| HS Code | 604246 |
| Product Name | Luteinizing Hormone Veterinary Grade API |
| Active Substance | Luteinizing hormone (LH, lutropin) |
| Chemical Class | Glycoprotein gonadotropin |
| Cas Number | 3932-22-7 |
| Molecular Weight | Approximately 29,500 Daltons |
| Appearance | White to off-white lyophilized powder |
| Solubility | Soluble in water and physiological saline; practically insoluble in organic solvents |
| Purity | Greater than or equal to 98% as determined by HPLC |
| Biological Activity | Greater than or equal to 5,000 international units per milligram |
| Water Content | Less than or equal to 5% as determined by Karl Fischer |
| Microbial Limits | Total aerobic microbial count less than or equal to 1000 CFU/g; absence of Escherichia coli and Salmonella |
| Endotoxin Level | Less than or equal to 10 EU/mg |
| Storage Conditions | Store at 2 to 8 degrees Celsius, protected from light and moisture |
| Shelf Life | 24 months from date of manufacture when stored under recommended conditions |
| Target Species | Cattle, sheep, goats, pigs, horses, and dogs |
| Therapeutic Indications | Induction of ovulation, luteinization, and treatment of reproductive disorders |
| Compatible Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Packaging Recommendation | Store in vacuum-sealed, light-protective, moisture-resistant containers |
As an accredited Luteinizing Hormone 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, light-protected, tamper-evident packaging suitable for pharmaceutical use. Quantity: 25 grams per container. |
| Container Loading (20′ FCL) | 20′ FCL: Luteinizing Hormone veterinary API, packed in sealed containers/pallets for tablets, injections, powders, granules, premix, and solutions. |
| Shipping | Ship as temperature-controlled, hazardous biological material in sealed, inert containers. Use double-walled packaging with desiccant and tamper-evident seals. Comply with veterinary pharmaceutical and IATA/IMDG regulations for active pharmaceutical ingredients. Avoid prolonged exposure to light, heat, and moisture; ensure chain of custody documentation accompanies shipment. |
| Storage | Store Luteinizing Hormone Veterinary Grade API in its original, tightly closed container at 2–8°C, protected from light, moisture, and excessive heat. Avoid freezing. Maintain dry conditions during handling to prevent degradation. For formulated tablets, capsules, injections, powders, or premixes, follow the manufacturer’s specified stability and storage guidelines to ensure potency throughout shelf life. |
| Shelf Life | Shelf Life: 24 months from manufacture date when stored in unopened original packaging under recommended cool, dry conditions. |
In fixed-time artificial insemination programmes for Bos taurus heifers and multiparous cows, LH veterinary grade API is processed into an injectable solution under controlled temperature because the non-covalent heterodimer is susceptible to deamidation in the presence of trace metal ions. The bulk compounding batch record generally specifies LH at 0.1–0.5 mg/mL as anhydrous protein dissolved in 10–25 mM acetate buffer, pH 5.8–6.2, containing 2–5% (w/v) trehalose dihydrate and 0.9% (w/v) sodium chloride. Dissolution is performed at 4–8°C in a vessel with low-shear magnetic agitation at 150–200 rpm; shear rates above 2000 s⁻¹ generated by rotor-stator mixers have been associated with increased high-molecular-weight aggregate index by 3–5% on size-exclusion HPLC. The solution is filtered through a 0.22 µm PVDF membrane with a polyethersulfone prefilter; filter-loading density above 25 mL per 10 cm² shortens throughput due to gel-layer deposition on the membrane surface. Moist-heat terminal sterilisation is not applied because the glycoprotein unfolds above 45°C; sterile filtration followed by aseptic filling is mandatory. The terminal solution is filled into Type I borosilicate vials with chlorobutyl rubber stoppers at 2 mL or 5 mL fill volume on a 12-pump peristaltic volumetric filling line with a fill weight tolerance of ±1.5%. Batch release tests include sterility per USP <71>, bacterial endotoxins per USP <85> at 0.5 EU/mg, and visible particulates per USP <790>. The designated storage is 2–8°C; more than 3 successive freeze-thaw cycles produce non-native aggregation that is detectable by dynamic light scattering as an increase in Z-average diameter above 50 nm. The compounding boundary is a processing window of ≤+5°C from dissolution temperature; excursions above 10°C for longer than 2 h increase turbidity and reduce potency. Mixing with oil-based adjuvants is avoided because the aqueous phase separates and dose uniformity becomes biased. The terminal product is an immediate-release injection for intramuscular use in controlled breeding programmes; it is not a sustained-release implant.
Freeze-dried powders intended for reconstitution in equine and camelid breeding programmes require lyophilisation cycle control that respects the collapse temperature of the formulated matrix. A pre-lyophilisation bulk solution typically contains LH 10–50 mg per vial, mannitol 5% (w/v), sucrose 2% (w/v), and potassium phosphate buffer 5 mM adjusted to pH 7.0. The fill volume is 2.1–2.3 mL in 10R Type I glass vials. Freezing is performed from 4°C to -45°C at 0.5°C/min; annealing at -20°C for 2–3 h can be inserted to improve cake uniformity. Primary drying is controlled at shelf temperature -30°C and chamber pressure 0.1 mbar; product temperature must remain below -35°C during the first 24 h. Exceeding this collapse threshold causes cake collapse, extends reconstitution time beyond 60 s, and increases turbidity. Secondary drying is run at 25°C for 12–16 h until residual moisture is below 1.5% by USP <921> Karl Fischer titration. Headspace oxygen is limited to 0.5% by nitrogen vacuum backfill at 600–700 mbar; stopper closure is performed under Class 5 unidirectional airflow in accordance with ISO 14644-1. The terminal powder is reconstituted with 2 mL Water for Injection or sterile saline and held at 2–8°C for no longer than 24 h. Reconstitution time, pH, and content uniformity are tested with a validated UV method at 280 nm against a compendial LH reference standard. Edge-vial residual moisture on production freeze dryers with shelf temperature uniformity of ±1.0°C can be 0.2–0.4% higher than centre-vial values, requiring defined load patterns and not full shelf utilisation. The product is not exposed to room temperature for more than 30 min during unloading. Published data for long-term storage at 25°C for this specific configuration is limited.
| Parameter | Sterile injection | Lyophilised powder | Dry premix/granule |
|---|---|---|---|
| Bulk API content | 0.1–0.5 mg/mL | 10–50 mg/vial | 1–10 µg/g carrier |
| Residual moisture limit | Not applicable; aqueous | <1.5% | <5% |
| Critical temperature | >10°C aggregate risk | collapse <-35°C | >60°C thermal unfolding |
| Release standard | USP <71>, USP <85> | USP <921>, USP <905> | USP <905>, VICH GL3 |
In in vitro embryo production laboratories, the same LH API is used as a maturation medium supplement rather than an injectable. Frozen 100× stock solutions are thawed once and diluted into TCM-199 with Earle’s salts to a working concentration of 0.01–0.1 IU/mL after potency normalisation. The complete maturation medium is adjusted to 270–285 mOsm/kg; values above 300 mOsm/kg retard cumulus cell expansion and reduce the proportion of oocytes reaching metaphase II. The medium is equilibrated in 5% CO₂, 5% O₂, and balance nitrogen at 38.5°C for not less than 4 h before use. Stock solutions contain bovine serum albumin at 1–4 mg/mL to reduce surface adsorption to tubing and filters. Sterile filtration of the complete medium is performed with 0.2 µm low-protein-binding membranes; filter capacity is typically no more than 50 mL per 10 cm² because media proteins compete with LH for hydrophobic binding sites. Batch acceptance is based on osmolality, pH between 7.3 and 7.5, and an in vitro maturation rate of ≥85% metaphase II at 22 h post-maturation using slaughterhouse-derived oocytes. Lot-to-lot variation in sialic acid content on the beta subunit is normalised by potency assay rather than by weight alone. Free copper in medium above 1 µM accelerates methionine oxidation, so chelex-treated water is used for stock preparation. The terminal product is a frozen single-use solution aliquot of 1 mL; it is not injected into animals and is not considered a veterinary medicinal product in this downstream application. Published data for scale-up beyond 1000 oocytes per week is limited.
Aqueous solutions for fixed-time single insemination programmes in gilts and multiparous sows are buffered differently from cattle injectables because the removal of oil adjuvants from the formulation requires higher ionic strength to prevent pH drift during storage. A typical extemporaneously prepared solution contains porcine LH at 0.05–0.2 mg/gilt, citrate buffer 20–30 mM pH 6.2–6.6, sodium chloride 0.75% (w/v), and mannitol 4% (w/v) for isotonicity. If a multi-dose vial is used for herd-level administration, benzyl alcohol is added at 0.3–0.5% (v/v); levels above 1.0% cause visible precipitation of the LH molecule. Compounding is conducted at 4–8°C; the solution is filtered through 0.22 µm polyethersulfone membranes and aseptically filled into 50 mL Type II glass vials with silicone-coated bromobutyl stoppers. Fill volume tolerance is held at ±2% on a rotary piston pump because peristaltic systems introduce pulsation-associated foaming. Sterility testing follows USP <71>; endotoxin levels are controlled to 0.5 EU/mg by USP <85>; visual inspection is performed per USP <790>. The terminal product is injected intramuscularly as a 2.5 mL dose at the time of insemination. The solution is stored at 2–8°C for up to 30 days; in-use stability after first stopper puncture is limited to 24 h due to microbial challenge and peptide aggregation at room temperature. If the solution is frozen, it must be discarded after thawing; a single freeze-thaw cycle can increase subvisible particle counts by 2–4 times when measured with light obscuration at ≥10 µm particle size. The aqueous porcine LH solution is not combined with oxytocin or prostaglandin injections in the same syringe because pH mismatch and solvent composition can cause immediate precipitation.
Dry premix and granule applications for LH are not common commercial routes because oral peptide degradation is extensive and systemic exposure is low. Research and teaching formulations use spray-dried LH coated onto lactose monohydrate or corncob meal at a ratio between 1:1000 and 1:2000 (w/w). The carrier is sieved to a D50 of 180–250 µm; the final blend should have a Hausner ratio below 1.25 and a Carr index below 15 for reliable flow through feed-mill hoppers and volumetric augers. Mixing in a double-ribbon blender at plough tip speed 85 rpm is continued for 35–40 batch turnovers. Segregation occurs when the API fraction has a D90 below 20 µm and the carrier D50 exceeds 250 µm, because fine LH particles accumulate at the bottom of the mixer after discharge. Residual moisture in the premix must remain below 5% by loss on drying; the glycoprotein is hygroscopic and water uptake above this threshold increases molecular mobility and aggregation during storage. Wet granulation, when necessary for dust control, uses 2–3% (w/w) purified water as binder and drying in a fluidised-bed unit at 40–50°C until moisture is below 5%. Extrusion or pelleting above 60°C is not used because thermal unfolding increases aggregate index and the product fails size-exclusion HPLC acceptance criteria. Finished granules are controlled to a D50 of 300–850 µm; fines below 150 µm are limited to 10% of total mass. Stability testing follows VICH GL3 and residual solvent testing follows VICH GL18. The terminal product is not marketed as a systemic oral LH replacement; it is a research formulation or an oral-compartment exposure model. Published data for this specific configuration is limited; process capability is inferred from generic peptide dry-blend behaviour rather than product-specific commercial trial data.
Tablet and capsule formats containing LH are confined to non-parenteral formulation research because the dimeric glycoprotein is degraded by gastric acid and luminal proteases. No systemic bioavailability claim is intended for this dosage form; published data for this specific configuration is limited. Direct compression blends for stress studies contain microcrystalline cellulose at 60–80% (w/w), lactose monohydrate at 10–20% (w/w), and sodium starch glycolate at 2–4% (w/w) as disintegrant. The API content is adjusted to 50–200 µg per tablet; blend uniformity is assessed according to USP <905> with acceptance value not exceeding 15. Compression is performed on an instrumented single-punch tablet press at 5–8 kN compaction force. Higher force reduces core porosity below 20% and increases disintegration time, which is not a meaningful release parameter for LH but is monitored for process characterisation. Ejection force above 700 N indicates insufficient lubrication; sodium stearyl fumarate at 0.5–1.0% (w/w) is added when necessary. Tablets are packaged in induction-sealed HDPE bottles with desiccant; relative humidity in the compression suite is held below 40% RH and temperature below 25°C. Capsule filling uses size 3 hard gelatin capsules with low tamping pressure to limit shear-induced fracture; lubricant blending time is capped at 5 min to avoid electrostatic segregation and API loss. The terminal product is a research formulation intended for stability and excipient compatibility studies; it is not authorised as a veterinary medicinal product for oral administration. Analytical release includes content uniformity and impurity profiling by reversed-phase HPLC on a C8 column; deamidated species are limited to not more than 5% at release. Exceeding 40% RH during processing produces sticky granules and punch filming. No published confirmatory study supports therapeutic oral efficacy of LH in tablet or capsule form.
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Luteinizing Hormone Veterinary Grade API, designated LH-VET-API-01 for traceability, is supplied as a white to off-white lyophilized powder or cake. The active substance is a heterodimeric glycoprotein consisting of a common alpha subunit and a hormone-specific beta subunit that confers receptor recognition in ovarian theca, granulosa-luteal, and testicular Leydig cells. Bulk potency is assigned by comparative bioassay against the current WHO International Standard for luteinizing hormone and is expressed in International Units per vial or per milligram of total protein. The product is specified for incorporation into sterile injectable solutions after reconstitution, tablets, capsules, powders, granules, premix, and ready-to-use solutions; however, oral solid formats are limited by gastric acid and intestinal protease degradation of the intact glycoprotein unless a protective delivery system is used. The veterinary indication profile includes ovulation induction, treatment of cystic ovarian degeneration, and support of controlled breeding programmes in cattle, sheep, and pigs. The product differs from human chorionic gonadotropin by its shorter terminal half-life and pituitary-type glycosylation pattern, and from follicle-stimulating hormone by its target cell population and cyclic AMP-mediated steroidogenic response. The exact dose, route, and timing are species-specific and must comply with the authorised finished veterinary medicinal product.
For a bulk parenteral-grade LH, the release panel must combine bioassay potency with physicochemical and microbiological tests. The table shows a representative release specification for LH-VET-API-01; the limits are typical industrial acceptance criteria and must be confirmed against the marketing authorisation and current compendial requirements.
| Parameter | Acceptance criterion | Reference method |
|---|---|---|
| Appearance | White to off-white lyophilized powder or cake | Visual inspection |
| Potency | 90%–110% of label claim | In vivo bioassay calibrated against WHO International Standard for LH |
| Sterility | Sterile | Ph. Eur. 2.6.1 |
| Bacterial endotoxins | ≤0.5 EU/mg for parenteral grade | Ph. Eur. 2.6.14 |
| Water content | ≤5.0% | Ph. Eur. 2.5.12 |
| pH of reconstituted solution | 6.5–7.5 | Ph. Eur. 2.2.3 |
| Residual solvents | Meets ICH Q3C / VICH GL18 limits | Headspace gas chromatography |
| Particulate matter | Meets Ph. Eur. 2.9.19 limits for injectable preparations | Light obscuration particle count test |
Bioassay repeatability is a critical control point because potency is not directly proportional to mass. The lyophilized cake should be stored at 2–8°C in sealed glass vials under nitrogen; excursions above 25°C for more than 48 h can reduce bioactivity. At pH below 4.0 or above 9.0, heterodimer dissociation and oxidation of methionine residues in the beta subunit are accelerated. Residual moisture above 5.0% promotes aggregation in the solid state and increases the risk of visible particles after reconstitution. The sterile API is produced by aseptic filtration before lyophilization; terminal gamma irradiation or ethylene oxide is unsuitable because radiation cleaves the peptide backbone and ethylene oxide reacts with amino groups.
Reconstitution of LH-VET-API-01 into an injectable solution is performed in a controlled environment using Water for Injection. The lyophilized cake is dissolved to a target protein concentration of 0.5–2.0 mg/mL; hydration is continued for 10–15 min with gentle orbital agitation. The solution is clarified through a 0.45 µm prefilter and sterilized through a 0.22 µm sterilizing-grade filter. Aseptic filling on a peristaltic pump filling line with vial fill-volume tolerance of ±1% is used for single-dose and multi-dose presentations. Container closure integrity is verified by vacuum decay or dye ingress testing after sealing. For multi-dose vials, 0.5% phenol or 0.9% benzyl alcohol may be included; preservative compatibility must be demonstrated by potency retention over 28 days at 2–8°C. Mixing should be performed with a magnetic stirrer or low-shear impeller at 50–100 rpm; high-shear rotor-stator mixers generate foam and surface denaturation that lower bioassay potency. The formulated solution is filled under nitrogen overlay to limit oxidation of methionine and cysteine residues. For lyophilized presentations, the filling solution is loaded onto pre-chilled shelves at -40°C, held for 2 h, and primary drying is performed at shelf temperature -20°C and chamber pressure 50–100 µbar for 24–48 h. Published lyophilization data for this specific veterinary LH grade are limited; cycle development should be based on differential scanning calorimetry and freeze-drying microscopy to determine glass transition and collapse temperatures. The final cake should retain a porous structure that dissolves within 2 min after reconstitution.
Tablets, capsules, powders, granules, and premix containing LH-VET-API-01 are constrained by the gastric instability of the intact glycoprotein. Direct compression into tablets is not appropriate unless the API is first coated or embedded in an enteric matrix; pepsin and hydrochloric acid at pH 1.0–2.0 hydrolyse peptide bonds and eliminate receptor-binding activity before absorption. Capsule formats should be developed as enteric-coated multiparticulates that resist simulated gastric fluid for 2 h according to Ph. Eur. 2.9.3 and release the peptide in simulated intestinal fluid at pH 6.8. Wet granulation of LH with lactose or mannitol is risky if binder solution temperature exceeds 40°C; dry granulation by roll compaction is preferred for moisture-sensitive peptide processing. Powders and granules for oral administration are not a primary route for this API in cattle, sheep, or pigs because systemic bioavailability of the intact glycoprotein after oral delivery is negligible; published data for this specific dosage form are limited. Premixes for feed incorporation are technically feasible as carrier blends with calcium carbonate or lactose, but the expected systemic effect is not equivalent to injection and the formulation must be justified on a case-by-case basis. The API should not be processed in high-speed mixers because mechanical heat above 30°C and shear can denature the glycoprotein. Packaging for oral solid formats must use aluminium foil or high-barrier laminated sachets with desiccant to keep internal relative humidity below 30% and residual moisture below 5.0%.
For powders and granules intended for reconstitution at the veterinary clinic or farm, particle size and bulk density are controlled to ensure uniform withdrawal. The API is blended with a carrier such as lactose monohydrate or mannitol in a V-blender or ribbon blender; sampling from 10 locations should yield a coefficient of variation below 5.0%. Final granules are filled into unit-dose sachets or bottles at 20–25°C and relative humidity below 30%. Because the lyophilized powder is hygroscopic, open handling should not exceed 30 min in uncontrolled humidity. Moisture-activated aggregation and loss of activity are the main batch-failure modes in tropical manufacturing environments; dry nitrogen purging and continuous relative humidity monitoring are required in the dispensing suite. Solutions prepared from non-sterile powder must comply with microbial quality criteria for non-sterile oral preparations according to Ph. Eur. 5.1.4. If the solution is intended for injection, the powder must be sterile and pyrogen-limited as specified in the release panel. Polysorbate 20 or 80 may be added at 0.01–0.05% w/v to reduce surface adsorption to glass and plastic, but surfactant addition must be justified by container-closure compatibility and potency retention data. For large-volume farm use, the reconstituted solution should be administered promptly and not stored beyond the in-use period specified in the marketing authorisation.
Ready-to-use veterinary LH solutions are prepared for parenteral protocols where field reconstitution introduces dosing error. The solution is buffered with 10–20 mM citrate or phosphate at pH 6.5–7.0; sodium chloride is added to achieve isotonicity at 280–320 mOsm/kg. For intramuscular or subcutaneous injection, the product is filled into single-dose Type I glass vials or pre-filled syringes. Pre-filled syringes require a silicone-lubricated glass barrel and a bromobutyl plunger seal; tungsten residues from needle insertion can oxidise the glycoprotein and must be controlled to trace levels. The solution is stored at 2–8°C and protected from light. In-use stability for a preserved multi-dose vial is typically 28 days; a preservative-free formulation is limited to 24 h at 2–8°C after first use. Terminal sterilisation by autoclaving is not used because heating above 60°C irreversibly unfolds the heterodimer and reduces bioassay potency. Aseptic filtration through a 0.22 µm sterilizing-grade membrane remains the sterility assurance method. The final solution should be visually inspected for opalescence and particulate matter using light obscuration per Ph. Eur. 2.9.19.
LH binds to the luteinizing hormone/chorionic gonadotropin receptor on ovarian theca and luteal cells and on testicular Leydig cells; this binding stimulates adenylyl cyclase and increases intracellular cyclic AMP, leading to progesterone and testosterone production and final follicular maturation. FSH acts primarily on granulosa cells through the FSH receptor and drives follicular recruitment, making FSH and LH complementary rather than interchangeable in superovulation protocols. Human chorionic gonadotropin binds the same LH receptor but has a longer terminal half-life and higher receptor residence time due to its higher sialic acid content; therefore, hCG is commonly used as a substitute for LH in ovulation induction but produces a more prolonged lutrotropic stimulus. Equine chorionic gonadotropin has both FSH-like and LH-like activity in some species, but its prolonged half-life and species-specific response make it unsuitable as a direct substitute for native LH in all protocols. The veterinary LH API described in this monograph is intended for controlled ovarian stimulation, induction of ovulation, and treatment of anovulatory or cystic ovarian conditions in cattle, sheep, and pigs; the product must be administered according to the approved species-specific protocol. Differences in glycosylation affect receptor-binding affinity, bioassay potency, and clearance; batch-to-batch consistency is therefore controlled by in vivo or in vitro bioassay rather than by protein mass alone. The choice between LH, hCG, or eCG in a breeding programme is based on the desired duration of luteal stimulation, species, and regulatory status of the finished product.
The API is manufactured under good manufacturing practice for active pharmaceutical ingredients according to ICH Q7 and EU GMP Part II. Stability studies follow VICH GL3 for veterinary drug substances; residual solvents are controlled under VICH GL18 and ICH Q3C. The compliance matrix below identifies the main release and formulation controls. This API is not compatible with terminal autoclaving, strong acidic or alkaline diluents, or high-shear mixing. It should not be combined with amine-based buffers such as tris(hydroxymethyl)aminomethane at high concentration because pH shift and glycoprotein aggregation can occur. Bulk powder storage below 0°C is possible only if the container is desiccated and sealed under nitrogen; repeated freeze-thaw of reconstituted solutions must be avoided. Storage above 25°C for unopened bulk powder is not recommended unless stability data support a temporary excursion. The product is intended only for incorporation into licensed veterinary medicinal products; extemporaneous use in non-approved species requires a veterinary prescription and a documented risk assessment under the responsible veterinarian.
| Requirement | Standard/Guideline |
|---|---|
| Good manufacturing practice for active substances | ICH Q7 / EU GMP Part II |
| Stability testing of veterinary drug substances | VICH GL3 |
| Residual solvents | VICH GL18 / ICH Q3C |
| Sterility of injectable preparations | Ph. Eur. 2.6.1 |
| Bacterial endotoxins | Ph. Eur. 2.6.14 |
| Water content | Ph. Eur. 2.5.12 |
| Dissolution of oral dosage forms | Ph. Eur. 2.9.3 |
| Particulate matter for injectables | Ph. Eur. 2.9.19 |
