98% up by HPLC DMF Posaconazole 171228-49-2

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:98% up by HPLC DMF Posaconazole 171228-49-2
CAS No.:171228-49-2
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen, Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

     

    Product Information

     

    Product name

    Posaconazole

    CAS No.

    171228-49-2

    Molecular Formula

    C37H42F2N8O4

    Molecular Weight

    700.78

    Quality Standard

    98% up by HPLC, DMF

    Appearance

    White to off-white powder

     

    COA of Posaconazole

     

    ITEMS

    SPECIFICATION

    RESULT

    Appearance

    White to off-white powder

    Conforms

    Melting point

    167 〜171°C

    167.5 〜168.0°C

    Specific optical rotation

    -28.5°〜-24.5°

    The retention time of the major peak of the test

    -27.2°

     

     

    Identity

    The retention time of the major peak of the test solution corresponds to that of the standard solution, as obtained in the Assay.

     

    Conforms

    The infrared absorption spectrum of this

    product should corresponds to the reference spectrum.

     

    Conforms

    Crystallinity

    There are characteristic peaks at 7.7°±0.2°,9.9°±0.2°, 17.8°±0.2°, 19.5°±0.2°, 20.0°± 0.2°(Crystal form 1).

    Conforms

    Water content (%w/w)

    ≤0.5%

    0.1%

    Residue on ignition

    ≤0.1%

    0.02%

    Related substances

    QR0005DS-IN-01: ≤0.10%

    QR0005DS-IN-02: ≤0.10%

    QR0005DS-IM-08: ≤0.10%

    QR0005DS-IM-06: ≤0.10%

    Other maximum unknown impurity ≤0.10%

    Total impurities: ≤0.40%

    Not detected

    0.01%

    Not detected

    Not detected

    0.02%

    0.07%

    Enantiomeric and

     diastereoisomer

    QR0005DS-IM-02: ≤0.10%

    QR0005DS-IM-03: ≤0.10%

    QR0005DS-IM-04: ≤0.10%

    QR0005DS-IM-01+QR0005DS-IM-05+ QR0005DS-IM-06: ≤0.10%

    QR0005DS-IM-07 ≤0.10%

    Total isomer impurities: ≤0.50%

    0.01%

    Not detected

    Not detected

    Not detected

    Not detected

    0.02%

    0.04%

    Residual solvents

    Methanol: ≤3000 ppm

    Dichloromethane: ≤600 ppm

    Acetone: ≤5000 ppm

    Ethanol: ≤5000 ppm

    Dimethyl sulfoxide: ≤5000 ppm

    31 ppm

    53 ppm

    Not detected

    Not detected

    Not detected

    Benzene

    ≤2 ppm

    Not detected

    Heavy metals

    ≤10 ppm

    Conforms

    Bacterial endotoxin

    ≤0.25 EU/mg

    Conforms

    Microbial limit

    Total Aerobic Microbial Count (TAMC): ≤102 cfu/g

    Total molds and Yeast Count (TYMC): ≤101cfu/g

    Escherichia Coli: Absence

    10 cfu/g

    < 10 cfu/g

    Not detected

    Assay

    C37H42F2N8O4: 98.0% 〜102.0% (on the anhydrous basis)

    101.0%

    Conclusion

    Conform to Enterprise Standard

     

    Usage

     

    Function of Posaconazole

    Posaconazole is a triazole antifungal drug, which can inhibit the synthesis of fungal cell membranes, thereby producing antifungal effects. It can mainly be used to prevent invasive Aspergillus and Candida infections, and is suitable for the prevention of acute Aspergillus and Candida infections caused by severe immunodeficiency in patients 13 years of age and older.

    After the above patients received hematopoietic stem cell transplantation, patients with graft-versus-host disease, or patients with hematological malignancies with prolonged neutropenia caused by chemotherapy, so this drug is mainly used to prevent invasive Aspergillus and Candida Infection.

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