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Quality Inspection for Alprostadil - Spironolactone 52-01-7 Urinary system – Neore

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Quality Inspection for Alprostadil - Spironolactone 52-01-7 Urinary system – Neore Detail:

Payment: T/T, L/C
Product Origin: China
Shipping Port: Beijing/Shanghai/Hangzhou
Production capacity: 50kg/month
Order(MOQ): 25kg
Lead Time: 3 Working Days
Storage condition: Stored in cool, dry place, room temperature.
Package material: drum
Package size: 25kg/drum
Safety information:  Not dangerous goods

Spironolactone

Introduction

Spironolactone, is a medication that is primarily used to treat fluid build-up due to heart failure, liver scarring, or kidney disease. It is also used in the treatment of high blood pressure, low blood potassium that does not improve with supplementation, early puberty in boys, acne and excessive hair growth in women, and as a part of transgender hormone therapy in transfeminine people.

Specification (USP42)

Item

Specification

Appearance

Light cream-colored to light tan crystalline powder.

Solubility (annual)

Freely soluble in benzene and in chloroform; soluble in ethyl acetate and in alcohol; slightly soluble in methanol and in fiexed oils; practically insoluble in water.

Identification

Infrared Absorption: meets the requirement

HPLC: meets the requirement

Limit of mercapto compounds

≤0.10mL of 0.010N iodine is consumed

Organic impurities

Related compound B ≤0.2%

Related compound A ≤0.2%

Related compound C ≤0.2%

Related compound D ≤0.3%

Epimer ≤0.3%

Related compound I ≤0.1%

Any unspecified impurity ≤0.10%

Total impurities ≤1.0%

Optical rotation -41°~ -45°
Loss on drying ≤0.5%
Residual solvents (In-house) Methanol ≤3000ppm
Tetrahydrofuran ≤720ppm
DMF ≤880ppm
Particle size (In-house) 95% not more than 20 microns

Assay

97.0% ~103.0% on the dried basis


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Quality Inspection for Alprostadil - Spironolactone 52-01-7 Urinary system – Neore detail pictures


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    5 Stars By Mark from Albania - 2017.11.01 17:04
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    5 Stars By Honorio from UAE - 2018.06.05 13:10