贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.273125503123733124973124213124403124560.03
210.243139763138313139040.04
单位质量响应值RSD%判断
30424.1530654.690.54数据可信
供试品溶液-1996054批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11095-10950.3580.30136.690.360.30136.52
2-0.0000.00
3-0.0000.00
41193-11930.3900.39
5-0.0000.00
63188-31881.0411.04
10min11055-10550.3440.7271.760.350.7271.10
21061-10610.3460.35
35128-51281.6741.67
42610-26100.8520.85
51126-11260.3680.37
62246-22460.7330.74
15min15185-51851.6931.1526.911.691.1526.83
22368-23680.7730.77
33483-34831.1371.14
43605-36051.1771.18
52897-28970.9460.95
63645-36451.1901.19
20min13480-34801.1361.2014.231.141.2014.29
22806-28060.9160.92
34320-43201.4111.42
43998-39981.3051.31
53587-35871.1711.17
63889-38891.2701.27
30min14553-45531.4871.4211.001.491.4210.90
23536-35361.1551.16
34457-44571.4551.46
44987-49871.6281.63
54212-42121.3751.38
64305-43051.4061.41
45min14894-48941.5981.569.391.611.579.32
24077-40771.3311.34
35462-54621.7841.79
44895-48951.5981.61
54636-46361.5141.52
64759-47591.5541.56
60min15231-52311.7081.659.811.721.669.82
24134-41341.3501.36
35621-56211.8351.85
45235-52351.7091.72
55055-50551.6511.66
65101-51011.6661.68
极限15036-50361.6441.645.211.661.665.24
24559-45591.4891.50
35341-53411.7441.76
45063-50631.6531.67
55174-51741.6891.70
64972-49721.6241.64
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.273126293126103125793128383124463126200.05
210.243135033133463134240.04
单位质量响应值RSD%判断
30440.1230607.810.39数据可信
供试品溶液-1996054批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.19168.520.000.19168.17
2-0.0000.00
31154-11540.3770.38
42394-23940.7820.78
5-0.0000.00
6-0.0000.00
10min11551-15510.5070.6524.040.510.6524.09
21809-18090.5910.59
32571-25710.8400.84
42591-25910.8460.85
51672-16720.5460.55
61665-16650.5440.54
15min12720-27200.8891.0317.300.891.0317.36
22864-28640.9360.94
34041-40411.3201.32
43597-35971.1751.18
52880-28800.9410.94
62765-27650.9030.90
20min13369-33691.1011.2720.151.101.2820.17
23315-33151.0831.09
35309-53091.7341.74
44293-42931.4031.41
53407-34071.1131.12
63643-36431.1901.19
30min13874-38741.2661.3912.991.271.4013.06
23700-37001.2091.21
34916-49161.6061.61
45003-50031.6341.64
54005-40051.3081.31
64096-40961.3381.34
45min14429-44291.4471.5811.821.451.5811.90
24381-43811.4311.44
35718-57181.8681.88
45362-53621.7521.76
54484-44841.4651.47
64567-45671.4921.50
60min14559-45591.4891.7213.311.501.7313.28
25054-50541.6511.66
35905-59051.9291.94
46328-63282.0672.08
54956-49561.6191.63
64744-47441.5501.56
极限15135-51351.6781.788.001.691.808.05
25065-50651.6551.67
36041-60411.9741.99
45819-58191.9011.92
55019-50191.6401.65
65625-56251.8381.85
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.273130283131603131703131203132753131510.03
210.243128133130923129520.07
单位质量响应值RSD%判断
30491.8230561.720.17数据可信
供试品溶液-1996054批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11422-14220.4650.08244.950.460.08244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12319-23190.7581.5592.320.761.5492.38
23235-32351.0571.06
33193-31931.0431.04
42975-29750.9720.97
513618-136184.4494.45
63039-30390.9930.99
15min15052-50521.6501.564.261.651.574.06
24839-48391.5811.58
34668-46681.5251.53
44579-45791.4961.50
54598-45981.5021.51
64993-49931.6311.63
20min15963-59631.9481.934.871.951.944.82
25823-58231.9021.91
35698-56981.8611.87
45742-57421.8761.88
55786-57861.8901.90
66472-64722.1142.12
30min16953-69532.2712.222.102.282.222.13
26925-69252.2622.27
36670-66702.1792.19
46694-66942.1872.19
56852-68522.2382.25
66619-66192.1622.17
45min17616-76162.4882.617.052.502.627.14
27633-76332.4932.50
37654-76542.5002.51
48302-83022.7122.72
59002-90022.9412.96
67714-77142.5202.53
60min18123-81232.6532.723.822.672.743.69
28504-85042.7782.79
38260-82602.6982.71
48318-83182.7172.73
57927-79272.5892.61
68840-88402.8882.90
极限18361-83612.7312.771.132.752.791.17
28614-86142.8142.83
38513-85132.7812.80
48430-84302.7542.77
58572-85722.8002.83
68439-84392.7572.78
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.273126883130883130383127823131213129430.07
210.243124473127973126220.08
单位质量响应值RSD%判断
30471.5730529.490.14数据可信
供试品溶液-1996054批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min12888-28880.9440.886.270.940.886.11
22825-28250.9240.92
32491-24910.8140.81
42529-25290.8270.83
52791-27910.9130.91
62600-26000.8500.85
15min15151-51511.6841.487.671.691.487.84
24567-45671.4931.49
34643-46431.5181.52
44197-41971.3721.37
54411-44111.4421.44
64248-42481.3891.39
20min15630-56301.8411.734.461.851.734.42
25147-51471.6831.69
35347-53471.7481.75
45379-53791.7591.76
55273-52731.7241.73
64932-49321.6121.62
30min16643-66432.1722.141.992.182.152.09
26517-65172.1312.14
36756-67562.2092.22
46415-64152.0972.10
56546-65462.1402.15
66432-64322.1032.11
45min17780-77802.5442.442.712.552.452.62
27470-74702.4422.45
37243-72432.3682.38
47307-73072.3892.40
57578-75782.4782.49
67339-73392.3992.41
60min18055-80552.6342.513.022.652.523.09
27701-77012.5182.53
37782-77822.5442.56
47583-75832.4792.49
57371-73712.4102.42
67580-75802.4782.49
极限18076-80762.6402.765.542.662.785.43
29040-90402.9562.97
38384-83842.7412.76
48722-87222.8522.87
58695-86952.8432.86
67768-77682.5402.56
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