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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

    API Reference Price

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C.BERNASCONI 56830 - CHIASSOSDNF SWITZERLAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"SAPROPTERIN API 40 KG MERETO 300","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"49.70","actualQuantity":"49.7","unit":"KGS","unitRateFc":"15000","totalValueFC":"753693","currency":"USD","unitRateINR":"1274250","date":"28-Oct-2024","totalValueINR":"63330225","totalValueInUsd":"753693","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29335990","bill_no":"6381049","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"Piazza Col. C. Bernasconi 5 Chiasso SDNF Switzerland","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]
    11-Jan-2021
    28-Oct-2024
    KGS
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    Average Price (USD/KGS)

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    ABOUT THIS PAGE

    Sapropterin Hydrochloride Manufacturers

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

    Sapropterin Hydrochloride Suppliers

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

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

    Sapropterin Hydrochloride USDMF

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

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

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

    Sapropterin 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 Sapropterin Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sapropterin Hydrochloride GMP

    Sapropterin 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 Sapropterin 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 Sapropterin Hydrochloride GMP manufacturer or Sapropterin Hydrochloride GMP API supplier for your needs.

    Sapropterin Hydrochloride CoA

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

    Sapropterin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sapropterin 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.

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