| HS Code | 712674 |
| Product Name | Danggui Powder Veterinary Grade API |
| Plant Source | Angelica sinensis (Oliv.) Diels |
| Used Part | Root |
| Extraction Type | Powdered API |
| Grade | Veterinary Grade |
| Target Dosage Forms | Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Active Marker Compounds | Ferulic acid, ligustilide, angelica polysaccharides |
| Appearance | Light brown to yellowish-brown fine powder |
| Odor | Characteristic aromatic odor |
| Moisture Content | ≤ 8.0% |
| Loss On Drying | ≤ 8.0% |
| Solubility | Partially soluble in water; freely soluble in ethanol and dilute alkaline solutions |
| Heavy Metals Limit | Total heavy metals ≤ 20 ppm; Lead ≤ 5 ppm; Arsenic ≤ 2 ppm |
| Microbial Purity | Total bacterial count ≤ 1000 CFU/g; Yeast and mould ≤ 100 CFU/g; Absence of Salmonella and E. coli |
| Storage Conditions | Store in airtight containers in a cool, dry, and dark place |
| Shelf Life | 24 months when properly stored |
| Packing Specification | 25 kg fiber drums with double polyethylene bags inside |
| Functionality | Used as a veterinary API for blood-tonifying, circulation-promoting, and anti-inflammatory properties in animal health preparations |
As an accredited Danggui 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 | 25 kg per drum, double polyethylene-lined fiber drums, sealed and labeled for veterinary-grade Danggui powder API use. |
| Container Loading (20′ FCL) | Danggui Powder veterinary API packed in sealed drums/cartons for 20′ FCL, palletized, ventilated, dry, safe transport. |
| Shipping | Shipped in export-grade sealed drums with double polyethylene liners to protect against moisture and contamination. Storage at cool, dry temperature recommended. Transport by air, sea, or courier with careful handling, avoiding excessive heat and humidity. Documentation includes veterinary API certificate and safety data sheet per international shipping regulations. |
| Storage | Store in a cool, dry, well-ventilated area, away from direct sunlight, moisture, and heat. Keep the container tightly closed when not in use to protect from humidity. Avoid contact with strong oxidizing agents. Use appropriate personal protective equipment during handling. Maintain temperature below 25°C and ensure good ventilation for stability and potency. |
| Shelf Life | Shelf life: 24 months from manufacture, when stored tightly sealed in a cool, dry place, protected from light and moisture. |
In direct compression campaigns for Danggui Powder Veterinary Grade API derived from Angelica sinensis root, the main processing constraint is not chemical potency but the fibrous, low-bulk-density matrix that resists uniform die fill. Milling through a 500 μm oscillating screen produces a fraction with tapped bulk density of 0.45 g/mL to 0.62 g/mL, Carr index 28–35%, and loss on drying 8–12% prior to drying. At API loads above 35% w/w without dry granulation, elastic recovery after compression can exceed 8% and induce capping on 16-station rotary presses at speeds above 30 rpm. A robust tablet formulation uses milled Danggui powder 30–45% w/w, silicified microcrystalline cellulose 40–50% w/w, crospovidone 3–5% w/w, colloidal silicon dioxide 0.5–1.0% w/w, and magnesium stearate 0.5% w/w. Precompression at 2 kN and main compression at 12–18 kN with dwell time 20–30 ms produce 800 mg compacts with hardness 7–10 kp and friability below 0.8% under USP <1216>. If direct compression cannot maintain weight variation below ±5%, the blend is dry-granulated on a roller compactor at roll pressure 4.5 MPa, screen 0.8–1.25 mm, then compressed. Finished uncoated tablets are tested for disintegration under USP <701> at 37°C in purified water; the acceptance criterion is typically NMT 30 min. Published Danggui-specific compression data remain limited; the above ranges derive from production-scale work with polysaccharide-containing root powders rather than a single pharmacopoeial monograph.
Because milled Angelica sinensis powder below 180 μm develops a smooth but slightly hygroscopic surface, capsule filling on tamping-pin stations requires a free-flowing preblend and tight moisture control. Powder for hard gelatin or HPMC capsules can be set at API concentration 40–60% w/w, lactose monohydrate or mannitol 38–56% w/w, sodium starch glycolate 2–4% w/w, talc 1–2% w/w, and magnesium stearate 0.5% w/w. Blending in a V-type mixer at 15 rpm for 20 min, with lubricant added in the final 2 min, yields blend uniformity with active marker RSD below 5%. Tamping-pin fillers running at 1,000–2,000 capsules/min frequently show fill weight drift when the powder’s Carr index shifts above 25%; therefore a hopper vibration setting that keeps bulk density stable is used. In-process fill weight checks should comply with USP <2091> for average fill weights of 250–400 mg depending on shell size. Moisture is controlled below 6.0% w/w before filling to avoid shell brittleness or softening; finished capsules are tested for disintegration under USP <701> and packaged in HDPE bottles with silica gel desiccant at ≤25°C and ≤60% RH. Terminal dosage form is a two-piece hard capsule intended for oral veterinary administration.
Danggui Powder Veterinary Grade API is not directly injected as native root powder; it is extracted and purified before any sterile parenteral step. The main limitation in producing an injectable solution from Angelica sinensis roots is soluble polysaccharide with molecular mass distribution above 100 kDa, which raises process viscosity and fouls 0.22 μm membranes during terminal aseptic filtration. A typical extraction uses water-ethanol mixtures between 30% v/v and 60% v/v at 60–80°C for 2 h; the extract is cooled to 2–8°C for 12–24 h and centrifuged at 10,000×g to sediment high-molecular-mass gums. Depyrogenation with activated carbon at 0.1% w/v and 60°C for 30 min reduces endotoxin load but can also adsorb the marker ferulic acid, so a marker assay by HPLC using USP <621> is required before and after carbon treatment. Filtration should progress from 0.45 μm to 0.22 μm polyethersulfone or PVDF; a filter integrity test by bubble point or diffusive flow is performed after filling. If moist-heat terminal sterilization is used at 121°C for 15 min, conjugate stability data must show retention of ferulic acid and Z-ligustilide above 95%; otherwise aseptic processing under ISO 14644-1 Class 5 is selected. The finished injectable is filled in amber Type I borosilicate glass vials under nitrogen headspace to limit oxidative lactone ring opening of ligustilide; pH is buffered between 5.5 and 6.5, because alkaline conditions accelerate phthalide degradation. Release tests include sterility USP <71>, bacterial endotoxins USP <85>, particulate matter USP <788>, and residual solvents VICH GL18(R). Published Danggui-specific thermal degradation data in veterinary parenteral formulations are limited; process hold times should be validated with pilot batches rather than transferred from oral forms.
The analytical burden across the dosage forms is summarized in the following cross-form matrix, used as a release checklist rather than as a set of acceptance criteria.
| Dosage form | Critical test | Reference method |
|---|---|---|
| Tablet and hard capsule | Disintegration | USP <701> |
| Tablet and hard capsule | Uniformity of dosage units | USP <2091> / USP <905> |
| Oral powder and feed premix | Microbial enumeration | USP <61> / USP <62> |
| Injection | Sterility | USP <71> |
| Injection | Bacterial endotoxins | USP <85> |
| Injection | Particulate matter in injections | USP <788> |
| Oral solution | Antimicrobial effectiveness | USP <51> |
| All forms | Heavy metals | USP <232> / USP <233> |
| All forms | Residual solvents | VICH GL18(R) |
For single-dose oral powder sachets, the critical variable is the moisture threshold at which the fibrous root powder transitions from a free-flowing powder to a cohesive mass. The API is passed through a 250 μm screen and dried in a vacuum tray dryer at 45–55°C until loss on drying is ≤5.0% w/w. The powder is then blended with dextrose or maltodextrin at API loads of 20–50% w/w, plus colloidal silicon dioxide 0.5–1.0% w/w, in a double-cone blender at 12 rpm for 15 min. Weight variation of filled sachets is checked per USP <2091>; fill weights of 1.0–5.0 g are common for companion-animal or calf oral use. Packaging is carried out in a low-humidity area at ≤30% RH using foil laminate sachets with heat-seal integrity tested at 0.2 MPa seal pressure. Microbial limits are controlled by USP <61> and USP <62>; heavy metals according to USP <232> and USP <233>. Terminal product is a single-use oral powder for direct administration or suspension in water at point of use.
Incorporation of Danggui Powder Veterinary Grade API into a feed premix is governed by density mismatch and particle segregation rather than by dissolution or compression behaviour. The API’s tapped bulk density of 0.45–0.62 g/mL differs from ground corncob or rice hull carriers at 0.28–0.40 g/mL; unless the API is grounded and bonded to carrier particles with a small quantity of vegetable oil at 0.5–1.0% w/w, it migrates to the bottom of the hopper during discharge. A representative production procedure uses a horizontal ribbon mixer at 60–70% working volume, loads 50% of the carrier, then the API premixed with an equal volume of carrier and 1–2% w/w colloidal silicon dioxide, then the remaining carrier. Mixing at 20–30 rpm for 10–15 min is followed by sampling 10–15 points in the mixer and discharge stream; active marker RSD should be ≤5%. If the carrier moisture exceeds 12% w/w, the root powder absorbs moisture and forms lumps that resist dispersion in a feed mill, so carriers are dried to ≤10% w/w before use. Finished feed premix is packed in 25 kg paper-polyethylene bags with an inner liner and is intended for dilution into complete feed. When the material is placed on the EU market as a feed material or sensory additive, compliance with Regulation (EC) No 183/2003 and Directive 2002/32/EC on undesirable substances applies; FAMI-QS certification is commonly required by compound feed manufacturers. Danggui-specific regulatory feed data are limited; classification depends on the intended function and the final formulation.
For drinking-water application of Danggui powder, the most practical product is a water-dispersible granule rather than a true solution, because a portion of the root powder remains insoluble even after fine milling. Wet granulation is performed with API 25–40% w/w, lactose or dextrose 40–55% w/w, povidone K30 3–5% w/w dissolved in purified water as binder, and optionally xanthan gum 0.1–0.3% w/w as a suspending agent. The wet mass is passed through a 1.0 mm screen and dried in a fluid-bed dryer at inlet air 55–65°C until moisture is ≤4.0% w/w. In a 200 L dosing tank, a dispersion test of 5 g granules in 200 mL water at 25°C with stirring at 50 rpm should yield complete dispersion within 5 min; residue on a 75 μm sieve should not exceed 3%. Without agitation, insoluble fibrous particles settle after 6 h and can block drinking nipple lines; therefore the stock solution is continuously recirculated or mixed with a submersible agitator at 100 rpm during administration. Terminal product is a water-dispersible granule packed in foil-lined pails or dose bags, with microbial enumeration by USP <61> and USP <62> and loss on drying by USP <731>.
An oral solution or drench prepared from Danggui powder extract requires strict exclusion of headspace oxygen and control of pH to avoid progressive darkening and precipitation. A typical formulation uses standardized extract or purified powder equivalent to 5–15% w/v, propylene glycol 10–30% v/v, glycerin 5–15% v/v, sodium metabisulfite 0.05–0.1% w/v, benzyl alcohol 1.5% v/v as preservative, and purified water q.s. to 100%; pH is adjusted with citrate buffer to 5.5–6.5. The liquid is clarified by passage through a 10 μm polypropylene cartridge followed by a 1 μm cartridge, filled into amber HDPE bottles with nitrogen flushing of the headspace. Multi-dose containers require antimicrobial effectiveness testing under USP <51> when preservative is included; benzyl alcohol can precipitate with polysaccharide fractions above 2 mg/mL, so a compatibility study is performed before release. The terminal product is an oral liquid or drench for veterinary administration; published accelerated stability data specific to Danggui oral drench systems are limited, and oxidation of ferulic acid is monitored by HPLC at 320 nm to track degradation instead of relying on visual colour alone.
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Danggui Powder Veterinary Grade API is a dry, controlled botanical raw material obtained from the dried root of Angelica sinensis (Oliv.) Diels and assigned model designations according to downstream dosage-form processing requirements. The three release models are DGV-API-T for tablet, capsule, and granule manufacturing; DGV-API-S for injectable suspension or solution intermediate processing; and DGV-API-P for premix, direct powder, and oral solution compounding. Release against the Angelicae Sinensis Radix monograph of CP 2020 includes ferulic acid not less than 0.050% by HPLC on dried basis, loss on drying not more than 10.0%, total ash not more than 7.0%, acid-insoluble ash not more than 2.0%, lead not more than 5 mg/kg, cadmium not more than 1 mg/kg, arsenic not more than 2 mg/kg, mercury not more than 0.2 mg/kg, and aflatoxin B1 not more than 5 μg/kg. The total aerobic microbial count is specified at not more than 10³ CFU/g, with absence of Salmonella in 25 g for all models. Particle-size control is model-specific: DGV-API-T passes through an 80-mesh sieve at not less than 95%, DGV-API-P passes through a 65-mesh sieve at not less than 98%, and DGV-API-S is air-jet milled to a laser-diffraction D90 not more than 25 μm with D50 between 8 μm and 15 μm under USP <429> conditions.
Quantitative elemental analysis is performed by inductively coupled plasma mass spectrometry after microwave-assisted acid digestion. The method quantification limits are 0.01 mg/kg for lead, 0.005 mg/kg for cadmium, 0.02 mg/kg for arsenic, and 0.005 mg/kg for mercury. This provides lower detection capability than flame atomic absorption methods commonly used for commodity botanical powder.
Raw sliced Danggui root and commodity powder are not controlled API matrices. The veterinary-grade powder is identity-tested by thin-layer chromatography and HPLC assay of ferulic acid, and it is subject to enforced heavy-metal and mycotoxin limits. Unlike unprocessed botanical powder, the product’s particle-size distribution, bulk density, and tapped density are held within narrow ranges because tablet compression and capsule filling require reproducible flow and die-fill character. Tapped density for DGV-API-T is typically 0.48–0.62 g/mL, and Hausner ratio is 1.25–1.40 by USP <616>. Raw root powder can vary by ±18% in tapped density across lots; the controlled milling and blending operation for the veterinary-grade API reduces that variation to ±6% relative standard deviation. In addition, the API is shipped with a veterinary drug master-file-ready certificate of analysis and production batch record, while raw botanical material is generally limited to a commodity certificate of origin.
Microbial control does not rely on ethylene oxide fumigation or high-temperature steam treatment, which can alter ligustilide and polysaccharide content. The product is treated by validated low-moisture thermal processing at not more than 60°C for a time sufficient to achieve the specified bioburden. Process validation data demonstrate a minimum 4-log reduction of Bacillus subtilis spore challenge at the center of the powder bed without measurable ferulic acid loss.
In tablet and capsule manufacturing, DGV-API-T is generally incorporated at 5.0–25.0 wt% of the core granulation. Wet granulation using 2–5% polyvinylpyrrolidone binder in a high-shear mixer at impeller speed 200–400 rpm and chopper speed 1500–2500 rpm produces granules with moisture content 2.5–4.0% after fluid-bed drying at inlet air temperature 55–65°C. Inlet temperatures above 65°C are not recommended because ligustilide is thermally labile and may degrade under forced-drying conditions. Compression of granules containing 12 wt% Danggui powder with microcrystalline cellulose and sodium starch glycolate has produced tablet hardness of 60–80 N and disintegration time of 8–12 min by pharmacopoeial disintegration apparatus. Tablet friability for the 12 wt% formulation is not more than 0.8% after 100 rotations in a Roche friabulator. For capsule filling, the addition of 0.5–1.0% colloidal silicon dioxide reduces interparticle cohesion; no pre-drying is required at ambient relative humidity below 60%.
DGV-API-S is not a terminally sterilized solution; it is a low-endotoxin particulate intermediate intended for aseptic formulation or terminal sterilization after reconstitution. Bacterial endotoxin is controlled to not more than 0.15 EU/mg by the limulus amebocyte lysate method in USP <85>. When formulated at 10 mg/mL as a suspension, particulate matter is controlled by USP <788> limits of not more than 6000 particles at ≥ 10 μm and not more than 600 particles at ≥ 25 μm per container. Dry powder is compatible with gamma irradiation at 10–25 kGy. Aqueous suspensions should not be autoclaved at 121°C without forced-degradation verification, because ligustilide recovery declines by 12–18% after 30 min at that condition. If terminal heat treatment is unavoidable, a cycle of 115°C for 20 min is preferred, with post-cycle assay of ferulic acid and ligustilide.
The suspension formulation with 0.2% sodium carboxymethylcellulose and 0.05% polysorbate 80 passes a 21-gauge needle syringability test with a gliding force below 25 N at 10 mL/min. Viscosity of the suspension measured by cone-plate viscometer at 25°C and shear rate 100 s–1 is 35–55 mPa·s.
For premix and oral powder applications, DGV-API-P is dry-blended with feed carriers or mineral premixes. Segregation potential is controlled when the particle-size ratio between the API and carrier remains below 4:1. Typical corncob carriers with mean particle size 250–400 μm are compatible because the API has a D50 near 45–75 μm. Homogeneity testing in a ribbon blender at 60% working volume and 15 min mixing time produced a coefficient of variation for ferulic acid of 4.7% across 10 sampling points. In feed integration, the API is commonly included at 0.5–2.0% of complete feed by weight, although target-species dose confirmation and regulatory approval dictate the final inclusion rate. In oral solution compounding, the powder is not fully soluble. A suspending system with 0.1–0.3% xanthan gum or 0.5–1.0% hydroxyethylcellulose yields sedimentation volume not less than 0.85 after 24 h at 25°C. For clarified oral solutions, a 50 g/L dispersion may be heated to 60°C for 2 h and filtered through a 0.45 μm polyethersulfone membrane; the filtrate contains 62–68% of initial ferulic acid and is suitable for syrup compounding with pH adjustment to 4.5–6.0.
The following release matrix is used across all three models. Additional tests are required for injectable-grade material.
| Parameter | DGV-API-T | DGV-API-S | DGV-API-P | Test method |
|---|---|---|---|---|
| Ferulic acid | Not less than 0.050% dried basis | HPLC, CP 2020 | ||
| Loss on drying | Not more than 10.0% | CP 2020 0831 | ||
| Total ash | Not more than 7.0% | CP 2020 2302 | ||
| Acid-insoluble ash | Not more than 2.0% | CP 2020 2302 | ||
| Lead | Not more than 5 mg/kg | ICP-MS | ||
| Cadmium | Not more than 1 mg/kg | ICP-MS | ||
| Arsenic | Not more than 2 mg/kg | ICP-MS | ||
| Mercury | Not more than 0.2 mg/kg | ICP-MS | ||
| Aflatoxin B1 | Not more than 5 μg/kg | HPLC-FLD | ||
| Total aerobic microbial count | Not more than 10³ CFU/g | CP 2020 1105 | ||
| Salmonella | Absent in 25 g | CP 2020 1106 | ||
| Bacterial endotoxins | Not specified | Not more than 0.15 EU/mg | Not specified | USP <85> |
| Particle size | Not less than 95% through 80 mesh | D90 not more than 25 μm | Not less than 98% through 65 mesh | USP <786> / USP <429> |
Air-jet milling of DGV-API-S to D90 not more than 25 μm increases specific surface area from about 0.4 m²/g to 1.6 m²/g by BET nitrogen adsorption. The increase in exposed botanical matrix accelerates moisture sorption and surface oxidation of ligustilide. Milled material stored in unsealed containers at 25°C/60% RH showed ligustilide loss of 7.2% after 30 days, compared with 2.4% for unmilled control. Therefore, DGV-API-S is filled under nitrogen into double polyethylene bags inside sealed aluminum composite pouches and assigned a retest interval of 24 months from milling date when stored below 25°C. After opening, remaining material should be used within 30 days or re-sealed under desiccant.
For tablet and capsule dosage forms, release of ferulic acid is matrix-dependent. In a dissolution test using 900 mL of 0.1 M hydrochloric acid at 37°C and basket rotation 100 rpm, a tablet containing 15 wt% DGV-API-T released 42% of labeled ferulic acid at 30 min and 71% at 60 min. The same formulation tested in water showed release of 35% at 30 min and 64% at 60 min, indicating pH-dependent solubility of the botanical matrix. Substitution of sodium starch glycolate with crospovidone at the same 4 wt% level increased 30 min release by 9 percentage points in direct compression trials.
Danggui Powder Veterinary Grade API retains the full botanical matrix, including ferulic acid, ligustilide, butylidenephthalide, and native polysaccharides. Solvent-extract APIs standardized to ferulic acid may contain negligible native polysaccharides because ethanol or ethyl acetate extraction does not partition water-soluble polysaccharides efficiently. Total polysaccharide content in the powder API is typically 8–15% as glucose equivalents by phenol-sulfuric acid assay, while solvent-extract APIs may contain less than 2%. This difference affects granulation behavior and water-binding capacity in tablet and premix systems. Compared with synthetic haematinic additives such as ferrous sulfate or cyanocobalamin, Danggui powder does not supply elemental iron in a stoichiometric form. Its use in veterinary formulations is as a botanical matrix rather than a replacement for trace-mineral supplementation. Published efficacy data for Angelica sinensis in target veterinary species are limited; formulation decisions should be supported by species-specific studies before relying on marker-level comparisons.
| Attribute | Danggui Powder Veterinary Grade API | Solvent-extract Danggui API | Raw botanical powder |
|---|---|---|---|
| Ferulic acid marker | Not less than 0.050% by HPLC | Typically not less than 1.0% | 0.020–0.080% variable |
| Ligustilide | Present, batch-quantified | Present or enriched | Uncontrolled |
| Polysaccharides | 8–15% | Less than 2% | Variable, no limit |
| Microbial limits | Total aerobic count not more than 10³ CFU/g | Often low due to solvent processing | May exceed 10⁵ CFU/g |
| Particle-size control | Model-specific narrow range | Re-dried powder variable | Coarse plant fragments |
| Documentation | Veterinary GMP batch record | Extract batch record | Commodity certificate |
Stability of DGV-API-P stored in polyethylene-lined aluminum foil bags at 25°C/60% RH for 24 months demonstrated ferulic acid retention of 96.2% and ligustilide retention of 88.5% relative to initial. Storage at 40°C/75% RH for 6 months reduced ligustilide by 14.6%. The powder is hygroscopic; equilibrium moisture content reaches 7.8% at 60% RH and 11.2% at 75% RH. Bulk containers should remain sealed, and desiccant should be included in multi-dose packaging. The API is not compatible with strong oxidizing agents. Aqueous slurries at 5% solids have pH 5.0–6.5; formulation above pH 8.5 accelerates ligustilide hydrolysis. Dry premix combinations with free-amine-bearing synthetic additives should be subjected to compatibility testing because Maillard-type reactions between reducing sugars in the botanical matrix and primary amines can produce brown discoloration and loss of assayable marker over time.
