| HS Code | 909779 |
| Product Name | Aciclovir Veterinary Grade API |
| Active Ingredient | Aciclovir (Acyclovir) |
| Grade | Veterinary Grade |
| Available Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Cas Number | 59277-89-3 |
| Molecular Formula | C8H11N5O3 |
| Molecular Weight | 225.21 g/mol |
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; soluble in dilute mineral acids and alkali hydroxides; practically insoluble in alcohol |
| Therapeutic Use | Antiviral active pharmaceutical ingredient |
| Assay | Minimum 99.0% |
| Storage Conditions | Store in a cool, dry place, protected from light and moisture |
| Shelf Life | 24 months when properly stored |
| Packaging | Sealed double polyethylene bags inside aluminium foil bag or drum |
| Container Sealed | Suitable for veterinary pharmaceutical formulations |
As an accredited Aciclovir 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 | Packaged in 25 kg double-lined polyethylene bags inside sealed aluminum foil drums, ensuring stability, purity, and safety for veterinary pharmaceutical manufacturing. |
| Container Loading (20′ FCL) | One 20′ FCL loaded with sealed drums of Aciclovir Veterinary Grade API, suitable for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Shipments of Aciclovir Veterinary Grade API must be packed in sealed, inert containers, protected from moisture and light. Transport in secure, ventilated, non-hazardous freight with temperature control. Ensure compliance with veterinary drug regulations. Avoid extreme conditions during transit to preserve potency and stability for downstream pharmaceutical manufacturing. |
| Storage | Store Aciclovir Veterinary Grade API in a cool, dry place, ideally between 15–25°C, in tightly sealed, light-resistant containers. Protect from moisture, strong oxidizers, and excessive heat. Keep the original packaging intact and avoid direct sunlight. Ensure the storage area is well-ventilated, secure, and within labeled expiry limits to preserve potency and stability. |
| Shelf Life | Shelf life is typically 24 months when stored in original container below 25°C, protected from light and moisture. |
In feline referral hospitals where chronic felid alphaherpesvirus 1 (FeHV-1) keratitis, rhinitis, or ulcerative facial dermatitis persists after topical idoxuridine or famciclovir therapy, extemporaneously compounded aciclovir preparations are prepared as sterile ophthalmic solutions, oral suspensions, compressed tablets, and hard gelatin capsules. The application is anchored in published in vitro susceptibility data for FeHV-1 and constrained by the low oral bioavailability in cats—pharmacokinetic studies consistently report single-digit to low-teens percentage absolute bioavailability—which biases formulation toward topical ocular and lower-dose oral products. A representative compressed tablet core for veterinary compounding comprises aciclovir 250.0 mg (62.5% w/w), microcrystalline cellulose PH102 128.0 mg (32.0% w/w), croscarmellose sodium 12.0 mg (3.0% w/w), povidone K30 8.0 mg (2.0% w/w) as wet-granulation binder, and magnesium stearate 2.0 mg (0.5% w/w) as external lubricant. The ophthalmic solution is compounded at 0.5% w/v aciclovir in a preserved vehicle containing benzalkonium chloride 0.01% w/v, sodium chloride 0.9% w/v, and phosphate buffer to pH 6.8–7.4. Industry compliance for the nonsterile tablet and capsule line references USP <795> Pharmaceutical Compounding—Nonsterile Preparations, USP <905> Uniformity of Dosage Units with AV ≤15.0, USP <711> Dissolution using Apparatus 2 at 50 rpm in 900 mL of 0.1 M HCl, and USP <921> moisture determination with LOD ≤2.0% w/w. Downstream tablet manufacturing uses wet granulation in a 25 L high-shear granulator at impeller speed 300 rpm and chopper speed 1,500 rpm, tray drying at 50 °C to LOD 1.5–2.0% w/w, milling through a 1.0 mm conical screen, blending in a 50 L twin-shell blender at 25 rpm for 15 minutes, and compression on a 12-station B-tooling rotary press. Production-scale batch records document that ambient RH above 65% increases sticking on B-tooling punches and causes weight variation RSD to exceed 2.5%; pre-drying the API at 40 °C for 12 hours and maintaining the compression suite at 20–25 °C and 35–45% RH returns the process to a validated state. Terminal finished product types include 0.5% w/v sterile ophthalmic drops in 5 mL LDPE multidose bottles, 250 mg compressed tablets, 100 mg and 250 mg hard gelatin capsules, and 200 mg/5 mL oral suspension.
When a confirmed equine alphaherpesvirus 1 (EHV-1) viremia outbreak with neurological signs is managed in a referral equine hospital, aciclovir sodium is requested for intravenous infusion because published equine-specific pharmacokinetic data document oral bioavailability below 5% and an elimination half-life of approximately 2–3 h, which makes intravenous administration the only reliable route for acute myeloencephalopathy. The injectable product is manufactured as either a sterile lyophilised powder for reconstitution or a sterile concentrated solution: each vial contains aciclovir sodium equivalent to 500 mg aciclovir, with sodium hydroxide or hydrochloric acid for pH adjustment to 10.8–11.3. The addition ratio for the infusion is fixed at a 5 mg/kg dose diluted to 5 mg/mL in 0.9% w/v sodium chloride in a 500 mL PVC-free infusion bag; dilution into acidic dextrose-only vehicles at pH <6.5 is avoided because pH-dependent solubility reduces below the target concentration and precipitation may occur. Industry compliance for sterility assurance is governed by EU GMP Annex 1, 21 CFR 210 and 211, USP <797> for hospital sterile compounding, USP <788> Particulate Matter in Injections with acceptance limits of ≤6,000 particles ≥10 µm and ≤600 particles ≥25 µm per container, and USP <85> Bacterial Endotoxins. The manufacturing process for the lyophilisate uses aseptic filtration of the reconstituted solution through a 0.22 µm PVDF filter into depyrogenated 10 mL borosilicate vials under Grade A laminar airflow with Grade B background, followed by freeze-drying at primary drying shelf temperature −25 °C and secondary drying 30 °C at chamber pressure 0.2 mbar. Terminal steam sterilisation is not used for ready-to-use solution because aciclovir degradation exceeds the 2.0% total impurities acceptance criterion after 121 °C for 15 minutes; sterile filtration remains the validated method. Post-reconstitution stability data support storage at 2–8 °C for no more than 12 hours in the 50 mg/mL concentrate and no more than 24 hours in the 5 mg/mL infusion. The following infusion-worksheet variation is used for different single-vial loads:
| Vial aciclovir content | WFI reconstitution volume | Reconstituted concentration | Final infusion volume | Additional 0.9% NaCl | Final infusion concentration | Target infusion duration |
|---|---|---|---|---|---|---|
| 500 mg | 10 mL | 50 mg/mL | 100 mL | 90 mL | 5 mg/mL | 60 min |
| 1,000 mg | 20 mL | 50 mg/mL | 200 mL | 180 mL | 5 mg/mL | 60 min |
| 250 mg | 5 mL | 50 mg/mL | 50 mL | 45 mL | 5 mg/mL | 45 min |
For post-intravenous transition in non-hospitalised equines, oral granules are manufactured as aciclovir 200 mg/g in a sorbitol-based dry granule vehicle with sodium starch glycolate 4.0% w/w; the low oral bioavailability makes this route supported by limited published efficacy data, and the granules are restricted to a secondary role. The downstream granulation process uses fluid-bed top-spray granulation with inlet air temperature 55 °C, spray rate 12 g/min, atomisation air pressure 1.5 bar, and final LOD ≤1.8% w/w. Terminal finished product types include lyophilised powder for injection in 250 mg, 500 mg, and 1,000 mg vials, ready-to-use sterile infusion solution at 25 mg/mL, and oral granules at 200 mg/g.
Densely stocked psittacine breeding aviaries and quarantine units managing Psittacid alphaherpesvirus 1 (PsHV-1) shedding present a containment problem in which rapid crop-tube administration of aciclovir is used alongside strict isolation and culling of shedding birds. The oral route in large psittacines has published case-level descriptions with doses up to 80 mg/kg three times daily, but species-specific pharmacokinetic data remain limited; therefore the compounded powder for oral suspension is formulated with a conservative scalable concentration rather than a fixed feed premix. Industry compliance references USP <795> for nonsterile compounding, USP <51> Antimicrobial Effectiveness Testing for multi-dose containers, and VICH GL18(R2) for residual solvent control in the API. The addition ratio is a dispersible powder containing aciclovir 500 mg per sachet with xanthan gum 15 mg, colloidal silicon dioxide 10 mg, and sodium citrate 8 mg; reconstitution with 12.5 mL purified water at 25 °C yields a nominal 40 mg/mL oral suspension. Downstream production of the suspension uses a high-shear overhead disperser at 3,000 rpm for 5 minutes, followed by particle-size verification with laser diffraction at D90 ≤30 µm and pH adjustment to 4.5–7.0. Terminal finished product types include 40 mg/mL oral suspension for crop-tube administration, 500 mg sachets for in-house reconstitution, and 100 mg/mL paste for direct oral administration in smaller psittacines; medicated drinking water is not preferred because of low aqueous solubility and settling of the suspension over 6 hours even with xanthan gum.
A body weight below 1.5 kg imposes a narrow therapeutic index for oral aciclovir in chelonian patients with testudinid herpesvirus TeHV3-associated stomatitis, because low metabolic rate, variable gastrointestinal transit time, and species-specific renal clearance create absorption uncertainty. Published controlled efficacy data for this specific configuration are limited; clinical practice therefore relies on compounded oral pastes and gastric-tube granules in zoological and exotic-only hospitals rather than commercial premix. The regulatory framework for these nonsterile preparations is USP <795> Pharmaceutical Compounding—Nonsterile Preparations, USP <1231> Water Activity in Pharmaceutical Systems for powders, and USP <51> for preserved multi-dose paste containers. Addition ratios differentiate the two dosage forms: oral paste contains aciclovir 80 mg/g in a methylcellulose 1.5% w/w gel vehicle with glycerin 2.5% w/w, and gastric-tube granules contain aciclovir 50 mg/g with lactose monohydrate 730 mg/g, pregelatinised starch 200 mg/g, and sodium starch glycolate 20 mg/g. Downstream paste manufacture uses levigation of aciclovir with glycerin in a 1 L planetary mixer at 60 rpm for 10 minutes, then incorporation into methylcellulose gel and milling through an ointment mill with a 100 µm gap before filling into 5 g dial-a-dose syringes. Gastric-tube granule manufacture uses low-shear tumble blending at 25 rpm for 20 minutes, dry granulation through a roller compactor at roll pressure 3.5 MPa, and final particle sizing through a 0.8 mm sieve. Terminal finished product types include 80 mg/g oral paste in 5 g dial-a-dose syringes and 50 mg/g gastric-tube granules in 10 g aluminium foil pouches. Batch records document a critical viscosity boundary: below 15 °C the methylcellulose paste becomes difficult to extrude through the syringe tip, while above 35 °C syneresis increases and dose uniformity at the syringe tip declines; storage at 20–25 °C and limited light exposure is required. The following matrix reflects the two formulation branches and their production limits:
| Dosage form | Aciclovir content | Key excipient load | Processing equipment | Critical process boundary | Finished container |
|---|---|---|---|---|---|
| Oral paste | 80 mg/g | Methylcellulose 1.5% w/w, glycerin 2.5% w/w | Ointment mill 100 µm gap, 1 L planetary mixer 60 rpm | Extrusion force rises below 15 °C; syneresis above 35 °C | 5 g dial-a-dose syringe |
| Gastric-tube granules | 50 mg/g | Lactose monohydrate 730 mg/g, pregelatinised starch 200 mg/g, sodium starch glycolate 20 mg/g | Roller compactor 3.5 MPa, 0.8 mm sieve | Final LOD ≤2.0% w/w at 105 °C | 10 g aluminium foil pouch |
Use of the granules in tube-fed patients is restricted to those with confirmed patency of the oesophagus and adequate hydration, because the high lactose load can produce transient hyperosmotic diarrhoea when gastric emptying is delayed beyond 24 hours; this is stated as an operational boundary rather than a contraindication in all cases.
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Aciclovir Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a compendial synthetic purine nucleoside analogue supplied as a white or almost white crystalline powder. The substance model is set by the current pharmacopoeial monograph rather than by a single proprietary catalogue code; a lot-specific certificate of analysis is the release identity document. The chemical structure is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one, CAS 59277-89-3, molecular formula C8H11N5O3, and relative molecular mass 225.21 g/mol. The base form has very slight water solubility; aqueous solubility is approximately 1.3 mg/mL at 25°C, which drives downstream formulation choices for injection and solid-dose products. The API is released against the aciclovir monographs of the current Ph.Eur. and USP, with additional veterinary-grade controls for bioburden, particle size, and documentation of non-ruminant-origin processing aids.
Release of the veterinary grade API follows a monographed specification with chromatographic purity and residual solvent control. The assay is determined by HPLC with UV detection at 254 nm and is controlled at 98.0–101.0% on the dried basis. Related substance testing includes a specified limit for guanine, the principal degradation-related impurity, at ≤0.5%, with total impurities capped at ≤1.0%. Residual solvents are controlled according to USP <467>; residual solvent classes follow the ICH Q3C guideline, with class 2 solvents individually limited to the published option-1 concentrations. Loss on drying is set at ≤0.5% under the conditions specified in USP <731>. Identity is confirmed by infrared absorption matching the reference spectrum and by retention time in the HPLC assay. Sulfated ash is limited to ≤0.1% using the harmonized pharmacopoeial procedure. For non-sterile veterinary oral solid and premix applications, microbial enumeration limits are aligned with the harmonized non-sterile criteria; for parenteral grades, controlled bioburden and bacterial endotoxin testing are appended because the API is not supplied as a terminally sterilized substance.
| Parameter | Acceptance criterion | Analytical method |
|---|---|---|
| Appearance | White or almost white crystalline powder | Visual |
| Identification by infrared absorption | Conforms to aciclovir reference spectrum | Ph.Eur. 2.2.24 / USP <197> |
| Assay on dried basis | 98.0–101.0% | HPLC, USP <621> |
| Related substance guanine | ≤0.5% | HPLC |
| Total impurities | ≤1.0% | HPLC |
| Loss on drying | ≤0.5% | USP <731> |
| Sulfated ash | ≤0.1% | Ph.Eur. 2.4.14 |
| Residual solvents | Class 2/3 per monograph | USP <467> |
| Particle size, micronized grade | D90 ≤20 µm | Laser diffraction, ISO 13320:2020 |
When the API enters tablet and capsule unit operations, the low aqueous solubility and cohesive powder character of the unmilled crystal generate measurable weight-variation and content-uniformity risks. The compendial assay alone does not predict these processing faults; particle-size distribution and crystallinity are controlled as formulation-critical attributes. Micronized veterinary grade material is typically supplied with a laser-diffraction D90 ≤20 µm, measured by ISO 13320:2020. Micronization increases the specific surface area available for dissolution but simultaneously reduces bulk density and may raise electrostatic adhesion. Production-scale direct compression is generally unsuitable for the unprocessed powder; wet granulation with polyvinylpyrrolidone or pregelatinized starch binder, followed by fluid-bed drying with inlet air below 60°C, is used to produce free-flowing granules. Dry roller compaction is preferred when the formulation contains moisture-sensitive excipients. Compression is targeted to tablet hardness of 5–10 kp on rotary presses; hardness is not a release criterion but is linked to disintegration and dissolution development batches. For capsule filling, a preblend of micronized API with lactose or dibasic calcium phosphate is prepared and tested for blend uniformity before encapsulation; the powder flow is assessed under USP <1174>. Published data for aciclovir veterinary granulation endpoints in feed premixes is limited, so the stated ranges are initial process targets rather than pharmacopoeial acceptance values.
Mechanical particle-size reduction alters the solid-state order of aciclovir. X-ray powder diffraction is used to confirm that the milled material retains the characteristic diffraction peaks of the reference crystalline form. Milling can introduce amorphous domains that absorb moisture and change the dissolution profile; if the amorphous content is not controlled, the granulation endpoint and dissolution may drift between lots. The specification therefore includes a form identification by X-ray powder diffraction or differential scanning calorimetry. Differential scanning calorimetry of the unmilled material shows a melting endotherm with decomposition above 250°C; the exact onset varies with heating rate and particle size. In quality control, the heating rate is fixed at 10°C/min under nitrogen purge, and the result is compared with that of a qualified reference standard. This is especially relevant when the API is incorporated into semi-solid paste formulations or oral drenches, because partial solubilization and recrystallization can produce a different particle habit that affects syringeability and dose uniformity.
Injectable formulations require conversion of the poorly soluble aciclovir base to aciclovir sodium by reaction with sodium hydroxide in aqueous medium. The resulting solution is alkaline; reconstituted veterinary injectable preparations must be maintained above pH 9.0 to avoid precipitation of the base. Commercial acyclovir sodium injectable presentations typically have a reconstituted pH of 10.7–11.7, and the prepared solution is passed through 0.22 µm sterilizing-grade polyvinylidene fluoride or polyethersulfone filters under aseptic conditions. The API itself is not supplied sterile; bacterial endotoxin and bioburden limits are dose-dependent and aligned with the maximum intended daily veterinary dose using Ph.Eur. 2.6.14 or USP <85> methods. Steam sterilization of the final container is generally avoided because of pH-dependent degradation at elevated temperature; aseptic filling is the standard route. For oral solutions, the sodium salt is diluted with purified water and may include buffering agents; the pH is kept above 9.0 and preservative efficacy is tested according to USP <51>. Solutions containing calcium or magnesium salts should be evaluated for precipitation risk before compounding because polyvalent cations can interact with the strong alkaline pH and reduce compatibility.
Powders, granules, and feed premixes are formulated by adsorbing or granulating the API onto carriers such as lactose monohydrate, corn starch, or calcium carbonate. The critical requirement is segregation control during bin transfer and screw-feeding; particle-size differences between the API and carrier can allow fines to migrate. In feed mills, the premix is incorporated at defined inclusion rates, often through a paddle or ribbon mixer with batch uniformity tested by assay on 3 discrete sampling points. Moisture exposure is limited to ≤60% RH during sachet or drum packing. Granulation for oral drench products uses low-moisture binding to reduce hydrolysis; residual water is controlled by Karl Fischer titration under USP <921>. Published data for aciclovir stability in pelleted feed matrices is limited; mash premixes avoid the additional heat load of pelleting unless verified stability data are available.
The active molecule is identical in the human-use and veterinary-grade monographs; the veterinary designation does not imply relaxed chemical purity. Release limits for assay, related substances, and residual solvents are aligned with the same pharmacopoeial texts. The differences are operational and supply-chain-specific. Veterinary-grade aciclovir API incorporates a documented absence of ruminant-origin raw materials, a bioburden and endotoxin profile suitable for veterinary parenteral dosage forms, and segregation controls when the substance is manufactured in a facility that also handles penicillins, ionophores, or coccidiostats. Cleaning validation for shared equipment is reviewed against carryover limits calculated from the lowest veterinary dose and the batch size of the following product. Compared with valaciclovir hydrochloride, aciclovir is not an L-valyl ester prodrug; it does not require first-pass hydrolysis to release the active entity, but its base solubility is much lower. Valaciclovir hydrochloride is more readily soluble, which changes the relative ease of tablet coating and oral absorption in some monogastric species. Aciclovir also differs from the prodrug in its impurity profile: guanine is a principal degradation impurity, while valaciclovir contains aciclovir itself as a hydrolysis marker. Published veterinary pharmacokinetic data for aciclovir oral absorption in horses and cats are variable; dose selection for oral tablets should be supported by species-specific bioavailability studies rather than inferred from human data.
The API is packaged in double polyethylene liners within fiber drums or laminated aluminum pouches. Retest dating of 24 months is supported when storage below 25°C and 60% RH is maintained; temporary excursions to 40°C/75% RH are evaluated using stability-indicating HPLC. Light protection is specified because photodegradation can generate trace levels of color-developing impurities, even though pharmacopoeial monographs do not always include a quantitative light-stress test. Once containers are opened, the material should be reclosed immediately and protected from moisture ingress. Process operators should avoid fine dust generation during dispensing; local exhaust ventilation and conductive grounding are used because the micronized powder can form a flammable dust cloud at sufficient concentrations, although published minimum ignition energy data for aciclovir is limited.
