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  • Diltiazem Hydrochloride Usp - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Diltiazem Hydrochloride USP CAS No: 33286- 22- 5

    Batch No: DIL/ 030313 A. R. No 13/ FP/ DIL/ 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 a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

    Complies c) Chloride: Meets the requirements.

    4. Related Substances

    Individual Impurity Total Impurity

    0.22 %

    0.45%

    NMT 0.5%

    NMT 1.0%

    5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +112º Between +110° and +116°

    6. Loss on drying 0.23% NMT 0.5%

    7. Heavy Metals Complies 20ppm

    8. Residue On Ignition 0.02% NMT 0.1%

    9. Assay HPLC 99.75% 98.0% –102.0%

    . .

    Diltiazem

    Diltiazem structure. svg

    Diltiazem ball- and- stick. png

    Systematic ( IUPAC) name

    cis- ( +) - [ 2- ( 2- Dimethylaminoethyl) - 5- ( 4- methoxyphenyl) - 3- oxo- 6- thia- 2- azabicyclo[ 5.4.0] undeca- 7, 9, 11- trien- 4- yl] ethanoate

    Clinical data

    Trade names Cardizem, Dilacorxr

    AHFS/ Drugs. com monograph

    MedlinePlus a684027

    Pregnancy

    category

    US: C ( Risk not ruled out)

    Legal status

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 40%

    Metabolism Hepatic

    Biological half- life 3–4.5 hours

    Excretion Renal

    Biliary

    Lactic ( in lactating females)

    Identifiers

    CAS Registry Number 42399- 41- 7 Yes

    ATC code C05AE03 C08DB01

    PubChem CID: 39186

    IUPHAR/ BPS 2298

    DrugBank DB00343 Yes

    ChemSpider 35850 Yes

    UNII EE92BBP03H Yes

    KEGG D07845 Yes

    ChEBI CHEBI: 101278 Yes

    ChEMBL CHEMBL23 Yes

    Chemical data

    Formula C22H26N2O4S

    Molecular mass 414.519 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 7, 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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