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  • Octreotide Acetate Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Octreotide Acetate CAS No: 83150- 76- 9

    Batch No: OCT/ 011114 A. R. No 14/ FP/ OCT/ 0111

    Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

    Batch Quantity 100 kg Date of Retest Jan- 2017

    Sr. No Test Results Acceptance Criteria

    1. Appearance Complies White to off- white, amorphous powder of low density

    2. Solubility Complies Soluble in water and 1% acetic acid at a concentration of≥ 1mg/ ml to give a clear, colorless solution

    3. RT Complies According with Working Standard

    4. Amino acids Complies Cys: 1.7~2.3

    Lys: 0.9~1.1

    Phe: 1.8~2.2

    Thr: 0.8~1.2

    Thr- ol: Present

    5. pH 5.7

    5.0 to 7.0

    6. Peptide Purity ( By HPLC) 99.52% NLT 98.0%

    7. Related Substances

    ( By HPLC)

    Total Impurities

    Largest single impurity

    0.48

    0.22

    NMT 2.0%

    NMT 1.0%

    8. Acetic acid 7.1% 5.0% to 12.0%

    9. Water ( K. F. ) 1.8% NMT 10%

    10. Specific Optical Rotation - 71.7º - 66.0° to - 76.0°( C=0.5, HAc)

    11. Bacterial endotoxins Complies NMT 1 EU/ mg

    12. DMF( GC)Complies NMT 0.088%

    13. AcN( GC) Complies NMT 0.041%

    14. Assay( HPLC) 100.5% 95.0% to 103.0%

    Octreotide

    Octreotide. svg

    Octreotide3d. png

    Systematic ( IUPAC) name

    ( 4R, 7S, 10S, 13R, 16S, 19R) - 10- ( 4- aminobutyl) - 19-

    [ [ ( 2R) - 2- amino- 3- phenyl- propanoyl] amino] - 16-

    benzyl- N- [ ( 2R, 3R) - 1, 3- dihydroxybutan- 2- yl] - 7-

    ( 1- hydroxyethyl) - 13- ( 1H- indol- 3- ylmethyl) - 6, 9, 12,

    15, 18- pentaoxo- 1, 2- dithia- 5, 8, 11, 14, 17-

    pentazacycloicosane- 4- carboxamide

    Clinical data

    Trade names Sandostatin

    AHFS/ Drugs. com monograph

    Pregnancy

    category

    AU: C

    US: B ( No risk in non- human studies)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Subcutaneous, intramuscular, intravenous

    Pharmacokinetic data

    Bioavailability 60% ( IM) , 100% ( SC)

    Protein binding 40–65%

    Metabolism Hepatic

    Biological half- life 1.7–1.9 hours

    Excretion Urine ( 32% )

    Identifiers

    CAS Registry Number 83150- 76- 9 Yes

    79517- 01- 4 ( acetate)

    135467- 16- 2 ( pamoate)

    ATC code H01CB02

    PubChem CID: 448601

    IUPHAR/ BPS 2055

    DrugBank DB00104 Yes

    ChemSpider 395352

    UNII RWM8CCW8GP Yes

    KEGG D00442

    ChEMBL CHEMBL1680

    Chemical data

    Formula C49H66N10O10S2

    Molecular mass 1019.24 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 12, 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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