| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | Internal Use |
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Vancomycin hydrochloride for injection, the indication is that this product is suitable for infections caused by methicillin-resistant Staphylococcus aureus and other bacteria: sepsis, infective endocarditis, osteomyelitis, arthritis, burns, surgical trauma, etc. Superficial secondary infection, pneumonia, lung abscess, empyema, peritonitis, meningitis.
| ITEMS | SPECIFICATION | RESULT |
| Characters | White, almost white, or tan to brown, free-flowing powder, odorless, and having a bitter taste. | Almost white, free-flowing powder, odorless. |
| Identification | Complies | Complies |
| Tests | ||
| pH value | 2.5~4.5 | 2.7 |
| Water | ≤5.0% | 1.54% |
| Uniformity of dosage units | AV≤15.0 | 1.99 |
| Sub-visible particles | ≥10um,≤6000Particles/Bottle | 44.9Particles/Bottle |
| ≥25um,≤600Particles/Bottle | 0.0Particles/Bottle | |
| Formulated solution | ||
| Completeness solubility | No visible residue as undissolved matter | No visible residue as undissolved matter |
| Clarity of solution | Clarified | Clarified |
| Particulate matter | No detected | Not detected |
| Bacterial endotoxins | Not more than 0.33EU per mg of vancomycin | <0.33EU/mg |
| Sterility | Complies | Complies |
| Assay | Vancomycin B≥80.0% | 94.66% |
| the area of any other peak≤9.0% | 1.48% | |
| NLT 90.0% and NMT 115.0% of the labeled amount of vancomycin | 99.08% |
Reyoung Pharmaceutical Co., Ltd., established in 1966, is one of the leading manufacturer and distributor of pharmaceutical products in China. Reyoung Pharma is certificated by GMP, ISO9001, ISO14001, OHS18001. The trademark "REYOUNG" is famous trademark of China.
This product is used for treatment of moderate to severe infections caused by β-lactamase-producing bacteria that are resistant to cefoperazone monotherapy and sensitive to this product. When used for the treatment of mixed infections caused by cefoperazone single-drug-sensitive bacteria and cefoperazone single-drug-resistant β-lactamase-producing bacteria sensitive to this product, no additional antibiotics are required. Lower respiratory tract infection: susceptible to β-lactamase-producing Pseudomonas aeruginosa, Streptococcus pneumoniae and other Streptococcus, Klebsiella pneumoniae and other Klebsiella species, Haemophilus influenzae, Staphylococcus aureus, etc. bacterial pneumonia, acute exacerbations of chronic bronchitis, acute bronchitis, lung abscesses and other lung infections. Urogenital infection: acute pyelonephritis, acute pyelonephritis caused by sensitive bacteria such as β-lactamase-producing Escherichia coli, Proteus, Klebsiella, Pseudomonas aeruginosa, and Staphylococcus Exacerbations, complicated urinary tract infections, endometritis, gonorrhea, and other reproductive tract infections. Abdominal and pelvic infections.
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