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  • Fentanyl Citrate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Fentanyl Citrate USP CAS No: 990- 73- 8

    Batch No: FEN/ 030313 A. R. No 13/ FP/ FEN/ 0303

    Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

    Batch Quantity 165 kg Date of Retest Jan- 2016

    Sr. No Test Results Acceptance Criteria

    1. Appearance

    2. Solubility

    3. Identification

    Complies By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    4. Loss on drying 0.23% NMT 0.5%

    5. Heavy Metals Complies 20ppm

    6. Residue On Ignition 0.17% NMT 0.5%

    7. Assay HPLC 99.3% 98.0% –102.0%

    .

    Fentanyl

    Fentanyl2DCSD. svg

    Fentanyl- xtal- 3D- balls. png

    Systematic ( IUPAC) name

    N- ( 1- ( 2- phenylethyl) - 4- piperidinyl) - N- phenylpropanamide

    Clinical data

    Trade names Actiq, Duragesic, Fentora, Sublimaze and others

    AHFS/ Drugs. com monograph

    Pregnancy

    category

    AU: C

    US: C ( Risk not ruled out)

    Legal status

    AU: Controlled ( S8)

    UK: Class A

    US: Schedule II

    ℞ ( Prescription only)

    Dependence

    liability Very high

    Routes of

    administration TD, IM, IV, oral transmucosal, sublingual, buccal

    Pharmacokinetic data

    Bioavailability 92% ( transdermal)

    89% ( intranasal)

    50% ( buccal)

    33% ( ingestion)

    Protein binding 80–85%

    Metabolism hepatic, primarily by CYP3A4

    Onset of action 5 min[ 1]

    Biological half- life ( IV) = 10- 20 mins ( T1/ 2 β )

    2- 4 hours ( T1/ 2 ɣ )

    Intranasal = 6.5 mins

    Transdermal = 20–27 h[ 2]

    Duration of action 30 to 40 min[ 1]

    Excretion 60% Urinary ( metabolites, <10% unchanged drug) [ 3]

    Identifiers

    CAS Registry Number 437- 38- 7 Yes

    ATC code N01AH01 N02AB03

    PubChem CID: 3345

    IUPHAR/ BPS 1626

    DrugBank DB00813 Yes

    ChemSpider 3228 Yes

    UNII UF599785JZ Yes

    KEGG D00320 Yes

    ChEBI CHEBI: 119915 Yes

    ChEMBL CHEMBL596 Yes

    Chemical data

    Formula C22H28N2O

    Molecular mass 336.471 g/ mol


    Company Contact:


    • Phone: 912406641875

    • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

    • Email: Email


    Published date: September 8, 2015 -

    • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

      Pharmaceuticals of global quality standards to Pharma Companies all over

      the world. In our warehouse facilities, approved by FDA. we supply

      Pharmaceutical Finished products, Dental products and Active

      Pharmaceutical Ingredients.

      We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

      We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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