HEBEI SINOAH PHARM-TECH CO., LTD.  

Product Name: GMP Spiramycin/CAS: 8025-81-8/GMP/Pharmaceutical Model NO.: EP/USP Volatile: Not Volatile State: Solid Type: Analysis reagent Grade Standard: Medicine Grade Certification: GMP Function: Antibiotic and Antimicrobial Agents Trademark: SINOAH Transport Package: 25kg/Drum Specification: EP/USP Origin: China Product Description Spiramycin/CAS: 8025-81-8/GMP/PharmaceuticalGMP certified Spiramycin API 8025-81-8Product DescriptionSpiramycin 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.ParametersItemsSpecificationsResultsAppearanceA white or slightly yellowish powderWhite powderIdentificationConformA. UV SpectrumThe specific absorbance at the maximum (232nm) is about 340.B. TLCCorresponds to reference solution.C. Color ReactionBrown colour.pH8.5-10.59.6Specific 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 %ConformHeavy metals≤20ppmConformLoss on drying≤3.5 %1.40%Sulphated ash≤0.1 %ConformAssay (wet substance)No limits (IU/mg)4305 IU/mgAssay (dried substance)≥4100 IU/mg4366 IU/mgConCLUSIONCONFORM TO EP VIIFunctionSpiramycin 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 infectionApplicationThis 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.