| HS Code | 670215 |
| Product Name | Tongchang Shaoyao Powder Veterinary Grade API |
| Product Type | Active Pharmaceutical Ingredient for veterinary formulations |
| Target Species | Livestock including pigs, cattle, sheep, and poultry as directed by a veterinarian |
| Physical Form | Fine powder for formulation |
| Color Description | Light yellow to brownish powder with characteristic herbal odor |
| Solubility Profile | Partially soluble in water; suitable for extemporaneous suspensions or formulated solutions |
| Dosage Form Compatibility | Compatible with tablets, injections, capsules, powders, granules, premix, and solutions |
| Storage Conditions | Store in a tightly sealed container in a cool, dry, well-ventilated area protected from light and moisture |
| Shelf Life | 24 months from date of manufacture under recommended storage conditions |
| Regulatory Status | Veterinary grade API intended for incorporation into finished animal health dosage forms |
As an accredited Tongchang Shaoyao 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 | Supplied as 25kg per drum, Tongchang Shaoyao Powder Veterinary Grade API in double PE-lined sealed drums, protected from moisture and contamination. |
| Container Loading (20′ FCL) | Tongchang Shaoyao Powder veterinary grade API is loaded into a 20-foot FCL container, securely packed to ensure safe transport. |
| Shipping | Ships in sealed, moisture-proof, light-protected containers with proper hazard labeling. Transported under ambient conditions in ventilated, non-food vehicles, away from direct sunlight and incompatible materials. Documentation includes SDS, veterinary API declaration, and customs paperwork; import/export must comply with relevant veterinary drug regulations. |
| Storage | Store Tongchang Shaoyao Powder veterinary grade API in a cool, dry, well-ventilated area, away from direct sunlight, heat, and moisture. Keep the container tightly sealed when not in use. Protect from physical damage and contamination. Store separately from food, feed, and incompatible materials. Follow manufacturer’s labeled expiry and handling instructions for finished dosage forms. |
| Shelf Life | Stable for 24 months from manufacture when stored sealed, dry, and protected from light at controlled room temperature. |
During direct compression of Paeonia lactiflora root powder on a twelve-station rotary tablet press, capping and radial lamination are observed when the unmodified powder exceeds 30 wt% of the core formulation and main compression force is raised above 14 kN; the fibrous root tissue and low tapped density produce a compact with low tensile strength that cannot survive immediate ejection stress. The powder is therefore roll-compacted at 5–9 MPa hydraulic pressure, milled through a 0.8–1.4 mm screen, and screened to remove fines below 100 µm. A 500 mg core contains 15–30 wt% Tongchang Shaoyao Powder when the CoA reports raw root powder with paeoniflorin content 1.5–3.0%, or 3–8 wt% when a 10:1 dry extract standardized to 10% paeoniflorin is supplied; microcrystalline cellulose PH 102 is included at 20–30 wt%, croscarmellose sodium at 2–4 wt%, and magnesium stearate at 0.5–1.0 wt%. The lubricant is added for only the final 3–5 min of blending because longer exposure of magnesium stearate to the roll-compacted granules forms a hydrophobic coating that lowers compact hardness by 10–20% and retards disintegration. Compression is performed at 25–45 rpm turret speed with 4–8 kN precompression and 10–18 kN main compression to obtain hardness 60–90 N and friability below 1.0% under USP <1216>. In-process release checks include USP <905> uniformity of dosage units, USP <701> disintegration, and USP <711> dissolution; the incoming botanical powder must be tested for Salmonella by ISO 6579-1:2017, Staphylococcus aureus by ISO 6888-1, and paeoniflorin by USP <621> HPLC with a method validated under VICH GL18(R). Because the raw powder is hygroscopic, storage above 60% RH requires tray drying at 50–60°C until loss on drying by Ph. Eur. 2.8.17 falls below 5.0%. The terminal product is a film-coated convex tablet with core mass 0.4–1.0 g for oral administration to swine and ovine animals; the aqueous coating adds 3–5% weight gain and isolates the hygroscopic core from environmental moisture.
| Release parameter | Standard designation | Criterion before tablet compression |
|---|---|---|
| Paeoniflorin assay | USP <621> HPLC | CoA-defined, aligned to ChP 2020 Paeoniae Radix Alba content limit |
| Loss on drying | Ph. Eur. 2.8.17 | ≤ 5.0% before granulation |
| Salmonella spp. | ISO 6579-1:2017 | Absent in 25 g |
| Staphylococcus aureus | ISO 6888-1 | CoA-conformant |
| Heavy metals | Ph. Eur. 2.8.13 | CoA-conformant |
Injectable preparation of Paeonia lactiflora root powder is governed by the solubility of benzoylated monoterpene glycosides and co-extracted tannins; unextracted root powder produces visible precipitation above pH 6.2 and should not be processed into a parenteral product because subvisible particle counts exceed USP <788> light obscuration limits. The only technically justified route is dissolution of a purified extract with chromatographic paeoniflorin content of at least 90% and total ash below 1.0% in Water for Injections at 20–30°C to a target strength of 10–20 mg/mL paeoniflorin; higher concentrations risk precipitation during cold storage at 2–8°C. The solution pH is adjusted to 5.0–6.0 with a citrate buffer or dilute hydrochloric acid; oxygen-sensitive constituents are protected by nitrogen blanketing throughout compounding. The filtration train consists of a 0.45 µm polyethersulfone prefilter followed by two 0.22 µm sterilizing-grade polyvinylidene fluoride cartridges; differential pressure across the sterilizing filter must not exceed 1.0 bar at 25°C, and filter integrity is verified by bubble point or diffusion before and after filling. If terminal moist-heat sterilization at 121°C for 15 min is proposed, the sponsor must generate paeoniflorin recovery data under the specific headspace oxygen and pH conditions; published data for this specific configuration are limited, and an aseptic filtration route is the preferred default when the extract contains ester-linked glycosides. The injectable solution must comply with USP <1>, USP <85> bacterial endotoxins, USP <788> particulate matter in injections, and Ph. Eur. 2.9.19 subvisible particle counting; sterility is confirmed by USP <71> with 14 days incubation. Filling is performed on a piston-driven liquid filler into 10 mL or 20 mL Type I glass vials sealed with chlorobutyl rubber stoppers, and headspace oxygen is maintained below 2%. The terminal product is a single-dose injectable solution for intramuscular or subcutaneous administration in food-producing species; withdrawal period assignment remains a regional residue-safety decision, not a raw material property.
Feed-premix application of Tongchang Shaoyao Powder requires a two-stage dilution because the fibrous root powder agglomerates in a single-shaft mixer and adheres to the interior walls when added directly to final feed. In the first stage, the API is blended at 5–20 wt% on pre-dried corncob or rice-hull carrier with 0.5–1.0 wt% food-grade silica to suppress static charge and improve flow. This concentrated premix is transferred to a twin-shaft paddle mixer with a fill volume of 30–60% and shaft speed 40–70 rpm; mixing continues for 8–12 min, after which paeoniflorin content uniformity should be verified at 10–20 sampling points according to ISO 6497 with a coefficient of variation below 5%. Final feed inclusion is 0.5–2.0 kg/t for a 5:1 dry extract and 2–5 kg/t for raw root powder; the actual veterinary dosage is a label decision based on species, body weight, and regional registration, not a fixed raw-material parameter. The premix must satisfy EU 2002/32/EC undesirable-substance limits and is produced under GMP+ BA2 feed safety assurance; aflatoxin B1 screening follows ISO 17375:2006, and Salmonella absence is confirmed by ISO 6579-1:2017. Particle size is controlled by passing the carrier through a 0.5 mm sieve before blending and by re-milling any retained agglomerates; material below 100 µm increases dusting and cross-contamination risk in feed mills. The terminal product is a 1–5% veterinary herbal feed premix packed in 20 kg multi-wall paper bags with polyethylene liners for use in swine and poultry integrated feeding systems.
For hard gelatin capsule filling of Paeonia lactiflora root powder, direct encapsulation without granulation is possible only when the formulation contains at least 35–55 wt% silicified microcrystalline cellulose or spray-dried lactose because the raw botanical powder has an angle of repose above 40° and a flow function coefficient below 4. The capsule blend is assembled from 40–60 wt% Tongchang Shaoyao Powder when the paeoniflorin assay is 1.5–3.0%, with 1.0–2.0 wt% fumed silica and 0.5–1.0 wt% magnesium stearate; if a 10:1 dry extract is used, the active fraction is reduced to 10–20 wt% and the filler system is rebalanced to maintain acceptable flow. Blending is performed in a 200 L bin blender for 15–20 min, but magnesium stearate is withheld until the final 3–5 min to minimize hydrophobic surface coverage. Encapsulation is run on a dosator-type or tamping-pin filler with size 1 or 0 hard gelatin capsules, target fill weight 350–500 mg, and tamping pin compression depth 2–4 mm; the filling room is maintained at 40–45% RH and 18–22°C because gelatin shells lose flexibility below 35% RH and become tacky above 55% RH. Weight uniformity is controlled by USP <905>, disintegration by USP <701>, and dissolution by USP <711>; microbial quality of the finished capsules is assessed by USP <61> and USP <62>, and loss on drying by USP <731>. The terminal product is a hard gelatin capsule containing 300–500 mg of herbal powder, packaged in 60-count or 500-count high-density polyethylene bottles with a desiccant canister, for equine and camelid veterinary prescription compounding. Dissolution correlation for paeoniflorin in fasted equid gastric fluid is not available in public monographs; an in-house method is required rather than an unadjusted human pharmacopeial medium.
In poultry and swine drinking-water applications, the reconstitution behavior of the powder is governed more by particle porosity and carrier solubility than by paeoniflorin content: a top-spray fluid-bed granulated formulation will disperse within 3–5 min at 25°C in soft water, whereas a simple dry blend of root powder and dextrose settles within 10 min and clogs proportioner dosing lines. The soluble powder formulation consists of 5–20 wt% Tongchang Shaoyao Powder or dry extract, 70–90 wt% dextrose monohydrate or lactose, 2–4 wt% povidone K30 as granulation binder, 0.2–0.5 wt% fumed silica, and 1–2 wt% citric acid-sodium citrate buffer to hold the reconstituted solution at pH 5.0–6.0. Granulation is performed in a top-spray fluid-bed granulator with inlet air temperature 55–65°C, product temperature 32–42°C, and spray rate 20–60 g/min; drying continues until loss on drying is 2–4%. The final granulate is sieved to 40–80 mesh so that most particles remain below 425 µm but above 180 µm; this narrow fraction is critical for filling accuracy on volumetric sachet packaging lines. The diluted drinking-water solution is prepared at 1–5 g/L depending on the veterinary dosage requirement and should be used within 24 h when prepared with unchlorinated water; chlorinated hard water can promote flocculation of tannin residues unless a metal-sequestering citrate system is included. The finished powder is tested for microbial enumeration by USP <61>, absence of Escherichia coli by USP <62>, loss on drying by USP <731>, and reconstitution time by a wetting test referenced to USP <1236> solubility concepts. Packaging is in 100 g, 500 g, and 1 kg foil laminate sachets with low moisture-vapor transmission rate; the terminal product is a water-soluble powder for oral solution administered through a swine or poultry drinking line.
High-shear granulation of Tongchang Shaoyao Powder is selected when the dosage form must remain free-flowing for volumetric metering and must generate minimal dust in enclosed livestock housing. The granulation charge contains 10–25 wt% active dry extract when standardized to 10% paeoniflorin, or 25–40 wt% raw root powder when extract is not used; corn starch makes up 40–60 wt%, sucrose 10–20 wt%, and povidone K30 2–3 wt%. The wet mass is processed in a 100–300 L high-shear granulator with impeller speed 100–200 rpm and chopper speed 1000–1500 rpm; water is added until wet mass torque plateaus, typically at 8–12% added water, and the endpoint is confirmed by the formation of a compressible bead between fingers. The granulate is then dried in a static fluid-bed dryer at 60–70°C inlet air until loss on drying by Ph. Eur. 2.8.17 reaches 2–4%; over-drying below 1.5% moisture creates excessive fines during the subsequent oscillating sieve step. The dried granulate is passed through a 16–40 mesh sieve to maintain a volume median diameter of 300–600 µm, because finer granules bridge in a volumetric cup and coarser granules segregate in the feed carrier. Compliance testing includes particle size distribution by USP <786>, loss on drying by USP <731>, microbial limits by USP <61> and USP <62>, and paeoniflorin content by USP <621>. The terminal product is an oral granule packed in 500 g foil laminate pouches or 10 kg high-density polyethylene pails for top dressing on swine and poultry feed; it is not formulated for drinking-water proportioner lines because the starch framework and lower porosity produce slower water erosion than the dedicated soluble powder grade.
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Tongchang Shaoyao Powder Veterinary Grade API is a standardized botanical active pharmaceutical ingredient derived from Paeonia lactiflora root and intended solely for veterinary drug product manufacture. The product is supplied for incorporation into tablets, injections, capsules, powders, granules, premix, and solutions; however, the same dry lot is not automatically suitable for all seven dosage forms. The manufacturer’s model field on the certificate of analysis should be read as a dosage-form particle-size class rather than a pharmacopoeial model identity: a fine-milled injectable grade may be requested with a laser diffraction D90 of 75 µm or below, while a direct-compression grade may be controlled to a D90 of 250 µm. The marker compound is paeoniflorin. The veterinary API is differentiated from raw botanical powder by assay standardization, microbial limits, elemental impurity control, and a pesticide residue data package aligned with current pharmacopoeial and veterinary regulatory expectations.
The powder is not a single-analyte synthetic active ingredient. Paeonia lactiflora root contains flavonoids, monoterpene glycosides, polyphenols, and polysaccharides in addition to paeoniflorin. Batch-to-batch variance arises from geographic origin, harvest year, drying method, and milling energy. Standardization may involve blending assayed lots to a target paeoniflorin content, passing the blended material through a rotating-knife mill, and sieving through a stainless-steel screen. Magnetic separation is typically placed before packaging to reduce ferrous contamination. Published data for this specific manufacturer’s mixed-source lot performance are limited; therefore, vendor qualification should include retained samples, moisture-sorption profiles, forced-degradation data, and cross-validation of the HPLC assay before the API is introduced into commercial veterinary formulations.
The particulate and moisture properties of the API create different constraints in each dosage form. For tablet compression, residual moisture above 12.0 % and water activity above 0.60 increase the risk of capping and lamination on rotary presses with deep-fill cams. For capsule filling with a dosator nozzle, the powder may require a glidant if the angle of repose exceeds 35°. For injectable suspension production, the same powder may be wet-milled or air-jet milled to a D90 below 75 µm; this raises surface energy, increases hygroscopicity, and can reduce flowability unless the subsequent formulation step is executed in a humidity-controlled suite.
The controlling constraint is usually not assay but microbial quality and particle size. Dry oral forms such as tablets, capsules, powders, granules, and premix are governed by non-sterile microbial limits under USP <61> and USP <62>, or the corresponding ChP 1105 and ChP 1106 methods. Injectable use forces the same lot to meet bacterial endotoxin requirements under USP <85> and a bioburden level compatible with subsequent aseptic filtration or terminal sterilization. A lot released with total aerobic microbial counts above 103 CFU/g may be acceptable for oral tablets but cannot be used directly for an aseptically filled injectable unless a validated reduction step is introduced without degrading paeoniflorin.
| Control attribute | Dry oral or premix reference | Injectable or solution reference | Standard or method |
|---|---|---|---|
| Identity | TLC and HPLC retention time match | Same identity test plus solution clarity risk assessment | ChP 2020, USP <561>, Ph. Eur. 2.2.29 |
| Paeoniflorin assay | Not less than 1.2 % on dried basis | Same assay; injectable formulation must demonstrate marker stability | ChP 2020, USP <621> |
| Loss on drying | Not more than 12.0 % | May require tighter in-process moisture control | USP <731>, ChP 0831 |
| Total ash | As per monograph | Same | Ph. Eur. 2.4.16, ChP 2302 |
| Elemental impurities | Oral and premix PDE limits | Injectable PDE limits | ICH Q3D Option 1, USP <232>/USP <233> |
| Pesticide residues | Multi-residue GC-MS/MS and LC-MS/MS | Same | USP <561>, ChP 2341 |
| Microbial enumeration | TAMC 103 CFU/g, TYMC 102 CFU/g, absence of Salmonella and Escherichia coli | TAMC 102 CFU/g or lower depending on aseptic process | USP <61>/USP <62>, ChP 1105/ChP 1106 |
| Bacterial endotoxin | Not applicable for dry oral forms | Set in drug product dossier; cannot be inferred from dry powder monograph | USP <85>, ChP 1143 |
| Water activity | Not more than 0.60 | Often not more than 0.40 for aseptic filling | ISO 18787:2017 |
| Particle size | D90 150 µm to 250 µm for dry blending and direct compression | D90 75 µm or below for suspensions; solutions may require extraction or filtration | USP <429>, laser diffraction |
| Powder flow | Angle of repose 35° or less, Carr compressibility 20 % or less | Not primary release if wet dispersion is used | USP <1174> |
These limits are established in the veterinary drug product dossier and may be adjusted only after process performance qualification. A direct-compression lot with a D90 above 250 µm generally provides acceptable flow but creates content uniformity risk when tablet mass falls below 100 mg because the number of active particles per tablet is insufficient. An injectable suspension lot micronized to a D90 below 75 µm has higher surface energy and moisture uptake; it may agglomerate during storage, and the adsorption of formulation polymers onto fresh particle surfaces can delay paeoniflorin release unless the vehicle is optimised.
For solution dosage forms, the raw powder is not directly dissolved. A common operation is to reflux or dynamically extract the powder in purified water at 85 °C to 90 °C for 60 min to 120 min, filter through 0.45 µm and then 0.22 µm filters, and concentrate under vacuum at a temperature below 60 °C. The resulting extract is assayed for paeoniflorin before compounding. This step separates the API from insoluble fibre and reduces the risk of clogging sterilizing-grade membranes. The procedure must be validated because extraction efficiency depends on particle size, water-to-powder ratio, agitation, and pH.
For powders and granules, the API is dry-mixed, wet-granulated, and dried to a final moisture below 5.0 %. Even when the blend is simple, the powder should be screened through a 500 µm safety screen before charging to prevent lumps from entering the granulator.
Premix manufacture introduces occupational dusting and segregation risks. Fine particles below 50 µm become airborne during transfer and can deposit on equipment surfaces, leading to cross-contamination and low assay recovery. Using a closed transfer system, de-dusting the mill exhaust, and selecting a carrier with similar tapped bulk density reduce segregation. For ribbon blenders, fill level should be maintained at 50 % to 70 % of working volume to avoid dead zones at the ends of the trough.
The difference is not merely particle size. For direct compression, the API is usually blended with microcrystalline cellulose, lactose, or dicalcium phosphate in a high-shear mixer or V-blender, then compressed on a rotary tablet press with a precompression station. The optimum inlet blend is often characterised by a Carr compressibility of 20 % or less and a Hausner ratio below 1.25. If botanical polysaccharides impart plastic deformation, reducing tablet hardness to avoid capping can increase friability above 1.0 % on friability testing.
For injectable suspensions, the API is dispersed in an aqueous vehicle containing a wetting agent, suspending agent, and tonicity modifier. The suspension is passed through a high-shear rotor-stator mixer or a piston-gap homogenizer, and the final particle size is verified by laser diffraction after homogenization. Sterilizing-grade membrane filtration of a true solution is possible only if the powder is extracted and the extract is filtered; raw Shaoyao powder cannot be filtered through a 0.22 µm membrane as a suspension. If the formulation is intended as a solution, the botanical powder may be extracted in purified water or water-ethanol, filtered through a depth filter followed by a membrane filter, and then assayed for paeoniflorin before the final dosage form is prepared.
For capsule manufacture, the API is commonly pre-sieved through a 500 µm safety screen, blended with a lubricant and a glidant, and filled on a dosator or tamping-pin capsule machine. Fill weight is adjusted based on tapped density; split filling runs are avoided because the botanical powder can segregate by particle size if the hopper is refilled without flow control.
Botanical powders of Paeonia lactiflora are heat-sensitive with respect to color, solubility, and paeoniflorin stability. Steam sterilization at 121 °C for 15 min may degrade the marker and produce Maillard-type browning with residual sugars and amino acids. Aseptic processing is therefore common, but the dry API must then be supplied with a bioburden low enough to support sterile filtration or aseptic crystallization. Irradiation may be considered as an incoming raw material decontamination step, but it must be validated for paeoniflorin recovery and for the absence of radiolytic by-products in the finished injectable.
Endotoxin control is a separate concern from bioburden. The bacterial endotoxin limit for an injectable veterinary product is derived from the maximum dose, route, and target species. A fixed dry powder monograph cannot define this limit; it must be calculated in the drug product dossier. If the API is used in a solution after extraction, the extraction vessel, filter housings, and receiving tanks should be sanitized and rinsed with endotoxin-controlled water before use.
The milling operation itself can introduce physical and chemical instability. Air-jet milling increases surface area and may reduce crystallite domains of any semi-crystalline fraction. A post-milling assay should be performed because local temperature rise during milling can reduce paeoniflorin content. The milled powder should be stored in double polyethylene bags inside a sealed fibre drum at controlled room temperature; re-drying may be required if water activity rises above 0.60 after storage in high-humidity environments.
Commodity Shaoyao powder is often sold by particle size and botanical identity alone. It may lack batch-to-batch assay standardisation, microbial limits, elemental impurity data, pesticide residue data, stability data, and documented animal-source-free or non-GMO status. The veterinary grade is manufactured under veterinary pharmacopoeial quality systems and released with a certificate of analysis containing the paeoniflorin assay, drying loss, total ash, heavy metal screen, and microbial enumeration results. The difference is not limited to testing; it includes change control, packaging, cleaning validation, and traceability to a defined harvest batch.
Compared with synthetic small-molecule veterinary APIs, this botanical powder has a wider analytical fingerprint and a higher sensitivity to growing conditions. That means the specification must accommodate multiple marker compounds rather than a single molecule. The pharmacopoeial identity test may rely on TLC plus HPLC fingerprinting, and the assay limit may be based on a single marker while the manufacturing process is controlled by botanical ratio markers. Unstandardized powder does not provide this level of control.
The veterinary grade is also distinct from human-grade Paeoniae Radix Alba powder because the regulatory risk assessment includes target animal safety and, where relevant, food-producing animal residues and withdrawal periods. A human herbal powder meeting the same plant assay may not be suitable for veterinary injectable use if its bioburden, endotoxin, and particle-size distribution have not been evaluated under veterinary drug good manufacturing practice.
