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Spiramycin Micronized EP3/EP5/EP7/CEP
Spiramycin Micronized EP3/EP5/EP7/CEP

1.Competitive price high quatity 2.Fast delivery professional services 3.Financial credit support favorable payment

BASIC INFO

 Spiramycin

CAS NO:8025-81-8

Appearance: A slightly yellowish or white powder

 

FUNCTION & USAGE

 

This product can be used for the infections in ears, nasus, larynx and respiratory tract systemcaused by gram-positive bacterium and some gram-negative bacterium such as acute bronchitic, acute bout of acute bronchitis, pneumonia, scarlet fever, tonsillitis, tympanitis, periodontitis and acute nososinusitis. It also shows suitable to non-gonococcal urethritis. It possesses strong internal antibacterial function and Post-Antibiotic Effect (PAE). It’s able to improve the phagocytosis of phagocyte and  is widely distributed in body. The concentration in histiocyte is higher than erythromycin and is less adverse reaction as well.

 

 SPEC SHEET

 

Test  Item

Analysis  Specification

Result

Description

A slightly yellowish or white power

A slightly yellowish  power

Identification

UV spectrum according to Ph.Eur.7.0

TLC according to Ph.Eur.7.0

Colorimetric test according to Ph.Eur.7.0

 

 

Conform

 

 

 

Solubility

Slightly soluble I water, freely soluble in acetone in ethanol(96%)and in methanol

Conform

pH

8.5~10.5

10.0

Specific optical rotation

-85°~ -80°

-82°

Related Substances

Impurity A  ≤2.0%

Impurity B  ≤2.0%

Impurity D  ≤2.0%

Impurity E  ≤2.0%

Impurity F  ≤2.0%

Impurity G  ≤2.0%

Impurity H  ≤2.0%

Any other impurity  ≤2.0%

 

Total impurities ≤10.0%

 

 

 

 

 

0.1%

1.0%

1.2%

Not detected

1.6%

0.1%

Not detected

0.12,0.19%

0.26,0.37%

4.5%

Conforms

Loss on drying

≤3.5%

0.9%

Sulphated ash

Not more than 0.1%

0.06%

Heavy metals

≤20ppm

<20ppm

Butyl acetate

≤5000ppm

30ppm

Composition

Spiramycin1:not less than80.0%

Spiramycin2: not more than5.0%

Spiramycin3: not more than10.0%

Total Spiramycin1,2,3: not less than90.0%

95.8%

0.2%

0.3%

96.3%

Assay

Not less than 4100iu/mg calculated with reference to the substances

4892iu/mg

Conclusion

The above certificate of analysis is in compliance with Ph.Eur.7.0.

 

We ensure good quality and competitive price with best service. If you are interested in the product or have any questions, just feel free to contact us.

 

We have exported 11 categories of medicinal products ( including antibiotics, cardiovascular, anti-AIDS and diabetes) covering 366 varieties and specifications of products. Main products ( Spiramycin, Lincomycin HCL, Simvastatin) have been exported to more than 20 countries and areas in Western Europe, Southeast Asia, Middle-east, North Africa, South America.

As a professional company in pharmaceutical field, we are confident to provide you with our best products, quality service and favorable payment terms. And it will be our honor to become one of your partners in China.

 

Spiramycin Micronized EP3/EP5/EP7/CEP

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