| HS Code | 264112 |
| Botanical Source | Agastache rugosa (Fisch. & C.A.Mey.) Kuntze |
| Active Constituents | Rosmarinic acid, tilianin, acacetin, agastachoside |
| Appearance | Brownish-yellow to brown crystalline powder |
| Solubility | Slightly soluble in water; freely soluble in ethanol and dilute alkaline solutions |
| Microbial Limits | Total bacterial count ≤1000 CFU/g; yeasts and molds ≤100 CFU/g; absence of Salmonella and E. coli |
| Assay Content | Rosmarinic acid content ≥2.0% (w/w) by HPLC |
| Storage Conditions | Store in airtight containers, protected from light, in a cool, dry place below 25°C |
As an accredited Agastachis Herba 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 containers with tamper-evident closures. Supplied as 25 kg per drum, ensuring stability and safety for veterinary pharmaceutical use. |
| Container Loading (20′ FCL) | 20' FCL shipment of Agastachis Herba veterinary-grade API, securely palletized, protected against moisture, and properly labeled for pharmaceutical handling. |
| Shipping | Shipping: Packed in sealed, moisture-proof containers with tamper-evident seals. Transport in dry, ventilated conditions, avoiding extreme temperatures and sunlight. Full veterinary compliance documentation, MSDS, and batch certificates accompany shipment. Delivery options include air, sea, or land freight with tracking and temperature-controlled handling as required. |
| Storage | Store Agastachis Herba Veterinary Grade API in tightly sealed, moisture-proof containers in a cool, dry, well-ventilated area. Protect from direct sunlight, heat, and strong odors. Keep away from incompatible substances and food. Maintain temperatures below 25°C, avoiding freezing and excessive humidity. Ensure container is resealed immediately after use to preserve potency, stability, and suitability for all formulated dosage forms. |
| Shelf Life | Shelf life is 24 months from manufacture date when stored sealed in a cool, dry place, protected from light and moisture. |
Compression-grade Agastachis Herba extract is characterised before formulation by high-performance liquid chromatography for total hydroxycinnamic acids calculated as rosmarinic acid, typically between 2.5% and 5.0% w/w at release, with identity confirmed by HPTLC against a qualified botanical reference standard. For a 400 mg core tablet, the dried extract is incorporated at 120–160 mg per unit (30–40% w/w) after vacuum shelf drying at 50°C to a loss-on-drying limit of ≤5.0%. The dried extract is passed through a conical mill fitted with a 0.8 mm screen to remove stem fragments that increase weight variation, then blended with pregelatinized starch at 8–12% w/w, croscarmellose sodium at 2–4% w/w, and magnesium stearate at 0.5–1.0% w/w. Direct compression is rarely viable above 25% w/w extract because high-ash botanical matrices exhibit low plastic deformation and punch sticking, so slugging at 8–10 kN followed by oscillating granulation is used to densify the blend. Tablets are compressed on a rotary press to 60–80 N hardness; when extract content exceeds 40% w/w, capping appears within 15 min of start-up and hardness variability exceeds 15% RSD. Release testing follows Ph. Eur. 2.9.5 for uniformity of mass, Ph. Eur. 2.9.3 for dissolution where a target release profile is claimed, Ph. Eur. 5.1.4 for non-sterile microbiological quality, and VICH GL18 for residual solvent control. Finished formats are film-coated tablets for companion animal gastrointestinal supportive protocols and hard gelatin capsules for feline or small-breed canine dosing, with capsule fill ratios lower than tablet extract loads because of lower bulk density in powdered extract blends.
The limiting process variable in pelleted feed is the conditioner temperature, not premix homogeneity. The dried extract is first dispersed into calcium carbonate or wheat bran carrier at a 1:9 ratio in a ribbon mixer; this preblend is then incorporated into a 1% premix at 5–15 kg/tonne. Final complete-feed inclusion is calculated from the premix carry rate: a 0.5 kg/tonne complete-feed dose is achieved by adding 5 kg of a 10% extract preblend per tonne, while a 1.0 kg/tonne dose requires 10 kg. When steam conditioning runs at 80–85°C, volatile constituents degrade; plant trials show that rosmarinic acid recovery after pelleting at 65°C remains within 90–95%, but recovery can fall below 75% at 85°C depending on residence time in the conditioner. For this reason, microencapsulated extract or post-pelleting liquid application is selected when the feed mill cannot hold conditioning below 80°C; published kinetic data for this specific botanical in extruded complete feed are limited, so each batch must be validated against marker assay. The relevant compliance frame is EU 1831/2003 where the material is placed as a feed additive or feed material, 2002/32/EC for undesirable substances, FAMI-QS for premixture operators, GMP+ BA2 for feed safety assurance, and ISO 6497:2005 for sampling plans. Terminal product types are pelleted complete feed for weaned piglets, sow lactation feed, and broiler finisher rations, with finished feed retention samples assayed for marker loss after 6 months at 25°C/60% RH.
| Delivery form | Working API input | Critical process threshold | Release test designation |
|---|---|---|---|
| Tablet core | 30–40% w/w | Extract above 40% w/w causes capping | Ph. Eur. 2.9.5, Ph. Eur. 2.9.3 |
| Hard capsule | 20–30% w/w | Bulk density below 0.45 g/mL limits fill weight | Ph. Eur. 2.9.5 |
| Premix for complete feed | 5–15 kg/tonne in 1% premix | Conditioner temperature above 80°C reduces marker recovery | FAMI-QS, GMP+ BA2 |
| Drinking-water powder | 0.5–2.0 g/L final water | Final pH above 7.5 causes polyphenolic precipitation | Ph. Eur. 5.1.4 |
| Injectable solution | 10 g/L (10 mg/mL) | Endotoxin limit ≤0.5 EU/mg | Ph. Eur. 2.6.14, Ph. Eur. 2.6.1 |
| Oral drench | 20 g/L (2.0% w/v) | Extract above 30 g/L increases yield stress beyond pump range | Ph. Eur. 5.1.4 |
| Top-dress granule | 0.2–0.5 kg/tonne feed or 1–2 g/head/day | Fines below 63 µm are recycled to control segregation | Ph. Eur. 5.1.4, Ph. Eur. 2.9.5 |
Because drinking-water administration bypasses pellet-mill thermal history, it is the preferred route when rapid intake is required in poultry and swine barns, but it places stringent demands on particle size and water-line compatibility. The water-dispersible powder is produced by spray-drying the liquid extract with maltodextrin at 20–40% w/w carrier, followed by fluid-bed agglomeration with inlet air at 60°C to achieve a target particle size of 80–250 µm. The agglomerated material is filled into sachets or pails; stock solutions are prepared by adding 500 g to 1000 L of drinking water through a proportioner set at 1.0%, resulting in a working final concentration of 0.5–2.0 g/L after dilution. Hard water above 300 ppm CaCO3 and final pH above 7.5 cause polyphenolic acid salts to precipitate, so acidification with citric acid to pH 4.5–5.5 is used before the stock tank is circulated. In-line filters of 50 µm mesh are installed before nipple drinkers to prevent nozzle blockage, and pipeline biofilm is controlled by citric acid flushes at 1.0% w/v before and after the medication cycle. The compliance frame for water-administered material includes Ph. Eur. 5.1.4 for non-sterile microbiological quality with total aerobic microbial count below 10^4 CFU/g, total yeast and mould count below 10^2 CFU/g, absence of Escherichia coli in 1 g, and absence of Salmonella in 10 g, plus heavy metal limits under Ph. Eur. 2.4.8. Terminal product types are water-soluble powder sachets, bucket formulations for proportioner circuits, and water-dispersible granules for broiler chickens, turkeys, and fattening pigs.
Injectable dosage forms impose the tightest specification envelope because crude extract contains polysaccharides, tannins, and lipophilic volatiles that challenge clarifying filtration and endotoxin control. The dry extract is dissolved in water for injection with propylene glycol at 10–20% v/v and ethanol at 5–10% v/v as co-solvents, buffered with citrate to pH 4.5–6.0. The batch is chilled to 2–8°C for 12–24 h to precipitate poorly soluble polyphenol aggregates, then depth-filtered through cellulose or diatomaceous earth media before passage through 0.45 µm and 0.22 µm PVDF membranes. Terminal heat sterilisation is generally avoided because rosmarinic acid oxidises during autoclaving; aseptic filtration and isolator filling are therefore standard. The working concentration is 10 mg/mL dry extract, equivalent to 1.0% w/v, requiring 10 g API per litre; raising extract load above 15 mg/mL increases filter fouling and foaming during filling. Bacterial endotoxin limit is set at ≤0.5 EU/mg under Ph. Eur. 2.6.14; sterility is confirmed under Ph. Eur. 2.6.1; residual solvents are controlled under VICH GL4; and aseptic processing follows EU GMP Annex 1. Terminal product types are sterile ampoules and vials for cattle, swine, and equine supportive protocols in jurisdictions where traditional veterinary injectable formulations are registered. The main incompatibility is with oxidising sterilants and high-pH diluents; final solutions should be protected from light in borosilicate glass because ultraviolet exposure accelerates marker degradation.
Oral drenches and pump-administered solutions require preservation, viscosity control, and dosing accuracy rather than sterility, but the same botanical matrix can settle quickly if not properly suspended. The extract is dispersed in purified water heated to 40°C, with sorbitol at 20–30% w/v to increase osmolality and reduce bitterness, and xanthan gum at 0.2–0.5% w/v to prevent sedimentation. The mixture is homogenised in a rotor-stator device at 3000 rpm for 20 min, adjusted to pH 4.0–6.0 with citric acid or sodium citrate, and pasteurised at 85°C for 10 min before filling into high-density polyethylene bottles or single-dose drench syringes. The working extract concentration is 20 g/L (2.0% w/v); when a 10 mL drench dose is required, this supplies 0.2 g dry extract per dose. Higher extract loads, above 30 g/L, increase yield stress beyond the acceptable range for standard drench pumps and produce reversible flocculation in low-pH formulations. Non-sterile microbial quality is controlled under Ph. Eur. 5.1.4 with total aerobic microbial count below 10^4 CFU/g, total yeast and mould count below 10^2 CFU/g, absence of Escherichia coli in 1 g, and Salmonella absent in 10 g. Terminal product types are oral drench bottles, multi-dose pump bottles, and single-use paste syringes for calves, lambs, and goat kids; these formats are used in neonatal enteric supportive protocols where rapid dosing without feed mixing is required.
Granulation shifts the flow and dust profile of high-fiber botanical powders, making the material suitable for automatic feed line metering and top-dress application without changing the release specification. Wet granulation is carried out in a high-shear granulator using 10–15% w/w purified water or an aqueous binder containing povidone K30 at 2–3% w/w; the wet mass is dried in a fluid-bed dryer with inlet air at 50°C until loss-on-drying is ≤5.0%. Dried granules are sieved between 0.5 mm and 1.4 mm, with fines below 63 µm recycled into the next granulation batch to maintain flow and reduce segregation. The addition ratio for top-dress use is 1–2 g per head per day in dairy calf starter, while meal incorporation into complete feed runs at 0.2–0.5 kg/tonne, adjusted according to marker assay of the granulated batch. Granulation reduces dustiness but can lower dissolution speed; when the granule is intended for drinking-water reconstitution, binder selection is shifted to a more soluble carrier such as 5–10% maltodextrin instead of povidone to avoid gel blocking in proportioner circuits. The relevant release testing includes Ph. Eur. 5.1.4 for non-sterile microbiological quality and Ph. Eur. 2.9.5 for uniformity of mass when the granule is filled as a single-dose sachet. Terminal product types are sachet granules for direct oral dosing, top-dress granules for calf starter and lamb creep feed, and meal-integrated granules for swine and poultry rations.
Competitive Agastachis Herba Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Agastachis Herba Veterinary Grade API is a standardised botanical active pharmaceutical ingredient derived from the dried aerial parts of Agastache rugosa (Fisch. & C.A.Mey.) Kuntze. The material is manufactured for incorporation into veterinary dosage forms, including tablets, injections, capsules, powders, granules, premixes, and oral solutions. The base model designation AGH-VET/API is used with seven suffix variants that define the route-specific physical standardisation: AGH-VET/T for direct compression tablets, AGH-VET/C for capsule fill, AGH-VET/I for parenteral solutions, AGH-VET/P for dry powders, AGH-VET/G for granulation feed, AGH-VET/PM for premix concentrates, and AGH-VET/S for oral solutions. The suffixes do not denote separate chemical entities. The extract composition is held constant while particle size, endotoxin loading, residual solvent profile, and bulk flow are adjusted for the target dosage form. Botanical authenticity is confirmed by macroscopic, microscopic, and thin-layer chromatographic comparison with an Agastache rugosa reference herb; the extract is standardised to a multi-marker HPLC-UV/DAD fingerprint that includes rosmarinic acid, acacetin, and tilianin. The material is not equivalent to commodity herb powder: the veterinary API is extracted, clarified, concentrated, dried under defined thermal load, and milled to a controlled particle-size ceiling. Each batch is released against a specification that integrates botanical identity, marker content, residual solvents, heavy metals, aflatoxins, and microbial limits.
| Model suffix | Dosage form | Particle-size ceiling | Dry-state parameter | Loss on drying |
|---|---|---|---|---|
| AGH-VET/T | Tablet direct compression | D90 ≤ 150 µm | Tapped density 0.42–0.60 g/cm³ | ≤ 5.0 % |
| AGH-VET/C | Capsule fill | D90 ≤ 250 µm | Hausner ratio 1.25 max | ≤ 5.0 % |
| AGH-VET/I | Injection | D90 ≤ 75 µm | Endotoxin route-specific; typical < 0.5 EU/mg | ≤ 2.0 % |
| AGH-VET/P | Powder admixture | D90 ≤ 180 µm | Passes 2 mm sieve | ≤ 5.0 % |
| AGH-VET/G | Granulation feed | D90 ≤ 180 µm | Not specified | ≤ 5.0 % |
| AGH-VET/PM | Premix concentrate | D90 ≤ 250 µm | Bulk density 0.35–0.60 g/cm³ | ≤ 5.0 % |
| AGH-VET/S | Oral solution | D90 ≤ 100 µm | Wetting time ≤ 60 s at 25 °C | ≤ 5.0 % |
Extraction uses a defined water-alcohol mixture. Temperature is maintained no higher than 60 °C to limit degradation of rosmarinic acid, and the clarified concentrate is evaporated under reduced pressure at no more than 40 °C. Oral powder, tablet, capsule, granule, and premix grades are spray-dried with a drying aid such as maltodextrin; the spray dryer is operated at inlet air 140–160 °C and outlet air 70–85 °C. The injection grade is lyophilised using a freezing ramp to -40 °C and primary drying at -20 °C under 0.10 mbar chamber pressure. These drying conditions are selected to retain the HPLC fingerprint; published data for this specific configuration is limited, and the actual parameters depend on the solids content and glass transition temperature of the concentrated extract.
For AGH-VET/T and AGH-VET/C, the critical processing constraints are moisture uptake, particle-size segregation, and adhesion of polyphenolic extract fractions to metal tooling. The spray-dried powder is specified with a tapped density of 0.42–0.60 g/cm³ by USP <616>. In direct compression, the extract is blended with microcrystalline cellulose, dibasic calcium phosphate anhydrous, or lactose monohydrate. On an 8-station rotary tablet press operated at 30–50 rpm, powder with D90 above 150 µm segregates in the feed frame and widens weight variation. The extract is hygroscopic; open storage at 25 °C/60 % RH increases loss on drying by 1.5–2.5 % within 4 h, so blending rooms are held below 45 % RH or the blend is handled in sealed stainless-steel containers. Magnesium stearate is not the default lubricant because the extract discolours in contact with iron-based surfaces; sodium stearyl fumarate at 1–2 % w/w of the blend is substituted when lubrication time exceeds 5 min. For capsule filling, the D90 limit is 250 µm and the Hausner ratio is below 1.25; if the ratio exceeds this value on an intermittent-motion capsule machine at 60–100 capsules/min, the fill-weight relative standard deviation can rise above 5 %.
Parenteral use of Agastachis Herba Veterinary Grade API requires controls beyond those for oral dosage forms. The AGH-VET/I grade is lyophilised, assigned a bacterial endotoxin limit according to Ph. Eur. 2.6.14, and intended for final sterilisation or aseptic processing by the dosage-form manufacturer. Sterility is tested on the finished preparation by Ph. Eur. 2.6.1. The extract is dissolved in water for injection and clarified through a 0.45 µm polyethersulfone membrane before sterile filtration through a 0.22 µm membrane. Membrane fouling is the principal processing risk: polyphenol-protein complexes and residual polysaccharides reduce flux by more than 40 % after 5 L/m² throughput when the cold-water precipitation step is omitted. Cold-water precipitation at 2–8 °C for 12 h, followed by centrifugation at 8,000–12,000 × g, reduces the fouling burden. Terminal autoclaving at 121 °C for 15 min is not the default because it can shift the flavonoid fingerprint and increase colour; if terminal sterilisation is required, the specific formulation and container must be validated. The finished injection is buffered to pH 4.0–6.5, and the extract is tested for soluble extractives rather than total powder. Published data for this specific configuration is limited; the fouling threshold depends on extraction ratio and ionic strength.
AGH-VET/P, AGH-VET/G, AGH-VET/PM, and AGH-VET/S are released with lower endotoxin stringency than the injection grade but with tighter physical controls than raw herb powder. AGH-VET/P is diluted with silicon dioxide or calcium carbonate; the blend has a Hausner ratio below 1.25. AGH-VET/G is granulated in a high-shear mixer with an impeller tip speed of 2–6 m/s and a chopper speed of 1,500–3,000 rpm, using purified water or 30–40 % aqueous ethanol as the granulation liquid. The wet mass is dried in a fluid-bed dryer at inlet air 60–70 °C to a loss on drying below 5.0 %. AGH-VET/PM is blended with lactose monohydrate or wheat bran to an extract concentration of 5–20 % w/w; mix uniformity is determined after 10 min in a V-cone blender and requires a relative standard deviation below 5 % at three sampling points. AGH-VET/S is cold-water dispersible via 20–30 % maltodextrin or gum arabic on dry weight; a 1 % w/v solution wets within 30–60 s at 25 °C and is screened through 100 µm stainless steel before filling. Process failure modes observed in production include caking of spray-dried powder exposed to high humidity, colour darkening in tablet cores containing iron salts, and sedimentation in oral solutions where the wetting agent level is below 20 %. The extract should therefore be stored below 25 °C and 60 % RH in sealed containers. For oral solutions, the extract should be dispersed under a high-torque mixer; localised dumping onto the water surface without agitation can form gelled polyphenol-polysaccharide lumps that are not re-dispersible.
The release testing matrix follows compendial methods for veterinary herbal APIs. Oral-grade microbial limits are aligned with Ph. Eur. 5.1.4 for herbal medicinal products for oral use: total aerobic microbial count ≤ 10³ CFU/g, total yeast and mould count ≤ 10² CFU/g, Escherichia coli absent in 1 g, and Salmonella absent in 25 g. Enumeration is performed according to ISO 4833-1 for aerobic count, ISO 16649-2 for Escherichia coli, and ISO 6579-1 for Salmonella. Heavy metals are controlled by Ph. Eur. 2.4.8 or USP <233>; release limits are lead ≤ 5 mg/kg, cadmium ≤ 1 mg/kg, mercury ≤ 0.1 mg/kg, and arsenic ≤ 2 mg/kg. Aflatoxins B1, B2, G1, G2 and ochratoxin A are included because field-dried herb can develop storage fungi. Residual solvents are measured by headspace gas chromatography under Ph. Eur. 2.4.24; ethanol and methanol are controlled because water-alcohol extraction is used. Spray-dried oral grades have a loss on drying ≤ 5.0 % by USP <731>; the lyophilised injection grade has a loss on drying ≤ 2.0 %. The botanical source is processed under Good Agricultural and Collection Practice principles, and the API is manufactured under a pharmaceutical quality system aligned with ICH Q7 and 21 CFR Part 211 where applicable.
| Attribute | Method | Acceptance basis |
|---|---|---|
| Microbial enumeration | Ph. Eur. 2.6.12 / USP <61> | Oral limits per Ph. Eur. 5.1.4 |
| Specified organisms | Ph. Eur. 2.6.13 / USP <62> | E. coli absent in 1 g, Salmonella absent in 25 g |
| Bacterial endotoxins | Ph. Eur. 2.6.14 | Route-specific; typical < 0.5 EU/mg |
| Sterility | Ph. Eur. 2.6.1 | Finished injection |
| Loss on drying | USP <731> | ≤ 5.0 % oral; ≤ 2.0 % injection |
| Heavy metals | Ph. Eur. 2.4.8 / USP <233> | Pb ≤ 5 mg/kg, Cd ≤ 1 mg/kg, Hg ≤ 0.1 mg/kg, As ≤ 2 mg/kg |
| Residual solvents | Ph. Eur. 2.4.24 | Methanol and ethanol declared and limited |
| Particle size | ISO 13320 | D90 per model suffix in Table 1 |
Compared with commodity Agastache rugosa dried herb, the veterinary API differs in traceability, marker standardisation, particle size, and microbial control. Raw herb may vary in marker content by 2–3 fold across harvests and can exceed 10⁵ CFU/g total aerobic count; the API grade is extracted or, where whole-herb processing is specified, sieved and decontaminated to meet oral-dosage limits. Compared with Pogostemonis Herba preparations standardised to patchouli alcohol or pogostone, this extract is standardised to phenolic acids and flavones. The Agastache rugosa extract is more water-dispersible and can be incorporated into low-viscosity oral solutions without a separate emulsification step; patchouli essential-oil fractions can phase-separate and require polysorbate 80 at 5–15 % v/v. Compared with isolated rosmarinic acid or acacetin, the whole extract retains co-occurring flavonoids and polysaccharides. That retention preserves the botanical profile but demands water activity below 0.6 and desiccant packaging. It also means the extract cannot be treated as a pure crystalline API in compaction or filtration; particle-size and dispersibility attributes are therefore specified. Compared with synthetic veterinary APIs such as enrofloxacin or amoxicillin trihydrate, the herbal API is a multi-component matrix; batch-to-batch variation is managed by blending extraction lots to a defined marker window, not by recrystallisation or purity adjustment. The distinguishing feature is route-specific control of dissolution, microbial load, and physical compatibility with feed or liquid carriers, rather than chemical purity alone.
