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Donidalorsen API (Donidalorsen CAS 2304692-48-4) is a novel antisense oligonucleotide raw material. By targeting and regulating related gene expression, it provides an innovative intervention path for hereditary angioedema. As a free acid structure, it is more suitable for early R&D and preparation processes compared with its sodium salt form (CAS 2304701-45-7). With a specific target, it stably inhibits related protein production, barely interferes with normal body metabolism, and has good safety. It reduces the risk of edema attacks from the source, improves patients' daily tolerance, and is a key pharmaceutical raw material for hereditary angioedema prevention and treatment drugs.
Technical Specifications
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Product Name |
Donidalorsen |
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Synonyms |
Donidalorsen Powder, Donidalorsen Raw Material |
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Characteristics |
A white or off-white lyophilized powder |
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CAS Number |
2304692-48-4 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C296H435N83O151P20S15 |
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Package |
Technical Package |
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Storage |
Protect from light, keep tightly closed, dry and store at -20°C. Avoid repeated freeze-thaw cycles. |
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Structure |
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Donidalorsen API (Donidalorsen CAS 2304692-48-4) is a highly specific antisense oligonucleotide API, mainly used in the R&D of hereditary angioedema prevention and treatment, and holds important value in rare disease RNA targeted drug development. The physicochemical properties of this free acid raw material are significantly different from those of its sodium salt form (CAS 2304701-45-7). It can effectively inhibit the synthesis of pathogenic factors by precisely regulating target messenger RNA, providing a key raw material basis for clinical long-acting preventive drugs.
Product Features
Donidalorsen API adopts ligand-conjugated antisense oligonucleotide (LICA) technology and is a free acid raw material. It accurately targets liver-related genes, blocks the production of pathogenic inflammatory mediators from the source by specifically silencing PKK expression, and has high specificity and strong inhibitory activity.
This product is a white or off-white Donidalorsen Powder, with a molecular formula of C₂₉₆H₄₃₅N₈₃O₁₅₁P₂₀S₁₅ and a molecular weight of 8672.64. Compared with the sodium salt form CAS 2304701-45-7, its free acid form is more suitable for R&D stage preparation, with purity up to 99.0% or above tested by HPLC, and excellent batch stability.
As the core raw material of the world's first RNA targeted HAE preventive drug, this product can significantly reduce the frequency of HAE attacks, with clinical data showing an over 80% reduction in attack rate. It has strong targeting and low off-target effects, providing key raw material support for the long-term prevention and treatment of hereditary angioedema.
The product strictly follows COA standards and adopts professional packaging to ensure storage and transportation safety. It needs to be sealed and stored at -20℃, moisture-proof and light-proof to maintain activity. As an API, it has a mature process and can meet the high-standard requirements of formulation R&D and commercial production, with a quality system aligned to donidalorsen fda approval specifications.
Full-Cycle Quality Control & Consistent Quality
Full-Process Testing System
Donidalorsen( CAS 2304692-48-4) has established a full-cycle quality control chain covering synthesis, purification to finished products, and introduced high-precision testing equipment to achieve full-dimensional monitoring from the source to the terminal, laying a solid quality foundation.
Precise Purity Control
In view of the characteristics of the free acid form, we strictly implement purity standards verified by multiple methods such as HPLC, with stable purity ≥99.0%. Compared with the sodium salt form, its impurity control is more accurate, providing high-purity raw material guarantee for R&D and production.
Batch Stability Mechanism
We have established a standardized process and batch recording system, strictly control key parameters to ensure the consistency of activity and composition of each batch of products. It realizes stable output of free acid form and meets the quality requirements of continuous production.
Compliant Release & Storage
Finished products are released in strict accordance with COA standards, with comprehensive testing of various indicators. At the same time, we standardize -20℃ low-temperature and moisture-proof storage conditions to maintain its stable quality, and provide continuous and reliable raw material support for downstream formulation applications of Donidalorsen Powder.
Application Scenarios
Donidalorsen Raw Material (Donidalorsen CAS 2304692-48-4, free acid form) is a highly specific antisense oligonucleotide API, which provides core raw material support for the long-term prevention and treatment of hereditary angioedema (HAE), and is a key material for the R&D and production of rare disease RNA targeted therapy.
Donidalorsen Raw Material (Donidalorsen CAS 2304692-48-4) is the core API of long-acting preventive drugs for hereditary angioedema (HAE), providing a key material basis for the R&D of rare disease RNA targeted therapy.
As an upstream raw material for HAE subcutaneous injection preparations, its free acid form is compatible with the preparation process and can be converted into medicinal sodium salt (CAS 2304701-45-7) to support the large-scale production of clinical drugs.
This product can be used for the target validation of antisense oligonucleotides and the research of PKK gene silencing mechanism, providing high-purity experimental raw material support for the exploration of HAE pathogenesis and the optimization of new therapies.
It is suitable for the synthesis process optimization and pilot scale-up of antisense oligonucleotide drugs. The free acid form of Donidalorsen Raw Material is easier to control batch quality, providing raw material support for the process iteration of commercial production.
We provide high-quality Donidalorsen Raw Material for global pharmaceutical companies and CRO institutions, with complete COA and quality control system, to meet the compliance raw material requirements of international registration and production. As a professional China Donidalorsen manufacturers, we strictly control every production link.
Packaging and Transportation
As a highly specific antisense oligonucleotide API, Donidalorsen Powder (Donidalorsen CAS 2304692-48-4, free acid form) is packaged and transported in strict accordance with pharmaceutical industry specifications. Combined with the characteristics of the free acid form and its differences from the sodium salt (CAS 2304701-45-7), it ensures the activity, purity and safety of the raw material during the whole storage and transportation process, and supports downstream R&D and production needs.
Donidalorsen Powder (Donidalorsen CAS 2304692-48-4) adopts light-proof and moisture-proof pharmaceutical grade sealed packaging, which adapts to the characteristics of free acid form. Compared with sodium salt, it is easier to control the storage and transportation environment, can effectively isolate external interference, and ensure the stability of raw material activity and purity.
The product strictly follows international pharmaceutical cold chain transportation specifications, with full temperature control at -20℃, and a complete logistics monitoring system to ensure quality control during the whole transportation process, and meet the compliance raw material delivery needs of global pharmaceutical companies and scientific research institutions.
We can provide Customized Donidalorsen packaging of different specifications according to customer needs, with professional storage and transportation guidance documents, and provide differentiated solutions for the characteristic differences between free acid and sodium salt to ensure the safe delivery and long-term storage stability of raw materials.
Our Advantages
High Purity Raw Material Advantage
Donidalorsen API (Donidalorsen CAS 2304692-48-4) has stable and up-to-standard purity, strict impurity control, which is more conducive to process control compared with sodium salt form, and can directly meet the high-standard requirements of pharmaceutical companies' R&D and declaration.
Stable Supply Chain Advantage
As a reliable China Donidalorsen Raw Material factory, we have mature large-scale synthesis technology, strong batch consistency, and can provide stable and continuous supply, effectively ensuring that customers' project progress is not affected by raw material shortage, and adapting to long-term cooperation needs. All products are Donidalorsen made in China with full production traceability.
Professional Quality Control System Advantage
We have established a full-process quality control system, with item-by-item testing from synthesis to delivery, accompanied by complete quality inspection reports, to ensure that each batch of products meets pharmaceutical API specifications aligned with donidalorsen fda approval requirements.
Technical & Service Advantage
We are equipped with a professional technical team, which can provide targeted technical support, and support customized packaging and transportation solutions, providing one-stop guarantee for customers' R&D and production.
FAQ
Donidalorsen API relies on mature synthetic routes and strict full-chain traceable quality control, with better R&D adaptability, controllable purity and consistency than its sodium salt form. It supports target research, formulation development and industrial production of antisense oligonucleotide drugs, providing core material support for precise HAE treatment. As trusted China Donidalorsen suppliers, we drive breakthroughs in RNA-targeted rare disease therapies with stable supply and customized services, under a quality system fully compliant with donidalorsen fda approval standards.
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