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Chemistry

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Also known as:
Molecular Formula
C9H17Cl2N5O3
Molecular Weight
314.17  g/mol
InChI Key
RKSUYBCOVNCALL-NTVURLEBSA-N

Sapropterin Hydrochloride
1 2D Structure

Sapropterin Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one;dihydrochloride
2.1.2 InChI
InChI=1S/C9H15N5O3.2ClH/c1-3(15)6(16)4-2-11-7-5(12-4)8(17)14-9(10)13-7;;/h3-4,6,12,15-16H,2H2,1H3,(H4,10,11,13,14,17);2*1H/t3-,4+,6-;;/m0../s1
2.1.3 InChI Key
RKSUYBCOVNCALL-NTVURLEBSA-N
2.1.4 Canonical SMILES
CC(C(C1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl
2.1.5 Isomeric SMILES
C[C@@H]([C@@H]([C@H]1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl
2.2 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 314.17 g/mol
Molecular Formula C9H17Cl2N5O3
Hydrogen Bond Donor Count8
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass313.0708448 g/mol
Monoisotopic Mass313.0708448 g/mol
Topological Polar Surface Area132 A^2
Heavy Atom Count19
Formal Charge0
Complexity405
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

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11-Jan-2021
03-Feb-2025
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Looking for / Sapropterin Hydrochloride API manufacturers, exporters & distributors?

Sapropterin Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Sapropterin 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 Sapropterin Hydrochloride manufacturer or Sapropterin Hydrochloride supplier for your needs.

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

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

API | Excipient name

Sapropterin Hydrochloride

CAS-69056-38-8 Manufacturers

A CAS-69056-38-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-69056-38-8, including repackagers and relabelers. The FDA regulates CAS-69056-38-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-69056-38-8 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 CAS-69056-38-8 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

CAS-69056-38-8 Suppliers

A CAS-69056-38-8 supplier is an individual or a company that provides CAS-69056-38-8 active pharmaceutical ingredient (API) or CAS-69056-38-8 finished formulations upon request. The CAS-69056-38-8 suppliers may include CAS-69056-38-8 API manufacturers, exporters, distributors and traders.

click here to find a list of CAS-69056-38-8 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

CAS-69056-38-8 USDMF

A CAS-69056-38-8 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-69056-38-8 active pharmaceutical ingredient (API) in detail. Different forms of CAS-69056-38-8 DMFs exist exist since differing nations have different regulations, such as CAS-69056-38-8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A CAS-69056-38-8 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-69056-38-8 USDMF includes data on CAS-69056-38-8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-69056-38-8 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of CAS-69056-38-8 suppliers with USDMF on PharmaCompass.

CAS-69056-38-8 WC

A CAS-69056-38-8 written confirmation (CAS-69056-38-8 WC) is an official document issued by a regulatory agency to a CAS-69056-38-8 manufacturer, verifying that the manufacturing facility of a CAS-69056-38-8 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CAS-69056-38-8 APIs or CAS-69056-38-8 finished pharmaceutical products to another nation, regulatory agencies frequently require a CAS-69056-38-8 WC (written confirmation) as part of the regulatory process.

click here to find a list of CAS-69056-38-8 suppliers with Written Confirmation (WC) on PharmaCompass.

CAS-69056-38-8 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 CAS-69056-38-8 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for CAS-69056-38-8 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 CAS-69056-38-8 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 CAS-69056-38-8 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-69056-38-8 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of CAS-69056-38-8 suppliers with NDC on PharmaCompass.

CAS-69056-38-8 GMP

CAS-69056-38-8 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 CAS-69056-38-8 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 CAS-69056-38-8 GMP manufacturer or CAS-69056-38-8 GMP API supplier for your needs.

CAS-69056-38-8 CoA

A CAS-69056-38-8 CoA (Certificate of Analysis) is a formal document that attests to CAS-69056-38-8's compliance with CAS-69056-38-8 specifications and serves as a tool for batch-level quality control.

CAS-69056-38-8 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-69056-38-8 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.

CAS-69056-38-8 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-69056-38-8 EP), CAS-69056-38-8 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-69056-38-8 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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