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% |
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Impurity C ≤ 0.2% |
0.009% |
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|
Impurity D ≤ 0.2% |
ND |
||
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Impurity E ≤ 0.2% |
0.03% |
||
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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 |
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|
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℃ . |
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The above item conforms to EP9.0 standard. |
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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 imformation:
Hubei Ipure chemical Co., Ltd. is Established in 2011,which is located in Wuhan We have decades of experience
The company is a diversified product production and operation enterprise, with API, pharma intermediates, and other fine chemicals as well as R&D and pigments development and sales as one of the large enterprises, with more than 130 acres of plant in accordance with GMP production requirements.
we also have a strong team of professional R&D technology.we have about 300 employees, including 90 full-time PHD 15 PHD and masters above, 153 undergraduates, with reasonable professional knowledge structure and adequate staffing.
The company has passed the ISO 9001 quality system certification. The products are exported to North America, South America, Europe, Australia Japan, Korea and other country . High quality products and good service are deeply trusted and praised by customers at home and abroad.
