Product name

Meropenem for injection (with Sodium Carbonate)

Test Date

2013.04.10

Batch No.

2013.04.10

Report Date

2013.04.12

Quantity

20.8kg

Retest period:

2017.05.01

Items

Specifications

Results

Character

Appearance

White to light yellow powder

Light yellow powder

Solubility

Soluble in water

   Soluble in water

Identification

IR

Conforms to meropenem USP RS

Conforms

HPLC

Should be identical to that of USP RS

Conforms

Constituted Solution

Clarity of solution

The solution should be clear

Conforms

Visible Particles

Free from Visible Particles

Conforms

Color of solution

Not more than GY3

<GY3

Bacterial Endotoxins

Less than 0.125 EU/mg

<0.125 EU/mg

Sterility

Meets the requirements

Conforms

pH

Between 7.3 and 8.3

8.1

Loss on Drying

Between 9.0% and 12.0%

9.9%

Heavy Metals

Not more than 10ppm

<10ppm

Particulate Matter

Great than 10 μ m

Not more than 3000/g

115/g

Great than 25 μ m

Not more than 300/g

0/g

Content of Sodium

As is

Between 6.2% and 7.6%

7.3%

Of labeled amount

Between 90% and 110%

105%

Related Substances

Impurity RRT 0.45

Not more than 0.4%

0.04%

Impurity RRT 1.9

Not more than 0.4%

0.08%

Any unspecified impurity

Not more than 0.10%

0.02%

Sum of impurities

Not more than 2.0%

0.18%

Assay

On the dried basis

Between 78.0% and 86.0%

79.6%

Of labeled amount

Between 95.0% and 105.0%

96.8%

Residual Solvents

Aceton e

Not more than 500ppm

33ppm

Bulk Density

0.25~0.50g/ml

0.41g/ml

Tapped Density

0.50~0.80g/ml

0.68g/ml

Particle Size Distribution

D50

Not more than 150μ m

101.386 μ m

D90

Not more than 300μ m

241.437 μ m

Conclusion

The material complies as per USP 34