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Factory For 84380-01-8 - Posaconazole 171228-49-2 Antibiotic – Neore

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Factory For 84380-01-8 - Posaconazole 171228-49-2 Antibiotic – Neore Detail:

Payment: T/T, L/C
Product Origin: China
Shipping Port: Beijing/Shanghai/Hangzhou
Production capacity: 20kg/month
Order(MOQ): 10g
Lead Time: 3 Working Days
Storage condition: Stored in cool, dry place, room temperature.
Package material: vial
Package size: 10g/vial
Safety information:  Not dangerous goods

Posaconazole

Introduction

Posaconazole is a triazole antifungal medication.
Posaconazole is used to treat invasive Aspergillus and Candida infections. It is also used for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory to itraconzaole and/or fluconazole therapy.
It is also used to treat invasive infections by Candida, Mucor, and Aspergillus species in severely immunocompromised patients.

Specification (in house standard)

Item

Specification

Appearance White or almost white, hygroscopic powder

Item

Specification

Appearance

White or off-white crystalline powder

Specific rotation

-28.0°~-34.0°

Crystal form

It should be crystalline Ⅰ, with 2-theta angles of

14.4±0.2°,19.2±0.2°,21.7±0.2°,24.3±0.2°29.3±0.2°

Identification

IR, HPLC

Related substances I

PO-R1 NMT 0.10%

PO-R2 NMT 0.10%

PO-R3 NMT 0.10%

PO-R4 NMT 0.10%

PO-D3 & PO-D5 NMT 0.10%

PO-D7 & PO-D10 NMT 0.10%

Each of unspecified impurity NMT 0.10%

Total impurities NMT 0.5%

Related substances Ⅱ

PO-E NMT 0.10%

PO-D1 NMT 0.10%

PO-R5 NMT 0.10%

Residual solvents

Methanol NMT 3000ppm

Ethanol NMT 5000ppm

Dichloromethane NMT 600ppm

Tetrahydrofuran NMT 720ppm

N, N-dimethyl formamide NMT 880ppm

Triethylamine NMT 100ppm

Dimethy sulfoxide NMT 5000ppm

Water

NMT 2.0%

Residue on ignition

NMT 0.1%

Heavy metals

NMT 10ppm

Microbial limit

Total aerobic NMT 1000cfu/g

Total yeasts and molds NMT 100cfu/g

E.coli should be absent

Assay

98.0%-102.0%(on anhydrous basis)

98.0%-102.0%(on anhydrous and solvents free basis)


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    5 Stars By Sophia from Pakistan - 2018.12.10 19:03
    Perfect services, quality products and competitive prices, we have work many times, every time is delighted, wish continue to maintain!
    5 Stars By mary rash from Guatemala - 2018.05.15 10:52