GMP Spiramycin/CAS: 8025-81-8/GMP/Pharmaceutical

• Function: Antibiotic and Antimicrobial Agents
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Analysis reagent
• State: Solid
• Volatile: Not Volatile
• Model NO.: EP/USP
• Transport Package: 25kg/Drum
• Specification: EP/USP
• Trademark: SINOAH
• Origin: China
• Production Capacity: 20mt/Month

Product Description

Spiramycin/CAS: 8025-81-8/GMP/Pharmaceutical
 

GMP certified Spiramycin API 8025-81-8

 

Product Description

Spiramycin is a macrolide antibiotic. It is used to treat toxoplasmosis and various other infections of soft tissues. Although used in Europe, Canada and Mexico, spiramycin is still considered an experimental drug in the United States, but can sometimes be obtained by special permission from the FDA for toxoplasmosis in the first trimester of pregnancy.

Parameters

 

Items	Specifications	Results
Appearance	A white or slightly yellowish powder	White powder
Identification		Conform
A.  UV Spectrum	The specific absorbance at the maximum (232nm) is about 340.
B. TLC	Corresponds to reference solution.
C. Color Reaction	Brown colour.
pH	8.5-10.5	9.6
Specific optical rotation	-80°- -85°(dried substance)	-83°
Composition (HPLC)	Spiramycin≥80.0 %	88.20%
	Spiramycin≤5.0 %	0.30%
	Spiramycin≤10.0 %	3.70%
	Total Spiramycins ≥90.0 %	92.20%
Related substances (HPLC)	≤2.0 %	Conform
Heavy metals	≤20ppm	Conform
Loss on drying	≤3.5 %	1.40%
Sulphated ash	≤0.1 %	Conform
Assay (wet substance)	No limits (IU/mg)	4305 IU/mg
Assay (dried substance)	≥4100 IU/mg	4366 IU/mg
CONCLUSION	CONFORM TO EP VII

Function

 Spiramycin is applicable to the infections caused by sensitive bacteria of the following kinds:

1. Respiratory tract infection: pharyngitis, rhinitis, sinusitis, bronchitis, pneumonia, tonsillitis, cellulitis, ear infections, buccal mouth infection, etc.

2. Urinary tract infections: chlamydia infection and prostate infection, etc.

3. The orthopaedic: osteomyelitis, etc.

4. The parasitic infection toxoplasmosis, cryptosporidiosis.

5. Others: skin soft tissue infection

Application

 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.