| HS Code | 514247 |
| Product Name | Cliclitide Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Product Category | Pharmaceutical API |
| Grade | Pharma Grade |
| Form | Tablet / Capsule / Granule / Injection |
| Route Of Administration | Oral & Injectable |
| Purity | ≥99% |
| Appearance | White to off-white powder |
| Solubility | Soluble in water |
| Storage Conditions | Store in a cool, dry place away from direct sunlight |
| Shelf Life | 24 months |
| Packaging Type | Bottle, vial, blister pack, sachet |
| Minimum Order Quantity | 1 kg |
| Certification | GMP, ISO 9001, FDA |
| Country Of Origin | India |
| Application | Pharmaceutical manufacturing |
| Hs Code | 29420000 |
| Price | Negotiable |
| Delivery Time | 7-15 days |
| Payment Terms | L/C, T/T, Western Union |
As an accredited Cliclitide 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.
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Cliclitide pharma grade API is supplied for oral solid and parenteral finished drug products. Dry blending of Cliclitide for direct-compression tablets begins with a geometric pre-dilution of the API with sieved mannitol at 1:10 w/w, passed through a 600 µm hand screen, and then added to a bin blender at 60–70% fill volume. The tablet formulation is maintained at a 0.5–2.0% w/w Cliclitide load with 25–45% w/w microcrystalline cellulose, 20–40% w/w mannitol, 3–8% w/w crospovidone, and 0.5–1.5% w/w sodium stearyl fumarate. Blending runs at 15–25 rpm for 20–30 min; rotation above 35 min may increase fines and segregation of the low-dose API. Tablets are compressed on a rotary press at 10–15 kN compaction force to a hardness of 6–9 kP and friability below 1.0% by USP <1216>.
Content uniformity is assessed with USP <905>; the acceptance value must be 15.0 or less for the first stage. Dissolution uses USP <711> apparatus 2 at 50 rpm in 500 mL of pH 6.8 potassium phosphate buffer at 37 ± 0.5°C. If the Cliclitide assay after blending shows a relative standard deviation above 5.0%, the batch is re-screened through a 600 µm sieve and compaction force is reduced to 8–10 kN. Because no Cliclitide-specific compendial monograph is published, these ranges are formulation-development starting points rather than approved release specifications; bracketing studies under ICH Q1A(R2) should confirm the final limits. Magnesium stearate is added last at 0.25–0.50% w/w; overlubrication above 1.5% w/w may delay dissolution and should be avoided unless Cliclitide-specific dissolution data justify it.
Terminal tablets are moisture-protective seal coated with 3–4% w/w hypromellose-based film; enteric coating is introduced only if Cliclitide-specific stability data demonstrate unacceptable acid degradation. Tablet bed temperature during the subsequent coating step should remain below 45°C unless thermal-stability data for Cliclitide support higher exposure.
Hard gelatin or HPMC capsule shells of size 2 or 3 are filled with a final blend or granules containing 0.2–1.0% w/w Cliclitide. A tamping-pin capsule machine with 18–24 stations and pin penetration depth 2–4 mm is used; tamping force is limited to 50–100 N to avoid dose plug densification and shell deformation. The API pre-blend is prepared by geometric dilution at 1:10 with lactose monohydrate or mannitol, then combined with 10–20% w/w pregelatinized starch and 0.25–0.5% w/w colloidal silicon dioxide. The fill weight target is 150–250 mg for size 2 capsules; in-process fill weight checks are performed every 15 min with a control limit of ±3.0% around target.
Disintegration is tested according to USP <701>; capsule disintegration is validated against a product-specific limit, typically 15–30 min in 900 mL water at 37 ± 2°C. Content uniformity uses USP <905>; potency after filling must remain within 95.0–105.0% of label claim unless tighter internal limits are justified by Cliclitide-specific process capability. Hopper relative humidity is maintained below 40% RH to reduce API segregation and shell moisture uptake. Magnesium stearate above 1.5% w/w is avoided because it may delay peptide release from the low-dose plug.
When dry blending cannot maintain blend uniformity, Cliclitide is wet-granulated in a high-shear mixer with an impeller speed of 200–400 rpm and chopper speed of 300–600 rpm. The granulating fluid is 5–7% w/w hypromellose or povidone K30 solution at a binder-to-solid ratio of 10–15% w/w. Wet massing time is limited to 2–5 min; longer massing increases granule densification and may expose the API to elevated local shear and temperature. The granulate is dried in a fluid bed at inlet temperature 40–50°C until loss on drying is 1.5–2.5% w/w. Product temperature should remain below 40°C unless Cliclitide-specific thermal stability data support higher exposure. If Cliclitide is moisture-sensitive, dry granulation by roller compaction is used instead of aqueous wet granulation; roll force is held at 10–20 kN/cm and milled through a 1.0 mm screen.
After drying, granules are milled through a 1.0 mm screen; fines below 150 µm are kept below 25% of total granulate mass to prevent segregation. The dried granules are filled into unit-dose sachets with a fill weight of 500–1000 mg or encapsulated on the same tamping-pin line; moisture content is controlled below 2.5% w/w. The granulation process is validated under 21 CFR 211.110(b) to ensure in-process control of moisture, particle size, and blend uniformity. Terminal granules are used for oral administration after reconstitution or directly as a sachet dose.
Aseptic processing of Cliclitide solution into type I glass vials is performed according to ISO 13408-1 and 21 CFR 211.42. The formulation may consist of 0.5–10 mg/mL Cliclitide, 2–5% w/v mannitol as a bulking agent, 1–3% w/v trehalose dihydrate as a lyoprotectant, and 0.01–0.05% w/v polysorbate 20 in 10–20 mM histidine buffer at pH 6.0–6.5. The solution is passed through a 0.22 µm sterilizing-grade filter; a 0.45 µm prefilter is used if visual particulate load is elevated. If Cliclitide is prone to oxidation, the solution is sparged with nitrogen and the headspace is overlaid with nitrogen prior to stoppering.
Freeze-drying cycle design: freezing at -40°C to -45°C with a 2–4 h hold; primary drying shelf temperature -20°C to -10°C at chamber pressure 100–200 mTorr; secondary drying at 25°C for 6–12 h. The resulting cake must have moisture below 1.0% w/w and reconstitution time below 60 s at 25°C. Terminal product is a lyophilized powder in a 2 mL or 5 mL type I glass vial with a 13 mm or 20 mm elastomeric closure.
| Quality attribute | Method / standard | Acceptance criterion |
|---|---|---|
| Cake appearance | Visual inspection | Uniform cake, no meltback or collapse |
| Reconstitution time | Manual inversion | ≤ 60 s at 25°C |
| Moisture | Karl Fischer titration | ≤ 1.0% w/w |
| Bacterial endotoxins | USP <85> | Calculated by dose; typical 0.5 EU/mg for intravenous use |
| Sterility | USP <71> | No growth after 14 days |
| Visible particulates | USP <790> | Practically free from visible particles |
| Subvisible particulates | USP <788> after reconstitution | ≥10 µm: ≤6000 per container; ≥25 µm: ≤600 per container |
For lyophilized Cliclitide, reducing sugars are avoided in the formulation because of the potential for Maillard or Amadori degradation with peptide amino groups; if a stabilizing sugar is required, non-reducing trehalose or sucrose is used. Silicone oil from the stopper or barrel should be minimized because free silicone oil droplets can nucleate peptide aggregation after reconstitution. If Cliclitide-specific published data for this exact lyophilization configuration are limited, the cycle should be bracketed across ±2°C shelf temperature and ±20 mTorr chamber pressure to establish a robust design space under ICH Q1A(R2).
For a ready-to-use injectable solution, Cliclitide is dissolved in 10–20 mM acetate or citrate buffer at pH 4.0–5.5 with 0.5–1.0% w/v trehalose or sucrose to suppress aggregation. The solution is filtered through 0.22 µm PVDF or PES membrane, filled into 1 mL long or 2.25 mL borosilicate glass prefilled syringes, and closed with a fluoropolymer-coated plunger. Silicone oil levels in the glass barrel are controlled at 0.2–0.5 mg per syringe because free silicone oil droplets can nucleate peptide aggregation. Fill volume is 0.5–1.0 mL; fill weight is checked every 10 min with a limit of ±1.0% around target.
Sterile filtration is validated to retain Brevundimonas diminuta at 10⁷ CFU/cm² per ASTM F838-20. Terminal sterilization is avoided unless Cliclitide-specific thermal-stability data demonstrate no degradation; aseptic processing is the default for this API class. Subvisible particulate matter is measured by USP <787> for therapeutic protein products; visible particulates are assessed by USP <790>. If Cliclitide solution shows deamidation or oxidation above 1.0% after storage at 2–8°C for 6 months, formulation requires nitrogen overlay, antioxidant screening, or a shift to lyophilized presentation. Terminal product is a single-dose prefilled syringe stored at 2–8°C and protected from light.
Cliclitide tablets are coated in a side-vented pan of 36–48 inch diameter with spray rate 10–20 g/min, inlet temperature 60–70°C, exhaust temperature 40–50°C, and atomizing air pressure 1.5–2.0 bar. The coating solution contains 10–12% w/w hypromellose, 2–3% w/w polyethylene glycol 400, and 0.5–1.0% w/w talc; coating weight gain is 3–4% w/w. Tablet bed temperature must not exceed 45°C unless Cliclitide thermal stability data support higher exposure. Coating uniformity is confirmed by content uniformity testing after the coating step using USP <905>.
If acid protection is required, an enteric polymer such as methacrylic acid–ethyl acrylate copolymer is applied after a subcoat to 8–10% weight gain. Disintegration is then tested in 0.1 N HCl for 2 h followed by pH 6.8 buffer; drug release is measured by USP <711>. The terminal product is a moisture-protective coated tablet that remains intact in the mouth and stomach but releases Cliclitide in the intestinal pH range if the enteric overcoat is used.
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Cliclitide Pharma Grade API is a synthetic peptide active pharmaceutical ingredient supplied as a lyophilized powder for further processing into tablet, capsule, granule, and injectable dosage forms. The product model is differentiated from research-grade peptides by GMP batch release under a documented quality system aligned with ICH Q7 and EU GMP Part II. Oral and injectable presentations are manufactured from the same master peptide backbone but diverge at final particle-size control, depyrogenation, and packaging. Storage of the sealed primary container is specified at -20 °C ± 5 °C with desiccant; short-term transfer at 2–8 °C is allowed only while the original desiccant remains in the sealed package. The API is not a formulated drug product and is not supplied with penetration enhancers, enteric coatings, lyoprotectants, or tonicity-adjusting excipients. The manufacturing route comprises solid-phase peptide synthesis, preparative reverse-phase high-performance liquid chromatography using C18-bonded silica columns, and lyophilization. The certificate of analysis reports net peptide content rather than gross lyophilizate mass, so downstream weighing and blending calculations for low-dose tablet and capsule strengths are based on assay-adjusted input mass.
Unprocessed lyophilized Cliclitide powder is cohesive and electrostatically active on standard rotary tablet presses. Direct compression without granulation is generally limited to tablet strengths above 1.0 mg and requires force feeders and low-speed turret settings; below this mass, the flow variation across a gravity-fed USP <905> sampling plan can exceed uniformity of dosage units acceptance limits. Particle size is controlled by laser diffraction under ISO 13320:2020; for direct compression, a d90 ceiling of ≤ 100 µm is used, while dosator-based capsule filling may require d90 ≤ 50 µm to prevent plug formation. Surface moisture of the API and excipients is treated as a critical material attribute because cohesion increases sharply when processing-room relative humidity exceeds 60%. Pre-drying of the API and excipients in a vacuum tray dryer at 40 °C is therefore required before dry blending under high-humidity conditions. Powder flow is measured by Ph. Eur. 2.9.16 or USP <1174>; a Carr index above 30% triggers granulation instead of direct compression. Enteric-coated tablets or capsules containing Cliclitide should be evaluated under dissolution testing with USP <711> apparatus II; published data for this specific API-enteric polymer configuration is limited, and forced-degradation screening is required during formulation development.
Roller compaction is preferred over high-shear wet granulation for Cliclitide because residual water and thermal input during granule drying can increase deamidation. Compacted ribbon density is controlled to yield granules with Hausner ratio ≤ 1.25 and residual moisture ≤ 5.0% by Karl Fischer titration. Sieve analysis under ISO 3310-1 is used to verify granule distribution; oversized granules are milled through a conical mill fitted with a 0.5 mm screen. Capsule manufacture uses a dosator or tamping-pin machine under controlled humidity; because lyophilized Cliclitide powder has low bulk density, fill weight variation is minimized by granulation or by blending with spray-dried lactose that has been pre-dried at 60 °C. Dry granulation is also preferred for formulations containing sodium caprate or other permeation enhancers because wet massing may alter local pH and promote peptide aggregation.
The injectable-grade Cliclitide API is released with bacterial endotoxin data generated under Ph. Eur. 2.6.14 or USP <85>. The acceptance limit is calculated from the maximum clinical dose per kilogram using the K/M formula; for many parenteral formulations with a maximum daily dose not exceeding 4 mg per patient, an API limit of ≤ 0.25 EU/mg is applied. If the final route is intrathecal or ophthalmic, the limit is lowered to ≤ 0.06 EU/mg. Non-sterile oral-grade material is controlled by microbial enumeration under Ph. Eur. 2.6.12 or USP <61> rather than by an endotoxin limit. After reconstitution, sub-visible particle content is evaluated under Ph. Eur. 2.9.19 and USP <788>; a bioburden-reduction filtration step through a 0.22 µm low-protein-binding membrane is required before aseptic filling. Filtration differential pressure must not exceed 1.0 bar, and total recirculation time is recorded because peristaltic pump shear at air-liquid interfaces can aggregate peptide monomers.
Lyophilization of injectable-grade Cliclitide API is performed in a cGMP freeze dryer with shelf temperature and chamber vacuum controlled. The collapse temperature of the specific formulation is determined by freeze-dry microscopy before primary drying; published data for this specific buffered configuration is limited and may not apply to modified pH or tonicity agents. A representative cycle for an unprotected peptide solution uses a fill volume no greater than 5 mL per 6R vial, freezing to -40 °C, primary drying at chamber pressure ≤ 0.1 mbar with shelf temperature between -20 °C and -10 °C, and secondary drying at 25 °C. The ramp from frozen state to primary drying is controlled at ≤ 0.5 °C/min. Primary drying is terminated when the Pirani gauge/capacitance manometer differential indicates complete ice removal; residual moisture by Karl Fischer Ph. Eur. 2.5.12 is confirmed at ≤ 5.0%.
Reconstitution of injectable Cliclitide must be conducted in a buffer system selected to avoid the isoelectric point of the peptide and to suppress deamidation. Forced-degradation screening at pH 3.0, 5.0, and 7.0 at 40 °C for 7 days is used as a process-development boundary before scale-up. Acid-catalysed peptide backbone cleavage is accelerated below pH 3.0, while deamidation rates increase above pH 7.0; the exact stability window is formulation-specific. The solution should not be held for more than 24 h at 2–8 °C before filtration unless a hold-time study demonstrates peptide purity and sub-visible particle stability. Sodium chloride and other tonicity adjusters are added after API dissolution because high-shear mixing of concentrated peptide with ionic salts can promote local salting-out.
Cliclitide Pharma Grade API differs from technical-grade and research-grade lyophilized peptides in three release areas. First, residual trifluoroacetic acid is quantified by ion chromatography; for oral and injectable release, the limit is established at ≤ 0.1% if trifluoroacetate was used in cleavage, and therapeutic counterions are declared on the certificate of analysis. Second, elemental impurities are evaluated under ICH Q3D risk assessment rather than by default metal testing; residual solvents are controlled under ICH Q3C, with the synthesis route and lyophilization solvents listed in the batch record. Third, the injectable grade carries batch-specific bacterial endotoxin, bioburden, and sub-visible particulate data that are absent from non-GMP research lyophilizates. The oral grade is not interchangeable with the injectable grade without additional depyrogenation and bioburden control.
The following matrix summarizes representative release controls for the two presentations. Values reflect standard pharmacopeial acceptance criteria and should be confirmed against the current lot-specific certificate of analysis.
| Quality attribute | Test method | Oral-grade | Injectable-grade |
|---|---|---|---|
| Physical form | Visual inspection | Lyophilized or spray-dried powder; d90 ≤ 100 µm | Lyophilized powder supplied in sealed glass vials |
| Assay, net peptide | Ph. Eur. 2.2.46 / USP <621> | ≥ 95.0% | ≥ 98.0% |
| Related substances | Ph. Eur. 2.2.46 / USP <621> | Total impurities ≤ 5.0%; unspecified ≤ 0.5% | Total impurities ≤ 2.0%; unspecified ≤ 0.2% |
| Residual water | Ph. Eur. 2.5.12 / USP <921> | ≤ 10.0% | ≤ 5.0% |
| Residual trifluoroacetate | Ion chromatography | ≤ 0.1% | ≤ 0.1% |
| Microbial enumeration | Ph. Eur. 2.6.12 / USP <61> | TAMC ≤ 100 CFU/g; TYMC ≤ 10 CFU/g; absence of Escherichia coli | TAMC ≤ 10 CFU/g; TYMC ≤ 1 CFU/g after bioburden reduction |
| Bacterial endotoxins | Ph. Eur. 2.6.14 / USP <85> | Not required for non-sterile oral API | ≤ 0.25 EU/mg or lower based on K/M calculation |
| Particle size | ISO 13320:2020 | d90 ≤ 100 µm | Dissolution before filtration; not directly specified for solid particles |
On a standard 10-station rotary tablet press fitted with 8 mm B tooling, unprocessed lyophilized Cliclitide powder has demonstrated weight variation caused by cohesive bridging in the feed hopper. When the lot is roller compacted to a Hausner ratio ≤ 1.25, tablet mass variability returns to the acceptance range for USP <905>. In capsule filling, static charge during tamping-pin compression can be reduced by humidity control at 40–50% rather than by high-shear mixing, but this must be confirmed against particle aggregation data.
| Reference | Scope | Application to Cliclitide API |
|---|---|---|
| ICH Q7 / EU GMP Part II | GMP for active pharmaceutical ingredients from starting material onward | Controls synthesis, preparative HPLC, lyophilization, packaging, and batch review |
| ICH Q3C | Residual solvents | Limits for organic solvents used in peptide cleavage and drying; residual solvents reported by gas chromatography |
| ICH Q3D | Elemental impurities | Risk assessment for metal catalysts and processing equipment; routine testing may be omitted only when justified |
| Ph. Eur. 2.6.14 / USP <85> | Bacterial endotoxins | Injectable-grade acceptance based on K/M calculation |
| Ph. Eur. 2.9.19 / USP <788> | Sub-visible particles | Injectable grade after reconstitution; not applied to oral grade |
| ISO 14644-1 | Cleanroom classification | Final lyophilization and packaging area; typically ISO class 8 or better for non-sterile API, with further aseptic processing downstream |
| 21 CFR 211.113 | Microbiological contamination control | Applied when the API is incorporated into a registered drug product batch |
Cliclitide Pharma Grade API should not be dry-blended with amine-based alkalizing excipients such as meglumine or tris(hydroxymethyl)aminomethane without pre-granulation studies because local alkaline microenvironments can accelerate peptide degradation. It is incompatible with strong oxidizing agents and should not be exposed to direct sunlight during transfer. For injectable manufacturing, contact with stainless steel surfaces for more than 24 h at ambient temperature requires a stainless-steel hold-time study because peptide adsorption to passivated surfaces may reduce net concentration. These boundaries are operational controls rather than pharmaceutical claims.
