China Pharma Pure Powder manufacturer

Firazyr Icatibant Api 130308-48-4 For Acute Episodes Treatment

Product Details:
Place of Origin: Xi'an ,China
Brand Name: Wango
Model Number: WG-0018
Payment & Shipping Terms:
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

Appearence: White Fine Powder Other Name: Firazyr
Function: HAE Cas: 130308-48-4
High Light:

Firazyr Icatibant Api

,

Acute Episodes Treatment Icatibant Api

,

130308-48-4

Product Description

Icatibant 99% Treatment Of Acute Episodes Of Hereditary Angioedema Cas130308-48-4 Treatment of acute episodes of hereditary angioedema  with top quality from China !

Firazyr Icatibant Api 130308-48-4 For Acute Episodes Treatment 0

Items

Standard

Results

APPEARANCE

Off white to white powder

White powder

IDENTIFICATION

A: IR
B: Retention time

Complies
Complies

WATER

0.5%

0.06%

HEAVY METALS

≤0.002%

Complies

ISOMERS

SFBD1≤0.15%

Undetected

 

SFBD2≤0.15%

Undetected

 

SFBE≤0.15%

Undetected

RELATED SUBSTANCES

SFBA-1≤0.15%

0.04%

 

SFBMA≤0.15%

Undetected

 

CHLORO-SFB≤0.15%

0.05%

 

DiSFBMA-SFB≤0.15%

0.02%

 

Methyl-SFB≤0.15%

Undetected

 

Pentafluoro-phenol≤0.15%

Undetected

 

Amino-SFB≤0.15%

Undetected

 

Any unknown impurity≤0.1%

0.04%

 

Total impurity≤1.0%

0.21%

RESIDUE SOLBENTS

Methanol≤3000ppm

Undetected

 

Isopropyl alcohol≤5000ppm

19ppm

 

Dichloromethane≤600ppm

Undetected

 

Tetrahydrofuran≤720ppm

Undetected

 

Acetic acid≤5000ppm

Undetected

 

Toluene≤890ppm

Undetected

 

Chlorobenzene≤360ppm

Undetected

 

Methyl tert-butyl ether≤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.

 

FAQ


Q: What's your MOQ?


A: For the high value product, our MOQ starts from 1g and generally starts from 10gs. For other low, price product, our MOQ starts from 100g and 1kg.

Q: Is there a discount?


A: Yes, for larger quantity, we always support with better price.

Q: How to confirm the Product Quality before placing orders?


A: You can get free samples for some products, you only need to pay the shipping cost or arrange a courier to us and take the samples. You can send us your product specifications and requests, we will manufacture the products according to your requests

Q: How to start orders or make payments?


A: You can send our your Purchase order (if your company has), or just send a simple confirmation by email or by Trade Manager, and we will send you Proforma Invoice with our bank details for your confirmation, then you can make payment accordingly.

Q: How do you treat quality complaint?


First of all, our quality control will reduce the quality problem to near zero. If there is a quality problem caused by us, we
will send you free goods for replacement or refund your loss.

 

 

Firazyr Icatibant Api 130308-48-4 For Acute Episodes Treatment 1

 

 

 

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