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%
110.053050553048533048733052783050773050270.06
210.123041563043083042320.04
单位质量响应值RSD%判断
30350.9530062.450.68数据可信
供试品溶液-2010685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%
5min1-0.0000.32244.950.000.32244.95
22867-28671.8931.89
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11613-16131.0651.0512.091.071.0512.32
21632-16321.0781.10
31365-13650.9010.90
41491-14910.9840.98
51922-19221.2691.27
61489-14890.9830.98
15min12747-27471.8141.833.751.831.853.77
22791-27911.8431.88
32694-26941.7791.79
42674-26741.7661.78
52966-29661.9581.97
62782-27821.8371.85
20min13452-34522.2792.261.302.312.291.43
23416-34162.2552.31
33362-33622.2202.25
43391-33912.2392.27
53487-34872.3022.34
63406-34062.2492.28
30min14120-41202.7203.1215.522.783.1815.43
25997-59973.9604.04
35019-50193.3143.37
44130-41302.7272.78
54231-42312.7942.86
64851-48513.2033.26
45min15184-51843.4233.134.593.513.234.38
24693-46933.0993.22
34706-47063.1073.20
44606-46063.0413.13
54622-46223.0523.14
64672-46723.0853.18
60min14863-48633.2113.231.813.343.361.99
24985-49853.2913.45
34894-48943.2313.36
44838-48383.1943.31
55008-50083.3073.43
64777-47773.1543.28
极限15310-53103.5063.382.993.673.552.90
25138-51383.3923.59
35075-50753.3513.51
45280-52803.4863.64
54938-49383.2603.42
64982-49823.2893.45
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%
110.053037333034353032373039123034653035560.09
210.123023083024433023760.04
单位质量响应值RSD%判断
30204.5829879.050.77数据可信
供试品溶液-2010685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
10min11622-16221.0771.149.141.081.148.97
21916-19161.2721.27
31769-17691.1741.17
41456-14560.9670.97
51759-17591.1681.17
61759-17591.1681.17
15min12834-28341.8811.921.411.891.931.51
22945-29451.9551.97
32911-29111.9331.95
42861-28611.8991.91
52903-29031.9271.94
62865-28651.9021.92
20min13560-35602.3632.444.942.402.474.87
23506-35062.3282.36
33894-38942.5852.62
43470-34702.3042.34
53801-38012.5232.56
63807-38072.5272.56
30min14168-41682.7672.794.312.832.854.20
24537-45373.0123.07
34243-42432.8172.88
44126-41262.7392.80
54095-40952.7192.78
64024-40242.6722.73
45min14658-46583.0923.133.063.183.222.86
24707-47073.1253.22
34642-46423.0823.18
44996-49963.3173.40
54611-46113.0613.15
64645-46453.0843.18
60min15024-50243.3353.355.573.463.485.41
24928-49283.2723.40
35604-56043.7203.85
44963-49633.2953.42
54886-48863.2443.37
64856-48563.2243.35
极限18538-85385.6683.9123.265.834.0722.29
25015-50153.3293.50
35225-52253.4693.64
45316-53163.5293.69
56203-62034.1184.28
65035-50353.3433.50
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%
110.053038793042413046653045873041463043040.11
210.123033973027673030820.15
单位质量响应值RSD%判断
30279.0029948.810.78数据可信
供试品溶液-2010685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%
5min11599-15991.0590.18244.951.060.18244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13097-30972.0511.907.402.061.907.50
22782-27821.8431.84
32824-28241.8701.87
42659-26591.7611.76
52701-27011.7891.79
63172-31722.1012.10
15min14716-47163.1233.022.133.163.052.29
24579-45793.0333.05
34467-44672.9592.98
44456-44562.9512.97
54560-45603.0203.04
64618-46183.0593.08
20min16034-60343.9963.763.364.073.823.48
25595-55953.7063.76
35719-57193.7883.84
45487-54873.6343.69
55575-55753.6923.75
65695-56953.7723.83
30min17048-70484.6684.541.814.784.641.90
26711-67114.4454.54
36763-67634.4794.57
46809-68094.5104.60
56943-69434.5984.69
66854-68544.5394.64
45min17858-78585.2045.181.615.375.321.57
27926-79265.2495.39
37655-76555.0705.22
47940-79405.2595.40
57665-76655.0775.22
67848-78485.1985.35
60min18018-80185.3105.442.205.535.652.06
28160-81605.4045.61
38045-80455.3285.53
48456-84565.6005.80
58219-82195.4435.65
68398-83985.5625.77
极限18693-86935.7575.660.906.045.931.00
28482-84825.6185.88
38575-85755.6795.94
48502-85025.6315.89
58515-85155.6405.90
68536-85365.6535.92
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%
110.053028953030403028043032173026843029280.07
210.123022003019703020850.06
单位质量响应值RSD%判断
30142.0929850.300.69数据可信
供试品溶液-2010685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
10min12702-27021.7971.854.441.801.854.38
22680-26801.7821.78
32932-29321.9491.95
42954-29541.9641.96
52705-27051.7991.80
62738-27381.8201.82
15min14632-46323.0803.3826.223.103.4026.07
24505-45052.9953.02
37796-77965.1845.21
44517-45173.0033.03
54574-45743.0413.06
64461-44612.9662.99
20min15790-57903.8503.753.683.903.813.64
25561-55613.6983.75
35678-56783.7753.85
45401-54013.5913.65
55461-54613.6313.68
65949-59493.9554.01
30min16728-67284.4734.490.624.574.590.80
26737-67374.4794.57
36829-68294.5414.66
46766-67664.4994.59
56715-67154.4654.56
66744-67444.4844.58
45min17891-78915.2475.241.435.395.391.39
27989-79895.3125.46
37899-78995.2525.42
47717-77175.1315.28
57795-77955.1835.33
68012-80125.3275.47
60min18181-81815.4405.692.435.645.902.46
28705-87055.7885.99
38750-87505.8186.05
48611-86115.7255.93
58491-84915.6465.85
68651-86515.7525.96
极限18346-83465.5495.592.555.815.862.39
28829-88295.8706.14
38231-82315.4735.77
48336-83365.5435.81
58331-83315.5395.80
68336-83365.5435.81
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