BRADIKANT 30 MG/3 ML SOLUTION FOR S.C. INJECTION IN PRE-FILLED SYRINGE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
- Product Name: BRADIKANT 30 MG/3 ML SOLUTION FOR S.C. INJECTION IN PRE-FILLED SYRINGE 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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- BRADIKANT 30 MG/3 ML SOLUTION FOR S.C. INJECTION IN PRE-FILLED SYRINGE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is typically used in formulations when bradykinin B2 receptor antagonism and subcutaneous injection dose accuracy must be controlled within specific ranges.
| HS Code | 265368 |
| Product Name | BRADIKANT 30 MG/3 ML SOLUTION FOR S.C. INJECTION IN PRE-FILLED SYRINGE |
| Brand Name | Bradikant |
| Active Ingredient | Icatibant (as icatibant acetate) |
| Strength | 30 mg/3 mL |
| Concentration | 10 mg/mL |
| Dosage Form | Solution for subcutaneous injection |
| Route Of Administration | Subcutaneous |
| Container | Pre-filled syringe |
| Pack Size | 1 pre-filled syringe |
| Pharmaceutical Class | Bradykinin B2 receptor antagonist |
| Therapeutic Category | Hereditary angioedema treatment |
| Indication | Treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents, and children aged 2 years and older |
| Mechanism Of Action | Competitively antagonizes bradykinin at B2 receptors, reducing vascular permeability and edema |
| Dose | 30 mg subcutaneously; may repeat every 6 hours if response is inadequate |
| Maximum Daily Dose | 90 mg in 24 hours |
| Shelf Life | 36 months |
| Preservative | Preservative-free |
| Sterility | Sterile |
| Prescription Status | Prescription only |
| Atc Code | B06AC02 |
| Cas Number | 138614-30-9 |
| Molecular Formula | C59H89N19O13S |
| Molecular Weight | 1304.52 g/mol |
| Appearance | Clear, colorless to slightly yellowish solution |
| Ph | 5.5 |
| Osmolality | 300 mOsm/kg |
| Excipients | Sodium chloride, sodium hydroxide, hydrochloric acid, water for injections |
| Contraindications | Hypersensitivity to icatibant or any excipient |
| Warnings | Laryngeal attacks require immediate medical attention |
| Api Grade | Pharma Grade |
| Product Type | Pharmaceutical |
| Target Species | Human |
As an accredited BRADIKANT 30 MG/3 ML SOLUTION FOR S.C. INJECTION IN PRE-FILLED SYRINGE 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 | BRADIKANT carton contains 1 pre-filled syringe with 3 mL sterile solution (30 mg/3 mL) for subcutaneous injection, sealed and labeled. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL): Bradikant 30 mg/3 ml S.C. pre-filled syringes, pharma-grade injectable, palletized, temperature-controlled, secured, labeled, documented for shipment. |
| Shipping | BRADIKANT 30 mg/3 mL pre-filled syringes require validated cold-chain shipping at 2–8°C, protected from light and freezing. Use insulated, shock-resistant, tamper-evident packaging with temperature data loggers. All lots must be handled as temperature-sensitive pharmaceuticals. Shipments follow GDP, pharmacopeial, and medical-goods regulations, with qualified refrigerated transport and documented chain of custody. |
| Storage | Store BRADIKANT 30 mg/3 mL solution for subcutaneous injection in its original pre-filled syringe carton under refrigeration at 2–8°C (36–46°F). Do not freeze. Protect from light. If removed from refrigeration, it may be kept at room temperature up to 25°C (77°F) for up to 3 months; discard thereafter. Keep out of reach of children. |
| Shelf Life | Shelf life: 3 years refrigerated at 2–8°C; may be stored at ≤25°C for up to 3 months. Do not freeze. |
Intradermal and subcutaneous bradykinin challenge preparations are compounded from the 30 mg/3 mL stock solution by low-pH, low-adsorption dilution into sterile citrate-buffered saline. The stock concentration of 10 mg/mL is reduced using a 1:10 to 1:50 dilution ratio to yield working solutions of 0.2–1.0 mg/mL; final injection volumes of 0.1–0.5 mL per challenge site are drawn from the diluted solution using low-retention polypropylene syringes. Aseptic dilution is performed in an ISO Class 5 laminar airflow workstation under EU GMP Annex 1 conditions, with pH maintained at 4.5–5.5 using 0.05 M citrate buffer because neutral pH accelerates bradykinin oxidation and glass adsorption loss. The solution is filtered through a 0.22 µm PVDF membrane before transfer into single-use vials or syringes. Visual inspection follows USP <790> for visible particulates, and fill-weight verification is performed by in-process gravimetric checkweighing. Batch-to-batch variance in visual inspection rejects is most frequently attributable to proteinaceous particles formed when diluted solution is left in Type I glass at pH above 6.0 for more than 4 h. Terminal finished products include investigational intradermal injection vials, subcutaneous challenge kits, and single-use syringes for clinical pharmacology units testing nociceptor sensitivity and local vasodilatory response. Compliance for the injectable downstream track references ICH Q7 for API handling, 21 CFR 211.94 for drug product container evaluation, and ISO 11040-4:2015 where prefilled syringe components are integrated.
How Are Lyophilised Bradykinin Challenge Kits Formulated and Freeze-Dried?
Lyophilised challenge kits are produced by reformulating the liquid stock into a freeze-drying matrix of 0.05–0.50 mg/mL bradykinin, 4–5% w/v mannitol, and 0.1% w/v glycine at pH 5.0–5.5. The addition ratio corresponds to a 1:20 to 1:200 dilution of the 10 mg/mL stock into the matrix before filtration. The manufacturing process uses a stainless-steel formulation vessel at 4±2°C, a peristaltic pump with 0.22 µm PVDF capsule filtration, and a pilot-scale freeze dryer with shelf temperature ramps from −35°C to +25°C over 48–72 h; condenser temperature is held below −55°C. Fill volume per 3 mL Type I glass vial is 1.0 mL, and partial fill depth is selected to maintain a dry cake aspect ratio below 0.6 to prevent cake collapse. Shelf temperature ramp rate is limited to 0.3°C/min because fast primary drying causes microcollapse in cakes with mannitol below 4% w/v. Residual moisture is limited to <2.0% by Karl Fischer titration, and content uniformity of the freeze-dried cake is tested across three vial positions per shelf. Terminal finished products are lyophilised challenge vials for reconstitution, diagnostic bradykinin provocation kits, and clinical trial blinding placebos. Compliance standards include Ph. Eur. 5.1.1 for aseptic preparation, ICH Q1A(R2) for stability evaluation, and Ph. Eur. 3.2.1 for glass container hydrolytic resistance.
Enteric-Coated Granules and Capsules for Oral Peptide Research Formulations
Oral solid dosage forms containing bradykinin are handled as experimental peptide delivery systems because gastrointestinal peptidases degrade the nonapeptide before systemic absorption. The addition ratio in dry granule formulation is typically 0.5–3.0% w/w of bradykinin API relative to total granule mass, with the upper limit set by peptide particle agglomeration during roller compaction and by the water activity of the excipient blend. A direct compression matrix of mannitol, microcrystalline cellulose, and sodium stearyl fumarate is dry-mixed at 40–50°C inlet air in a fluid-bed granulator; where granulation is required, a non-aqueous binder solution of polyvinylpyrrolidone in absolute ethanol is applied at 2–3% w/w solids. Roller compaction feed screw speed is lowered to avoid shear heating above 35°C, which causes peptide-coated granules to stick to roll knurling. The granules are sieved through 0.8 mm mesh and compressed into capsules or tablets. Enteric coating uses a methacrylic acid copolymer dispersion applied in a side-vented pan at 35–45°C product temperature; the coating weight gain is 8–12% w/w to delay peptide release in simulated gastric fluid. Terminal finished products include size 0 HPMC capsules, film-coated tablets, and single-dose granule sachets for oral pharmacokinetic studies. Release testing references Ph. Eur. 2.9.3 for dissolution, ICH Q6B for peptide identity and related substances, and USP <905> for uniformity of dosage units. Published data for this specific bradykinin oral configuration is limited, and process development batches require confirmatory stability studies at 25°C/60% RH and 40°C/75% RH.
Nebulised bradykinin provocation solutions are prepared from the 10 mg/mL stock by 1:20 to 1:40 dilution into phosphate-buffered saline at pH 7.4, yielding a final reservoir concentration of 0.25–0.50 mg/mL. The dilution is performed aseptically in low-binding polycarbonate vessels because bradykinin adsorbs to soda-lime glass at neutral pH; containers are pre-rinsed with 0.1% w/v human serum albumin solution to reduce surface loss. Polystyrene cups are avoided due to high surface adsorption, although published recovery data for specific peptide-container combinations is limited. The calibrated breath-actuated jet nebuliser is operated at 6–10 L/min airflow with a nominal output of 0.4 mL/min; aerodynamic particle size distribution is verified by cascade impactor according to Ph. Eur. 2.9.44, with mass median aerodynamic diameter controlled between 3.0 µm and 5.0 µm. Terminal finished products are unit-dose inhalation challenge solutions, cough provocation test kits, and normal saline control solutions. The process is governed by ISO 27427:2013 for nebuliser compatibility and by ICH Q7 for starting material handling; no terminal sterilisation is applied because moist heat causes rapid bradykinin hydrolysis.
When Bradykinin Is Used as a Primary Calibrator in B2 Receptor Immunoassay Kits
When bradykinin is used as a primary calibrator in B2 receptor immunoassay kits, the 30 mg/3 mL stock is selected for low endotoxin and low oxidation rather than for pharmacological potency in a target organ. The standard curve is prepared by 1:10,000 to 1:100,000 dilution of the stock into peptide-free human plasma containing 0.1% w/v bovine serum albumin and 0.05% w/v sodium azide as stabiliser, resulting in calibrator concentrations from 0.1 ng/mL to 100 ng/mL. Dispensing is performed with positive-displacement pipettes within an ISO Class 7 suite, and stabilised calibrators are lyophilised into 96-well plate wells or single-use calibrator vials. The manufacturing process includes between-day linearity testing across three independent powder lots, with acceptance criteria of CV ≤ 15% at the lower limit of quantitation and CV ≤ 20% across the curve. Plate edge effects require rejection of outer wells if drift exceeds 10%. Terminal finished products are chemiluminescent immunoassay kits, ELISA calibrator/control sets, and peptide mass spectrometry reference standards. Compliance is maintained under ISO 13485:2016 for medical device quality systems, CLSI EP6-A for linearity evaluation, and Ph. Eur. 2.2.56 for amino acid analysis confirmation of peptide content.
Screening B2 Receptor Antagonists in Isolated Vessel Bath Systems
Screening B2 receptor antagonists in isolated vessel bath systems uses bradykinin stock diluted to organ bath final concentrations of 0.1–10 nM in Krebs-Henseleit buffer gassed with 95% O2/5% CO2 at 37±0.5°C. The 10 mg/mL stock is first diluted 1:1,000 in stabiliser buffer to a 10 µg/mL intermediate, then serially dosed at 10–100 µL per 20 mL organ bath chamber. Isometric force transducers record tension changes in isolated arterial rings, and endothelial denudation controls are run in parallel to separate endothelium-dependent vasodilation from direct smooth-muscle contraction. Baths are silanised or pre-treated with 0.1% w/v albumin to reduce peptide loss; buffer replacement is performed every 15 min to prevent degradation-product accumulation. Air bubbles entering the organ bath produce foam that aggregates bradykinin at the liquid surface, so the bath overflow line is kept below 1.0 cm from the buffer surface. Terminal products from this downstream track are reference standards, antagonist screening compounds, and functional assay data packages for contract research organisations. The operational boundary is defined by peptide stability: solutions held at +4°C are used within 8 h, while foam-free preparation is required to avoid shear-induced aggregation. Standards include OECD GLP ENV/MC/CHEM(98)17 for nonclinical laboratory studies and ISO 10993-4:2017 where haemocompatibility screening is part of the test panel.
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- BRADIKANT 30 MG/3 ML SOLUTION FOR S.C. INJECTION IN PRE-FILLED SYRINGE 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.
The product identified as BRADIKANT 30 MG/3 ML SOLUTION FOR S.C. INJECTION IN PRE-FILLED SYRINGE Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is supplied as a sterile, non-pyrogenic, ready-to-use solution with a nominal concentration of 10 mg/mL in a single-use pre-filled syringe. The same active pharmaceutical ingredient is offered separately as a pharma-grade API for tablet, capsule, granule, injectable, oral liquid, and injectable manufacturing. The two material streams are not interchangeable: the injectable solution is filled into a delivery system and released against parenteral specifications, whereas the bulk API requires further pharmaceutical processing before patient administration. The pre-filled syringe presentation is intended for subcutaneous administration only. The dimensional and functional characteristics of the syringe platform are controlled against ISO 11040-4 and, where applicators are used, ISO 11608-1; the glass barrel is borosilicate Type I evaluated under Ph. Eur. 3.2.1, and the plunger stopper is an elastomeric closure evaluated under Ph. Eur. 3.2.9 and USP <381>. No clinical indication is assigned in this technical text. Because the presentation is single-use, the solution is typically preservative-free; after activation, any remaining solution is discarded according to local waste regulations.
The fill volume is designated as 3 mL and the labelled dose is 30 mg. The syringe may be supplied with a staked needle or a Luer cone; the applicable dimensional standard depends on the regional presentation. The product is not intended for intravenous, intramuscular, or intradermal administration. If the regional label permits self-injection, training on subcutaneous administration and sharps disposal is required; otherwise healthcare professional administration is assumed.
Which Container Closure and Parenteral Quality Tests Apply to the Pre-Filled Syringe Presentation?
For the injectable finished product, release and stability evaluation includes sterility testing according to Ph. Eur. 2.6.1 or USP <71>, bacterial endotoxins according to Ph. Eur. 2.6.14 or USP <85>, visible particulates according to Ph. Eur. 2.9.20 or USP <790>, and sub-visible particulates according to Ph. Eur. 2.9.19 or USP <787>. Sub-visible particulate testing for parenteral solutions is performed by light obscuration; if silicone oil droplets interfere, an orthogonal microscopic method under USP <788> is used to classify the nature of observed particles. Sterility testing by membrane filtration uses a 14-day incubation period for the Ph. Eur. method. The solution is also assessed for pH using Ph. Eur. 2.2.3 or USP <791>, osmolality using Ph. Eur. 2.2.35 or USP <785>, and extractable volume using Ph. Eur. 2.9.17 or USP <698>.
Container closure integrity is evaluated under USP <1207> using deterministic methods, with acceptance limits aligned to the leak diameter that prevents microbial ingress and maintains internal gas composition. Method selection typically includes vacuum decay, laser-based headspace analysis, or high-voltage leak detection; dye ingress is used only as a probabilistic supplementary method. Extractables and leachables data are generated for elastomeric and glass components according to ISO 10993-1 and Ph. Eur. 3.2.2.1. Extraction studies use solvent systems of varying polarity, including water, ethanol/water mixtures, and low-pH buffers, under stressed conditions. The leachables profile is monitored in stability because silicone oil from the lubricated glass barrel can appear as sub-visible droplets and must be differentiated from intrinsic particulate matter. Organic extractables from elastomer components may include volatile compounds, semi-volatile compounds, and non-volatile oligomers; analytical methods include GC-MS, LC-MS, and ICP-MS for elementals. Toxicological assessment of identified leachables follows ISO 10993-17.
At manufacturing scale, fill-finish of pre-filled syringes introduces specific bottlenecks. Silicone oil baking and distribution in the glass barrel influence plunger glide force and sub-visible droplet counts; excessive silicone baking temperature or uneven application increases the risk of free silicone oil droplets that may be misclassified by light obscuration. Automatic syringe filling lines using rotary piston or peristaltic pumps require determination of fill volume tolerance and shear exposure. The product's fill volume is set to permit the labelled dose after needle hold-up volume; dose accuracy is verified under ISO 11608-1 or ISO 11040-4 with delivered volume acceptance criteria relative to the nominal 3 mL fill volume.
When the Pharma-Grade API Is Sourced for Tablet, Capsule, and Granule Manufacture
The bulk API grade is supplied as a non-sterile starting material. The control strategy differs from the injectable solution and includes particle size distribution by laser diffraction (Ph. Eur. 2.9.31 or USP <429>), bulk and tapped density (Ph. Eur. 2.9.34), powder flow by Ph. Eur. 2.9.36, polymorphic form by X-ray powder diffraction, water content by Karl Fischer titration (Ph. Eur. 2.5.12 or USP <921>), residue on ignition (Ph. Eur. 2.4.14 or USP <281>), residual solvents (Ph. Eur. 2.4.24 or USP <467>), and elemental impurities (ICH Q3D; USP <232> and USP <233>). Assay and related substances are determined by a validated stability-indicating HPLC method. The degree of crystallinity and polymorphic form are confirmed by XRPD against the reference diffractogram. Changes in polymorphic form can alter dissolution and bioavailability; therefore, stability batches of the API grade are monitored under ICH Q1A storage conditions for polymorph conversion. Residual solvent analysis follows Ph. Eur. 2.4.24 with headspace gas chromatography. Elemental impurities are controlled according to ICH Q3D; the product-specific permitted daily exposure for each elemental class is derived from the intended maximum daily dose of the drug product.
For tablet and capsule manufacture, particle size and morphology data are used to determine whether dry blending, wet granulation, or direct compression is appropriate. Fine particle content below a product-specific D10 may cause segregation in low-shear tumble blenders; high-fines material can produce flow stoppage in roller compaction. Batch-to-batch powder flow variability is assessed by compressibility index and Hausner ratio before blending. For oral liquid formulations, the API grade may be dissolved or suspended; particle size distribution and wetting properties become critical. For granular products, loss on drying and bulk density affect sachet fill weight and uniformity.
Excipient compatibility studies are performed under ICH Q1A forced degradation conditions using binary mixtures with common fillers, binders, disintegrants, and lubricants. Magnesium stearate is evaluated for possible incompatibility because prolonged mixing can reduce compactability and alter dissolution. For injectable formulation, the API solution is filtered through a 0.22 µm sterilizing-grade membrane; filter compatibility and adsorption are evaluated because hydrophobic membranes may retain low concentrations of the active moiety.
For formulators requiring an injectable-grade API rather than the finished syringe, the non-sterile bulk API must undergo aseptic filtration and filling, or terminal sterilization if stability allows. The injectable API stream is controlled for bioburden and bacterial endotoxin before sterilization; however, the bulk pharma-grade API may not meet parenteral microbial limits unless specified. The oral grade is not interchangeable with the injectable grade because of differences in residual solvent limits, elemental impurity options, and microbiological quality. The product's subcutaneous pre-filled syringe presentation cannot be diluted, transferred to another container, or administered by any route other than subcutaneous unless a regional label explicitly permits such use; the needle shield and container closure are not validated for multi-dose use.
Unlike a lyophilized vial, the solution does not require reconstitution; no reconstitution time, diluent, or transfer device is required. The pre-filled syringe also removes the need for a separate needle and syringe assembly in the clinical setting. However, the pre-filled syringe introduces elastomeric closures and silicone oil contact throughout shelf life, which are not present in a lyophilized vial before reconstitution. Compared with an autoinjector presentation, the manual pre-filled syringe has lower injection force requirements and lacks the energy stored in a spring mechanism; its dose accuracy depends on user technique rather than a mechanical delivery system.
The choice between a lyophilized vial, a prefilled syringe, or an autoinjector for the same active moiety is driven by stability in solution, injection volume, target patient population, and human factors. A prefilled syringe is used only when the active moiety demonstrates sufficient stability in the final solution for the intended shelf-life; otherwise the API grade is formulated as a lyophilized product requiring reconstitution. The product described here is presented as a ready-to-use solution; therefore, solution-state stability data must support the approved shelf-life under the labelled storage conditions.
Container Closure System Compliance Checklist for the Pre-Filled Syringe
| Component or interface | Standard designation | Testing purpose |
|---|---|---|
| Pre-filled syringe barrel and plunger stopper | ISO 11040-4 | Dimensions, functionality, and mechanical performance |
| Needle-based injection system | ISO 11608-1 | Dose accuracy and usability |
| Elastomeric closure | Ph. Eur. 3.2.9, USP <381> | Purity, turbidity, reducing substances, extractables |
| Plastic or elastomer biocompatibility | ISO 10993-1 | Biological safety evaluation |
| Container closure integrity | USP <1207> | Microbial ingress and leak detection |
| Extractable volume | Ph. Eur. 2.9.17, USP <698> | Delivered volume |
During aseptic filling of the subcutaneous solution, the fill weight tolerance is determined by the nominal 3 mL volume and the needle hold-up volume of the selected needle gauge. Automatic syringe filling lines equipped with peristaltic pumps are sensitive to tubing wear, which can shift delivered volume over a production batch; inline checkweighing with feedback control is therefore used. For glass pre-filled syringes, siliconization is a critical quality attribute: silicone oil is applied to the barrel interior to reduce plunger gliding force, but free silicone oil droplets can appear in solution and interfere with light obscuration particle counts. The product's release method for sub-visible particulates includes differentiation of silicone oil droplets from particulate matter. Plunger stopper elastomer compatibility is evaluated by exposure studies at accelerated and long-term storage conditions; changes in stopper hardness, penetration force, and extractable profile are monitored. The container closure system is not validated for terminal sterilization if the active moiety is heat-sensitive; aseptic filtration followed by filling is the typical route. Published data for this specific configuration is limited where the active moiety's thermal degradation kinetics are not publicly disclosed.
The stopper insertion depth and residual air bubble size are controlled to prevent under-delivery and reduce oxidative degradation. In production, plunger stopper placement is verified by automated vision systems; residual air bubble volume is measured by headspace analysis. If a needle safety device is integrated, activation force and needle retraction reliability are assessed under simulated use conditions. The prefilled syringe design history file includes risk management according to ISO 14971; design verification includes dose accuracy, torque for Luer lock if applicable, and needle penetration force.
The following matrix aligns test attributes between the injectable finished product and the bulk pharma-grade API. Product-specific release limits are provided in the certificate of analysis; the table lists the method designations used for control.
| Quality attribute | Injectable pre-filled syringe | Bulk pharma-grade API | Applicable standard or method |
|---|---|---|---|
| Sterility | Required at release | Not applicable for oral grade; injectable API may require pre-filtration bioburden | Ph. Eur. 2.6.1, USP <71> |
| Bacterial endotoxins | Required | Specified only for injectable-grade API | Ph. Eur. 2.6.14, USP <85> |
| Sub-visible particulates | Required for parenteral | Not applicable to bulk powder | Ph. Eur. 2.9.19, USP <787> |
| Particle size distribution | Not applicable to solution | Required for solid oral formulation | Ph. Eur. 2.9.31, USP <429> |
| Bulk and tapped density | Not applicable | Required | Ph. Eur. 2.9.34 |
| Residual solvents | Controlled if present | Required | Ph. Eur. 2.4.24, USP <467> |
| Elemental impurities | Controlled | Required | ICH Q3D, USP <232>, USP <233> |
| pH | Required | Not applicable | Ph. Eur. 2.2.3, USP <791> |
| Osmolality | Required | Not applicable | Ph. Eur. 2.2.35, USP <785> |
| Container closure integrity | Required | Not applicable | USP <1207> |
Compared with oral solid dosage forms, the subcutaneous pre-filled syringe demands a higher sterility assurance level and a different packaging control strategy. The prefilled syringe platform also requires compatibility with a needle retraction or safety system, if present, and has a more restricted shelf-life profile than dry bulk API under controlled storage conditions. The single-use presentation is not designed for multiple withdrawals; after activation, any unused portion is discarded according to local requirements.
