Product Name

Norepinephrine Bitartrate

CAS No.

69815-49-2

Batch No.

20210202

Quantity

 28.5kg

Date of Production

2021.02.02

Analysis Date

2021.02.28

Analysis According

USP42                                

Durability

2024.02.02

Inspection Item

Requirements

Test Results

Appearance

White or fainitly gray，odorless，crystalline prwder，slowly darkens on exposure to and light

Complies

Solubility

Freely soluble in water, slightly soluble in alcohol，practically insoluble in chloroform and in ether

Conforms

Appearance of solution

It solutions are acid to litmus，having a PH of about 3.5

Conforms

PH

3.5-5.0

3.6

Identification

A：IR Spectrum SIMILAR TO Working standard(197K)

B: An intensely green color develops

C: The solution is colorless or has at a slight pink or slight violet color

A: Complies

B: Complies

C: Complies

Melting point

98～104℃

101.0～103.0℃

Organic Impurities Limit of Arterenone

Not more than 0.2

Complies

Specific Rotation

-10.0～-12.0°

-11.0°

Clarity

Clarity colorless

Complies

Limit of acetone body

A310nm≤0.2

0.01

Bacterial  Endotoxn

Not more than 83.4EU/mg

Complies

Water Content

4.5~5.8%

5.2%

Residue on ignition

≤0.1%

0.025%

Residual solvents Ethanol         

≤5000ppm or ≤0.5%

0.05%

Assay( Dried)

97.0～102.0%

99.9%

Conclusion                 Meets the Requirements