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  • Gestodene Usp Ip Ep Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Gestodene CAS No: 60282- 87- 3

    Batch No: GES/ 011114 A. R. No 14/ FP/ GES/ 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 yellowish crystalline powder

    2. Identification Complies

    - 190º IR

    Specification optical rotation: - 188° to

    - 198°

    ( 0.01g/ ml, methanol)

    3. Solubility Complies Slightly soluble in water, freely soluble

    in dilute acetic acid and methanol,

    slightly soluble in alcohol

    4. Melting point 198.5- 200℃ 196 ℃ to 200℃

    5. Solubility Practically insolubIe in water, freely

    solubIe in rnethyIene chIoride, solubIe

    in methanoI, sparingIy soluble in96 % ethanol.

    6. Loss on drying 0.04% NMT 0.5%

    7. Residue on ignition 0.04% NMT 0.3%

    8. Related substances

    Impurity A

    Impurity B

    Impurity C

    Impurity I

    Impurity L

    Individual impurity

    Total impurities

    0.05%

    ND

    0.09%

    0.15%

    NMT 0.3%

    NMT 0.2%

    NMT 0.15%

    NMT 0.1%

    NMT 0.5%

    9. Residual solvents

    Acetone

    Ethyl acetate

    1896 PPM

    795 PPM

    NMT 5000 PPM

    10. Assay 100.6% 97.5% to 102.0

    11. Particle size Complies NMT 90% 10 microns

    Gestodene

    Gestodene. svg

    Gestodeno3D. png

    Systematic ( IUPAC) name

    ( 8R, 9S, 10R, 13S, 14S, 17R) - 13- Ethyl- 17- ethynyl- 17- hydroxy- 1, 2, 6, 7, 8, 9, 10, 11, 12, 14- decahydrocyclopenta[ a] phenanthren- 3- one

    Clinical data

    AHFS/ Drugs. com International Drug Names

    Pregnancy

    category

    X

    Legal status

    ℞ ( Prescription only)

    Routes of

    administration oral administration

    Pharmacokinetic data

    Bioavailability in vitro 99% using 3H=R5020 / in vivo similar to progesterone

    Biological half- life 16 to 18 hrs.

    Excretion urinary tract mainly

    Identifiers

    CAS Registry Number 60282- 87- 3 Yes

    ATC code G03AA10 G03AB06 ( only combinations with estrogens)

    PubChem CID: 3033968

    DrugBank DB06730 Yes

    ChemSpider 2298532 Yes

    UNII 1664P6E6MI Yes

    KEGG D04316 Yes

    ChEMBL CHEMBL1213583 Yes

    Chemical data

    Formula C21H26O2

    Molecular mass 310.430 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 8, 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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