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  • Lurasidone Hydrochloride Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Lurasidone hydrochloride CAS No:

    Batch No: LUR/ 011114 A. R. No 14/ FP/ LUR/ 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 crystalline powder, odorless

    2. Identification Complies

    Complies

    Complies 1) Reversed phase chromatography: The retention time of the

    major peak in the chromatogram of the Test solution

    corresponds to that in the chromatogram of the standard

    solution, as obtained in the Assay.

    2) Normal phase chromatography: The retention time of the

    corresponds to that in the chromatogram of the SST

    solution, as obtained in the Related substances II.

    3) IR: IR spectrum of sample should correspond to that of

    reference standard.

    4) Chloride: a solution in methanol responds to the test for

    chloride.

    3. Solubility Complies Sparingly soluble in methanol, slightly soluble in ethanol or

    in acetone, very slightly soluble in water, and insoluble in

    0.1 mol/ L hydrochloric acid or in toluene.

    4. Water 0.12% NMT 0.5%

    5. Residue on ignition 0.03% NMT 0.1%

    6. Heavy metals Complies NMT 10 PPM

    7. Specific rotation - 46º - 43º to - 48º

    8. Chloride content 6.90% 6.75% to 7.03%

    9. Related substances

    Impurity A

    Impurity B

    Impurity C

    Impurity D+E+F

    Individual unknown impurity

    Total impurities

    ND

    0.06%

    0.025%

    0.13%

    NMT 0.10%

    NMT 0.50%

    Lurasidone

    Lurasidone structure. svg

    Ball- and- stick model of the lurasidone molecule

    Systematic ( IUPAC) name

    ( 3aR, 4S, 7R, 7aS) - 2- { ( 1R, 2R) - 2- [ 4- ( 1, 2- benzisothiazol- 3- yl) piperazin- 1- ylmethyl] cyclohexylmethyl} hexahydro- 4, 7- methano- 2H- isoindole- 1, 3- dione

    Clinical data

    Trade names Latuda

    AHFS/ Drugs. com Consumer Drug Information

    MedlinePlus a611016

    Licence data US Daily Med: link

    Pregnancy

    category

    AU: B1

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

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 9–19% ( oral) [ 1]

    Metabolism Hepatic ( CYP3A4- mediated) [ 1]

    Biological half- life 18 hours[ 1]

    Excretion Faecal ( ~80% ) , renal ( ~9% ) [ 1]

    Identifiers

    CAS Registry Number 367514- 87- 2

    ATC code N05AE05

    PubChem CID: 213046

    IUPHAR/ BPS 7461

    ChemSpider 184739

    UNII 22IC88528T Yes

    ChEBI CHEBI: 70735 Yes

    ChEMBL CHEMBL1237021

    Synonyms SM- 13, 496

    Chemical data

    Formula C28H36N4O2S

    Molecular mass 492.68 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 9, 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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