HK Neopharm Limited is one of the most reliable manufacturers and suppliers of etelcalcetide hydrochloride in China, featured by quality products and good price. Please rest assured to buy etelcalcetide hydrochloride in stock here and get quotation from our factory. Customized orders are welcome.
Etelcalcetide Hydrochloride, also known as CAS 1334237-71-6, is a new generation of longacting calcimimetic peptide API, serving as a potent agonist of calcium-sensing receptor (CaSR). It is the core raw material for the clinical treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease undergoing hemodialysis.This product can allosterically activate the parathyroid calcium-sensing receptor, rapidly and potently inhibit the synthesis and secretion of parathyroid hormone (PTH), without the severe gastrointestinal adverse reactions common in oral calcimimetics. It has a higher PTH compliance rate and better patient compliance, making it a safe and efficient high-end peptide raw material in the field of nephrology endocrine treatment.
Technical Specifications
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Product Name |
Etelcalcetide Hydrochloride |
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Synonyms |
Etelcalcetide hydrochloride injection |
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Characteristics |
Colorless clear liquid |
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CAS Number |
1334237-71-6 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C38H73N21O10S2 • xHCl, 4≤x≥5 |
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Package |
Technical Package |
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Storage |
Store at 2-8℃ |
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Structure |
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This product is produced on a large scale using solid-phase peptide synthesis technology, in full compliance with GMP and ICH international quality control standards throughout the process. It features high purity, controllable impurities and excellent batch-to-batch consistency. It can be directly used in injectable preparation development, process scale-up, clinical trials and commercial production, providing stable and compliant raw material support for global nephrology pharmaceutical enterprises, CDMO platforms and research institutions.
Product Features
As an intravenous-specific calcimimetic, Etelcalcetide Hydrochloride can specifically activate parathyroid CaSR, rapidly reduce PTH within 30 minutes, with long-lasting and stable effect, no need for daily oral administration; there is no risk of initial PTH surge, and it can significantly correct calcium and phosphorus metabolism disorders, with a higher PTH compliance rate than traditional oral drugs.
Excellent safety, higher tolerance: It has almost no severe gastrointestinal reactions such as nausea and vomiting, the incidence of adverse reactions is only 3%~4%, which greatly improves the long-term treatment tolerance of dialysis patients. The target is specific, with little impact on other tissues of the whole body, and maternal and cardiovascular risks are controllable.
Mature peptide process, stable and reliable quality: Adopting solid-phase peptide synthesis + multi-stage purification process, key impurities, residual solvents and microbial limits are strictly controlled within the limits of international pharmacopoeia. The crystal form and physical and chemical properties are stable, and the deviation of purity and potency between batches is minimal, meeting the needs of industrial continuous production.
Adaptable to injection preparations, complete registration support: Specially developed for intravenous injection, it has good solubility and compatibility stability, adapting to clinical standard specifications such as 0.5mL:2.5mg, 1mL:5mg, 2mL:10mg. Equipped with complete COA, structure confirmation and stability data, it supports domestic and foreign preparation registration and consistency evaluation.
Full-Cycle Quality Control & Consistent Quality
Quality is the core competitive strength of our Etelcalcetide Hydrochloride. We have built a complete traceable quality control system from raw materials to finished products, to fully guarantee the compliance and safety of the API:
- Strict raw material access control: We select pharmaceutical-grade synthetic amino acids, all suppliers have GMP qualifications, and only after full inspection upon entry can they be put into production.
- Production process control: Production is carried out in a 10,000-level clean workshop, with precise control of reaction, purification, lyophilization and sub-packaging parameters, real-time online monitoring, to eliminate batch fluctuations.
- Full inspection of finished products: Through multiple tests such as HPLC, MS, sterility and endotoxin, we issue COA batch by batch, to ensure that the content, related substances, properties, etc. meet the EP/USP standards.
- Storage and transportation guarantee: Cold chain storage and transportation at 2~8℃, with light-proof sealed packaging, real-time temperature and humidity monitoring throughout the process, to prevent degradation and pollution, and maintain the stability of product activity.
- Continuous quality optimization: We regularly carry out stability investigation and process review, dynamically upgrade the quality control plan, to ensure long-term stable Supply.
Application Scenarios
As the core raw material for SHPT treatment, Etelcalcetide Hydrochloride is widely used in the fields of pharmaceutical R&D, clinical production and scientific research:
SHPT preparation production for dialysis patients
As the core raw material for large-scale production of intravenous injection, it is suitable for adult hemodialysis patients, potently inhibiting PTH and preventing complications such as renal osteodystrophy and vascular calcification.
Generic drug R&D and registration
Benchmarking against international original research standards, we provide high-purity raw materials and complete registration data, helping pharmaceutical companies shorten the R&D cycle, reduce registration risks, and accelerate the launch of generic drugs.
Nephrology pharmacological research:
As a tool compound, it is used for basic research such as parathyroid function regulation, calcium and phosphorus metabolism mechanism, and new drug screening, providing scientific research support for the field of nephrology endocrinology.
CDMO/CRO cooperation
We support full-specification supply from milligram to kilogram, and provide customized purification, testing and process development services, adapting to R&D pilot test, pilot scale-up and commercial production.
Packaging and Transportation
To ensure the stable quality of the product during the whole process of storage and transportation, we strictly implement standardized packaging and logistics solutions:
Professional sealed packaging: The inner layer is sterile medicinal aluminum foil bag, the outer layer is pressure-resistant and moisture-proof hard drum/vial, with built-in desiccant, light-proof, sealed and leak-proof, effectively isolating oxygen, moisture and microbial pollution.
Flexible supply of multiple specifications: We provide scientific research-grade milligram packaging and industrial-grade kilogram packaging, which can be customized on demand.
The packaging clearly marks the product name, batch number, storage conditions and expiration date, complying with the global pharmaceutical raw material compliance requirements.
Cold chain logistics guarantee: The whole transportation is temperature-controlled at 2~8℃, equipped with a real-time temperature and humidity traceability system, using shockproof buffer packaging, avoiding high temperature and strong light environment, to ensure that the product quality is not damaged when delivered. We have sufficien.
Etelcalcetide Hydrochloride in stock to support rapid delivery, and accept Bulk Etelcalcetide Hydrochloride orders to meet the supply needs of pharmaceutical enterprises and research institutions.
Our Advantages
1. GMP-compliant production, traceable quality
The whole process follows GMP and ICH Q7 standards, we have established a complete quality traceability system, the product meets international pharmacopoeia requirements, and we can provide a complete set of registration support documents.
2. Leading peptide technology, stable purity
We master the core technology of long-acting peptide synthesis and purification, the purity is stably ≥99.0%, the impurity control is strict, and the batch-to-batch consistency is excellent, meeting the requirements of high-end preparations.
3. Large-scale production capacity, stable supply
We have a mature peptide production base, dual-source backup of raw materials, sufficient safety inventory, which can quickly respond to the procurement needs of pilot test, pilot scale-up and large batch, eliminating the risk of supply interruption.
4. Professional technical service, full-process support
We have a professional peptide preparation and registration technical team, providing one-stop services such as prescription development, process optimization and registration data guidance, helping customers quickly promote project implementation. We also offer Etelcalcetide Hydrochloride Free Sample for your R&D trial. If you want to buy EtelcalcetideHydrochloride, we can provide Customized Etelcalcetide Hydrochloride solutions to meet your specific needs.
5. Global compliant supply, outstanding cost performance
The product meets the market access requirements of Europe, America, Japan, South Korea and other regions, large-scale production effectively reduces costs, providing customers with high-cost performance raw material solutions.
FAQ
If you are looking to source high-quality Etelcalcetide Hydrochloride, etelcalcetide hydrochloride injection or Etelcalcetide raw material, please feel free to contact us at any time for an accurate product quotation, technical support and customized CAS 1334237-716 cooperation solutions!
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