This product is applicable to moderate to severe infections caused by -lactamase producing bacteria that are resistant to piperacillin but sensitive to piperacillin tazobactam: 1.Appendicitis (with perforation or abscess) and peritonitis caused by piperacillin - resistant, lactamase - producing Escherichia coli and Bacteroides genera (Bacteroides fragilis, Bacteroides ovale, Bacteroides polyformis or common Bacteroides).2.Uncomplicated and complex skin and soft tissue infections caused by piperacillin - resistant, -lactamase-producing Staphylococcus aureus, including cellulitis, skin abscesses, ischemic or diabetic foot infections.3.Postpartum endometritis or pelvic inflammatory disease caused by piperacillin - resistant, -lactamase-producing Escherichia coli.4.Community-acquired pneumonia caused by piperacillin - resistant, -lactamase-producing Haemophilus influenzae (only moderate).5.Moderate to severe hospital-acquired pneumonia (in-hospital pneumonia) caused by piperacillin - resistant staphylococcus aureus producing lactamase.To treat systemic and/or local bacterial infections caused by sensitive bacteria.
| ITEMS |
SPECIFICATION |
RESULT |
| Identification |
Complies |
Complies |
| Tests |
|
|
| Water |
≤2.5% |
0.66% |
| Acidity |
5.0~7.0 |
6.21 |
| Formulated solution |
|
|
| Completeness solubility |
No visible residue as undissolved matter |
No visible residue as undissolved matter |
| Clarity of solution |
Clarified |
Clarified |
| Particulate matter |
Not detected |
Not detected |
| Sub-visible particles |
≥10um,≤6000Particles/Bottle |
133.2Particles/Bottle |
| ≥25um,≤600Particles/Bottle |
2.0Particles/Bottle |
| Related substances |
|
|
| Tazobactam related compound A |
≤1.0% |
0.04% |
| Piperacillin impurity4 |
≤1.0% |
0.04% |
| Piperacillin penilloic acid |
≤1.0% |
Not detected |
| Piperacillin penicilloic acid |
≤5.0% |
0.08% |
| Acetylated penicilloic acid of piperacillin |
≤1.0% |
0.01% |
| Piperacillin impurity 5 |
≤1.0% |
0.05% |
| Piperacillin impurity 6 |
≤1.0% |
0.01% |
| Single unkown impurity |
≤1.0% |
0.28% |
| Total impurities does not include piperacillin penicilloic acid |
≤5.0% |
0.56% |
| Uniformity of dosage units |
Piperacillin:AV≤15.0 |
1.22 |
| Tazobactam:AV≤15.0 |
2.76 |
| Bacterial endotoxins |
Not more than 0.08EU in a portion equivalent to 1 mg of a mixture of piperacillin and tazobactam |
<0.08EU/mg |
| Sterility |
Complies |
Complies |
| Assay |
NLT 90.0% and NMT 110.0% of the labeled amount of piperacillin |
99.20% |
| NLT 90.0% and NMT 110.0% of the labeled amount of tazobactam |
102.10% |
Reyoung Pharmaceutical Co., Ltd., established in 1966, is one of the leading manufacturer and distributor of pharmaceutical products in China. Reyoung Pharma is an GMP, ISO9001, ISO14001, OHS18001 authentication enterprise and so on. The trademark "REYOUNG" is famous trademark of China.
Reyoung Pharma has three main factories which covers an area of 1,000,000 square meters and owns total asset of more than 1.5 billion USD dollar. There is more than 5000 staff in Reyoung Pharma, of whom approximate 21 percent of the total staff is sales & marketing personnel. Reyoung Pharma has 30 workshops that can produce ten categories and more than 400 specifications of pharmaceutical products including tablets, capsules, granules, sterile active ingredients, small volume injection, powder for injection, lyophilized powder for injection, suppository, traditional Chinese medicine and aerosol. The annual production capacity can reach 2.5 billion vials of powder for injection, 300 million ampoules of liquid injection, 4 billion tablets, 6 billion capsules and 200 million bags granule of solid formulation, and 2000 tons API respectively. As a professional pharmaceutical manufacturer, Reyoung Pharma is the first enterprise to manufacture powder for injection in Shandong province. The sales and marketing network for its products covers all the big and medium cities through the mainland of PRC and also has been successfully covered more than 70 countries all over the world. In order to praise Reyoung Pharma making so much contribution to Chinese pharmaceutical industry, the government granted many awards and certifications, such as state-focused high & new tech enterprise of China, national contract-stressing and promise-keeping enterprise of China, the production base of cephalosporin raw material, advanced Collective of pharmaceutical industry of Shandong province and so on.
Reyoung Pharma commenced international business and exported products in 1997. Reyoung Pharma, with an excellent sales&documentation team, owned over 20 years experience in the international transaction and registered products in different countries. Reyoung Pharma has passed the GMP inspection of Colombia, Peru, Congo, Ethiopia, Uganda, Nigeria, Ghana, Tanzania, Kenya, Cote d′Ivoire, Pakistan, Ukraine, Philippines, Cambodia, etc. Products have been exported to Asia, South America, Africa, CIS Countries, Middle East and Europe including Thailand, Philippines, Cambodia, Hong Kong, Vietnam, India, Pakistan, Colombia, Peru, Chile, Costa Rica, Venezuela, Congo, Ethiopia, Uganda, Nigeria, Tanzania, Kenya, Cameroon, Russia, Kazakhstan, Ukraine, Uzbekistan, Georgia, Yemen, Iraq, Germany, Denmark, and so on.
Look into the future, as entering into the market successively of the new products, the product structure of Reyoung Pharma will be upgraded, the producing levels and the market-controlling power will be enhanced further, and Reyoung Pharma will provide a wider platform for our old and new friends to go hand in hand and seek common development.
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