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  • Tacrolimus Monohydrate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Tacrolimus Monohydrate CAS No: 3056- 17- 5

    Batch No: STA/ 011114 A. R. No 14/ FP/ STA/ 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

    2. Identification Complies Meets the requirements

    3. Mesh size/ sieve analysis

    4. Water 0.1% NMT 0.5%

    5. Specific rotation Complies - 45º to - 40º

    6. Residue on ignition Complies

    NMT 0.1%

    7. Heavy metals Complies NMT 20 PPM

    8. Related substances

    Any individual impurity

    Total Impurities

    Complies

    NMT 0.1%

    NMT 1.0%

    9. Melting point

    10. Assay by HPLC 99.43% 98.0% to 102.0%

    11. Microbiological Control

    Total Plate Count

    Fungi

    Salmonella

    Coli

    78 cfu/ g

    Negative

    Negative

    NMT 1000 cfu/ g

    <100/ g

    Tacrolimus

    Tacrolimus2DCSD. svg

    Tacrolimus3Dan. gif

    Systematic ( IUPAC) name

    3S- [ 3R* [ E( 1S* , 3S* , 4S* ) ]

    , 4S* , 5R* , 8S* , 9E, 12R* , 14R* , 15S* , 16R* , 18S* , 19S* , 26aR*

    -

    - hexadecahydro- 5, 19- dihydroxy

    - 3- [ 2- ( 4- hydroxy- 3- methoxycyclohexyl)

    - 1- methylethenyl] - 14, 16- dimethoxy

    - 4, 10, 12, 18- tetramethyl- 8- ( 2- propenyl)

    - 15, 19- epoxy- 3H- pyrido[ 2, 1- c] [ 1, 4] oxaazacyclotricosine- 1, 7, 20, 21( 4H, 23H)

    - tetrone, monohydrate

    Clinical data

    Pregnancy

    category

    AU: C

    US: C ( Risk not ruled out)

    Legal status

    ℞ ( Prescription only)

    Routes of

    administration Topical, oral, iv

    Pharmacokinetic data

    Bioavailability 20% , less after eating food rich in fat

    Protein binding 75- 99%

    Metabolism Hepatic CYP3A4, CYP3A5

    Biological half- life 11.3 h ( range 3.5- 40.6 h)

    Excretion Mostly faecal

    Identifiers

    CAS Registry Number 104987- 11- 3 Yes

    ATC code D11AH01 L04AD02

    PubChem CID: 6473866

    DrugBank DB00864 Yes

    ChemSpider 4976056 Yes

    UNII Y5L2157C4J

    ChEMBL CHEMBL269732

    Chemical data

    Formula C44H69NO12

    Molecular mass 804.018 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 14, 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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