| HS Code | 452465 |
| Product Name | Licorice Liquid Extract Veterinary Grade API |
| Api Form | Liquid Extract |
| Veterinary Grade | Yes |
| Source Plant | Glycyrrhiza glabra root |
| Active Constituent | Glycyrrhizin (glycyrrhizic acid) |
| Extraction Solvent | Water and ethanol mixture |
| Appearance | Dark brown viscous liquid |
| Solubility | Soluble in water and hydroalcoholic solutions |
| Ph Range | 5.0 to 7.0 |
| Density | 1.02 to 1.10 g/cm³ |
| Compatible Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Microbial Compliance | Meets veterinary pharmacopoeia microbial limits |
| Storage Conditions | Store in tightly closed containers, protected from light and moisture |
| Shelf Life | 24 months from date of manufacture |
| Packaging | Sealed HDPE drums with tamper-proof closures |
As an accredited Licorice Liquid Extract 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 in 25 kg high-density polyethylene drums with tamper-evident seals, nitrogen-purged to preserve stability and purity for veterinary use. |
| Container Loading (20′ FCL) | 20′ FCL loaded with Licorice Liquid Extract Veterinary Grade API, secured in drums/pails, ready for tablet, injection, and premix manufacturing. |
| Shipping | Ship in sealed, light-resistant, tamper-evident containers with clear veterinary API labeling. Maintain cool, dry conditions and avoid moisture, heat, or direct sunlight. For injections and solutions, use temperature-controlled transport. Ensure compliance with pharmaceutical and local chemical shipping regulations. Handle with care to preserve stability and purity. |
| Storage | Store Licorice Liquid Extract Veterinary Grade API in tightly sealed, suitable containers away from light, heat, and moisture. Maintain a cool, dry environment below 25°C. Avoid freezing and direct sunlight. Ensure containers remain undamaged to preserve stability, potency, and quality for tablets, injections, capsules, powders, granules, premix, and solution formulations. Follow manufacturer’s specified shelf-life guidelines. |
| Shelf Life | Shelf life is typically 24 months from manufacture date when stored in sealed, light-resistant containers under controlled conditions. |
For poultry barns using closed medicator proportioning pumps at 0.5–4.0 % stock solution settings, licorice liquid extract veterinary grade API is converted into water-soluble granules whose dissolution cloud point and mineral hardness tolerance govern line uniformity. The formulation is constrained by the glycyrrhizic acid content of the liquid extract, typically specified at 4.0–8.0 % w/w, and by the hardness of the drinking water; at total hardness above 250 ppm CaCO₃ the acidic saponin fraction can form insoluble calcium complexes that reduce dosing accuracy. Compliance for the dry granule is verified by ISO 6579-1:2017 for absence of Salmonella in 25 g, and the reconstituted oral liquid is tested to Ph. Eur. 5.1.4 category 3B with TAMC ≤ 10³ CFU/mL and TYMC ≤ 10² CFU/mL. The liquid extract is adsorbed onto a carrier blend of maltodextrin DE 12–20 and lactose monohydrate in a top-spray fluid-bed granulator; inlet air is held at 55–70 °C, product bed temperature at 35–45 °C, and spray rate calibrated to maintain droplet size between 10 µm and 30 µm. Final granule moisture is controlled at ≤ 5.0 % by USP 731 loss on drying. Formula addition ratios in the final drinking water range from 0.05 % to 0.20 % v/v for liquid extract when targeting 10–40 mg glycyrrhizic acid per litre; the corresponding dry soluble powder is packaged as 1 kg, 5 kg, and 25 kg sachets, and dissolved in the stock bucket before proportioning. Terminal product types include water-soluble powder sachets, soluble granules for breeder water lines, and concentrated liquid stock solutions for medicator mixing, with the liquid stock solution filtered through a 10 µm mesh before entering the dosing line to protect proportioner seals.
Compounding licorice liquid extract into a swine premix requires separation of the heat-sensitive saponin fraction from the steam-conditioning step that precedes pellet pressing. The extract is first dispersed onto porous carriers such as precipitated silica and calcium carbonate at a ratio of 0.75–1.50 kg/t complete feed when the liquid extract is standardized to 8 % w/w glycyrrhizic acid, delivering 60–120 mg of the marker compound per kg of finished creep or weaner feed. Batch uniformity is validated in a double-ribbon mixer with tip speed 22 m/min and mixing time 8–12 min, targeting a coefficient of variation ≤ 8 % for glycyrrhizic acid in ten sampling ports. For pelleted feeds, the premix is introduced after the first mixing stage; conditioning is limited to 70–78 °C and retention time 20–40 s because glycyrrhizin degrades rapidly above 85 °C under moist conditions. When the line exceeds 60 s at high temperature, the extract is applied post-pelleting as a liquid coating onto cooled pellets at 35–40 °C. Compliance follows Regulation (EC) No 1831/2003 for feed additives where the extract must be registered or treated as a feed material under Regulation (EU) No 68/2013, and the batch identity is confirmed by HPTLC against monograph Ph. Eur. 0277 with HPLC quantification of glycyrrhizic acid. Terminal finished product types include prestarter crumbs, pelleted complete feed, creep feed, and top-dressed powder premix.
In feline and canine oral liquid compounding, the high content of polar saponins in licorice liquid extract imposes a pH and viscosity window that differs from alcohol-based human cough syrups. The extract is incorporated at 2.5–8.0 % v/v of the final oral solution, with final glycyrrhizic acid adjusted to 0.5–2.0 mg/mL by blending with propylene glycol, glycerol, and citrate buffer at pH 4.5–5.8. Preservation is validated by Ph. Eur. 5.1.3 challenge testing using Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis; the finished liquid is tested to Ph. Eur. 5.1.4 category 3B, and residual solvent control follows VICH GL18 with methanol below 3000 ppm if the liquid extract was ethanol-precipitated. The compounding process uses cold mixing at 300–600 rpm in a propeller mixer to avoid foaming and shear-induced precipitation of lipophilic flavonoids; the bulk liquid is passed through a 10 µm polypropylene cartridge filter before filling into amber PET bottles under nitrogen headspace. Fill temperature is held at 40±2 °C to reduce viscosity and ensure volumetric accuracy, and the bottle is induction-sealed with a polyethylene liner. Terminal product types include veterinary oral drops for cats, palatable syrups for dogs, dosing solutions for small mammals, and pump-bottle liquid feeds.
The following matrix consolidates the main test boundaries for the oral liquid, premix, and injectable routes where batch-to-batch confirmation is required before release.
| Standard / test method | Acceptable boundary | Relevant formulation |
|---|---|---|
| Ph. Eur. 5.1.4 category 3B | TAMC ≤ 10³ CFU/g or mL; TYMC ≤ 10² CFU/g or mL | Oral solutions, syrups, granules |
| ISO 6579-1:2017 | Salmonella absence in 25 g | Feed premixes, water-soluble powders |
| VICH GL18 | methanol ≤ 3000 ppm; ethanol ≤ 5000 ppm | All routes using solvent-extracted liquid API |
| Ph. Eur. 2.6.14 | bacterial endotoxin below 0.50 EU/mL | Injectable aqueous solutions |
| USP 731 | loss on drying ≤ 5.0 % | Granules, powders for oral use |
Equine oral paste formulation with licorice liquid extract focuses on mucosal residence time rather than rapid systemic absorption, because the pyloric transit of a viscous paste determines the duration of contact with the squamous and glandular mucosa. The liquid extract is dispersed in a methylcellulose or xanthan gum base at 5–15 % w/w of the paste, corresponding to a daily dose of 0.5–2.0 mL extract per 100 kg body weight and delivering 20–80 mg glycyrrhizic acid per 100 kg. Viscosity is a critical release specification: the paste is measured on a Brookfield RV spindle 7 at 10 rpm and 25 °C, with an acceptance range of 25,000–60,000 mPa·s to prevent both dropper leakage and syringe blockages. The process employs a planetary mixer with vacuum deaeration at -0.8 bar to remove air bubbles that would alter dose accuracy; mixing temperature is kept below 35 °C to avoid phase separation of the licorice lipophilic fraction. Batch compliance includes Ph. Eur. 5.1.4 category 3B, aflatoxin B1 below 10 µg/kg by ISO 16050, and screening for prohibited plant cross-contaminants for competition horses under FEI Clean Sport rules. Terminal product types are multidose oral paste syringes, single-dose dial-a-dose syringes, and top-dressed granules blended with alfalfa meal or sugar-beet pulp.
Because shrimp and tilapia extruded feed lines expose added botanicals to high-temperature extrusion and prolonged water immersion, post-extrusion vacuum coating becomes the only viable point for heat-sensitive licorice saponins. In this route the liquid extract is homogenised with fish oil, lecithin emulsifier at 0.2–0.5 % of the oil fraction, and an antioxidant before being applied in a vacuum coater at -0.4 to -0.6 bar; the oil phase is held at 40–50 °C and residence time is 6–12 min. Coating addition ranges from 0.5–2.0 kg/t final feed, with the extract diluted to 1:1 or 1:2 in the oil phase to improve distribution and reduce leaching. After coating, the pellets are cooled and recovered at 25–30 °C for 15–20 min before bagging. Compliance for the premix and coated feed uses ISO 6579-1:2017 for Salmonella absence in 25 g, and the background feed mill hygiene is assessed under ISO 22000; if the product is intended for European aquaculture feed, the additive status under Regulation (EC) No 1831/2003 must be established. Published data for glycyrrhizic acid leaching kinetics in seawater at 35 ppt and 28 °C is limited, so tank validation with immersion sampling is required before a commercial claim is made. Terminal finished product types include slow-sinking shrimp pellets, extruded floating tilapia feed, and oil-top-coat premix for on-farm application.
Because the moisture component in licorice liquid extract behaves as a humectant binder during wet granulation, tablet disintegration becomes directly coupled to residual granule moisture. The liquid extract is used at 5–15 % w/w as a binder phase, but the dry solid contribution is only 1.5–4.5 % of the tablet core after drying; crospovidone at 2–4 % is added extragranularly to offset the extended disintegration time caused by glycyrrhizic acid gel formation at low pH. Granulation is performed in a high-shear mixer with impeller speed 300–500 rpm and chopper speed 1500–3000 rpm; the wet mass endpoint corresponds to 3.0–5.5 % moisture after binder addition, and the granulate is dried in a fluid-bed dryer at 45–55 °C to a final loss on drying of 1.5–3.0 % by USP 731. Compression is carried out on a rotary press using concave tooling at 6–12 kN, and tablet hardness is held at 40–80 N to avoid over-lubrication defects. Dissolution is assessed by Ph. Eur. 2.9.3, mass uniformity by Ph. Eur. 2.9.5, and content uniformity by USP 905; residual solvent compliance follows VICH GL18. Terminal product types are scored tablets, chewable tablets with liver flavour base, and capsules filled with dried granules.
In injectable aqueous formulation, the presence of polysaccharide and polyphenol impurities in licorice liquid extract imposes demanding clarification and endotoxin control before the sterile barrier. The extract is diluted to 0.1–0.5 % v/v in the final injection vehicle, equivalent to 4–20 mg/L glycyrrhizic acid; the vehicle is buffered to pH 6.5–7.5 and adjusted to isotonicity with 0.9 % sodium chloride or 4.5 % mannitol. The solution is first clarified through a 0.45 µm PVDF membrane and then sterile-filtered through a 0.22 µm membrane under aseptic conditions; terminal sterilisation at 121 °C for 15 min is incompatible with glycyrrhizin stability and is not used. Bacterial endotoxin release is controlled to below 0.50 EU/mL by Ph. Eur. 2.6.14, sterility is confirmed by Ph. Eur. 2.6.1, and sub-visible particulate counts are checked by Ph. Eur. 2.9.19 against the 10 µm and 25 µm thresholds. Residual solvent compliance follows VICH GL18. Published data for this specific injectable configuration is limited; any batch must be supported by a forced-degradation study in the chosen aqueous vehicle. Terminal product types are 10 mL amber ampoules and multidose vials with antimicrobial preservation where permitted by the target species.
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Licorice liquid extract veterinary grade API, product code LRE-VG-20, is a hydroalcoholic extract of Glycyrrhiza glabra root standardised for glycyrrhizic acid content and processed for use as an active pharmaceutical ingredient in veterinary dosage forms. The material is supplied as a dark brown, medium-viscosity liquid intended for incorporation into tablets, injections, capsules, powders, granules, premixes, and solutions. Unlike botanical extracts sold for food flavouring or cosmetic use, this grade is released under a pharmacopoeia-aligned specification covering residual solvents, heavy metals, microbial limits, and, for injection-designated lots, bacterial endotoxins and subvisible particulate matter. The extract is produced via ethanol-water extraction, centrifugation, concentration, and terminal filtration. The resulting liquid retains both glycyrrhizic acid and co-extracted flavonoids and polysaccharides. A defined input of the liquid extract can be dispensed volumetrically in manufacturing, which reduces the assay adjustment burden associated with dry extracts of variable concentration.
| Parameter | Oral grade LRE-VG-20-O | Injection grade LRE-VG-20-I | Method reference |
|---|---|---|---|
| Glycyrrhizic acid content | 4.0–5.0% w/w | 4.0–5.0% w/w | HPLC-UV, external standard |
| pH | 5.0–6.5 | 5.0–6.5 | Ph. Eur. 2.2.3 |
| Density at 20 °C | 1.10–1.20 g/mL | 1.10–1.20 g/mL | Ph. Eur. 2.2.5 |
| Ethanol content | 20–25% v/v | 20–25% v/v | GC headspace |
| Viscosity at 25 °C | 150–300 mPa·s | 150–300 mPa·s | Brookfield rotational viscometer |
| Total aerobic microbial count | ≤ 100 CFU/g | ≤ 100 CFU/g | Ph. Eur. 2.6.12 |
| Yeast and moulds | ≤ 10 CFU/g | ≤ 10 CFU/g | Ph. Eur. 2.6.12 |
| Bacterial endotoxins | not routinely tested | < 0.5 EU/mL | Ph. Eur. 2.6.14 |
| Subvisible particulate matter | not applicable | after dilution, meets USP <788> small-volume injection limits | USP <788> |
| Total heavy metals | ≤ 10 ppm | ≤ 10 ppm | Ph. Eur. 2.4.8 |
Injection formulations containing licorice liquid extract API are subject to constraints that are not shared by oral granules or premixes. The extract’s native pH range of 5.0–6.5 is compatible with common aqueous injection vehicles, but acidification below pH 3.0 precipitates glycyrrhizic acid. Buffered vehicles at pH 5.0–6.5 are therefore used for injectable solutions. The ethanol content of 20–25% v/v acts as a co-solvent during compounding; after dilution with water for injection, the final ethanol concentration in the injection solution should remain below the limit defined by the target species and route of administration. Terminal sterilising filtration through a 0.22 µm membrane is feasible only when the diluted solution has a viscosity below approximately 50 mPa·s at 20 °C. Highly concentrated solutions may require prefiltration through a 0.45 µm polypropylene depth filter to prevent colloidal polysaccharides from fouling the sterilising-grade membrane.
Injection-grade lots designated LRE-VG-20-I are controlled for bacterial endotoxins with a release limit of 0.5 EU/mL. The diluted final dosage form should be validated to the pharmacopoeial limit for the intended injection volume. Subvisible particle counts after dilution must meet USP <788> small-volume injection acceptance criteria. Process experience with botanical hydroalcoholic extracts indicates that sterile filtration throughput on polyethersulfone membranes can decline by 20–50% when the solution is chilled below 10 °C due to viscosity increase. Therefore, filtration is typically performed at 20–25 °C directly after compounding. Batches intended for parenteral use should not be subjected to terminal steam sterilisation because prolonged thermal exposure above 121 °C may hydrolyse glycyrrhizic acid and increase the free glycyrrhetinic acid fraction.
For tablet and capsule manufacture, the liquid extract is commonly adsorbed onto microcrystalline cellulose or maltodextrin to form a loadable premix. Spraying the extract as a diluted 1:1 aqueous solution onto a moving powder bed in a top-spray fluidised-bed granulator yields a free-flowing granulate with a typical loss on drying below 3.0% w/w. If direct addition to high-shear granulation is used, the extract should be diluted to reduce localised binder accumulation and impeller torque variability. In a 50 L high-shear granulator, addition of undiluted extract can increase endpoint power draw by 10–20% and produce coarse agglomerates; dilution with purified water at a 1:1 ratio is recommended. Tablets containing the extract may be film-coated after preheating at 40–45 °C because residual moisture and hydroalcoholic content can affect coating adhesion. Assay adjustment of the extract input is performed using the HPLC glycyrrhizic acid value; this procedure compensates for batch-to-batch variation without over-drying the material.
In medicated premixes for swine or poultry, the liquid extract is dispersed onto soybean meal, dextrose, or calcium carbonate carrier. Homogeneity is assessed by extracting glycyrrhizic acid from multiple composite samples; a coefficient of variation of ≤ 5.0% is a typical release criterion for premix distribution. The extract should not be combined with strongly alkaline mineral premixes because hydrolysis of glycyrrhizic acid accelerates above pH 8.0. For drinking water solutions, the extract is metered into buffered water at 0.1–1.0 L per 1000 L depending on the prescribed dose. The solution remains clear for 24 h when stored at 20–25 °C in a closed tank protected from light; oxidation and microbial growth are controlled by citric acid–buffered vehicles at pH 5.5–6.0.
The principal distinction is not botanical origin but specification depth and process consistency. Powdered licorice extract typically contains higher glycyrrhizic acid content on a dry-weight basis, often 10–26% w/w, but reconstitution for liquid dosage forms can introduce solubility failures and particulate load. The liquid extract API is standardised to a narrower range of 4.0–5.0% w/w and is supplied as a filtered liquid, which eliminates dry milling-induced particle-size variability. Food-grade licorice extract may have equivalent glycyrrhizic acid content, but its residual solvent, heavy metal, and microbial limits are usually aligned to food additive rather than veterinary API criteria. A food-grade material may also contain preservatives or process aids that are incompatible with parenteral administration.
| Parameter | Liquid extract API LRE-VG-20 | Powdered licorice extract | Food-grade licorice extract | Synthetic ammonium glycyrrhizinate |
|---|---|---|---|---|
| Glycyrrhizic acid content | 4.0–5.0% w/w | 10–26% w/w dry basis | 2–15% w/w depending on grade | ≥ 98% w/w as ammonium glycyrrhizinate |
| Physical form | filtered liquid | spray-dried powder | liquid or powder | crystalline powder |
| Injection suitability | injection-designated lots controlled for endotoxins and particulates | requires reconstitution and filtration validation | not specified | high purity; single molecule may not match natural extract profile |
| Co-extractives | flavonoids, polysaccharides retained | variable, depending on process | variable | absent |
| Regulatory release | microbial, heavy metal, residual solvent, assay | assay and microbial, variable | food additive limits | chemical purity |
Each batch is released against solvent, elemental, and microbiological limits relevant to veterinary dosage forms. Residual ethanol is controlled at 20–25% v/v by gas chromatography with headspace injection; methanol and isopropanol are monitored to ≤ 50 ppm for each solvent. Total heavy metals are limited to ≤ 10 ppm. The microbial specification for non-sterile oral grades follows harmonised pharmacopoeial limits for botanical extracts; total aerobic microbial count is ≤ 100 CFU/g, and yeast and moulds are ≤ 10 CFU/g. The injection-designated grade is additionally tested for bacterial endotoxins and subvisible particles. The material should be stored in sealed, light-resistant containers at 15–25 °C. Unopened containers are stable for 24 months from release; after opening, the extract should be purged with nitrogen and consumed within 30 days to limit oxidation. Freezing should be avoided because phase separation of ethanol and water can produce localised glycyrrhizic acid precipitation.
During continuous metering into wet granulation lines, the extract should be held at 35–40 °C to reduce viscosity below 100 mPa·s and to maintain uniform flow through mass-flow or positive-displacement pumps. If volumetric dispensing is performed without temperature correction, density variation at 20–35 °C can introduce a dosing bias of up to 2.0% relative to the gravimetric assay. The extract is incompatible with concentrated mineral acids, strong alkalis, and oxidising disinfectants. Avoid co-administration with drinking water lines containing chlorine dioxide at residual concentrations above 5 ppm because oxidative degradation of glycyrrhizic acid may occur. For liquid oral solutions, the extract should be diluted with purified water containing 0.1–0.2% w/v sodium benzoate or an alternative validated preservative if multidose use is intended. Published data for this specific configuration is limited for long-term compatibility beyond 30 days, so stability trials should be performed under the intended storage conditions.
