Isosorbide 5-mononitrate CAS NO.16051-77-7

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Raw materials from chinese origin
Wuxi TAA Chemical Industry Co., limited(ISO 9001: 2008), are strong in the field of Pharmaceuticals,
food additives, plant extract and fine chemicals for more than 14 years.

1.Product description

Product Name: Isosorbide 5-mononitrate

CAS: 16051-77-7

MF: C6H9NO6

MW: 191.14

EINECS: 240-197-2



2.Physical properties

mp 88-93 °C

alpha 170 o (c=1, EtOH)

refractive index 145 ° (C=5, H2O)

storage temp. -20°C Freezer

Water Solubility soluble



3.Specification



Items

Specifications

Results

Description

A white powder

White powder

Identification

a) IR: consistent with the spectrum obtained with that of its RS.

b) HPLC: the retention time of the principle peak corresponds to that of its RS.

c) TCL for lactose: position, color and size to the principal spot is consistent with that obtained with reference solution

Conforms



Conforms



Conforms

Nitrates

NMT 0.5%

Conforms

Heavy metals

NMT 10ppm

Conforms

Related substances

Isosorbide: NMT 0.20%

Isosorbide 2-nitrate: NMT 0.25%

Isosorbide dinitrate: NMT 0.25%

Any other single impurity (major): NMT 0.1%

Total impurities: NMT 0.5%

Conforms

0.023%

0.041%

0.0026%

0.067%

Microbiological Quality

Total aerobic microbial count: NMT 900cfu/g

Total combined yeasts/Molds count: NMT 90 cfu/g

Escherichia. Coli: absence

<10cfu/g

<10cfu/g

absence

Assay (Isosorbide Mononitrate)

66.5%~73.5%

68.5%