Storage conditions

Storage time(days)

Assay (based on the labeled amount of cefpiramide)

crystalline form

amorphous form

A-1

A-2

B-1

B-2

B-3

Initial (0 day)

105.7%

106.3%

97.2%

94.4%

90.8%

40°C/75% RH

10 days

106.1%

105.8%

93.4%

90.5%

87.6%

20 days

105.0%

105.1%

91.7%

91.0%

84.3%

40 days

105.0%

104.6%

91.4%

89.6%

83.2%

60 days

103.5%

104.1%

88.4%

85.8%

82.1%

Maximum change

-2.2%

-2.2%

-8.8%

-8.6%

-8.7%

60°C/75% RH

30 days

103.1%

104.0%

82.8%

77.6%

75.7%

60 days

103.4%

104.0%

73.5%

64.2%

66.3%

Maximum change

-2.6%

-2.3%

-23.7%

-30.2%

-24.5%

Table 3: Stability data of assay for up to 60 days at 40°C/75% RH and 60°C/75%
RH, respectively.
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