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Chemistry

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Also known as: Sevelamer hcl, 152751-57-0, 2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride, 182683-00-7, Chebi:32127, Bcp21176
Molecular Formula
C6H13Cl2NO
Molecular Weight
186.08  g/mol
InChI Key
KHNXRSIBRKBJDI-UHFFFAOYSA-N

Sevelamer Hydrochloride
A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease.
1 2D Structure

Sevelamer Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride
2.1.2 InChI
InChI=1S/C3H5ClO.C3H7N.ClH/c4-1-3-2-5-3;1-2-3-4;/h3H,1-2H2;2H,1,3-4H2;1H
2.1.3 InChI Key
KHNXRSIBRKBJDI-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C=CCN.C1C(O1)CCl.Cl
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Carbonate, Sevelamer

2. Gt335 012

3. Gt335-012

4. Gt335012

5. Hydrochloride, Sevelamer

6. Renagel

7. Sevelamer

8. Sevelamer Carbonate

2.2.2 Depositor-Supplied Synonyms

1. Sevelamer Hcl

2. 152751-57-0

3. 2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride

4. 182683-00-7

5. Chebi:32127

6. Bcp21176

7. Cga75157

8. Sevelamer Hydrochloride (jan/usan)

9. S4129

10. Akos025149504

11. Ac-2089

12. Hs-0082

13. Db-063954

14. Ft-0653684

15. D01983

16. Ab01568265_01

17. 2-propen-1-amine Hydrochloride Polymer With (chloromethyl)oxirane

2.3 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 186.08 g/mol
Molecular Formula C6H13Cl2NO
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count2
Rotatable Bond Count2
Exact Mass185.0374194 g/mol
Monoisotopic Mass185.0374194 g/mol
Topological Polar Surface Area38.6 Ų
Heavy Atom Count10
Formal Charge0
Complexity55.1
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Chelating Agents

Chemicals that bind to and remove ions from solutions. Many chelating agents function through the formation of COORDINATION COMPLEXES with METALS. (See all compounds classified as Chelating Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Phosphate Chelating Activity [MoA]; Phosphate Binder [EPC]
5.3 ATC Code

V03AE02


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18-Jan-2021
21-Jan-2025
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DOSAGE - TABLET;ORAL - 400MG

USFDA APPLICATION NUMBER - 21179

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DOSAGE - TABLET;ORAL - 800MG

USFDA APPLICATION NUMBER - 21179

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PharmaCompass offers a list of Sevelamer Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sevelamer Hydrochloride manufacturer or Sevelamer Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sevelamer Hydrochloride manufacturer or Sevelamer Hydrochloride supplier.

PharmaCompass also assists you with knowing the Sevelamer Hydrochloride API Price utilized in the formulation of products. Sevelamer Hydrochloride API Price is not always fixed or binding as the Sevelamer Hydrochloride Price is obtained through a variety of data sources. The Sevelamer Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Sevelamer Hydrochloride

Synonyms

Sevelamer hcl, 152751-57-0, 2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride, 182683-00-7, Chebi:32127, Bcp21176

Cas Number

152751-57-0

About Sevelamer Hydrochloride

A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease.

Sevelamer Hydrochloride Manufacturers

A Sevelamer Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevelamer Hydrochloride, including repackagers and relabelers. The FDA regulates Sevelamer Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevelamer Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Sevelamer Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sevelamer Hydrochloride Suppliers

A Sevelamer Hydrochloride supplier is an individual or a company that provides Sevelamer Hydrochloride active pharmaceutical ingredient (API) or Sevelamer Hydrochloride finished formulations upon request. The Sevelamer Hydrochloride suppliers may include Sevelamer Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Sevelamer Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Sevelamer Hydrochloride USDMF

A Sevelamer Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sevelamer Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sevelamer Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sevelamer Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sevelamer Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sevelamer Hydrochloride USDMF includes data on Sevelamer Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sevelamer Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sevelamer Hydrochloride suppliers with USDMF on PharmaCompass.

Sevelamer Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Sevelamer Hydrochloride Drug Master File in Japan (Sevelamer Hydrochloride JDMF) empowers Sevelamer Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Sevelamer Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sevelamer Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Sevelamer Hydrochloride suppliers with JDMF on PharmaCompass.

Sevelamer Hydrochloride WC

A Sevelamer Hydrochloride written confirmation (Sevelamer Hydrochloride WC) is an official document issued by a regulatory agency to a Sevelamer Hydrochloride manufacturer, verifying that the manufacturing facility of a Sevelamer Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sevelamer Hydrochloride APIs or Sevelamer Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sevelamer Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Sevelamer Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Sevelamer Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sevelamer Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sevelamer Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Sevelamer Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Sevelamer Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sevelamer Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Sevelamer Hydrochloride suppliers with NDC on PharmaCompass.

Sevelamer Hydrochloride GMP

Sevelamer Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Sevelamer Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sevelamer Hydrochloride GMP manufacturer or Sevelamer Hydrochloride GMP API supplier for your needs.

Sevelamer Hydrochloride CoA

A Sevelamer Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sevelamer Hydrochloride's compliance with Sevelamer Hydrochloride specifications and serves as a tool for batch-level quality control.

Sevelamer Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sevelamer Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Sevelamer Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sevelamer Hydrochloride EP), Sevelamer Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sevelamer Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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