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  • Meropenem Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Meropenem USP CAS No: 119478- 56- 7

    Batch No: MER/ 030313 A. R. No 13/ FP/ MER/ 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 Soluble in dimethyl formamide and in 5% monobasic potassium phosphate solution; sparingly soluble in water; very slightly soluble in alcohol; practically insoluble in acetone and in ether. Soluble in dimethylformamide and in 5% monobasic potassium phosphate solution; sparingly soluble in water; very slightly soluble in alcohol; practically insoluble in acetone and in ether.

    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. Related Substances

    Individual Impurity Total Impurity

    0.042%

    0.061%

    NMT 0.1%

    NMT 0.3%

    5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 19º Between - 17° to - 21°

    6. pH 5.4 Between 4.0–6.0

    7. Heavy Metals Complies 10ppm

    8. Water Content by KF 12.4% 11.4% –13.4%

    9. Residue On Ignition 0.025% NMT 0.1%

    10. Assay HPLC 99.46% 98.0% –101.0%

    11. Bacterial Endotoxins Test 0.102 EU/ mg NMT 0.125 USP EU/ mg

    Meropenem

    Meropenem. svg

    Meropenem- from- xtal- 1992- 3D- balls. png

    Systematic ( IUPAC) name

    3- [ 5- ( dimethylcarbamoyl) pyrrolidin- 2- yl] sulfanyl- 6- ( 1- hydroxyethyl) - 4- methyl- 7- oxo- 1- azabicyclo[ 3.2.0] hept- 2- ene- 2- carboxylic acid

    Clinical data

    Trade names Merrem

    AHFS/ Drugs. com monograph

    Pregnancy

    category

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

    Legal status

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration IV

    Pharmacokinetic data

    Bioavailability 100%

    Protein binding Approximately 2% .

    Biological half- life 1 hour

    Excretion Renal

    Identifiers

    CAS Registry Number 119478- 56- 7 Yes

    ATC code J01DH02

    PubChem CID: 441130

    DrugBank DB00760 Yes

    ChemSpider 389924 Yes

    UNII FV9J3JU8B1 Yes

    KEGG D02222 Yes

    ChEBI CHEBI: 43968 Yes

    ChEMBL CHEMBL127 Yes

    Chemical data

    Formula C17H25N3O5S

    Molecular mass 383.464 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 10, 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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