China Injectable Grade Amiodarone HCL API EP9.0China Injectable Grade Amiodarone HCL API EP9.0China Injectable Grade Amiodarone HCL API EP9.0

China Injectable Grade Amiodarone HCL API EP9.0

  • Name: Amiodarone hydrochloride
  • Synonyms: 2-Butyl-3-benzofuranyl-4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride
  • Molecular Formula: C25H29I2NO3.HCl
  • Molecular Weight: 681.78
  • CAS Registry Number: 19774-82-4
  • EINECS: 243-293-2
  • Packing: 25kgs/drum
  • Grade:Injectable Grade/medicine Grade
  • Shelf Life: Four years
  • Conforms to EP9.0

Product Description

 

Amiodarone HCL

 

Brief Description

 

Name: Amiodarone hydrochloride 
Synonyms: 2-Butyl-3-benzofuranyl-4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride 
Molecular Formula: C25H29I2NO3.HCl
Molecular Weight: 681.78 
CAS Registry Number: 19774-82-4 
EINECS: 243-293-2

Packing: 25kgs/drum

Grade:Injectable Grade/medicine Grade

Shelf Life: Four years

 Conforms to EP9.0

 

It is used to correct irregular heartbeats to a normal rhythm. Amiodarone produces its helpful effects by slowing nerve impulses in the heart and acting directly on the heart tissues.

 

Amiodarone HCL Specification

 

 

ITEMS

SPECIFICATION

RESULTS

Methods

Appearance

White or almost white fine crystalline powder

Almost white fine crystalline powder

In house

Solubility

Very slightly soluble in water, freely soluble in methylene chloride; soluble in methanol; sparingly soluble in ethanol(96%)

Very slightly soluble in water, freely soluble in methylene chloride; soluble in methanol; sparingly soluble in ethanol(96%)

In house

Identification

IR: Conforms to Amiodarone Hydrochloride CRS

Conforms to Amiodarone Hydrochloride CRS

EP2.2.24

Chlorides: It gives reaction (b) of chlorides

It gives reaction (b) of chlorides

EP2.3.1

Appearance of solution

Clear and not more than GY5 or BY5

Clear and less than GY5

EP2.2.1 EP2.2.1

MethodII

Melting point

158.0 ~ 162.0

159.8 ~ 161.0

EP2.2.15

PH

3.2 ~ 3.8

3.4

EP2.2.3

Loss on drying

≤ 0.5%

0.09%

EP2.2.32

Sulfated ash

≤ 0.1%

0.04%

EP2.4.14

Heavy metals

≤ 20 ppm

< 20 ppm

EP2.4.8  Method C

Iodides

≤ 150 ppm

< 150 ppm

EP2.2.25

Impurity H

≤ 0.02%

< 0.02%

EP2.2.27

Related substances

Impurity A ≤ 0.2%

0.03%

EP2.2.29

Impurity B ≤ 0.2%

0.05%

Impurity C ≤ 0.2%

0.009%

Impurity D ≤ 0.2%

ND

Impurity E ≤ 0.2%

0.03%

Impurity F ≤ 0.2%

0.05%

Impurity G ≤ 0.2%

ND

Unspecified impurities ≤ 0.1%

0.03%

Total impurities ≤ 0.5%

0.21%

Residual solvents

Ethanol ≤ 5000 ppm

534 ppm

In house

Toluene ≤ 890 ppm

29 ppm

Microbiological

TAMC ≤ 1000 CFU/g

10 CFU/g

EP2.6.12

TYMC ≤ 100CFU/g

10 CFU/g

EP2.6.12

Escherichia coli absent in 1g

Undected

EP2.6.13

Bacterial endotoxin

≤ 1.0 IU/mg

< 1.0 IU/mg

EP2.6.14

Assay

98.5% to 101.0% (dried substance)

ND

EP2.2.20

Storage conditions: Protected from light,at a temperature not exceeding 30 .

The above item conforms to EP9.0 standard.

 

 

Usage 

 

1) Amiodarone Hcl is an anti-arrhythmic agent used for various types of cardiac dysrhythmias, both ventrucular and artrial. 

2) It is also used in arrhythmias that are otherwise difficult to treat with medication.

 

Packaging & Shipping

Amiodarone Hcl Packaging

1kg/bag or according to client request
Amiodarone Hcl Delivery Detail

1~2 weeks after confirm order.Some of the products can be supplied within 7 days on the strength of EDC warehouse.

 

Our Services

1. Exporting chemical products from China over 5 years of experience.

2. Arrange the orders and shipping with requests in time, According to the different countries export policy provide complete customs clearance documents..

3. Variety of high quality chemical products with competitive price.

 

Company Information

Hubei Ocean Biotechnology has concentrated on food additives,Vitamins,and some relative chemica

Wuhan Ocean Biotech Co., Ltd.

Tel:+86-27-8373-3110

Contact Person:Yolanda

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