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    Chemistry

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    Also known as: Dtxsid10151274
    Molecular Formula
    C256H387N65O79S6
    Molecular Weight
    5832  g/mol
    InChI Key
    VOMXSOIBEJBQNF-UTTRGDHVSA-N
    Insulin aspart
    1 2D Structure

    Insulin aspart

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (4S)-4-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S,3S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2R)-2-[[(2R)-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3S)-2-[(2-aminoacetyl)amino]-3-methylpentanoyl]amino]-3-methylbutanoyl]amino]-4-carboxybutanoyl]amino]-5-oxopentanoyl]amino]-3-sulfanylpropanoyl]amino]-3-sulfanylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-methylpentanoyl]amino]-3-sulfanylpropanoyl]amino]-3-hydroxypropanoyl]amino]-4-methylpentanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-5-oxopentanoyl]amino]-4-methylpentanoyl]amino]-5-[[(2S)-4-amino-1-[[(2S)-1-[[(2R)-1-[[(1S)-3-amino-1-carboxy-3-oxopropyl]amino]-1-oxo-3-sulfanylpropan-2-yl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-5-oxopentanoic acid;(4S)-4-[[2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-amino-3-phenylpropanoyl]amino]-3-methylbutanoyl]amino]-4-oxobutanoyl]amino]-5-oxopentanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-3-sulfanylpropanoyl]amino]acetyl]amino]-3-hydroxypropanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-3-methylbutanoyl]amino]-4-carboxybutanoyl]amino]propanoyl]amino]-4-methylpentanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-methylbutanoyl]amino]-3-sulfanylpropanoyl]amino]acetyl]amino]-5-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S,3R)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1-oxohexan-2-yl]amino]-3-carboxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-2-oxoethyl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-5-oxopentanoic acid
    2.1.2 InChI
    InChI=1S/C157H232N40O44S2.C99H155N25O35S4/c1-77(2)54-102(180-130(214)84(15)172-135(219)101(48-51-123(210)211)179-152(236)126(82(11)12)194-149(233)105(57-80(7)8)183-145(229)111(64-93-68-165-76-171-93)188-151(235)114(72-198)175-121(207)71-169-133(217)115(73-242)191-140(224)103(55-78(3)4)181-144(228)110(63-92-67-164-75-170-92)187-137(221)100(46-49-117(160)203)178-146(230)112(65-118(161)204)189-153(237)125(81(9)10)193-131(215)96(159)58-87-30-21-18-22-31-87)139(223)184-108(61-90-38-42-94(201)43-39-90)142(226)182-104(56-79(5)6)148(232)195-127(83(13)14)154(238)192-116(74-243)134(218)168-69-119(205)173-99(47-50-122(208)209)136(220)176-97(37-29-53-166-157(162)163)132(216)167-70-120(206)174-106(59-88-32-23-19-24-33-88)141(225)185-107(60-89-34-25-20-26-35-89)143(227)186-109(62-91-40-44-95(202)45-41-91)150(234)196-128(85(16)199)155(239)190-113(66-124(212)213)147(231)177-98(36-27-28-52-158)138(222)197-129(86(17)200)156(240)241;1-12-46(9)77(121-73(134)36-100)97(156)122-76(45(7)8)95(154)108-56(25-29-75(137)138)80(139)105-54(23-27-70(102)131)83(142)117-66(40-161)93(152)119-68(42-163)94(153)124-79(48(11)127)98(157)116-64(38-126)90(149)123-78(47(10)13-2)96(155)120-67(41-162)92(151)115-63(37-125)89(148)110-58(31-44(5)6)85(144)111-59(32-49-14-18-51(128)19-15-49)86(145)106-53(22-26-69(101)130)81(140)109-57(30-43(3)4)84(143)107-55(24-28-74(135)136)82(141)113-61(34-71(103)132)88(147)112-60(33-50-16-20-52(129)21-17-50)87(146)118-65(39-160)91(150)114-62(99(158)159)35-72(104)133/h18-26,30-35,38-45,67-68,75-86,96-116,125-129,198-202,242-243H,27-29,36-37,46-66,69-74,158-159H2,1-17H3,(H2,160,203)(H2,161,204)(H,164,170)(H,165,171)(H,167,216)(H,168,218)(H,169,217)(H,172,219)(H,173,205)(H,174,206)(H,175,207)(H,176,220)(H,177,231)(H,178,230)(H,179,236)(H,180,214)(H,181,228)(H,182,226)(H,183,229)(H,184,223)(H,185,225)(H,186,227)(H,187,221)(H,188,235)(H,189,237)(H,190,239)(H,191,224)(H,192,238)(H,193,215)(H,194,233)(H,195,232)(H,196,234)(H,197,222)(H,208,209)(H,210,211)(H,212,213)(H,240,241)(H4,162,163,166);14-21,43-48,53-68,76-79,125-129,160-163H,12-13,22-42,100H2,1-11H3,(H2,101,130)(H2,102,131)(H2,103,132)(H2,104,133)(H,105,139)(H,106,145)(H,107,143)(H,108,154)(H,109,140)(H,110,148)(H,111,144)(H,112,147)(H,113,141)(H,114,150)(H,115,151)(H,116,157)(H,117,142)(H,118,146)(H,119,152)(H,120,155)(H,121,134)(H,122,156)(H,123,149)(H,124,153)(H,135,136)(H,137,138)(H,158,159)/t84-,85+,86+,96-,97-,98-,99-,100-,101-,102-,103-,104-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,125-,126-,127-,128-,129-;46-,47-,48+,53-,54-,55-,56-,57-,58-,59-,60-,61-,62-,63-,64-,65-,66-,67-,68-,76-,77-,78-,79-/m00/s1
    2.1.3 InChI Key
    VOMXSOIBEJBQNF-UTTRGDHVSA-N
    2.1.4 Canonical SMILES
    CCC(C)C(C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CCC(=O)N)C(=O)NC(CS)C(=O)NC(CS)C(=O)NC(C(C)O)C(=O)NC(CO)C(=O)NC(C(C)CC)C(=O)NC(CS)C(=O)NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC1=CC=C(C=C1)O)C(=O)NC(CCC(=O)N)C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CC(=O)N)C(=O)NC(CC2=CC=C(C=C2)O)C(=O)NC(CS)C(=O)NC(CC(=O)N)C(=O)O)NC(=O)CN.CC(C)CC(C(=O)NC(CC1=CC=C(C=C1)O)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CS)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CC2=CC=CC=C2)C(=O)NC(CC3=CC=CC=C3)C(=O)NC(CC4=CC=C(C=C4)O)C(=O)NC(C(C)O)C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)O)NC(=O)C(C)NC(=O)C(CCC(=O)O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC5=CN=CN5)NC(=O)C(CO)NC(=O)CNC(=O)C(CS)NC(=O)C(CC(C)C)NC(=O)C(CC6=CN=CN6)NC(=O)C(CCC(=O)N)NC(=O)C(CC(=O)N)NC(=O)C(C(C)C)NC(=O)C(CC7=CC=CC=C7)N
    2.1.5 Isomeric SMILES
    CC[C@H](C)[C@@H](C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CS)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CS)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC1=CC=C(C=C1)O)C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](CC2=CC=C(C=C2)O)C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(=O)N)C(=O)O)NC(=O)CN.C[C@H]([C@@H](C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)O)NC(=O)[C@H](CC1=CC=C(C=C1)O)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CC3=CC=CC=C3)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@H](CS)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC4=CC=C(C=C4)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC5=CN=CN5)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CS)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC6=CN=CN6)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC7=CC=CC=C7)N)O
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. Dtxsid10151274

    2.3 Create Date
    2007-07-03
    3 Chemical and Physical Properties
    Molecular Weight 5832 g/mol
    Molecular Formula C256H387N65O79S6
    Hydrogen Bond Donor Count86
    Hydrogen Bond Acceptor Count91
    Rotatable Bond Count188
    Exact Mass5829.6654893 g/mol
    Monoisotopic Mass5827.6587796 g/mol
    Topological Polar Surface Area2350 Ų
    Heavy Atom Count406
    Formal Charge0
    Complexity13000
    Isotope Atom Count0
    Defined Atom Stereocenter Count52
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameNovolog
    PubMed HealthInsulin Aspart Protamine/Insulin Aspart (Injection)
    Drug ClassesAntidiabetic
    Drug LabelNovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is a human insulin analog suspension containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. NovoLog Mix 70/30 is a b...
    Active IngredientInsulin aspart recombinant
    Dosage FormInjectable
    RouteSubcutaneous
    Strength1000 units/10ml (100 units/ml)
    Market StatusPrescription
    CompanyNovo Nordisk

    2 of 2  
    Drug NameNovolog
    PubMed HealthInsulin Aspart Protamine/Insulin Aspart (Injection)
    Drug ClassesAntidiabetic
    Drug LabelNovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is a human insulin analog suspension containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. NovoLog Mix 70/30 is a b...
    Active IngredientInsulin aspart recombinant
    Dosage FormInjectable
    RouteSubcutaneous
    Strength1000 units/10ml (100 units/ml)
    Market StatusPrescription
    CompanyNovo Nordisk

    USDMF

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    01

    BIO Partnering at JPM
    Not Confirmed

    01

    Amphastar Nanjing Pharmaceuticals In...

    U.S.A
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    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32700

    Submission : 2018-05-16

    Status : Active

    Type : II

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    02

    BIO Partnering at JPM
    Not Confirmed

    02

    Novo Excipients Pvt Ltd

    India
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    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27184

    Submission : 2013-05-15

    Status : Active

    Type : IV

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    03

    Ningbo Kunpeng Biotech Co Ltd

    Country

    USDMF

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    BIO Partnering at JPM
    Not Confirmed

    03

    Ningbo Kunpeng Biotech Co Ltd

    Country
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    BIO Partnering at JPM
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39605

    Submission : 2024-03-14

    Status : Active

    Type : II

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    API Reference Price

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    [{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698172200,"product":"INSULIN ASPART PROCESS INTERMEDIATE","address":"BIOCON PARK, PLOT NO.2,3,4 AND 5,,","city":"BANGALORE,KARNATAKA","supplier":"BIOCON","supplierCountry":"MALAYSIA","foreign_port":"N\/A","customer":"BIOCON","customerCountry":"INDIA","quantity":"15.47","actualQuantity":"15470","unit":"GMS","unitRateFc":"123","totalValueFC":"1925002.5","currency":"USD","unitRateINR":"10356.6","date":"25-Oct-2023","totalValueINR":"160216602","totalValueInUsd":"1925002.5","indian_port":"Biocon-SEZ","hs_no":"29371200","bill_no":"1014561","productDescription":"Intermediate","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"NO.1,JALAN BIOTEKNOLOGI 1 KAWASAN PERINDUSTRIAN SILC JOHOR,79200, MALAYSIA MY","customerAddress":"BIOCON PARK, PLOT NO.2,3,4 AND 5,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698604200,"product":"INSULIN ASPART PROCESS INTERMEDIATE","address":"BIOCON PARK, PLOT NO.2,3,4 AND 5,,","city":"BANGALORE,KARNATAKA","supplier":"BIOCON","supplierCountry":"MALAYSIA","foreign_port":"N\/A","customer":"BIOCON","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"60","unit":"GMS","unitRateFc":"123","totalValueFC":"7466.1","currency":"USD","unitRateINR":"10356.6","date":"30-Oct-2023","totalValueINR":"621396","totalValueInUsd":"7466.1","indian_port":"Biocon-SEZ","hs_no":"29371200","bill_no":"1014833","productDescription":"Intermediate","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"NO.1,JALAN BIOTEKNOLOGI 1 KAWASAN PERINDUSTRIAN SILC JOHOR,79200, MALAYSIA MY","customerAddress":"BIOCON PARK, PLOT NO.2,3,4 AND 5,,"}]
    25-Oct-2023
    30-Oct-2023
    KGS
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    ABOUT THIS PAGE

    NOVOLOG Manufacturers

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

    NOVOLOG Suppliers

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

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

    NOVOLOG USDMF

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

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

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

    NOVOLOG 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 NOVOLOG as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    NOVOLOG GMP

    NOVOLOG 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 NOVOLOG 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 NOVOLOG GMP manufacturer or NOVOLOG GMP API supplier for your needs.

    NOVOLOG CoA

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

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

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