贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.233110203110203107973109093109263109340.03
210.343105693105813105750.01
单位质量响应值RSD%判断
30394.3330036.270.84数据可信
供试品溶液-24082101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%
5min1-0.0000.11244.950.000.11244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
61031-10310.6810.68
10min14448-44482.9362.845.032.942.845.08
24319-43192.8512.85
34188-41882.7642.76
44023-40232.6562.66
54188-41882.7642.76
64631-46313.0573.06
15min16653-66534.3924.153.964.424.193.97
26312-63124.1664.20
36067-60674.0054.04
46077-60774.0114.04
56126-61264.0444.07
66523-65234.3064.35
20min17383-73834.8734.862.154.954.942.19
27377-73774.8694.95
37411-74114.8924.97
47122-71224.7014.78
57300-73004.8194.89
67608-76085.0225.11
30min17973-79735.2635.111.935.405.241.91
27857-78575.1865.32
37765-77655.1265.26
47611-76115.0245.15
57637-76375.0415.17
67617-76175.0285.17
45min18609-86095.6835.601.265.885.791.29
28517-85175.6225.81
38294-82945.4755.66
48449-84495.5775.76
58533-85335.6335.82
68490-84905.6045.81
60min18745-87455.7725.821.866.036.071.78
29041-90415.9686.22
38805-88055.8126.06
48937-89375.8996.14
58564-85645.6535.90
68799-87995.8086.07
极限19083-90835.9966.011.256.326.321.23
28935-89355.8986.22
39166-91666.0506.36
49109-91096.0136.32
59047-90475.9726.28
69271-92716.1206.45
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.233099563099633100143099643100193099830.01
210.343100123101373100740.03
单位质量响应值RSD%判断
30301.3729987.810.74数据可信
供试品溶液-24082102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%
5min12749-27491.8190.30244.951.820.30244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13724-37242.4642.534.742.482.534.67
23677-36772.4332.43
33809-38092.5202.52
43788-37882.5062.51
54174-41742.7622.76
63738-37382.4732.47
15min15801-58013.8383.932.263.893.962.20
25952-59523.9383.97
35887-58873.8953.92
46018-60183.9824.01
56162-61624.0774.11
65829-58293.8573.88
20min17016-70164.6424.788.634.734.868.41
26947-69474.5964.67
36900-69004.5654.64
46895-68954.5624.63
57106-71064.7024.78
68486-84865.6155.68
30min18943-89435.9175.404.766.065.534.78
28106-81065.3635.49
37922-79225.2415.36
47971-79715.2745.40
57967-79675.2715.40
68074-80745.3425.47
45min18649-86495.7226.099.415.936.289.13
28856-88565.8596.04
38841-88415.8496.03
48812-88125.8306.01
510943-109437.2407.43
69113-91136.0296.22
60min19203-92036.0896.090.626.366.340.50
29223-92236.1026.35
39239-92396.1136.36
49211-92116.0946.34
59087-90876.0126.28
69227-92276.1056.36
极限19072-90726.0026.041.126.346.361.17
29028-90285.9736.29
39116-91166.0316.34
49066-90665.9986.31
59215-92156.0976.43
69293-92936.1496.48
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.233102963102293102373101103102643102270.03
210.343101703099193100440.06
单位质量响应值RSD%判断
30325.2229984.910.80数据可信
供试品溶液-24082101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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11856-18561.2281.2614.181.231.2614.36
22340-23401.5481.55
31624-16241.0741.07
41912-19121.2651.26
51652-16521.0931.09
62087-20871.3801.38
15min13142-31422.0782.054.322.092.074.27
23163-31632.0922.11
33002-30021.9862.00
43256-32562.1542.17
52893-28931.9131.93
63184-31842.1062.12
20min13963-39632.6212.543.952.662.573.97
23808-38082.5192.56
33624-36242.3972.43
44011-40112.6532.69
53700-37002.4472.48
63894-38942.5762.61
30min14592-45923.0373.073.173.103.133.08
24596-45963.0403.11
34716-47163.1193.18
44621-46213.0563.12
54437-44372.9353.00
64877-48773.2263.29
45min15251-52513.4733.401.733.573.501.69
25076-50763.3573.46
35052-50523.3413.44
45083-50833.3623.46
55100-51003.3733.47
65240-52403.4663.57
60min15354-53543.5413.541.303.683.681.30
25288-52883.4973.64
35314-53143.5153.65
45475-54753.6213.76
55296-52963.5033.63
65364-53643.5483.69
极限15390-53903.5653.643.543.743.823.49
25877-58773.8874.07
35441-54413.5993.77
45373-53733.5543.73
55395-53953.5683.74
65573-55733.6863.87
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.233099873100853098113100073098613099500.04
210.343097563097223097390.01
单位质量响应值RSD%判断
30298.1429955.420.81数据可信
供试品溶液-24082102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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11375-13750.9100.9051.420.910.9051.44
21378-13780.9120.91
31730-17301.1451.15
41858-18581.2301.23
51815-18151.2021.20
6-0.0000.00
15min12587-25871.7131.888.351.721.898.55
22940-29401.9461.96
32972-29721.9681.98
43190-31902.1122.13
52692-26921.7821.80
62630-26301.7411.74
20min13471-34712.2982.476.982.332.507.05
23788-37882.5082.54
33951-39512.6162.65
44095-40952.7112.75
53514-35142.3262.36
63535-35352.3402.36
30min14497-44972.9773.032.593.033.092.61
24640-46403.0723.13
34741-47413.1393.20
44661-46613.0863.15
54422-44222.9272.99
64538-45383.0043.05
45min15000-50003.3103.432.613.403.522.48
25125-51253.3933.49
35206-52063.4463.55
45257-52573.4803.58
55085-50853.3663.46
65380-53803.5623.64
60min15486-54863.6323.581.803.763.711.74
25280-52803.4953.63
35540-55403.6683.80
45384-53843.5643.70
55409-54093.5813.71
65329-53293.5283.65
极限15365-53653.5523.631.183.723.801.28
25539-55393.6673.84
35503-55033.6433.82
45528-55283.6603.84
55494-54943.6373.81
65449-54493.6073.76
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