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  • Memantine Hcl Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Memantine HCL CAS No:

    Batch No: MEM/ 011114 A. R. No 14/ FP/ MEM/ 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 or almost white crystalline powder

    2. Identification Complies IR

    3. Relatived Substance

    1- methyladamantane

    1, 3, 5- Trimethyladamantane

    Unknow impurity

    Total impurity

    0.08%

    0.03%

    0.3%

    NMT 0.3%

    NMT 0.1%

    NMT 0.5%

    4. Residue on ignition 0.05% NMT 0.1%

    5. Heavy metals Complies NMT 10 PPM

    6. Loss on drying 0.12% NMT 0.5%

    7. Assay 99.7% 98.5% to 101.0%

    8. Residual solvents

    Ethanol

    Ethylacetate

    0.08%

    9. Contamination

    microbiologica Complies Max5×102aerobes and fungi per 1 g

    No Escherichia coli

    10. Size of distributed particles Complies 100µm

    Memantine

    Memantine. svg

    Memantine- 3d- sticks. png

    Systematic ( IUPAC) name

    3, 5- dimethyltricyclo[ ] decan- 1amine

    or

    3, 5- dimethyladamantan- 1- amine

    Clinical data

    Trade names Namenda

    AHFS/ Drugs. com monograph

    MedlinePlus a604006

    Licence data EMA: Link, US FDA: link

    Pregnancy

    category

    AU: B2

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

    Legal status

    AU: Prescription Only ( S4)

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability ~100%

    Metabolism Hepatic ( <10% )

    Biological half- life 60–100 hours

    Excretion Renal

    Identifiers

    CAS Registry Number 19982- 08- 2 Yes

    ATC code N06DX01

    PubChem CID: 4054

    IUPHAR/ BPS 4253

    DrugBank DB01043 Yes

    ChemSpider 3914 Yes

    UNII W8O17SJF3T Yes

    KEGG D08174 Yes

    ChEMBL CHEMBL807 Yes

    Chemical data

    Formula C12H21N

    Molecular mass 179.3 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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