| ITEMS |
SPECIFICATION |
RESULT |
| Characters |
White to milky white ,crystalline powder |
Almost white crystalline powder. |
| Identification |
|
|
| A |
Complies |
Complies |
| B |
Positive |
Positive |
| Tests |
|
|
| Acidity |
5.0~7.5 |
6.15 |
| Loss on drying |
≤13.5% |
12.84% |
| Sodium carbonate |
8.0%~10.0%( Moisture) |
9.64% |
| Sub-visible particles |
≥10um,≤6000Particles/Bottle |
110.2Particles/Bottle |
| |
≥25um,≤600Particles/Bottle |
2.8Particles/Bottle |
| 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 |
| Uniformity of dosage units |
AV≤15.0 |
6.86 |
| Limit of pyridine |
≤0.4% |
0.06% |
| Bacterial endotoxins |
It contains not more than 0.1 Endotoxin Unit per mg of ceftazidime |
<0.1EU/mg |
| Sterility |
Complies |
Complies |
| Assay |
It contains not less than 90.0 percent and not more than 105.0 percent of ceftazidime (C22>H22N6O7S2)on the dried and sodium carbonate free basis |
99.75% |
| NLT 90.0% and NMT 120.0% of the labeled amount of ceftazidime (C22H22N6O7S2) |
100.70% |
Ceftazidime is indicated for the treatment of the following infections :
Respiratory Tract infection such as pneumonia, bronchitis , etc.; mixed infections caused by two or more susceptible organisms.
Ear, nose and throat infections; renal and urinary tract infections; Sepsis , meningitis; pre-operative prophylaxis of infections;
Infections of bones and joins; infections of skin, wounds and soft tissue; peritonitis , cholecystitis, cholangitis and infection of gastrointestinal tract; general infections such as gonorrhea etc.; infections in patients with impaired defence mechanisms.
Ceftazidime can be used for the treatment of infections caused by organisms that are resistant to other antibiotics such as amino glycosides and many cephalosporins
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.
Audited Supplier 
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