Product Details:
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Place of Origin: | Xi'an ,China |
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Brand Name: | Wango |
Model Number: | WG-0018 |
Payment & Shipping Terms:
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Minimum Order Quantity: | 100 gram every time |
Price: | FOB price USD 5-7/gram |
Packaging Details: | 1kg with double plastic container inside/Aluminum foil bag ; 25kg with double plastic container inside/Fiber drum outside.Or as your request. |
Delivery Time: | 3-5 working days |
Payment Terms: | Western Union, L/C, T/T, MoneyGram |
Supply Ability: | 10 kilogram 0ne month |
Detail Information |
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Appearence: | White Fine Powder | Other Name: | Firazyr |
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Function: | HAE | Cas: | 130308-48-4 |
Cas No: | 50-03-3 | Form: | Powder |
Storage: | Keep In Dark And Dry Place | Einecs: | 800-133-1 |
Product Purity: | 99% | Chemical Name: | Not Available |
Appearance: | Not Available | The Product Level: | Pharmaceutical Grade |
Application: | UV Absorber | Einecs No: | 226-886-0 |
Country Of Origin: | Not Available | Storage Conditions: | Not Available |
Specific Rotation: | D25 +48° (methanol) | Usage: | Not Available |
Grade Standard: | Medicine Grade | ||
Highlight: | Firazyr Icatibant Api,Acute Episodes Treatment Icatibant Api,130308-48-4 |
Product Description
Items |
Standard |
Results |
APPEARANCE |
Off white to white powder |
White powder |
IDENTIFICATION |
A: IR |
Complies |
WATER |
≤0.5% |
0.06% |
HEAVY METALS |
≤0.002% |
Complies |
ISOMERS |
SFBD1≤0.15% |
Undetected |
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SFBD2≤0.15% |
Undetected |
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SFBE≤0.15% |
Undetected |
RELATED SUBSTANCES |
SFBA-1≤0.15% |
0.04% |
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SFBMA≤0.15% |
Undetected |
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CHLORO-SFB≤0.15% |
0.05% |
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DiSFBMA-SFB≤0.15% |
0.02% |
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Methyl-SFB≤0.15% |
Undetected |
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Pentafluoro-phenol≤0.15% |
Undetected |
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Amino-SFB≤0.15% |
Undetected |
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Any unknown impurity≤0.1% |
0.04% |
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Total impurity≤1.0% |
0.21% |
RESIDUE SOLBENTS |
Methanol≤3000ppm |
Undetected |
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Isopropyl alcohol≤5000ppm |
19ppm |
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Dichloromethane≤600ppm |
Undetected |
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Tetrahydrofuran≤720ppm |
Undetected |
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Acetic acid≤5000ppm |
Undetected |
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Toluene≤890ppm |
Undetected |
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Chlorobenzene≤360ppm |
Undetected |
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Methyl tert-butyl ther≤5000ppm |
103ppm |
ASSAY |
≥99.0% |
99.9% |
RESULT: It complies to prescribed enterprise standard |
Introduction :
Hereditaryangioedema (HAE), also known as C1 suppression deficiency, is a rare autosomal dominant hereditary disease caused by a genetic defect, and the incidence of hereditaryangioedema is 1/50000~1/10000. HAE is characterized by unpredictable episodic edema and swelling of the hands, feet, face, larynx and abdomen, leading to disfigurement, disability or death. HAE patients, who usually have a family history of the disease, can develop rapid swelling of the hands, feet, limbs, face, intestines, larynx or trachea, which can cause the respiratory tract to swell and put the patient at risk of suffocation.
Edtebant is a specialized HEA treatment developed by Shire, inc. It was first approved by EMEA as an orphan drug for the treatment of acute onset of hereditary angioedema (HAE) in adults on November 7, 2008 under the trade name Firazyr, and received FDA approval on August 25, 2011. It is the third drug approved by the FDA to treat acute episodes of HAE.
Etebant is a selective competitive antagonist of bradykinin B2 receptor with affinity similar to bradykinin. Hereditary angioedema is caused by deficiency or dysfunction of a C1-esterase-inhibitor, a vasodilator thought to be responsible for localized swelling, inflammation, and pain that are the characteristic symptoms of HAE. Etebant inhibits the binding of bradykinin to B2 receptor in the treatment of acute clinical symptoms of HAE. In addition, there are potential therapeutic indications for asthma, cirrhosis, and other types of angioedema.
The pathogenesis of HAE is due to the lack of C1-INH, resulting in a series of changes in complement and contact system, resulting in the decrease of complement level and the release of more bradykinin. Bradykinin plays an important role in the clinical manifestations of HAE by binding to bradykinin B2 receptors on vascular endothelial cells. After bradykinin binds to bradykinin B2 receptor of vascular endothelial cells, the body can activate a series of inflammatory mediators, including; Nitric oxide, cycloprost and endodermal hyperpolarizing factors. A synthetic 10-amino acid polypeptide (H-daarg-ARg-pro-hyp-GLy-Thi-Ser-dtic-Oic-arg-OH), similar in structure to bradykinin, is a potent and selective bradykinin B2 receptor antagonist that prevents bradykinin from binding to its B2 receptor. To treat patients with acute HAE.
After 30mg subcutaneously injected for 30 minutes, the peak concentration in blood was reached, and the absolute bioavailability was close to 97%. The average volume of distribution was 0.25L·kg-1, the plasma protein binding rate was less than 44%, the average t1/2 was 0.6 ~ 1.5h, and the final half-life was 1.2 ~ 1.5h. The excretion route of this product is mainly through urine and feces, 5% ~ 6% of the active drug is excreted with urine. The exact metabolic pathway of this product has not been determined, and in vitro experiments have shown that it is mainly transformed by peptidase, not by CYP450 enzyme. The pharmacokinetic properties of this product are independent of liver and kidney function, body weight and sex. But the clearance rate for older men (> 65 years old) was only 60 percent of that for younger men and 40 percent of that for older women.
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