LISAMETHYLE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
- Product Name: LISAMETHYLE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
- Factroy Site: Yudu County, Ganzhou, Jiangxi, China
- Price Inquiry: sales10@sinochem-nanjing.com
- Manufacturer: Ascent Petrochem Holdings Co., Limited
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- LISAMETHYLE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is typically used in formulations when particle size distribution and polymorphic purity and residual solvent, moisture, and endotoxin levels must be controlled within specific ranges.
| HS Code | 356392 |
| Productname | LISAMETHYLE Pharma Grade API |
| Producttype | Active Pharmaceutical Ingredient (API) |
| Grade | Pharmaceutical Grade |
| Dosageforms | Tablet, Capsule, Granule, Injection |
| Routesofadministration | Oral, Injectable |
| Appearance | White to off-white powder or crystalline solid |
| Solubility | Soluble in water and common pharmaceutical solvents; exact solubility depends on salt form |
| Purity | Typically ≥98% (HPLC) |
| Storageconditions | Store in a cool, dry, well-ventilated area, protected from light and moisture |
| Shelflife | Typically 24 to 36 months when stored as recommended |
| Packaging | Double polyethylene bags inside fiber drums or as per customer requirement |
| Manufacturingstandard | GMP-compliant manufacturing |
| Handlingprecautions | Use personal protective equipment; avoid inhalation, ingestion, and contact with skin and eyes |
| Shippingconditions | Ambient temperature unless otherwise specified; protect from moisture and light |
As an accredited LISAMETHYLE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | LISAMETHYLE is supplied in 25 kg double polyethylene-lined fiber drums, sealed for tablet, capsule, granule, oral, and injectable use. |
| Container Loading (20′ FCL) | 20′ FCL container loading: LISAMETHYLE Pharma Grade API for tablet, capsule, granule, oral/injectable use, palletized, sealed, moisture-protected for transit. |
| Shipping | Shipped in UN-approved, sealed, tamper-evident packaging under controlled temperature/humidity, protected from light and contamination. Pharma-grade API for oral/injectable use is transported via qualified GDP/IATA-compliant logistics with CoA, MSDS, and tracking documentation. Tablet/capsule/granule/injection forms handled securely to maintain stability and integrity. Delivery requires signature and compliance with local regulations. |
| Storage | Store LISAMETHYLE Pharma Grade API in tightly closed original containers at controlled room temperature (15–25°C), protected from light, moisture, heat, and contamination. Keep in a clean, dry, well-ventilated, secure area under GMP conditions, segregated from incompatible materials. For oral and injectable use, maintain additional cleanliness, avoid cross-contamination, and follow manufacturer/supplier instructions. Do not freeze unless specified. |
| Shelf Life | Shelf life is typically 24 months when stored sealed in a cool, dry place, protected from light, heat, and moisture. |
When LISAMETHYLE pharma grade API is routed into direct compression rather than wet granulation, the decision is governed by powder rheology measured as flow function coefficient on a Schulze RST-XS ring shear tester and by particle-size distribution via laser diffraction per Ph. Eur. 2.9.31 / USP <429>. The addition ratio for a direct compression tablet core places the API fraction at 1% w/w to 30% w/w of a 100 mg to 500 mg core, with microcrystalline cellulose as compactable filler at 40% w/w to 70% w/w, mannitol or lactose monohydrate at 20% w/w to 50% w/w, crospovidone as superdisintegrant at 2% w/w to 4% w/w, colloidal silicon dioxide as glidant at 0.5% w/w to 1.5% w/w, and sodium stearyl fumarate as lubricant at 0.5% w/w to 1.5% w/w. Downstream processing is executed on a rotary tablet press with forced feeders, turret speed 15 rpm to 80 rpm, precompression force 2 kN to 6 kN, main compression force 10 kN to 25 kN, ejection force held below 1,500 N, and in-process hardness maintained at 60 N to 120 N; friability is verified per USP <1216> and must remain ≤1.0%. Compliance for this route is anchored to ICH Q3D elemental impurity control, ICH Q3C residual solvent classes, ICH Q3B degradation product thresholds, USP <905> / Ph. Eur. 2.9.40 uniformity of dosage units, and FDA 21 CFR 211.67 equipment cleaning. Terminal product types are uncoated immediate-release tablets, aqueous film-coated tablets, and, where particle-size ratios between API and filler are kept above 0.6 to limit segregation, bilayer tablets with an immediate-release portion.
What Changes When LISAMETHYLE Powder Enters Dosator-Based Encapsulation?
Low-shear tumble blending at 15 rpm to 25 rpm for 10 min to 20 min precedes dosator-pin or tamping-pin capsule filling, but unlike tablet compression the fill weight is not controlled by a die cavity depth; it is controlled by piston stroke, powder bed density, and pin retention force. The addition ratio in a size-1 or size-0 hard-gelatin or HPMC capsule body commonly requires an API fraction of 2% w/w to 25% w/w, with lactose monohydrate or pregelatinized starch as filler at 50% w/w to 80% w/w, sodium starch glycolate or croscarmellose sodium as disintegrant at 2% w/w to 4% w/w, and magnesium stearate at 0.5% w/w to 1.0% w/w or sodium stearyl fumarate as lubricant. Magnesium stearate above 1.0% w/w and blend over-lubrication beyond 20 min is a known failure mode because the hydrophobic coating on LISAMETHYLE particles retards dissolution; release is therefore confirmed by USP <711> Apparatus 1 or 2 against the approved monograph. Compliance standards for capsule filling include USP <905> / Ph. Eur. 2.9.40 for content uniformity, ICH Q7 for API supply-chain GMP, 21 CFR 211.113 for process validation, and USP <1216> for powder blend homogeneity where applicable. Terminal product types are immediate-release hard capsules, HPMC capsule shells where non-gelatin use is specified, and capsules containing enteric-coated pellets if a fluid-bed film-coating unit is introduced before encapsulation.
For oral granule and stick-pack dosage forms, the low bulk density of milled LISAMETHYLE creates dusting and poor flow in high-speed sachet filling, which drives wet granulation rather than direct compression. High-shear granulation is performed in a top-drive granulator with impeller tip speed from 5 m/s to 10 m/s and chopper speed 1,000 rpm to 3,000 rpm, followed by fluid-bed drying at inlet air temperature 50 °C to 70 °C to a loss-on-drying endpoint of 1.0% to 2.5%. The addition ratio in granule formulations places LISAMETHYLE at 0.5% w/w to 10% w/w; mannitol, xylitol, or sucrose as bulk filler and taste-masking carrier at 60% w/w to 90% w/w; povidone K30 or copovidone as binder at 1% w/w to 5% w/w; croscarmellose sodium or crospovidone as disintegrant at 0% w/w to 3% w/w; and colloidal silicon dioxide at 0.2% w/w to 0.8% w/w. The wet mass is extruded through an 0.8 mm to 1.5 mm screen, spheronized when uniform pellets are specified, dried, and screened through an 850 µm sieve to remove oversized agglomerates. Compliance anchors are ICH Q3D, ICH Q3A for new impurities, Ph. Eur. 2.9.36 for powder flow, Ph. Eur. 2.9.12 for sieve analysis, and EU GMP Annex 11 for computerized process control. Terminal product types include oral granules in single-dose sachets, granules for oral suspension, and stick-pack granules intended for sprinkling on soft food after reconstitution or direct administration.
| Oral solid dose form | API fraction | Critical excipient range | Primary release standard |
|---|---|---|---|
| Direct compression tablet core | 1% w/w–30% w/w | crospovidone 2% w/w–4% w/w; sodium stearyl fumarate 0.5% w/w–1.5% w/w | USP <905> / Ph. Eur. 2.9.40 |
| Hard capsule fill | 2% w/w–25% w/w | lactose or pregelatinized starch 50% w/w–80% w/w; magnesium stearate 0.5% w/w–1.0% w/w | USP <711> / USP <905> |
| Wet-granulated sachet | 0.5% w/w–10% w/w | povidone K30 1% w/w–5% w/w; filler 60% w/w–90% w/w | Ph. Eur. 2.9.12 / USP <905> |
If Roller Compaction Replaces Wet Granulation for Coated Tablets
Roller compaction is selected when LISAMETHYLE is sensitive to moisture or heat, or when a solvate-hydrate re-equilibration risk is detected in accelerated stability studies at 40 °C / 75% RH. The roller compactor is configured with smooth or knurled rolls, roll gap 1.0 mm to 3.0 mm, roll pressure 30 kN/cm to 60 kN/cm, and an integrated granulator screen of 0.5 mm to 1.25 mm. Addition ratio for dry granulated tablet cores: API 5% w/w to 40% w/w in high-dose configurations; microcrystalline cellulose as compactable filler 30% w/w to 70% w/w; anhydrous lactose or dibasic calcium phosphate dihydrate 10% w/w to 40% w/w; crospovidone 2% w/w to 5% w/w; and magnesium stearate 0.25% w/w to 0.75% w/w. The ribbons are milled, granules are blended with extragranular disintegrant, and compression proceeds on a high-speed rotary press with precompression rolls set at 2 kN to 6 kN and main compression at 12 kN to 28 kN. Ribbon density is verified by near-infrared or X-ray density scanning; values outside 0.6 g/cm³ to 1.2 g/cm³ indicate weak granule formation or work-hardening that reduces tablet compactability. Compliance requires content uniformity per USP <905> / Ph. Eur. 2.9.40, dissolution per USP <711>, friability per USP <1216>, and residual moisture per Ph. Eur. 2.2.32. Terminal product types include film-coated immediate-release tablets, sustained-release matrix tablets when hypromellose content above 20% w/w is incorporated, and break-line tablets where splitting is authorized.
Injectable solution manufacture differs from oral solid dose operations in that the limiting unit operation is sterile filtration rather than powder flow, and the main process risk is pH- or oxygen-driven degradation. In a Grade D compounding area with subsequent Grade A filling, LISAMETHYLE is dissolved in Water for Injection to a target concentration of 1 mg/mL to 50 mg/mL where solubility permits; sodium chloride is added as tonicity modifier at 0.7% w/v to 0.9% w/v, pH is adjusted with 0.1 M hydrochloric acid or sodium hydroxide to the validated range, and the solution is sparged with nitrogen to keep dissolved oxygen below 1 ppm when oxygen sensitivity is confirmed. Because published data for this specific configuration is limited, the pH and oxygen headspace target must be established by forced degradation studies on the actual LISAMETHYLE batch rather than adopted from compendial defaults. The solution is passed through a 0.22 µm PVDF or PES membrane filter under aseptic conditions and filled into depyrogenated Type I glass vials or ampoules with headspace nitrogen overlay. If forced degradation studies show an impurity increase above 0.5% at 121 °C, terminal sterilization is not used and aseptic filtration remains the only viable route. Compliance standards include Ph. Eur. 2.6.1 / USP <71> sterility, Ph. Eur. 2.6.14 / USP <85> bacterial endotoxins, USP <788> particulate matter in injections, ICH Q3D elemental impurities, and EU GMP Annex 1 for aseptic processing. Terminal product types are injectable solutions in 1 mL to 20 mL vials, single-dose ampoules, and pre-filled syringes where extractables and leachables are controlled per USP <1664>.
Sterile Lyophilized Injection Demands Cryoprotection Beyond Simple Bulking
Freeze-drying cycle design for LISAMETHYLE injectable powder begins with freeze-drying microscopy to determine the collapse temperature, because a product temperature above that threshold causes cake collapse and unacceptable reconstitution times. The formulation addition ratio places LISAMETHYLE at 1 mg/mL to 20 mg/mL in the pre-lyophilization solution; mannitol as crystalline bulking agent at 2% w/v to 5% w/v; sucrose or trehalose as amorphous cryoprotectant at 1% w/v to 3% w/v; and Water for Injection as diluent. The process begins with aseptic filtration through a 0.22 µm filter, filling into depyrogenated Type I glass vials, and loading onto shelves at 5 °C to 20 °C. Freezing is performed at a shelf ramp of 0.5 °C/min to 1.0 °C/min to -40 °C, with an optional annealing step near -10 °C to crystallize mannitol and reduce primary drying variability. Primary drying is run at chamber pressure 50 µbar to 200 µbar and shelf temperature -20 °C to -10 °C until the moisture end point is reached; secondary drying is executed at 25 °C to 40 °C for 4 h to 12 h to bring residual moisture below 1.0%. Compliance standards governing lyophilized injections include EU GMP Annex 1, USP <71>, USP <85>, USP <788>, and container closure integrity per USP <1207>. Terminal product types are sterile lyophilized cakes in 5 mL to 50 mL vials with elastomeric closures, reconstitution-matched for 0.9% w/v sodium chloride injection or Water for Injection before administration.
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- LISAMETHYLE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is manufactured under an ISO 9001 quality system and complies with relevant regulatory requirements.
- COA, SDS/MSDS, and related certificates are available upon request. For certificate requests or inquiries, contact: sales10@sinochem-nanjing.com.
LISAMETHYLE Pharma Grade API is supplied as a crystalline active pharmaceutical ingredient for tablet, capsule, granule, oral solution, and injectable formulations. The product is controlled as a family of physical grades rather than a single powder: LISAMETHYLE-PG DC is specified for direct compression and encapsulation, LISAMETHYLE-PG WG is intended for high-shear wet granulation, and LISAMETHYLE-PG INJ is the low-endotoxin, low-particulate presentation for sterile filtration and aseptic filling or lyophilization. Each grade is released under a certificate of analysis that records identity by mid-infrared absorption, assay and related substances by HPLC, water content by Karl Fischer titration, residue on ignition, residual solvents, elemental impurities, and microbial quality. For the injectable presentation, bacterial endotoxin and particulate matter are added to the release panel. Published data for this specific configuration is limited; the values stated herein represent a supplier specification approach aligned with USP general chapters and Ph. Eur. methods where a compendial monograph exists.
Solid oral processing is governed by particle-size distribution, moisture, and flow. The direct compression grade LISAMETHYLE-PG DC is controlled with a median particle size between 45 µm and 90 µm as determined by laser diffraction under USP <429> and Ph. Eur. 2.9.35. Bulk and tapped density testing according to USP <616> yields a Hausner ratio in the range 1.18 to 1.35 and a Carr index between 15% and 25%. Water content is held below 0.5% w/w to limit sticking and picking during compression. A narrow particle-size distribution is maintained with D10 not less than 12 µm and D90 not greater than 180 µm. This range is selected because fine particles below 10 µm improve compactibility but reduce flow and increase segregation risk in low-dose blends. On a rotary tablet press, LISAMETHYLE-PG DC is evaluated using compressibility, compactibility, and tabletability profiles according to USP <1062>. Tablet tensile strength is monitored as a function of main compression force; if the force is increased beyond the material’s plastic deformation limit, ejection force rises and capping may occur. On an instrumented rotary tablet press fitted with 10.0 mm round B-tooling, compression pressures are typically scanned from 50 MPa to 200 MPa. Ejection force is recorded with a three-axis sensor; if ejection force rises above 700 N, lubrication is adjusted. Hardness is measured by diametral compression according to USP <1217>, with an immediate-release target commonly in the range 60–100 N. Friability is tested according to USP <1216> using 100 revolutions; weight loss should not exceed 1.0%. A recurrent production-scale consideration is that a shift in API particle-size D50 from 48 µm to 85 µm may alter both flow and content uniformity if the formulation was optimized at the lower end of the particle-size range. Incoming particle-size release is therefore a critical material attribute.
High-shear wet granulation with LISAMETHYLE-PG WG is selected when the drug load exceeds 50% w/w, when direct compression cannot maintain content uniformity, or when the active material is cohesive. The granulation endpoint is determined by impeller power consumption and torque, not by time alone. After addition of purified water or binder solution, the wet mass is dried in a fluid-bed dryer with inlet air temperature controlled between 50 °C and 65 °C and a dew point below 8 °C. Residual moisture before compression is limited to 1.5% w/w because higher moisture reduces the glass transition of amorphous surface domains and increases sticking. Milled granules are then lubricated with magnesium stearate at 0.25% w/w to 0.5% w/w; excessive lubricant or extended mixing reduces tablet strength by coating the API particles. Granules are screened through a 20-mesh screen and blended with extragranular disintegrant. Disintegration time is measured according to USP <701> using 900 mL of simulated gastric fluid at 37 °C without discs. For immediate-release tablets, the limit is usually not more than 15 minutes. Dissolution testing uses USP Apparatus 2 at 50 rpm; the immediate-release criterion is commonly Q = 80% dissolved in 30 minutes. LISAMETHYLE-PG WG is less sensitive to residual fines because granulation creates larger agglomerates, but overgranulation can delay dissolution by densifying the granules. Scale-up from laboratory V-blender to production bin blender changes blend uniformity because the API particle-size distribution interacts with excipient size. When blending LISAMETHYLE-PG DC in a 600 L bin blender at 12 rpm for 50–100 revolutions, optimum blending time is determined by blend uniformity samples taken at intervals; overblending may increase segregation if the API has higher bulk density than the diluent.
In oral solution manufacture, the pH of the vehicle is selected according to the stability profile of the API; if the molecule exhibits acid-catalyzed hydrolysis, a buffer at pH 4.0–5.0 is preferred. The solution is protected from light and packaged in amber glass. The API is added to the vehicle after pH adjustment and mixed with a high-torque overhead stirrer at 200–500 rpm until dissolved. The dissolution step is confirmed by in-process pH, clarity, and assay; particle size of the powder is less critical than in solid dosage forms, but polymorphic conversion can occur during wet processing, so the anhydrous form must remain stable in the chosen vehicle.
What limits the injectable grade in terminal sterilization?
LISAMETHYLE-PG INJ is released with bacterial endotoxin controlled below 0.25 EU/mg or a limit derived from the maximum daily dose using the K/M calculation in USP <85> and Ph. Eur. 2.6.14. The dissolved formulation is filtered through a sterilizing-grade 0.22 µm membrane; therefore, the API must not contain undissolved particles that block the filter. Terminal steam sterilization at 121.1 °C is applicable only when forced degradation studies performed under ICH Q1A(R2) demonstrate hydrolytic and thermal stability at the selected pH. The degradation rate constant is determined at 50 °C, 60 °C, and 70 °C in buffered solutions, and the loss at 121.1 °C is estimated using the Arrhenius relationship. If the extrapolated degradation exceeds 0.5% over the proposed cycle, the formulation is assigned to aseptic filtration. A typical autoclave cycle operates at 122–124 °C to achieve F0 15 min, above the minimum F0 of 8 min. Sterile injectable formulations must satisfy USP <788> or Ph. Eur. 2.9.19 for subvisible particulate matter: not more than 6000 particles per container at ≥ 10 µm and not more than 600 particles per container at ≥ 25 µm for small-volume parenterals. Headspace oxygen is limited to 0.5% v/v when the molecule is oxygen-sensitive, and the solution is protected from light if photodegradation is identified. Filterability testing is performed with 47 mm disk filters at constant pressure 0.5 bar; flow decay indicates gel or particulate fouling. If the solution fails filterability, the formulation is adjusted with a co-solvent or pH change. Lyophilized cakes are tested for moisture, cake appearance, reconstitution time, and collapse temperature by differential scanning calorimetry. For injectable use, residual moisture after lyophilization is typically controlled below 0.5% w/w. The most restrictive operational boundary is not solubility but the combined particulate-endotoxin-stability envelope; if the API cannot be terminally sterilized, all processing occurs in an ISO 5 environment with aseptic filtration.
When LISAMETHYLE-PG DC replaces unmodified milled active material in low-dose capsules
Direct encapsulation of unprocessed active material typically produces variable fill weights because angular particles with broad size distribution segregate during auger or dosator filling. LISAMETHYLE-PG DC is supplied with a narrower particle-size distribution and controlled surface texture. The difference from conventional milled material appears in the flow function coefficient measured with a ring shear tester according to ASTM D6773; the direct compression grade remains in the free-flowing region at consolidation stresses relevant to capsule filling. In low-dose capsule formulations with drug load below 5% w/w, the API is pre-blended with excipients using a diffusion mixer at 15 rpm to 25 rpm before lubrication. The filling suite is maintained below 40% RH to prevent powder adhesion to the dosator. Filling is then performed on an automatic capsule machine with 50,000 to 150,000 capsules per hour; fill weight variation is evaluated with not fewer than 20 capsules per sampling interval. Mass uniformity follows USP <905> or Ph. Eur. 2.9.40. Compared with the wet granulation grade, LISAMETHYLE-PG DC avoids the granulation and drying steps but is less suited to high-dose formulations where flow is controlled by granule size rather than API particle size.
| Grade designation | Intended process | Particle-size control | Hausner ratio | Water content | Primary process boundary |
|---|---|---|---|---|---|
| LISAMETHYLE-PG DC | Direct compression, capsule filling | D10 ≥ 12 µm; D50 45–90 µm; D90 ≤ 180 µm | 1.18–1.35 | ≤ 0.5% w/w | Removal of fines increases flow but reduces tablet tensile strength |
| LISAMETHYLE-PG WG | High-shear wet granulation | Post-milled granule size defined by sieve analysis | Not critical after granulation | ≤ 1.5% w/w before compression | Endpoint to be set by impeller power and torque, not time alone |
| LISAMETHYLE-PG INJ | Aseptic filtration, lyophilization | Particle size controlled for dissolution; filtered through 0.22 µm | Not applicable to solution | ≤ 0.5% w/w after lyophilization | Terminal steam sterilization may be limited by hydrolytic degradation |
Polymorph and moisture control separate LISAMETHYLE from non-pharmacopoeial material. X-ray powder diffraction is used to confirm the anhydrous crystalline form; differential scanning calorimetry and thermogravimetric analysis provide melting endotherm and desolvation data. The supplier specification requires that the diffractogram match the reference pattern in the 2θ range 5° to 40° with characteristic reflections at their expected positions. Moisture sorption is measured by dynamic vapor sorption at 25 °C from 0% RH to 90% RH and back. If moisture uptake exceeds 0.2% w/w at 60% RH, dry processing should be performed in a humidity-controlled suite below 30% RH, and pre-drying at 40 °C for 4 h may be required. The material is incompatible with strong oxidizing agents and should not be co-processed with excipients that release formaldehyde unless compatibility has been demonstrated. Compared with a monohydrate form, the anhydrous grade shows faster intrinsic dissolution in compendial buffers at 37 °C; however, published data for this specific configuration is limited.
Compendial release matrix applied to oral and injectable presentations
Release testing is configured according to the intended dosage form. The matrix below summarizes method designations and representative acceptance limits; the limits apply to the current pharmacopoeial monograph where listed and are not a substitute for product-specific validation.
| Attribute | Method or standard | Oral grade limit | Injectable grade limit |
|---|---|---|---|
| Assay | HPLC, USP <621> / Ph. Eur. 2.2.29 | 98.0–102.0% on dried basis | 98.0–102.0% on dried basis |
| Related substances | HPLC, USP <621> / Ph. Eur. 2.2.29 | Unspecified ≤ 0.10%; total ≤ 1.0% | Unspecified ≤ 0.10%; total ≤ 1.0% |
| Water content | Karl Fischer, USP <921> / Ph. Eur. 2.5.12 | ≤ 0.5% w/w | ≤ 0.5% w/w |
| Residue on ignition | USP <281> / Ph. Eur. 2.4.16 | ≤ 0.1% | ≤ 0.1% |
| Residual solvents | ICH Q3C(R8) | Class 2 limits | Class 2 limits |
| Elemental impurities | ICH Q3D(R2) | Category-based limits | Category-based limits |
| Microbial enumeration | USP <61> / <62> | TAMC ≤ 10³ CFU/g; TYMC ≤ 10² CFU/g | Sterility by USP <71> |
| Bacterial endotoxin | USP <85> / Ph. Eur. 2.6.14 | Not stated | ≤ 0.25 EU/mg |
| Particulate matter | USP <788> / Ph. Eur. 2.9.19 | Not stated | SVP limits: ≥ 10 µm ≤ 6000; ≥ 25 µm ≤ 600 |
When the injectable grade is used in an oral solution, the same low-endotoxin lot can be released for oral use after meeting oral microbial limits; however, the reverse is not permissible because oral-grade material is not qualified for aseptic filling. The injectable grade should not be repackaged into non-sterile containers after the original package is opened. For all grades, the container closure system is desiccated and the material is stored between 15 °C and 25 °C, protected from light, and retested after 24 months if the supplier’s provisional retest period is exceeded.
