| HS Code | 375382 |
| Appearance | Light yellow to pale brown amorphous powder |
| Solubility | Freely soluble in water; soluble in methanol and ethanol; practically insoluble in ether and acetone |
| Particle Size | 95% through 80 mesh; suitable for further processing into tablets, capsules, powders, granules, premixes, solutions, and injections |
| Ph Value | 6.0 to 8.0 in a 1% aqueous solution |
| Bulk Density | 0.40 to 0.65 g/mL for loose bulk density |
| Storage Conditions | Store in tightly sealed, light-resistant containers in a cool, dry place below 30°C |
| Shelf Life | 24 months when stored under recommended conditions |
As an accredited Notoginseng Total Saponins 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 | 25kg per drum, double-layer polyethylene liner, sealed, moisture-proof, labeled, ideal for tablets, injections, capsules, powders, granules, premix, solutions. |
| Container Loading (20′ FCL) | One 20′ FCL containing Notoginseng Total Saponins veterinary grade API, packaged in sealed drums on pallets for safe transport. |
| Shipping | Notoginseng Total Saponins Veterinary Grade API ships as sealed, moisture-proof packaging in temperature-controlled conditions to preserve stability. Documentation includes SDS, COA, and veterinary API certification. Transport via air or sea with proper labeling, avoiding direct sunlight and extreme temperatures. Ensure compliance with regional veterinary pharmaceutical regulations. |
| Storage | Store Notoginseng Total Saponins Veterinary Grade API in a tightly sealed, moisture-proof container in a cool, dry, well-ventilated area at room temperature (2–30°C). Protect from direct sunlight, heat, and humidity. Avoid repeated opening, and use dry utensils. Keep away from incompatible substances and ensure proper labeling for handling. |
| Shelf Life | Shelf life is 24 months when stored unopened in a cool, dry, airtight container, protected from light and moisture. |
Notoginseng total saponins veterinary grade API is formulated into drinking-water-soluble oral powders only after granulation from a 95% ethanol-water mixture to control dust and reduce foaming. The spray-dried extract, typically standardized to not less than 90.0% total saponins calculated as the sum of notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1, and ginsenoside Rd by HPLC-ELSD, is hygroscopic and electrostatically cohesive. Open handling above 55% relative humidity produces surface wetting and lumping within 20 min on stainless-steel. A representative granular oral powder contains API 10.0% w/w, anhydrous dextrose 82.5%, sodium citrate dihydrate 5.0%, colloidal silicon dioxide 1.5%, and povidone K30 1.0%. The dextrose carrier is milled to D90 ≤ 150 µm; API is passed through a 60-mesh sieve before blending. Dry mixing occurs in a V-blender at 60–70% fill volume, 25 rpm for 15–20 min. Granulation uses a top-spray fluidized bed with inlet air 55–65°C, product temperature 35–40°C, and final moisture ≤ 3.0%. The spray-dried API before granulation commonly shows bulk density 0.35–0.55 g/mL and Carr index above 30%; after granulation the Carr index is reduced to ≤ 20% so that sachet filling weight variation remains within ±5%.
Foaming during reconstitution is controlled by slow addition of the granulated product to water at 20–25°C under gentle agitation; simethicone 0.05–0.1% may be incorporated if drinking water hardness is above 300 mg/L as CaCO3. The finished sachet is filled under ≤ 45% RH and sealed with laminated aluminum foil. A 100 g sachet reconstituted in 100 L drinking water produces a 0.1% w/v solution used within 24 h and protected from light. The terminal granule specification includes moisture ≤ 3.0% by ISO 6496, residue on ignition ≤ 5.0%, pH of a 10% aqueous dispersion 5.0–7.0, heavy metals ≤ 20 mg/kg by ICP-MS, and sieve retention on 80-mesh ≤ 5.0%. Published dissolution data for granulated veterinary drinking-water saponins are limited; batch release therefore relies on dispersion time ≤ 3 min in 20°C water and absence of foam above 5 mL per liter.
Injectable-grade PNS must be designated as low-endotoxin and low-bioburden before formulation. The bulk solution is prepared in Water for Injections at 20–25°C with a low-shear impeller at 100–200 rpm; high shear introduces stable foam because the dammarane saponins lower surface tension. The solution is deaerated under vacuum at -0.08 MPa for 15 min before aseptic filtration. Sequential filtration uses a 0.45 µm polyethersulfone prefilter and a 0.22 µm PVDF membrane. Membrane flux is kept below 80 L/m²/h to prevent concentration polarization and foaming at the membrane surface. Filter integrity testing is performed by bubble point or diffusion flow before and after filling; a pressure hold below the manufacturer minimum is cause for batch rejection.
Buffering at pH 6.0–7.0 is critical. Acidic conditions below pH 4.0 hydrolyze the C-20 glycosidic bonds of ginsenoside Rb1 and notoginsenoside R1; alkaline conditions above pH 7.5 accelerate oxidation of the dammarane skeleton. A 10 mM sodium phosphate buffer at pH 6.5 is used for thermolabile fills. Because saponins can chelate iron, the supporting stainless-steel tank should be passivated and the solution protected with nitrogen overlay; dissolved oxygen is limited to ≤ 2 mg/L. Bulk holding time is limited to 4 h at 20–25°C or 24 h at 2–8°C after filtration before filling. If a liquid parenteral is intended for autoclaving at 121°C for 15 min, content of notoginsenoside R1 and ginsenoside Rg1 must be re-assayed because published data for this specific configuration is limited.
For lyophilized presentations, a representative cake contains PNS 50 mg/vial, mannitol 25 mg/vial, disodium edetate 0.1 mg/vial, and sodium phosphate 10 mM; primary drying at shelf -40°C, chamber pressure 100 µbar for 20 h, secondary drying at 20°C for 8 h produces a porosity that reconstitutes in ≤ 2 min with 5 mL WFI. The parenteral release panel includes sterility per USP <71>, bacterial endotoxins per USP <85> with limit ≤ 0.5 EU/mg, particulate matter per USP <788>, pH 6.0–7.0, osmolality 280–320 mOsm/kg, and subvisible particulates by light obscuration. Storage at 2–8°C with protection from light is common; freeze-thaw cycles are not recommended because precipitation and cake collapse may occur.
Feed premixes containing PNS at 1% to 5% active are manufactured by adsorption onto calcium carbonate particles with mean particle size 80–120 µm or onto pre-dried rice hull powder. The carrier is pre-conditioned to moisture ≤ 7.0% before loading because saponins become cohesive above this threshold. API is first diluted 1:5 with carrier in a tumbler before addition to a ribbon mixer operating at 60 rpm for 10 min; this sequence achieves blend uniformity coefficient of variation ≤ 5% when sampled at 10 points. Segregation occurs if the carrier D50 differs from the API D50 by more than 2:1; sieve analysis per ISO 2591-1 is used to verify particle size overlap. Mineral oil can be sprayed at 0.5–1.0% by weight as a dust suppressant, but addition above 1.0% reduces flow and causes bridging in feed batching hoppers. The final premix is packed in multi-wall paper sacks with an inner polyethylene liner under ≤ 55% RH. Compliance records must reference EU Regulation (EC) No 183/2005 for feed hygiene, Directive 2002/32/EC for undesirable substances, and ISO 6497 sampling plans. Carry-over limits in the mixing line are validated by cleaning verification using a surrogate marker; swab limits are set so that cross-contamination of the next batch is ≤ 0.1% of the lowest therapeutic level. The finished feed concentration is governed by the target species marketing authorization and is not determined by this manufacturing procedure.
| Dosage form | Critical process boundary | Analytical or release test | Standard designation |
|---|---|---|---|
| Oral granule / drinking-water powder | final moisture ≤ 3.0%; filling RH ≤ 45%; reconstituted use within 24 h | moisture, heavy metals, pH of dispersion, sieve retention | ISO 6496, ISO 2591-1 |
| Injectable solution / lyophilized powder | pH 6.0–7.0; dissolved oxygen ≤ 2 mg/L; filtration 0.22 µm | sterility, endotoxin, particulate matter | USP <71>, <85>, <788> |
| Feed premix | carrier D50 ratio ≤ 2:1; blend uniformity CV ≤ 5%; mineral oil ≤ 1.0% | blend uniformity, sieve distribution, cross-contamination | ISO 2591-1, ISO 6497, EU 183/2005 |
| Tablet | blend moisture ≤ 3.5%; main compression 10–20 kN; coating weight gain 2.0–3.0% | friability, disintegration, content uniformity | USP <1216>, <701>, <905> |
| Capsule | encapsulation hall 35–40% RH; fill moisture ≤ 4.0%; tamping pin 15–25 N | weight variation, dissolution | USP <905>, <711> |
| Oral solution | pH 5.8–6.5; dissolved oxygen ≤ 2 mg/L; preservative efficacy | pH, preservative efficacy, assay of markers | USP <51> |
Direct compression of PNS is viable only with low-moisture excipients. A representative tablet core contains PNS 15.0% w/w, microcrystalline cellulose PH102 35.0%, spray-dried lactose 44.5%, croscarmellose sodium 4.0%, colloidal silicon dioxide 1.0%, and magnesium stearate 0.5%. Final blend moisture is held ≤ 3.5%; above 4.0% the saponins become tacky and cause punch sticking. Compression on a rotary tablet press uses B-tooling, precompression 5–8 kN, main compression 10–20 kN, and turret speed 20–40 rpm. Tablets of 800 mg target weight are produced at hardness 70–110 N, friability ≤ 1.0% per USP <1216>, and disintegration ≤ 15 min in water at 37±0.5°C per USP <701>. Capping occurs when magnesium stearate exceeds 1.5%, when main compression exceeds 22 kN, or when precompression dwell time is insufficient to relieve elastic recovery of the saponin agglomerates. Forced feeder speed is restricted to 20–40 rpm to avoid particle attrition and electrostatic charging.
Film coating is required for moisture protection and bitter taste masking. An aqueous HPMC 6 cP coating dispersion is applied to 2.0–3.0% weight gain in a perforated pan at inlet air 60–70°C, product temperature 38–42°C, pan speed 6–12 rpm. If ambient RH exceeds 50%, dehumidified coating air with dew point ≤ 10°C prevents saponin hydration and edge chipping. The terminal tablet specification includes content uniformity per USP <905>, assay of notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1, and ginsenoside Rd by HPLC, and total aerobic microbial count ≤ 10² CFU/g. For chewable veterinary tablets, crospovidone may replace croscarmellose at 3–5% to reduce hydration swelling and improve palatability when co-processed with dried liver powder.
Encapsulation of PNS into hard capsules requires air-handling setpoint 18–22°C and 35–40% RH. A representative capsule fill contains PNS 20.0%, lactose monohydrate 75.5%, sodium starch glycolate 3.0%, colloidal silicon dioxide 1.0%, and magnesium stearate 0.5%. The blend is sieved through a 30-mesh screen and mixed in a bin blender at 12 rpm for 20 min; API D90 ≤ 180 µm is required to prevent segregation during automatic capsule filling. Tamping pin pressure is set at 15–25 N on the dosing disc; higher pressure compacts the low-density saponin powder and delays dissolution. Capsule weight variation is controlled to ≤ ±5% per USP <905>. Dissolution testing uses 900 mL water at 37±0.5°C with paddle speed 50 rpm per USP <711>; 0.1 M HCl is not used as a default veterinary medium because gastric pH differs among target species and published biorelevant media for this configuration is limited. Gelatin capsule shells show acceptable compatibility when the fill moisture is ≤ 4.0%; HPMC capsules are preferred where moisture migration from the shell causes saponin lumping. Packing in HDPE bottles with 1 g silica gel desiccant and induction sealing maintains headspace RH ≤ 30% during stability monitoring at 25°C/60% RH and 30°C/65% RH.
A compounded oral solution containing PNS at 5–20 mg/mL is buffered to pH 5.8–6.5 with citric acid and sodium citrate. Propylene glycol 5–10% is used as a co-solvent; polysorbate 80 0.05–0.1% reduces surface tension and prevents foaming during bottle filling. Sweetening with sucralose 0.05–0.2% and flavoring with a non-alcoholic meat or vanilla mask 0.1–0.3% are required because PNS has a persistent bitter aftertaste. Sodium benzoate 0.1% is effective only at pH ≤ 5.0; potassium sorbate 0.1–0.2% is used when the product is buffered above this range. Preservative efficacy is verified per USP <51>. pH below 4.0 accelerates acid-catalyzed hydrolysis of the C-20 glycosidic bonds, generating sapogenins that precipitate as a haze and reduce marker content; pH above 6.8 increases oxidative browning and saponin ring degradation. Sodium edetate 0.05% may be added as a chelating agent where trace metals are present in water above 50 mg/L total hardness.
Nitrogen sparging is maintained during bulk mixing to keep dissolved oxygen ≤ 2 mg/L. Filtration through a 5 µm polypropylene cartridge before filling prevents occasional particulate from buffer salts. The product is filled into amber PET bottles with a 28 mm child-resistant closure and a 5 mL dosing syringe; terminal torque is 1.8–2.2 N·m. Storage at 15–25°C and protection from light are recommended; published data for oral liquid PNS stability in veterinary species is limited, so real-time stability at 25°C/60% RH and 30°C/65% RH should be generated before marketing.
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Notoginseng Total Saponins Veterinary Grade API is supplied as a standardized dry extract derived from the root of Panax notoginseng (Burk.) F.H. Chen. The manufacturer assigns the model code NTS-VG-100, with subgrades NTS-VG-100-T for direct compression, NTS-VG-100-I for injectable formulations, and NTS-VG-100-P for premix and granule applications. The product is intended as an active pharmaceutical ingredient for veterinary tablets, injections, capsules, powders, granules, premix, and oral solutions. Standardization is performed against five marker saponins: notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, and ginsenoside Rd. The total saponin content, calculated as the sum of these markers by HPLC-UV, is specified as not less than 80.0% on the dried basis. Total ash is not more than 5.0%, and loss on drying is not more than 5.0% at 105°C for 2 h according to USP 731. Residual ethanol is controlled under USP 467 as a Class 3 solvent, with a limit of not more than 5000 ppm. The appearance is a light yellow to pale brown amorphous powder. Bulk density for the direct-compression subgrade ranges from 0.35 g/cm³ to 0.55 g/cm³; the injection subgrade is supplied with a documented bioburden of not more than 10 CFU/g before terminal processing.
The marker profile is quantified by reversed-phase HPLC using a C18 column of 250 × 4.6 mm, 5 μm particle size, with UV detection at 203 nm and a mobile phase gradient of acetonitrile and 0.1% phosphoric acid. The method is adapted from compendial ginsenoside assay approaches and is calibrated with certified reference standards for notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, and ginsenoside Rd. The sum of the five markers is expressed as total notoginseng saponins. The ratio of notoginsenoside R1 to ginsenoside Rb1 is controlled between 0.10:1 and 0.40:1, while the ratio of ginsenoside Rg1 to ginsenoside Rb1 is typically 1.0:1 to 2.5:1. These ratios distinguish Panax notoginseng from Panax ginseng, where the Rg1-to-Rb1 ratio may fall below 1.0:1 and notoginsenoside R1 is absent or only trace. Validated method precision shows relative standard deviation for total saponins not more than 2.0% across six injections. Unknown individual saponin peaks are limited to not more than 2.0% of total saponin peak area. The specification table below summarizes the release limits.
| Parameter | Release limit | Reference standard or method |
|---|---|---|
| Appearance | Light yellow to pale brown amorphous powder | Visual |
| Total saponins by HPLC | ≥ 80.0% on dried basis | Manufacturer method TM-NTS-01 |
| Loss on drying | ≤ 5.0% | USP 731 |
| Total ash | ≤ 5.0% | USP 561 |
| Heavy metals as lead | ≤ 10 ppm | ICP-MS after microwave digestion |
| Arsenic | ≤ 2 ppm | ICP-MS after microwave digestion |
| Residual ethanol | ≤ 5000 ppm | USP 467 Class 3 |
| Total aerobic microbial count | ≤ 1000 CFU/g | USP 61 |
| Combined yeasts and molds | ≤ 100 CFU/g | USP 61 |
| Escherichia coli / Salmonella | Absent in 10 g | USP 62 |
| Bacterial endotoxins, injection subgrade | ≤ 0.5 EU/mg | USP 85 |
For tablet and capsule manufacture, the direct-compression subgrade NTS-VG-100-T is co-processed with dibasic calcium phosphate anhydrous, microcrystalline cellulose, and crospovidone to compensate for the low bulk density and cohesive nature of the saponin fraction. In a typical direct-compression formulation, the API is pre-blended with a 1:1 portion of microcrystalline cellulose for 5 min in a bin blender at 12 rpm before addition of the remaining excipients. The particle size distribution of NTS-VG-100-T is controlled by laser diffraction according to ISO 9276-2:2014, with D50 between 80 μm and 180 μm and D90 not more than 300 μm. The fraction below 45 μm is limited to not more than 30% because excess fines increase punch filming on rotary tablet presses. Compaction runs on a rotary press with precompression force of 5–12 kN and main compression force of 20–40 kN generally produce hardness values of 60–90 N for veterinary tablets; friability is controlled to not more than 1.0% by USP 1216. Capsule filling on a dosator machine benefits from a forced feeder to maintain fill weight variability below 3.0% relative standard deviation. Published compression data for this specific API designation is limited; these ranges should be confirmed in process validation.
The NTS-VG-100-I injectable grade is processed through macroporous resin purification followed by aseptic spray drying. Bacterial endotoxin is limited to 0.5 EU/mg because parenteral veterinary doses may exceed 100 mg; this is consistent with the endotoxin dose calculation in USP 85. Subvisible particulate matter in the finished injection is controlled according to USP 788 for small-volume injectables: not more than 6000 particles per container for particles ≥10 μm and not more than 600 particles per container for particles ≥25 μm. The API is soluble in water at approximately 20 mg/mL at 25°C with gentle agitation. Concentrations above this level may require co-solvents such as 5–10% propylene glycol or 2–5% ethanol. Filtration through a 0.22 μm polyethersulfone membrane is used for sterilizing-grade filtration; nylon membranes are not recommended because saponins can bind to polyamide surfaces, and published recovery data for this specific API is limited. Terminal steam sterilization at 121°C for 15 min is not applied without thermal degradation validation because published data on malonyl-ginsenoside conversion in this specific API is limited. Aseptic processing with pre-sterilized vials and rubber closures is the standard route for injectable formulations.
Oral powder and premix applications use the NTS-VG-100-P subgrade, milled to pass through a 60-mesh sieve. Mixing in a horizontal ribbon mixer at 60–70% fill volume for 10–15 min typically achieves a coefficient of variation for saponin content not more than 5.0% when sampling is performed according to ISO 6497:2002. Segregation tendency is controlled by selecting carriers with a D90 not exceeding 400 μm; in V-blender trials at 50 kg scale, inclusion rates from 1% to 10% show acceptable uniformity when the API is pre-dispersed in a portion of carrier. Granulation is performed with a top-spray fluid bed using a 3–5% povidone K30 binder solution. Inlet air temperature is maintained at 50–60°C, and product temperature is kept below 40°C to reduce saponin oxidation. The granules are dried to residual moisture between 2.0% and 4.0% and sieved to 20–60 mesh. Hygroscopicity of the finished granules is managed by packaging in aluminum-lined bags; desiccant is required when storage relative humidity exceeds 60%. Published granulation data for NTS-VG-100-P is limited, so pilot-scale trials are required to establish the exact excipient ratios for each premix formulation.
Solutions prepared from the water-soluble powder subgrade are most stable between pH 5.5 and 6.5. Below pH 3.0, hydrolysis of glycosidic linkages can liberate sapogenin aglycones and produce visible precipitation within 24 h at 25°C; above pH 8.0, base-catalyzed degradation of ginsenoside Rg1 and Rb1 accelerates. For preserved oral solutions, a combination of 0.2% potassium sorbate and 0.1% sodium benzoate is used; unpreserved solutions are assigned a maximum hold time of 24 h at 15–25°C or 48 h at 2–8°C. Light exposure is controlled because ultraviolet irradiation at 254 nm degrades ginsenoside Rg1; amber glass or opaque high-density polyethylene containers are specified. For drinking water dosing, water hardness and chlorine residuals may reduce saponin recovery; published compatibility data for this specific API in different drinking water matrices is limited, and a use-site compatibility test is required before field administration.
Manufacturing of NTS-VG-100 begins with authenticated Panax notoginseng root that is extracted in 60–70% ethanol at 60–70°C for 2–3 h per cycle. The extract is clarified by centrifugation and loaded onto a macroporous adsorption resin column of D101 or AB-8 type. After water washing, saponins are eluted with 65–75% ethanol and concentrated under vacuum below 60°C. The concentrate is spray dried at inlet temperature 160–180°C and outlet temperature 75–85°C for the oral grades; the injectable grade is dried under aseptic conditions using a vacuum belt dryer to limit thermal load. Critical quality attributes include total saponins, marker ratio, loss on drying, residual ethanol, heavy metals, arsenic, aflatoxins, pesticide residues, microbial limits, and endotoxin for the injectable subgrade. Pesticide residues are controlled according to USP 561 botanical extract limits, and mycotoxins are limited to 5 ppb for aflatoxin B1, 10 ppb for total aflatoxins, and 50 ppb for ochratoxin A. The API is released only after HPLC assay, microbial testing, and residual solvent analysis. Batch-to-batch variability of total saponins is monitored by statistical process control; the manufacturer’s release data show a typical range of 82–88% total saponins on the dried basis, though published compendial batch data for this exact designation is limited.
Long-term storage of NTS-VG-100 should be at 25°C or lower in sealed containers with desiccant. Accelerated stability data at 40°C and 75% relative humidity typically show total saponin loss below 5.0% over 6 months for the oral grade, but published data for this specific designation is limited. Moisture absorption above 8.0% causes caking and poor flow; reconditioning by drying at 40°C for not more than 4 h may be applied only if saponin content is re-assayed. The injectable subgrade should be stored under positive-pressure nitrogen in sealed aluminum bags. Open containers should be re-tested for endotoxin and bioburden if not used within 30 days.
The product differs from Panax ginseng total saponins by the presence of notoginsenoside R1 and a higher ginsenoside Rg1-to-Rb1 ratio. Compared with Tribulus terrestris saponins, which are furostanol-type steroids, notoginseng total saponins are dammarane-type triterpenoid glycosides and therefore have different solubility, foaming, and chromatographic behavior. Compared with crude powdered Panax notoginseng root, the API reduces polysaccharide and fiber burden and provides consistent saponin concentration, which lowers tablet friability and injection particulate load. Compared with purified single ginsenoside Rg1 or Rb1, the total saponin API retains the native marker profile, but the batch release must control the marker ratio. The following table summarizes key differences.
| Attribute | NTS-VG-100 | Panax ginseng total saponins | Tribulus terrestris saponins |
|---|---|---|---|
| Glycoside class | Dammarane-type triterpenoid | Dammarane-type triterpenoid | Furostanol steroidal |
| Total saponin release | ≥ 80.0% dried basis | ≥ 80.0% dried basis | ≥ 40.0% as protodioscin |
| Unique marker | Notoginsenoside R1 | Ginsenoside Re, Rb1, Rg1 | Protodioscin, protogracillin |
| Rg1-to-Rb1 ratio | 1.0:1 to 2.5:1 | 0.5:1 to 1.0:1 | Not applicable |
| Water solubility at 25°C | Approximately 20 mg/mL | Similar to notoginseng total saponins | Limited; surfactant often required |
| Endotoxin control for injectables | ≤ 0.5 EU/mg | Not typically injectable | Not typically injectable |
| Veterinary formulation focus | Tablets, injections, capsules, powders, granules, premix, solutions | Capsules, tablets, oral liquids | Oral liquids, boluses |
For finished dosage forms, the API must be supported by a type II drug master file or veterinary master file in the target jurisdiction. Compliance with VICH GL11 for elemental impurities and VICH GL18 for residual solvents is expected; limits should be justified by the maximum daily dose and route of administration. The API does not contain materials of animal origin and is not classified as a specified risk material. Registration of the finished veterinary product remains the responsibility of the marketing authorization holder.
