| Function: | Anti-Allergic Agents, Respiratory System Agents |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
Suppliers with verified business licenses
Audited Supplier | Items | Standard of quality | Results of analysis |
| Characters | White or almost white powder | Meets the requirements |
| Solubility | Soluble in water,lightly soluble in methanol,undissolved in aether,acetone and chloroform | Meets the requirements |
| Identification | Positive reaction | Positive reaction |
| PH | 5.0-7.0 | 5.7 |
| Related Substance | NMT3.0% | 1.6% |
| Loss on drying | NMT2.0% | 1.3% |
| Residue on ignition | NMT0.3% | 0.1% |
| Heavy metal | NMT 20ppm | NMT 20ppm |
| Clarithromycin rotation | -94° to -102° | -99.85° |
| Assay Clarithromycin | NLT 608μg/mg O.D.B. | 673μg/mg |
| Residual solvent | Acetone≤5000ppm | 507ppm |
| Bacteric Endotoxin | ≤0.47Eu/mg | <0.47Eu/mg |
| Microbial testing | Escherichia coli:Absent/g | Meets the requirements |
| Total aerobic microbial count:<100cfu/g | Meets the requirements | |
| Total coliform count:<10cfu/g | Meets the requirements | |
| Total yeasts and molds count:<10molds/g | Meets the requirements | |
| Pseudomona aeroginosa:Absent/g | Meets the requirements | |
| Staphylococcus aureus:Absent/g | Meets the requirements | |
| Salmonella s.p:Absent/g | Meets the requirements | |
| Storage | Maintain temperature under 20ºC on dry environment. | |
| Usage Life | 36 months | |
Suppliers with verified business licenses
Audited Supplier 
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