Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Cefepime for injection, USP is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C19H24N6O5S2).
Items
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Specifications
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Results
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Appearance
|
White powder |
Confirm
|
Odor& Taste
|
Characteristic
|
Confirm
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Loss on drying
|
≤8.0%
|
2.8%
|
Assay(HPLC)
|
10.0% min
|
10.2%
|
Ash
|
≤1.0%
|
0.35%
|
Heavy Metal
|
≤10 ppm
|
Confirm
|
As
|
≤1.0ppm
|
Confirm
|
Pb
|
≤1.0ppm
|
Confirm
|
Cd
|
≤1.0ppm
|
Confirm
|
Hg
|
≤0.1ppm
|
Confirm
|
Total plate count
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≤1000 cfu/g
|
Confirms
|
Yeast&Mold
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≤100 cfu/g
|
Confirms
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E.Coli
|
Negative
|
Negative
|
Salmonella
|
Negative
|
Negative
|
Staphylococcus aureus
|
Negative
|
Negative
|