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%
1 10.193034773035493035023034893033383034710.03
2 10.193034343037073035700.07
单位质量响应值RSD%判断
29781.2629790.970.03数据可信
供试品溶液-24121001批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168490-6849022.93029.4332.2522.9329.4332.24
277794-7779426.04426.04
375172-7517225.16725.17
4144609-14460948.41348.41
585882-8588228.75228.75
675439-7543925.25625.26
10min1226511-22651175.83377.912.9275.8777.962.93
2225638-22563875.54175.58
3229042-22904276.68076.72
4242749-24274981.26981.35
5237423-23742379.48679.53
6234947-23494778.65778.70
15min1265381-26538188.84689.441.6989.0189.621.71
2261166-26116687.43587.60
3263268-26326888.13988.31
4272394-27239491.19491.41
5270405-27040590.52890.71
6270249-27024990.47690.65
20min1280152-28015293.79193.741.3894.1094.071.39
2274702-27470291.96792.28
3275905-27590592.36992.69
4283538-28353894.92595.29
5282540-28254094.59194.92
6283238-28323894.82495.15
30min1290722-29072297.33096.961.5097.8097.441.51
2283852-28385295.03095.50
3284627-28462795.28995.76
4294213-29421398.49999.02
5291666-29166697.64698.13
6292659-29265997.97898.46
45min1296496-29649699.26398.581.3899.8999.231.39
2289029-28902996.76397.39
3289725-28972596.99697.63
4298608-29860899.970100.66
5295943-29594399.07899.73
6296995-29699599.430100.08
60min1299309-299309100.20599.281.34101.00100.081.35
2291295-29129597.52298.31
3291686-29168697.65398.44
4299781-299781100.363101.22
5297909-29790999.736100.55
6299220-299220100.175100.99
极限1312058-312058104.473102.741.50105.44103.721.50
2301163-301163100.825101.78
3302254-302254101.191102.14
4310926-310926104.094105.12
5305533-305533102.288103.27
6309363-309363103.571104.55
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%
1 10.193031123030543030973029523028493030130.04
2 10.193028813029393029100.02
单位质量响应值RSD%判断
29736.3129726.200.03数据可信
供试品溶液-24121001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
10min13892-38921.3051.288.271.311.288.24
23900-39001.3081.31
33831-38311.2851.28
43561-35611.1941.19
53425-34251.1491.15
64334-43341.4541.45
15min14552-45521.5271.603.911.531.603.86
25097-50971.7101.71
34699-46991.5761.58
44680-46801.5701.57
54786-47861.6051.61
64847-48471.6261.63
20min14957-49571.6631.693.461.671.703.42
25028-50281.6861.69
34909-49091.6471.65
44832-48321.6211.63
55258-52581.7641.77
65232-52321.7551.76
30min15412-54121.8151.872.581.821.882.56
25661-56611.8991.91
35528-55281.8541.86
45618-56181.8841.89
55801-58011.9461.95
65460-54601.8311.84
45min15431-54311.8221.914.201.831.924.12
25518-55181.8511.86
35821-58211.9521.96
46093-60932.0442.05
55599-55991.8781.89
65666-56661.9001.91
60min15740-57401.9251.932.921.941.942.89
25849-58491.9621.98
35564-55641.8661.88
45759-57591.9321.95
56018-60182.0182.03
65592-55921.8761.89
极限15803-58031.9461.913.311.961.923.29
25376-53761.8031.82
35653-56531.8961.91
45629-56291.8881.91
55935-59351.9912.01
65694-56941.9101.93
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%
1 10.193031403031953030993032173032063031710.02
2 10.193031173032293031730.03
单位质量响应值RSD%判断
29751.8229752.010.01数据可信
供试品溶液-24121001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%
5min12294-22940.7690.7350.840.770.7350.87
22351-23510.7880.79
33092-30921.0361.04
42519-25190.8440.84
52779-27790.9310.93
6-0.0000.00
10min16551-65512.1962.263.362.202.263.39
26717-67172.2512.25
37127-71272.3892.39
46587-65872.2082.21
56878-68782.3052.31
66575-65752.2042.20
15min18376-83762.8072.841.752.812.841.80
28409-84092.8182.82
38430-84302.8252.83
48692-86922.9132.92
58579-85792.8752.88
68284-82842.7772.78
20min19053-90533.0343.031.873.043.041.86
28887-88872.9792.99
39196-91963.0823.09
49305-93053.1193.13
58980-89803.0103.02
68895-88952.9812.99
30min110174-101743.4103.332.813.423.342.72
29469-94693.1743.19
39913-99133.3233.34
49850-98503.3013.32
59917-99173.3243.34
610260-102603.4393.45
45min110234-102343.4303.482.243.453.502.20
210417-104173.4913.51
310221-102213.4263.45
410836-108363.6323.65
510291-102913.4493.47
610306-103063.4543.47
60min111673-116733.9123.634.103.943.664.07
210686-106863.5823.61
310868-108683.6433.67
410418-104183.4923.52
510727-107273.5953.62
610566-105663.5413.57
极限110631-106313.5633.570.993.603.610.93
210591-105913.5503.58
310665-106653.5753.61
410862-108623.6413.67
510572-105723.5433.58
610655-106553.5713.60
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%
1 10.193023923024783024233024533025293024550.02
2 10.193023243026163024700.07
单位质量响应值RSD%判断
29681.5529683.020.01数据可信
供试品溶液-24121001批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118747-187476.2988.4421.866.308.4421.87
227058-270589.0909.09
323957-239578.0498.05
422753-227537.6447.64
523251-232517.8117.81
634906-3490611.72711.73
10min166855-6685522.46023.684.4522.4723.694.46
269376-6937623.30723.32
368609-6860923.05023.06
469906-6990623.48523.50
572425-7242524.33224.34
675684-7568425.42725.45
15min183374-8337428.01028.982.6628.0629.032.66
284374-8437428.34628.40
388370-8837029.68929.74
484892-8489228.52028.57
588028-8802829.57429.63
688458-8845829.71829.78
20min192142-9214230.95631.701.5931.0531.801.59
295644-9564432.13232.23
393395-9339531.37731.48
493928-9392831.55631.66
594917-9491731.88831.99
696149-9614932.30232.41
30min1103300-10330034.70434.720.6934.8534.870.70
2103072-10307234.62834.78
3102674-10267434.49434.65
4102584-10258434.46434.62
5104134-10413434.98535.14
6104239-10423935.02035.19
45min1109189-10918936.68337.631.6136.8937.851.61
2113465-11346538.11938.33
3113823-11382338.24038.45
4110604-11060437.15837.37
5112129-11212937.67137.88
6112926-11292637.93838.16
60min1119204-11920440.04839.551.0940.3139.821.08
2118981-11898139.97340.25
3116201-11620139.03939.31
4116362-11636239.09339.36
5118075-11807539.66839.95
6117469-11746939.46539.75
极限1124458-12445841.81342.731.6342.1443.071.63
2127116-12711642.70643.05
3126249-12624942.41442.75
4126171-12617142.38842.72
5129254-12925443.42443.77
6129963-12996343.66244.01
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