依折麦布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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159645409666079665279638879673599657840.16
211.179656349661799659060.04
单位质量响应值RSD%判断
86617.4086473.230.12数据可信
供试品溶液-1996049批-依折麦布-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%
5min147008-470084.8765.074.034.885.074.02
249686-496865.1545.15
346222-462224.7954.79
451018-510185.2925.29
550735-507355.2635.26
648505-485055.0325.03
10min167872-678727.0406.911.767.096.961.75
266007-660076.8476.90
365684-656846.8146.87
468229-682297.0787.14
566058-660586.8526.91
665570-655706.8026.86
15min172943-729437.5677.452.377.707.582.37
273515-735157.6267.76
369812-698127.2427.37
473468-734687.6217.76
570142-701427.2767.41
670974-709747.3627.49
20min174782-747827.7577.632.117.977.842.12
275369-753697.8188.04
371190-711907.3857.59
473631-736317.6387.86
573768-737687.6527.87
672312-723127.5017.71
30min175537-755377.8367.822.508.148.122.46
278716-787168.1658.47
374336-743367.7118.00
475991-759917.8838.19
574128-741287.6897.99
673509-735097.6257.92
45min177849-778498.0757.991.668.478.371.65
278775-787758.1718.57
377322-773228.0218.40
476733-767337.9608.35
575330-753307.8148.20
675881-758817.8718.25
60min175241-752417.8057.961.368.288.441.31
277902-779028.0818.57
377993-779938.0908.56
476705-767057.9578.44
576247-762477.9098.38
676606-766067.9468.42
极限177620-776208.0527.961.388.628.531.39
278381-783818.1318.71
376150-761507.8998.46
476825-768257.9698.54
576176-761767.9028.46
675547-755477.8378.39
依折麦布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对照品来源中检院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100
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%
110.162570452580892578462568822570122573750.22
210.192563172561862562520.04
单位质量响应值RSD%判断
25332.1925147.400.52数据可信
供试品溶液-1996049批-贝派度酸-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%
5min12386-23860.9430.876.440.940.876.22
22300-23000.9090.91
32213-22130.8740.87
42075-20750.8200.82
52285-22850.9030.90
62015-20150.7960.80
10min14571-45711.8061.636.151.821.646.28
24060-40601.6041.61
34244-42441.6771.69
44004-40041.5821.59
54086-40861.6141.62
63826-38261.5121.52
15min15569-55692.2002.3732.632.232.4032.16
25101-51012.0152.04
35009-50091.9792.01
49993-99933.9483.97
55252-52522.0752.10
65139-51392.0302.06
20min15810-58102.2962.5920.412.352.6419.97
26473-64732.5572.61
36071-60712.3992.45
45781-57812.2842.35
59230-92303.6473.70
65935-59352.3452.39
30min16867-68672.7132.662.622.792.742.53
26691-66912.6442.72
36972-69722.7552.83
46672-66722.6362.73
56774-67742.6762.77
66462-64622.5532.63
45min17312-73122.8893.052.923.003.162.92
27715-77153.0483.16
37738-77383.0573.16
47865-78653.1073.23
57979-79793.1523.27
67740-77403.0583.16
60min18045-80453.1793.4617.883.323.6017.13
27996-79963.1593.30
311919-119194.7094.85
48034-80343.1743.33
58496-84963.3573.51
68007-80073.1643.30
极限18383-83833.3123.535.153.493.714.93
28719-87193.4453.62
39570-95703.7813.97
48852-88523.4973.69
58653-86533.4193.61
69401-94013.7143.89
依折麦布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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159695639698319687269690869685579691530.06
211.179708749703439706080.04
单位质量响应值RSD%判断
86919.5586894.180.03数据可信
供试品溶液-1996049批-依折麦布-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%
5min146611-466114.8154.968.134.814.958.18
250792-507925.2475.25
351719-517195.3435.34
450619-506195.2295.23
541380-413804.2754.27
646678-466784.8224.82
10min165432-654326.7596.842.386.816.892.45
267752-677526.9997.06
367899-678997.0147.07
466591-665916.8796.94
563763-637636.5876.63
665573-655736.7746.83
15min169234-692347.1527.262.537.287.402.56
270693-706937.3037.44
372417-724177.4817.62
472056-720567.4437.58
567719-677196.9957.12
669781-697817.2087.34
20min171523-715237.3887.501.917.607.711.94
274565-745657.7037.92
373330-733307.5757.80
473453-734537.5887.80
571787-717877.4167.61
670990-709907.3337.54
30min173103-731037.5527.692.057.847.982.02
276983-769837.9528.26
373014-730147.5427.85
475232-752327.7718.07
574527-745277.6997.98
673628-736287.6067.90
45min174030-740307.6477.883.038.028.263.00
279864-798648.2508.64
377298-772987.9858.37
477526-775268.0088.40
574603-746037.7078.07
674472-744727.6938.07
60min172279-722797.4667.782.647.938.252.56
277943-779438.0528.53
374936-749367.7418.22
476995-769957.9548.43
575332-753327.7828.23
674572-745727.7038.16
极限174441-744417.6907.851.888.238.401.91
278455-784558.1048.68
375761-757617.8268.39
476626-766267.9158.48
575630-756307.8138.35
674923-749237.7408.29
依折麦布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对照品来源中检院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100
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%
110.162578652573522576252578062573012575900.10
210.192568072573602570840.16
单位质量响应值RSD%判断
25353.3525229.050.35数据可信
供试品溶液-1996049批-贝派度酸-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%
5min12319-23190.9141.0343.060.911.0343.19
21807-18070.7120.71
32094-20940.8260.83
44781-47811.8851.89
51869-18690.7370.74
62745-27451.0821.08
10min14441-44411.7511.6516.071.761.6615.91
25454-54542.1502.16
33833-38331.5111.52
43919-39191.5451.57
53681-36811.4511.46
63810-38101.5021.51
15min14836-48361.9072.058.931.942.088.71
24991-49911.9682.00
35980-59802.3582.38
45451-54512.1492.19
54723-47231.8621.89
65259-52592.0742.10
20min17634-76343.0102.4512.813.062.5012.51
26693-66932.6392.69
35764-57642.2732.32
45777-57772.2782.34
55784-57842.2812.33
65629-56292.2192.27
30min16492-64922.5602.7910.662.642.8710.32
26866-68662.7072.79
36758-67582.6652.74
47130-71302.8112.90
56694-66942.6392.71
68564-85643.3773.45
45min17132-71322.8122.955.222.923.065.13
27217-72172.8462.96
37221-72212.8472.95
48145-81453.2113.33
57733-77333.0493.15
67457-74572.9403.05
60min18202-82023.2343.4515.703.383.6015.20
28663-86633.4163.56
37443-74432.9353.07
410852-108524.2794.43
57461-74612.9423.08
69912-99123.9084.05
极限18325-83253.2823.352.733.463.532.51
28511-85113.3563.54
38302-83023.2733.44
48344-83443.2903.49
58890-88903.5053.67
68647-86473.4093.60
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