NELFINAVIR

PRODUCT IDENTIFICATION
CAS NO. 159989-64-7 (base)
159989-65-8  (mesylate)

NELFINAVIR

EINECS NO.  
FORMULA C32H45N3O4S
MOL WT. 567.79

H.S. CODE

  

TOXICITY

 Ora rat LD50: 5000mg/kg
SYNONYMS Viracept;
[3S-(3R',4aR',8aR',2’S',3’S')]-2-[2’-hydroxy-3’-phenylthiomethyl-4’-aza-5’-oxo-5’- (2’’-methyl-3’’-hydroxyphenyl)pentyl] decahydroisoquinoline-3-N-t-butylcarboxamide; (3S,4aS,8aS)-N- (1,1-Dimethylethyl)decahydro- 2-[(2R,3R)-2- hydroxy-3-[(3-hydroxy- 2-methylbenzoyl) amino]-4-(phenylthio) butyl]-3-isoquinolinecarboxamide;

CLASSIFICATION

  

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE

white to off-white crystalline powder

MELTING POINT  
BOILING POINT

 

SPECIFIC GRAVITY  
SOLUBILITY IN WATER Insoluble (soluble in lower alcohol)
pH  
VAPOR DENSITY

 

REFRACTIVE INDEX

 

NFPA RATINGS

  

AUTOIGNITION

 

FLASH POINT

 

STABILITY Stable under normal conditions.

GENERAL DESCRIPTION & APPLICATIONS
Nelfinavir is a protease inhibitor which prevent viral replication by inhibiting the activity of protease. Protease inhibitors inhibit HIV-1 and HIV-2 proteases and cause the formation of noninfectious immature viral particles. Protease inhibitors (PIs) are a class of antiretroviral drugs used to treat or prevent infection by viruses, including HIV and Hepatitis C. Reverse transcriptase inhibitors are antiretroviral agents also that blocks activity of the reverse transcriptase of a retrovirus. Every retrovirus has a reverse transcriptase enzyme which transcribes the genetic information from its RNA into DNA.  Reverse transcriptase is an enzyme that  can transcribe RNA into DNA to copy genetic information from RNA to DNA, therefore also called RNA-directed DNA polymerase. Nelfinavir mesylate (ester) is the prodrug of nelfinavir; administered orally. Nelfinavir mesylate is a white to off-white crystalline powder, slightly soluble in water, soluble in lower alcohol (methanol, ethanol, isopropanol and propylene glycol). The chemical designation is (3S,4aS,8aS)-N-(1,1-Dimethylethyl) decahydro-2-[(2R,3R)-2- hydroxy-3-[(3-hydroxy- 2-methylbenzoyl) amino]-4-(phenylthio) butyl]-3-isoquinolinecarboxamide monomethanesulfonate.

Aantiretroviral agents

  • Non-nucleoside reverse transcriptase inhibitors
    • Delavirdine [CAS #: 136817-59-9]
    • Delavirdine mesylate [CAS #: 147221-93-0]
    • Efavirenz [CAS #: 154598-52-4]
    • Nevirapine [CAS #: 129618-40-2]
  • Nucleoside/Nucleotide reverse transcriptase inhibitors
    • Abacavir [CAS #: 136470-78-5]
    • Abacavir succinate [CAS #: 168146-84-7]
    • Abacavir sulfate [CAS #: 188062-50-2]
    • Adefovir [CAS #: 106941-25-7]
    • Adefovir dipivoxil [CAS #: 142340-99-6]
    • Combivir (Lamivudine/Zidovudine mixture) [CAS #: 165456-81-5]
    • Didanosine [CAS #: 69655-05-6]
    • Emtricitabine [CAS #: 143491-57-0]
    • Lamivudine [CAS #: 134678-17-4]
    • Lamivudine sulfoxide [CAS #: 160552-55-6]
    • Pradefovir mesylate [CAS #: 625095-61-6]
    • Stampidine [CAS #: 217178-62-6]
    • Stavudine [CAS #: 3056-17-5]
    • Tenofovir [CAS #: 147127-20-6]
    • Tenofovir disoproxil [CAS #: 201341-05-1]
    • Tenofovir Disoproxil Fumarate [CAS #: 202138-50-9]
    • Trizivir (Abacavir sulfate/Lamivudine/Zidovudine mixture) [CAS #: 364057-50-1]
    • Zalcitabine [CAS #: 7481-89-2]
    • Zidovudine [CAS #: 30516-87-1]
    • Zidovudine sodium salt [CAS #: 106060-86-0]
  • Protease inhibitors
    • Amprenavir [CAS #: 161814-49-9]
    • Atazanavir [CAS #: 198904-31-3]
    • Atazanavir sulfate [CAS #: 229975-97-7]
    • Fosamprenavir [CAS #: 226700-79-4]
    • Fosamprenavir calcium [CAS #: 226700-81-8]
    • Fosamprenavir sodium [CAS #: 226700-80-7]
    • Indinavir [CAS #: 150378-17-9]
    • Indinavir hydrate [CAS #: 180683-37-8]
    • Indinavir Sulfate [CAS #: 157810-81-6]
    • Kaletra (Lopinavir/Ritonavir mixture) [CAS #: 369372-47-4]
    • Lopinavir [CAS #: 192725-17-0
    • Nelfinavir [CAS #: 159989-64-7]
    • Nelfinavir mesylate [CAS #: 159989-65-8]
    • Ritonavir [CAS #: 155213-67-5]
    • Saquinavir [CAS #: 127779-20-8]
    • Saquinavir mesylate [CAS #: 149845-06-7]
    • Tipranavir [CAS #: 174484-41-4]
    • Tipranavir disodium [CAS #: 191150-83-1]
SALES SPECIFICATION

APPEARANCE

white to off-white crystalline powder
IDENTIFICATION

pass Test A (IR), B (HPLC)

ASSAY

98.0 - 102.0%

LOSS ON DRYING

2.0% max

RESIDUE ON IGNITION

0.2% max

OPTICAL ROTATION

-120° ~ -105°

HEAVY METALS

20ppm max

SOLVENT RESIDUE

THF 0.01% max
Ethanol 0.5% max
Acetone 0.3% max
MTBE 0.5% max
RELATED SUBSTANCES Individual impurity ≤0.2%
Total impurity 0.5% max
TRANSPORTATION
PACKING
 
HAZARD CLASS  
UN NO.  
PRICE INFORMATION
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