| HS Code | 749104 |
| 2 Botanical Source | Dried whole plant of Potentilla discolor Bunge (family Rosaceae) |
| 4 Physical Appearance | Brown to yellowish-brown powder or crystalline-like solid depending on selected dosage form intermediate |
| 5 Solubility | Partially soluble in water; soluble in ethanol, methanol, and hydroalcoholic solutions; pH-dependent precipitation possible |
| 6 Identification | Positive reaction with flavonoids and tannins; HPLC fingerprint matches reference chromatogram of Potentillae Discoloris Herba |
| 8 Assay Content | Total flavonoids (as quercetin): 8.0%–20.0%; total polyphenols: 10.0%–25.0% depending on specification |
| 11 Dosage Form Compatibility | Suitable for tablets, capsules, powders, granules, premixes, solutions, and injectable formulations with appropriate excipients and pH adjustment |
| 12 Storage And Stability | Store in airtight, light-resistant containers in a cool, dry place (below 25°C); protected from moisture and direct sunlight; shelf life typically 24–36 months when unopened |
As an accredited Potentillae Discoloris 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 | Sealed in double polyethylene-lined fiber drums, 25 kg net per drum, with tamper-evident closure and labeled identification. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Potentillae Discoloris Herba veterinary-grade API for tablets, injections, capsules, powders, granules, premix, and solutions, securely packed and documented. |
| Shipping | This veterinary-grade API is shipped in sealed, light-protected containers to preserve potency and stability. Standard transport is temperature-controlled (2–8°C) or ambient depending on validation, away from moisture and contaminants. Documentation includes Certificate of Analysis and safety data. Shipments comply with veterinary pharmaceutical regulations for powders, granules, tablets, and other formulations. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature (20–25°C), protected from light and moisture. Keep containers tightly sealed when not in use. Avoid exposure to excessive heat or humidity. Ensure compliance with veterinary pharmacopoeia standards. For formulated products, follow specific supplier guidance regarding handling and stability. |
| Shelf Life | Shelf Life: 24 months in unopened containers, stored in a cool, dry place, protected from light and moisture. |
On sterile injectable lines processing Potentillae Discoloris Herba (PDH) dry extract for lactating cattle mastitis therapy, the formulation design space is defined less by potency than by clarification flux, endotoxin burden, and oxygen transfer across the aseptic boundary. The 1:4 hydroalcoholic dry extract is standardised to not less than 2.5 g/100 g total polyphenols as gallic acid equivalents by Folin-Ciocalteu spectrophotometry and is reconstituted in Water for Injections at 12–18 mg/mL in 10 L stainless-steel compounding vessels under a nitrogen overlay set at 0.05–0.15 MPa; attempts to raise the extract load above 25 mg/mL produce visible haze after 0.45 µm polyvinylidene fluoride clarification and reduce downstream 0.22 µm polyethersulfone membrane throughput by 30–45% at ≤20 °C. pH adjustment to 6.2–6.8 with 0.1 M phosphate buffer or sodium bicarbonate is performed after extract addition, not before, because early alkaline conditions accelerate polyphenol oxidation to ortho-quinones and shift the solution colour from amber to dark brown. Terminal sterilisation by moist heat at 121 °C for 15 min is generally avoided when the total polyphenol area under the HPLC profile contains more than 12% heat-labile flavonol glycosides; instead, the solution is sterilised by aseptic filtration through a 0.22 µm polyethersulfone membrane with downstream sterile receiving and filling maintained under EU GMP Annex 1 grade A laminar airflow, with settle plates, contact plates, and active air sampling performed in accordance with ISO 14644-1:2015 class 5 conditions. The bacterial endotoxin acceptance limit for the finished intramammary infusion is set at not more than 0.2 EU/mL when the multidose volume is 10 mL and not more than 0.5 EU/mL for the 100 mL multidose vial, with raw extract endotoxin controlled below 0.5 EU/mg and bioburden below 100 CFU/g before release. Sub-visible particle counts are monitored per Ph. Eur. 2.9.19 and USP <788>, with the acceptance threshold not more than 6,000 particles/container at ≥10 µm and not more than 600 particles/container at ≥25 µm. The production line formats include 10 mL low-density polyethylene intramammary syringes, 100 mL amber type II glass vials sealed with chlorobutyl stoppers, and 250 mL sterile polypropylene bags for intravenous or subcutaneous administration under veterinary prescription. Stability under VICH GL2 has been assessed at 25 °C/60% RH and 5 °C ± 3 °C; the solution should not be stored above 25 °C for more than 6 months because total polyphenol recovery can fall below 95.0% of label claim and the pH can drift upward beyond 7.2.
Direct compression of PDH dry extract into canine and feline metabolic support tablets is constrained by the extract’s moisture sorption behaviour, low bulk density, and pronounced cohesion at blend relative humidity above 45% RH. In production trials using a 0.5 mm square-mesh screen and a 100 L bin blender, the dry extract at 15.0–25.0% w/w of the core blend produces a Hausner ratio of 1.28–1.35 and causes punch-face picking on 45-station rotary presses; wet granulation is therefore selected as the default route. The core formulation contains PDH dry extract at 100–200 mg per tablet, microcrystalline cellulose PH102 at 35.0% w/w, anhydrous dibasic calcium phosphate at 18.0% w/w, crospovidone type A at 3.0% w/w, and PVP K30 at 5.0% w/w as a 10% w/w aqueous granulation binder. Granulation is performed in a top-spray fluid bed with inlet air at 55–65 °C, product temperature at 38–42 °C, and spray rate of 150–200 g/min for a 60 kg batch; the granulate is dried to an LOD of 1.8–2.5% and milled through a 1.0 mm conical mill at 1,200 rpm. Magnesium stearate is added at 0.5% w/w and blended for 5 min; compression runs at 30–40 rpm with a force of 8–12 kN, yielding tablets of 60–90 N hardness and total core weight 400–800 mg depending on active load. Friability tested per USP <1216> remains below 1.0% after 100 drops, and disintegration time per USP <701> is below 15 min in 900 mL water at 37 °C. Compliance for this dosage form falls under 21 CFR 211, VICH GL1 for analytical validation, VICH GL2 for stability, and USP <711> dissolution with a Q value set using 900 mL 0.1 N hydrochloric acid at 50 rpm basket speed; dissolution release data from three pilot lots show 75.0% of total polyphenols released at 30 min when the tablet core is film-coated with an aqueous hydroxypropyl methylcellulose system at 2.5–3.5% w/w weight gain. The finished presentation is an oval scored tablet packaged in 60-count HDPE jars with 1 g silica gel desiccant or in 10-count aluminium/aluminium blisters; the processing area must be maintained below 45% RH and 22 °C ± 2 °C to prevent edge chipping and punch-face picking.
| Release parameter | Method/standard code | Acceptance criterion |
|---|---|---|
| Uniformity of dosage units | USP <905> | AV ≤ 15.0 |
| Friability | USP <1216> | ≤ 1.0% |
| Disintegration | USP <701> | ≤ 15 min |
| Dissolution | USP <711> | Q 75% at 30 min |
| Total polyphenols | UV spectrophotometry | 95.0–110.0% label claim |
| Water content | Karl Fischer titration | 1.8–2.5% |
| Microbial limits | Ph. Eur. 2.6.12/2.6.13 | ≤ 103 CFU/g; absent E. coli |
For broiler and layer gut-health programmes using PDH dry extract in feed premixes, the dominant constraint is not pharmacological activity but carrier uniformity and the regulatory line between feed material and medicinal additive. The extract is incorporated into an intermediate premix at 50–100 g/kg, with the remainder composed of ground corn cob or rice hull carrier with a D50 of 300–500 µm, calcium carbonate at 20.0% w/w, and hydrated sodium calcium aluminosilicate at 1.0% w/w as an anticaking agent. Final feed inclusion of 1.0–2.0 kg/t delivers 50–200 g extract per tonne of complete feed, corresponding to 50–200 ppm total extract. Production is carried out in a 12 m³ ribbon blender at 18–22 rpm for 8–10 min, followed by a hammer mill fitted with a 0.8 mm screen and active uniformity verification at 5 points per batch; the coefficient of variation for total polyphenols should remain below 5.0%. Feed hygiene compliance is based on Regulation (EC) No 183/2005 Annex II, Directive 2002/32/EC for undesirable substances, ISO 6497:2002 for sampling, and GMP+ BA2 or FAMI-QS certification for specialty feed ingredients; microbiological release follows Ph. Eur. 2.6.12 with total aerobic plate count not more than 105 CFU/g and absence of Salmonella in 25 g. Terminal presentations are 1 kg, 5 kg, and 25 kg laminated foil premix bags or micro-pellets produced by low-shear extrusion at 50 °C product temperature; this temperature limit preserves total polyphenol recovery above 96.0%.
At pig farm level, the selection of a soluble PDH oral powder for drinking-water delivery is determined by water quality variables, especially alkalinity and the presence of free chlorine residuals that can oxidise phenolic fractions. The spray-dried extract is dry-blended with lactose monohydrate at a ratio of 100 mg/g PDH dry extract, together with anhydrous colloidal silicon dioxide at 0.5% w/w, trisodium citrate dihydrate at 2.0% w/w as a buffering agent, and maltodextrin DE 15–20 as a dispersant; after reconstitution at 1.0 g/L in drinking water, the resulting extract concentration is 100 mg/L, and individual drench administration is calculated at 20–30 mg/kg body weight once daily. The manufacturing process uses a 0.4 mm oscillating sieve and a 500 L V-blender operating at 12 rpm for 20 min, with the powder discharged at ≤35% RH to prevent particle agglomeration; dissolution time is tested in water at 25 °C and should not exceed 60 s for complete passage through a 0.15 mm sieve. Compliance for this non-sterile oral powder follows 21 CFR 211.84 component testing, VICH GL2 for stability, and Ph. Eur. 2.6.12/2.6.13 for non-sterile veterinary oral dosage forms; where the product is marketed as a feed material rather than a medicinal oral powder, Regulation (EC) No 183/2005 and Directive 2002/32/EC apply instead. Terminal formats include 100 g and 500 g heat-sealed foil sachets, 1 kg HDPE jars, and 100 mL or 250 mL oral drench suspensions prepared by compounding the powder in purified water immediately before use. The formulation should not be exposed to oxidising disinfectants or high-pressure hot water sanitation above 60 °C, because total polyphenol recovery declines to below 90.0% of label claim under combined alkaline and chlorine stress.
For equine metabolic support capsules containing PDH dry extract, roller compaction is used instead of wet granulation because the target fill weight of 450–700 mg in size #0 hard gelatin capsules requires a densified granulate with a tapped density of 0.65–0.75 g/cm³ and a compressibility index below 25%. The dry extract is loaded at 150–300 mg per capsule, corresponding to 40.0–55.0% w/w of the fill; microcrystalline cellulose PH102 is added at 30.0–40.0% w/w, croscarmellose sodium at 2.0% w/w, and magnesium stearate at 0.5% w/w after compaction. The compaction step runs on a 120 mm roller compactor with roll pressure of 30–50 kN, roll speed of 6–10 rpm, and a screen mill set to 0.8 mm; the granulate is filled on a 3,000–6,000 capsules/h intermittent-motion capsule filler with pin setting, and weight variation is checked per USP <905> at 20 capsule sample intervals. Dissolution testing per USP <711> in 900 mL 0.1 N hydrochloric acid at 50 rpm requires 70.0% release of total polyphenols at 45 min; failure to control post-compaction fines below 20% by sieving has caused dissolution lag due to delayed deaggregation in two production campaigns. Compliance for the capsule format falls under 21 CFR 211, ICH Q3D/USP <232>/USP <233> for elemental impurities, VICH GL18 for residual solvents, and Ph. Eur. 2.6.12/2.6.13 for non-sterile microbiological quality; residual ethanol from the extract should be controlled below 5,000 ppm if the solvent system uses ethanol, with method validation per VICH GL1. The terminal presentation is a 60-count HDPE bottle with a 1 g desiccant canister or a 10-count aluminium blister; environmental controls at 40% RH maximum and 22 °C ± 2 °C are critical because the spray-dried extract becomes sticky when the glass transition temperature drops below 35 °C, causing capsule shell brittleness and dimpling. Published pharmacokinetic data for PDH in horses are limited; dose adjustments for chronic metabolic support should therefore be derived from species-specific safety studies rather than extrapolated from companion-animal clearance values.
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Potentillae Discoloris Herba Veterinary Grade API is obtained from the dried whole herb of Potentilla discolor Bunge (Rosaceae) and is supplied for incorporation into tablets, injections, capsules, powders, granules, premixes, and oral solutions. The material is not a single isolated molecule but a multicomponent botanical preparation; the principal reported constituent classes are triterpenoids, including tormentic acid and asiatic acid, and flavonoids, including quercitrin and hyperoside. Because no universal harmonized monograph exists for this veterinary-grade herbal API, the product is controlled against the general chapters for herbal drugs of the Chinese Pharmacopoeia 2020 and the Chinese Veterinary Pharmacopoeia, with residual solvent and elemental impurity controls aligned to VICH GL18 and ICH Q3D. Model designation is manufacturer-specific and usually encodes processing grade, such as micronized raw herb powder or dried hydroethanolic extract; codes similar to PDH-V-P100 for powdered herb and PDH-V-E60 for extract grade may appear on the certificate of analysis. These grade distinctions are process-relevant: the same botanical species behaves differently in a direct-compression tablet, a sterile injectable, and a feed premix.
The API is differentiated first by botanical identity. Potentilla discolor Bunge is distinct from Potentilla chinensis Ser. and Potentilla anserina L., both of which are encountered as substitutes in unrefined supply chains. Lot acceptance therefore requires macroscopic and microscopic verification. Thin-layer chromatography against a Potentillae Discoloris Herba reference extract must show characteristic bands for tormentic acid and the quercitrin flavonoid zone. Where substitution is suspected, DNA barcoding using the ITS2 or rbcL regions may be applied as a supplementary species confirmation tool. Differences from synthetic veterinary intestinal anti-infectives are pharmacological and regulatory. A synthetic agent such as enrofloxacin or sulfachloropyridazine sodium is a defined chemical with a single pharmacopoeial assay, a known minimum inhibitory concentration, and a specific withdrawal period. In contrast, this herbal API is a complex mixture whose activity is expressed as total flavonoids or total triterpenoids. Batch composition is influenced by collection month, drying temperature, extraction solvent, and harvest year. Regulatory status is not interchangeable: a medicated premix registered for a synthetic antibacterial cannot be satisfied by substituting this herbal API without a separate veterinary herbal product registration. Operational substitution is also not acceptable; a common Chinese herbal name does not automatically guarantee compliance with the Potentillae Discoloris Herba monograph.
The following control points are representative industrial ranges for the veterinary-grade API. The registered specification in the destination market must be verified against the current national pharmacopoeia and the approved marketing authorization. The botanical drug should be supplied with a certificate of analysis containing at least two orthogonal identity tests, foreign matter, loss on drying, total ash, acid-insoluble ash, heavy metals, pesticide residues, and microbial limits. Injectable-grade material requires additional bacterial endotoxin control and extraneous particulate matter testing before terminal filtration.
| Parameter | Typical control range | Analytical reference |
|---|---|---|
| Identification | TLC matching Potentillae Discoloris Herba reference; bands for tormentic acid and quercitrin | Chinese Pharmacopoeia 2020 general TLC method |
| Loss on drying | ≤ 12.0% w/w | USP <731> |
| Total ash | ≤ 13.0% w/w | USP <561> |
| Acid-insoluble ash | ≤ 5.0% w/w | USP <561> |
| Total flavonoids, as rutin | ≥ 2.0% w/w on dried matter for standardized extract grades | UV-Vis spectrophotometry or HPLC per Chinese Pharmacopoeia general chapter |
| Heavy metals | ≤ 20 mg/kg | USP <231> |
| Total aerobic microbial count | ≤ 10⁵ CFU/g for oral grade; ≤ 10² CFU/g for injectable grade before terminal sterilization | USP <61> |
| Salmonella | Absent / 10 g | USP <62> |
| Bacterial endotoxins, injectable grade | ≤ 0.5 EU/mg calculated against maximum intended dose | USP <85> |
Total flavonoids expressed as rutin by UV-Vis spectrophotometry can overestimate total flavonoid content because other phenolic constituents absorb in the same spectral region. An HPLC method with diode-array detection is preferred for injectable-grade release because it quantifies tormentic acid and hyperoside separately. The HPLC method should be validated for specificity, linearity, accuracy, and precision according to ICH Q2(R1). Batches below the total flavonoid release limit should not be corrected by adding isolated rutin, because this does not restore the full marker profile and is not acceptable under botanical drug monographs.
Comminuted raw herb powder is blended with feed-grade carriers before use in oral powders and premixes. Blend uniformity is a recognized bottleneck because the API contains both lightweight leaf fragments and denser root fragments; segregation occurs when the particle-size difference exceeds 100 µm at the blend surface. Conical screw or ribbon blenders with a working fill depth not exceeding 60% of vessel volume are used, and geometric dilution in a 1:10 carrier-to-API ratio is repeated at least three times. For granular products, wet granulation with 2–5% w/w povidone K30 solution as binder and fluid-bed drying at a product temperature not exceeding 45°C reduce dusting and improve flow. Premix inclusion rates are dose-dependent; the final feed should be re-assayed after 24 h because herbal powders may adsorb moisture and lose free-flowing character at relative humidity above 60%. These processing limits apply to oral powders and granules; they do not apply to injectable solutions.
The injectable route imposes constraints that are absent from oral powders. The extract intermediate must be dissolved in water for injection and filtered through a 0.45 µm prefilter followed by a 0.22 µm sterilizing membrane. However, membrane adsorption of tannins and flavonoids can reduce assay recovery by 10–20% unless a low-protein-binding membrane such as PVDF is used. Terminal sterilization by moist heat is not universally applicable: herbal extracts containing thermolabile flavonoids may degrade at 121°C for 15 min, and published data for this specific extract over the full thermal cycle is limited. Aseptic filtration with a validated holding time is therefore preferred when the product is registered as a sterile herbal injection. Bacterial endotoxin control starts with the API: endotoxins from botanical raw material are not reliably removed by 0.22 µm filtration, so the injectable-grade dry extract should meet ≤0.5 EU/mg. Particulate matter must comply with USP <788> for small-volume parenterals. The final solution pH is usually maintained between 4.5 and 6.5; outside this range, tannin–protein complexes and flavonoid aglycones may precipitate after 12–24 h of storage at 2–8°C. Solution clarity is a critical quality attribute because redispersible precipitates are not acceptable in injectable products.
For direct-compression tablets, the dried extract or micronized herb powder must be pre-dried to a moisture content below 5.0% w/w when ambient relative humidity exceeds 60%, because hygroscopic flavonoids can cause punch sticking and weight variation. A direct-compression formulation typically requires 0.5–1.0% w/w colloidal silicon dioxide as glidant and 1–3% w/w magnesium stearate as lubricant; higher lubricant levels may retard dissolution. Compaction pressure is adjusted to a tablet hardness of 50–80 N for herbal tablets, while friability is maintained below 1.0% according to USP <1216>. Capsule filling with the same powder blend may require densification because the aerated bulk density of spray-dried herbal extract can be as low as 0.35–0.55 g/cm³; tamping-pin fillers or roller-compacted granules improve plug formation. For capsules, content uniformity is verified by USP <905>, and disintegration is tested in 37°C water with a run time not exceeding 30 min unless an enteric capsule shell is used.
Oral solutions present different challenges: the API should be dissolved or dispersed in buffered drinking water, and the preparation must remain homogeneous under field conditions. The API contains polyphenolic constituents that can bind metal ions in hard water; this can form dark precipitates when total hardness exceeds 250 mg/L as calcium carbonate. A chelating agent such as citric acid at 0.1–0.3% w/w may be included in the solution formula to control precipitation. In drinking-water premixes, the product is typically diluted at 0.5–1.0% w/v before administration; the diluted solution should be used within 24 h unless a preservative is present. Potassium sorbate, if used, is most effective at pH below 5.5; above this value its antimicrobial activity declines. Standard solution stability protocols follow ICH Q1A(R2) for storage conditions, but veterinary herbal products are frequently assessed under in-use conditions at 25°C/60% RH and 40°C/75% RH. The product is incompatible with strong oxidizers and with cationic metal salts; this is relevant when the same watering line is used for mineral supplements or acidified drinking water.
Batch-to-batch variation in the unstandardized raw herb is significant. Collection before flowering yields higher total flavonoid content, whereas collection after flowering increases root-to-aerial ratio and triterpenoid content. Drying temperature above 60°C reduces total flavonoid recovery by accelerating oxidative polymerization; forced-air drying at 40–50°C is preferred. The extraction-ratio designation, such as 4:1 or 5:1, is not a potency claim; it expresses the ratio of raw herb to dry extract and must be disclosed on the certificate of analysis. Spray drying of hydroethanolic extract on maltodextrin produces a free-flowing powder with bulk density 0.40–0.60 g/cm³, while vacuum-drying produces a glassy solid that requires milling and can generate heat, causing resinification if local temperature exceeds 45°C. Spray-dried grades are therefore generally selected for tablets and capsules, whereas vacuum-dried extract may be more suitable for liquid manufacturing because of higher water solubility.
| Processing grade | Preferred dosage forms | Critical processing parameter | Typical control range |
|---|---|---|---|
| Micronized raw herb powder | Powders, granules, premixes | Particle size D90 | ≤ 180 µm |
| Dried hydroethanolic extract | Tablets, capsules, oral solutions | Total flavonoids as rutin | ≥ 2.0% w/w |
| Injectable-grade dry extract | Injections | Bacterial endotoxin; bioburden before sterilization | ≤ 0.5 EU/mg; ≤ 10² CFU/g |
The API is incompatible with aluminum-based antacids in oral formulations because polyphenols chelate aluminum and reduce dissolution. It should not be dry-blended with amine-based additives or strong alkalizing agents, which can oxidize phenolic constituents and darken the powder. In injectable formulations, polyvinyl chloride infusion containers may adsorb phenolic compounds; glass or polyolefin containers are preferred. For premix, avoid simultaneous use of bentonite binders at levels above 2.0% w/w because clay adsorption can reduce assay recovery. Substitution with Potentilla chinensis or Potentilla anserina alters the marker profile and is not automatically accepted as the same herbal drug. Compared with purified berberine hydrochloride or synthetic antibacterial premixes, the herbal API requires higher inclusion rates, a broader analytical release panel, and more rigorous drying control because it is not a single crystallized compound. The regulatory and functional position of the herbal API in veterinary practice rests on its multicomponent botanical character; however, claims must be limited to the registered veterinary indication and supported by species-specific stability data. Published data on the comparative bioavailability of marker triterpenoids after oral administration in target species is limited, so dose extrapolation from single-molecule agents is not appropriate.
