identification and assay are anchored to the diterpene lactones andrographolide and 14-deoxy-11,12-didehydroandrographolide. High-performance liquid chromatography with ultraviolet detection at 225 nm following Ph. Eur. 2.2.29 or USP <621> is suitable for quantification; thin-layer chromatography per Ph. Eur. 2.2.27 provides a compendial identity check. The release specification should state loss on drying by Ph. Eur. 2.2.32, total ash and acid-insoluble ash by Ph. Eur. 2.4.16, heavy metals by Ph. Eur. 2.4.8 or USP <233>, and microbial enumeration by Ph. Eur. 2.6.12 and 2.6.13. Sampling is performed under a statistically valid plan, with one composite sample per 25 kg drum and reserve samples retained for marker stability.
Commercial raw herb lots may vary from approximately 0.5% to 2.0% w/w andrographolide depending on leaf-to-stem ratio and harvest time. To control this variation, production-scale blending after milling is required. Air-classified milling generates heat; when the product temperature exceeds 60 °C during size reduction, the lot is re-sampled for moisture and assay because published degradation data for the crude powder under those processing conditions are limited. Batch records should include milling chamber temperature, mill speed, feed rate, and final bag-filling humidity to ensure that the particle-size model and assay remain within certified limits.
Example release specification profiles are shown below.
| Parameter | Example oral-grade criterion | Example injectable-grade criterion | Test reference |
|---|---|---|---|
| Appearance | Brownish-green to greenish-brown powder | Finer, lighter odour-controlled powder | Visual against reference standard |
| Andrographolide assay | Not less than 1.0% w/w dried basis | Not less than 1.0% w/w dried basis; lot-specific | HPLC/UV 225 nm, Ph. Eur. 2.2.29 / USP <621> |
| Loss on drying | Not more than 10.0% | Not more than 6.0% | Ph. Eur. 2.2.32 |
| Total ash | Not more than 15.0% | Not more than 15.0% | Ph. Eur. 2.4.16 |
| Heavy metals | Not more than 10 mg/kg | Not more than 10 mg/kg | Ph. Eur. 2.4.8 / USP <233> |
| Aerobic microbial count | Not more than 104 CFU/g | Not more than 102 CFU/g | Ph. Eur. 2.6.12 |
| Yeast/mould count | Not more than 102 CFU/g | Not more than 101 CFU/g | Ph. Eur. 2.6.12 |
| Escherichia coli / Salmonella | Absent in 25 g | Absent in 25 g | Ph. Eur. 2.6.13 / ISO 6579-1:2017 |
| Bacterial endotoxins | Not specified for non-sterile oral | Not more than 0.5 EU/mg or as validated | Ph. Eur. 2.6.14 |
| Particle-size model | 80, 120, 200, or 325 mesh D90 | Micronized D90 <10 µm for suspension | ISO 13320:2020 |
The injectable-grade criteria in the table are illustrative; they must be confirmed against a current certificate of analysis because endotoxin limits depend on dose volume and target species. The difference between oral and injectable grades is not only particle size. Injectable-grade material requires a closed, low-bioburden mill; batch release includes endotoxin and particulate-matter controls that are not required for an oral tablet premix. Consequently, the injectable model is not automatically interchangeable with the 80-mesh oral premix model in a manufacturing schedule.
Injectable formulation work with this crude powder is constrained primarily by insoluble botanical residue. The powder cannot be regarded as a true solution-former in water; aqueous suspensions for injection require particle-size reduction below the capillary-safety threshold, typically D90 <10 µm, and terminal sterilization must be validated because autoclaving may alter the lactone ring or colour. Endotoxin load, rather than gross microbial count alone, becomes the controlling parameter. Injectable-grade lots are processed in a cleaned, low-bioburden environment and tested for bacterial endotoxins by Ph. Eur. 2.6.14; acceptance is lot-specific and must be declared on the certificate of analysis. If the final product is a sterile suspension, viscosity, sedimentation ratio, and resuspendability are measured by procedures based on Ph. Eur. 2.9.36 and 2.9.34 after sterilization. If the intended dosage form is a clear injectable solution, a purified extract or isolated andrographolide is normally preferred because the crude powder contributes colloidal plant fragments that cannot pass sterilizing-grade filtration reliably.
In tablet and capsule manufacture, the powder is evaluated for bulk density, tapped density, Carr index, and Hausner ratio by Ph. Eur. 2.9.34 and 2.9.36. Lots with Hausner ratio above 1.35 or Carr index above 25 typically require wet granulation or roller compaction rather than direct compression. On a high-shear wet granulation line, the binder solution is added in controlled increments while recording impeller power consumption; the process is stopped before the mass becomes overwetted and dense. The 80-mesh model is often selected for manual or low-speed auger fillers, while the 200-mesh and 325-mesh models are preferred for vibratory or dosator filling systems requiring denser, free-flowing powder. For hard gelatin capsule filling, the 325-mesh model with D90 <180 µm is typically used in size 0 or size 3 bodies, because coarser fractions can produce erratic plug formation in tamping-pin and dosing-disc machines. Direct compression formulations with botanical powders may require glidants such as colloidal silicon dioxide and lubricants such as magnesium stearate; the lubricant level must be kept below the point at which hydrophobic films retard disintegration per Ph. Eur. 2.9.1. If the formulation contains a highly hygroscopic carrier such as sorbitol, pre-drying is required at relative humidity above 60% to prevent granule liquoring and caking during compression.
Between the 80-mesh and 120-mesh models, the larger particle fraction reduces segregation and dusting in feed premixes and oral granule intermediates. The chosen model is usually blended with lactose monohydrate, dextrose, corn starch, or calcium carbonate carriers in a ribbon blender or double-cone blender. Mixing studies should demonstrate uniformity of the marker compound with relative standard deviation not more than 5.0% across sampling locations; the blending time is validated by withdrawing samples at defined intervals and quantifying andrographolide by HPLC. Because the powder has a different bulk density from many carriers, ordered mixing or stepwise geometric dilution is used to prevent dense particles from settling. For oral granules, the API is incorporated either before or after wet granulation; if the powder is added post-drying, particle-size binding by agglomeration is avoided, but segregation risk increases. Moisture protection is required at ambient relative humidity above 60%; sachets should include desiccant and be sealed in aluminium foil to prevent caking and lactone hydrolysis.
Solution and suspension preparation with this botanical powder begins with a solvent-selection step rather than a universal dissolution method. Andrographolide is sparingly soluble in water; the crude powder disperses but does not fully dissolve, and simple aqueous mixtures produce sediment. Veterinary oral solutions commonly use hydroalcoholic systems or pH-adjusted aqueous vehicles; the powder is added after the cosolvent phase to avoid clumping. The suspension is homogenized under high shear, and particle-size stability is checked over the intended storage period. If the final product is an oral solution, a clarified extract is preferred over the crude powder; if the final product is an oral suspension, the 325-mesh model is typically specified to minimize grittiness and sedimentation rate. After high-shear mixing, the product is usually passed through an 800 µm or 500 µm in-line screen to remove agglomerates before filling. High-shear dispersion times above the validated duration should be avoided because prolonged mechanical energy input raises the temperature and can alter the native botanical colloid fraction. The preparation should be protected from alkaline conditions above pH 8.0 and from strong acid below pH 3.0, because the lactone functionality may undergo hydrolysis. These pH boundaries are derived from the general behaviour of diterpene lactones; published formulation-specific stability data for the crude powder are limited and require stress testing on the finished product.
Compared with a standardized Andrographis paniculata extract containing not less than 10.0% or 50.0% andrographolide, the veterinary herbal powder has a lower active-marker concentration per gram. A tablet targeting 10 mg of andrographolide would require roughly 500–2000 mg of raw herb powder if the assay is 0.5–2.0% w/w, whereas a 10% extract would require approximately 100 mg of extract. This difference is not a defect; it defines the formulations for which the crude powder is viable, mainly bulk oral products, premixes, and traditional botanical dosage forms. Synthetic antimicrobial molecules are characterized by defined minimum inhibitory concentrations, pharmacokinetic parameters, and residue limits; the crude powder cannot be directly substituted for such compounds unless regional regulatory authorities accept a botanical claim. Veterinary-grade botanical powder is not necessarily interchangeable with food-grade or dietary supplement-grade material because of stricter control of potential pathogens such as Salmonella and Escherichia coli, and because residual solvent and pesticide data must be traceable to the target species. The veterinary-grade designation implies that the material is controlled for heavy metals, aflatoxins, pesticides, and microbiological burden appropriate to target species, and that the intended use includes food-producing animals only when withdrawal periods have been established. Published pharmacopoeial monographs for the crude herb may not fully cover every veterinary premix or injectable model; each finished-product manufacturer is responsible for demonstrating dose uniformity, stability, and target-species safety under relevant regional requirements.
