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

Name: 98% up by HPLC DMF Posaconazole 171228-49-2
Availability: 98-up-by-hplc-dmf-posaconazole-171228-49-276184.html

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.

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

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

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