贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
110.901124494112327511244441126276112322211243420.12
211.021154123115367211538980.03
单位质量响应值RSD%判断
103150.64104709.441.07数据可信
供试品溶液-24032001批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149406-494064.2654.3831.384.264.3831.38
265745-657455.6755.67
374576-745766.4376.44
438658-386583.3373.34
538929-389293.3603.36
637089-370893.2013.20
10min191832-918327.9277.5211.837.977.5711.95
294042-940428.1178.18
3102016-1020168.8068.88
480278-802786.9296.97
577816-778166.7176.75
676866-768666.6356.67
15min1112096-1120969.6768.358.389.818.488.37
295470-954708.2418.39
398723-987238.5218.69
491491-914917.8978.01
591935-919357.9358.05
690742-907427.8327.94
20min1117925-11792510.1798.5010.0610.428.729.92
299366-993668.5778.82
393350-933508.0588.32
494245-942458.1358.34
593721-937218.0908.29
691881-918817.9318.13
30min1137334-13733411.8549.0216.1312.219.3415.83
2101094-1010948.7269.07
3105947-1059479.1459.50
494952-949528.1968.49
593371-933718.0598.35
693973-939738.1118.40
45min1174550-17455015.0669.8028.0915.5510.2227.30
294946-949468.1958.63
3123208-12320810.63511.09
496214-962148.3058.69
597385-973858.4068.79
694659-946598.1718.55
60min1223374-22337419.28110.6740.4419.9411.2039.17
2110707-1107079.55610.08
3120831-12083110.43011.00
496677-966778.3458.82
595779-957798.2678.74
694254-942548.1368.60
极限1253379-25337921.87112.0445.1722.7412.6843.76
2168015-16801514.50215.14
3130492-13049211.26411.95
495078-950788.2078.78
594558-945588.1628.73
695083-950838.2078.76
贝派度酸依折麦布片项目信息
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%
110.103052103048653050683046683040213047660.16
210.173138333129683134000.20
单位质量响应值RSD%判断
30174.8530816.131.49数据可信
供试品溶液-24032001批-贝派度酸-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13782-37821.2370.89135.551.240.89135.57
23129-31291.0231.02
39353-93533.0593.06
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min115508-155085.0724.1166.125.094.1266.25
220353-203536.6566.67
323319-233197.6267.66
44466-44661.4611.46
57771-77712.5412.54
64059-40591.3271.33
15min124870-248708.1335.5165.008.205.5665.09
227140-271408.8768.96
328353-283539.2729.39
47109-71092.3252.34
57074-70742.3132.34
66533-65332.1372.15
20min128921-289219.4586.1658.929.626.2859.07
228905-289059.4539.64
329031-290319.4949.72
49002-90022.9442.99
58767-87672.8672.92
68346-83462.7292.77
30min132326-3232610.5726.7954.8410.846.9855.09
229860-298609.76510.05
331256-3125610.22210.55
410518-105183.4403.51
510349-103493.3843.47
610332-103323.3793.45
45min132811-3281110.7306.9851.4811.117.2451.84
230850-3085010.08910.49
330418-304189.94810.39
411486-114863.7563.87
511376-113763.7203.84
611178-111783.6563.76
60min133742-3374211.0357.1950.6211.547.5351.00
230953-3095310.12310.63
331615-3161510.33910.89
411951-119513.9084.06
511826-118263.8684.03
611807-118073.8614.01
极限133508-3350810.9587.2549.8011.587.6750.23
231354-3135410.25410.88
331828-3182810.40911.08
412109-121093.9604.16
511903-119033.8934.10
612332-123324.0334.22
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
110.901143398114303711437051139575113758511414600.24
211.021122821112276611227940.01
单位质量响应值RSD%判断
104721.10101886.931.94数据可信
供试品溶液-24032001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%
5min147803-478034.15227.6691.194.1527.6691.20
260370-603705.2435.24
353123-531234.6144.61
4607118-60711852.72852.73
5582838-58283850.62050.62
6559931-55993148.63048.63
10min181482-814827.07742.2490.437.1242.5590.44
289529-895297.7767.83
388453-884537.6827.73
4952011-95201182.68283.27
5876961-87696176.16476.73
6829800-82980072.06872.61
15min190078-900787.82354.2693.747.9555.0493.69
290091-900917.8247.97
390314-903147.8447.98
41164718-1164718101.156102.66
51153411-1153411100.174101.58
61159782-1159782100.727102.07
20min190817-908177.88757.5794.588.1058.9594.52
289670-896707.7888.02
391312-913127.9308.15
41227119-1227119106.576109.20
51238956-1238956107.604110.13
61239288-1239288107.633110.09
30min188502-885027.68658.0094.667.9960.0294.58
289334-893347.7598.08
395504-955048.2958.61
41208138-1208138104.927108.74
51249844-1249844108.549112.27
61275604-1275604110.787114.44
45min195832-958328.32358.7294.348.7161.3894.29
287455-874557.5958.00
398647-986478.5688.97
41241494-1241494107.824112.80
51255018-1255018108.999113.92
61278128-1278128111.006115.89
60min1105482-1054829.16157.8293.189.6461.1493.19
280918-809187.0287.52
3112452-1124529.76610.27
41223594-1223594106.270112.45
51224983-1224983106.390112.52
61246914-1246914108.295114.42
极限1134783-13478311.70657.2590.0712.2861.2090.28
287147-871477.5698.14
3130380-13038011.32411.93
41208156-1208156104.929112.29
51196239-1196239103.894111.21
61198072-1198072104.053111.38
贝派度酸依折麦布片项目信息
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%
110.103116783108083105863097223090983103780.33
210.173057073057083057080.01
单位质量响应值RSD%判断
30730.5030059.781.57数据可信
供试品溶液-24032001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%
5min151469-5146916.88815.3852.7816.8915.3852.80
283714-8371427.46827.47
367072-6707222.00822.01
427685-276859.0849.08
526362-263628.6508.65
624883-248838.1658.16
10min1158419-15841951.98043.1045.3052.1743.2745.33
2202109-20210966.31666.62
3191126-19112662.71262.96
486581-8658128.40928.51
577944-7794425.57525.67
671929-7192923.60123.69
15min1229450-22945075.28759.5333.8476.0560.1833.97
2241279-24127979.16880.21
3241127-24112779.11880.06
4130203-13020342.72243.14
5125024-12502441.02341.40
6121537-12153739.87940.23
20min1252901-25290182.98267.3727.5584.5868.6827.78
2257745-25774584.57186.49
3259772-25977285.23687.06
4159892-15989252.46453.35
5150354-15035449.33450.17
6151206-15120649.61450.41
30min1263810-26381086.56175.0319.7389.0877.0920.14
2271351-27135189.03591.90
3273954-27395489.88992.66
4185206-18520660.77062.24
5188035-18803561.69863.08
6189645-18964562.22663.57
45min1270347-27034788.70669.1749.2192.1972.0648.09
2274912-27491290.20494.05
3276849-27684990.83994.61
4217585-21758571.39473.54
5218374-21837471.65373.72
66691-66912.1954.23
60min16228-62282.04469.0748.706.5172.7346.06
2279263-27926391.63196.48
3277732-27773291.12995.90
4233496-23349676.61479.56
5232069-23206976.14679.01
6234215-23421576.85078.91
极限1270805-27080588.85684.637.2193.3589.068.12
2275452-27545290.38196.25
3277742-27774291.13296.92
4243914-24391480.03383.83
5241770-24177079.32983.04
6237826-23782678.03580.95
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