Clarithromycin. CAS NO.81103-11-9

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Clarithromycin
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ProName: Clarithromycin.
CasNo: 81103-11-9
Molecular Formula: C38H69NO13
Appearance: White or off-white crystalline powder
Application: Active pharmaceutical ingredients
DeliveryTime: Payment within three days after shipme...
PackAge: as the customers' request
Port: as the customers' request
ProductionCapacity: 1000 Kilogram/Day
Purity: 99%min
Transportation: by air/by sea
LimitNum: 1 Kilogram
Residue on Ignition: 0.05%
Heavy Metal: 《0.002%
Valid Period: 3 years

Superiority

Top Pharm Chemical Group is a regional, research , industry and trade of hightech pharmaceutical

chemical group .

Headquartered in JiuLong Hong Kong . In recent years, through continuous integration, mergers

and establish three domestic production base , now has its TOP Hanzhong plant extract production

base , production base TOP Xi'an food additives , chemical intermediates production base TOP Taizhou .

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1. Company Profile

Top Pharm Chemical Group is a regional, research , industry and trade of hightech pharmaceutical

chemical group .

Headquartered in JiuLong Hong Kong . In recent years, through continuous integration, mergers

and establish three domestic production base , now has its TOP Hanzhong plant extract production

base , production base TOP Xi'an food additives , chemical intermediates production base TOP Taizhou .

And China Marketing Center : Shaanxi TOP Pharm Chemical Co., Ltd.

Sole responsibility for the TOP Group of each base , raw material supply factories , sales and import and

export business ,

providing thousands of plant extracts , food additives , feed additives , vitamin , pharmaceutical raw

materials (API),

chemical intermediates and other related customers worldwide products.

The company has advanced production equipment , perfect quality assurance system and perfect quality

control system. Have multiple sets of high-pressure liquid chromatography, gas chromatography and ultraviolet spectrophotometer, such as efficient

high-sensitivity analytical instruments, for the product of effective analysis and monitoring.

To provide quality products , fast service is our final purpose , customer satisfaction is our relentless pursuit.

At Top Pharm, we firmly believe that customers' success is our success. Each staff member of our company is devoted to being ready for your requirements.

2. Prdouct Details

Name: Clarithromycin

Chemical name: 6-O-Methylerythromycin

CAS No .： C38H69NO13

MF： 81103-11-9

MW： 747.96

3. Certificate of Analysis

ITEMS	SPECIFICATIONS		RESULTS
Appearance	White to off white, crystalline powder		White crystalline powder
Identification	IR spectrum corresponds to clarithromycin RS		Complies
Solubility	Soluble in acetone; slightly soluble in dehydrated alcohol, In methanol, and in acetonitrile, and in phosphate buffer at pH values of 2 to 5; practically insoluble in water		Complies
Specific rotation	-94°～-102°(20℃,Anhydrous basis)		-98.0°
Crystallinity	Meets the requirements		Complies
PH	Between 8.0 and 10.0		9.0
Water	Not more than 2.0%		0.35%
Residue on ignition	Not more than 0.2%		0.05%
Heavy metals	Not more than 0.002%		Complies
Residual Solvents	Methanol	Not more than3000ppm	5ppm
	Ethanol	Not more than5000ppm	10ppm
	Methylene chloride	Not more than600ppm	4ppm
Related substances	Impurity I	Not more than 1.0%	ND
	Impurity A	Not more than 1.0%	0.13%
	Impurity J	Not more than 1.0%	ND
	Impurity L	Not more than 1.0%	0.09%
	Impurity B	Not more than 1.0%	0.03%
	Impurity M	Not more than 1.0%	ND
	Impurity C	Not more than 1.0%	0.05%
	Impurity D	Not more than 1.0%	0.24%
	Impurity N	Not more than 1.0%	ND
	Impurity E	Not more than 1.0%	0.65%
	Impurity F	Not more than 1.0%	0.18%
	Impurity P	Not more than 1.0%	ND
	Impurity O	Not more than 1.0%	ND
	Impurity K	Not more than 1.0%	ND
	Impurity G	Not more than 1.0%	0.10%
	Impurity H	Not more than 1.0%	0.01%
	Any other Impurity	Not more than 1.0%	ND
	Impurity more than 0.4%	Not more than 4	1
	Total impurities	Not more than 3.5%	1.48%
Assay	Not less than 96.0% and not more than 102.0%		97.2%
Tapped density	Not less than 0.6g/ml		0.7g/ml
Conclusion	This batch of product is in conformance with USP35

4. Usage: Clarithromycin is an antibiotic useful for the treatment of a number of bacterial infections. It is a macrolide antibiotic used particularly for respiratory infections (pharyngitis, tonsillitis, sinusitis, acute exacerbation of chronic obstructive pulmonary disease, pneumonia, skin infections and Lyme disease. In addition, it is used to treat Helicobacter pylori, a cause of gastritis.

Clarithromycin. CAS NO.81103-11-9

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