依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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500
标示量(mg)10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%
110.103397323414603415563422803416273413310.28
210.013429933435533432730.12
单位质量响应值RSD%判断
33795.1534293.011.04数据可信
中间条件12月-供试品溶液-2024012321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%
5min1210988-21098861.82347.7519.3561.8247.7519.35
2168650-16865049.41849.42
3143989-14398942.19142.19
4167903-16790349.19949.20
5170128-17012849.85149.85
6116118-11611834.02534.02
10min1278135-27813581.49982.956.2581.6883.096.26
2268594-26859478.70378.85
3277734-27773481.38181.51
4302714-30271488.70188.85
5306912-30691289.93190.08
6264409-26440977.47777.58
15min1300190-30019087.96191.113.7388.3991.503.72
2297166-29716687.07587.46
3318453-31845393.31393.68
4318721-31872193.39193.80
5325708-32570895.43895.86
6305350-30535089.47389.81
20min1295128-29512886.47894.044.7187.1794.714.66
2314687-31468792.20992.85
3329444-32944496.53397.18
4321597-32159794.23494.93
5325357-32535795.33696.04
6339497-33949799.479100.08
30min1298876-29887687.57694.394.1488.5395.344.10
2315976-31597692.58793.51
3335357-33535798.26699.21
4322083-32208394.37695.35
5329109-32910996.43597.43
6331349-33134997.09197.99
45min1303080-30308088.80895.113.8290.0296.343.78
2319374-31937493.58294.78
3337475-33747598.886100.12
4324002-32400294.93896.20
5330534-33053496.85298.13
6333160-33316097.62298.81
60min1302093-30209388.51995.153.9190.0096.663.86
2320210-32021093.82795.31
3337486-33748698.890100.42
4324865-32486595.19196.74
5330116-33011696.73098.30
6333539-33353997.73399.22
极限1335720-33572098.37298.621.24100.12100.421.21
2334854-33485498.11899.88
3343024-343024100.512102.34
4336743-33674398.672100.50
5330498-33049896.84298.70
6338622-33862299.222101.00
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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500
标示量(mg)10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%
110.103436133432423437273427963425043431760.16
210.013434973439983437480.11
单位质量响应值RSD%判断
33977.8234340.460.76数据可信
中间条件12月-供试品溶液-2024012421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%
5min1128454-12845437.51243.358.5937.5143.358.59
2159481-15948146.57246.57
3148043-14804343.23243.23
4164177-16417747.94447.94
5148670-14867043.41543.42
6141906-14190641.44041.44
10min1268966-26896678.54482.593.1478.6682.723.14
2285676-28567683.42483.56
3279964-27996481.75681.89
4294599-29459986.03086.17
5279169-27916981.52481.65
6288525-28852584.25684.38
15min1307460-30746089.78693.122.2390.1393.502.25
2324961-32496194.89695.29
3317719-31771992.78293.16
4325849-32584995.15695.56
5322832-32283294.27594.65
6314430-31443091.82192.20
20min1320219-32021993.51295.672.1494.1396.322.14
2334298-33429897.62398.30
3327205-32720595.55296.20
4333589-33358997.41698.10
5332080-33208096.97597.63
6318201-31820192.92293.57
30min1323967-32396794.60696.592.2395.5097.532.24
2338326-33832698.79999.77
3330954-33095496.64697.59
4336855-33685598.37099.35
5334425-33442597.66098.61
6319941-31994193.43094.36
45min1325991-32599195.19796.612.0396.3897.852.03
2338905-33890598.968100.23
3330085-33008596.39397.62
4335641-33564198.01599.29
5333772-33377297.46998.71
6320666-32066693.64294.85
60min1326517-32651795.35196.681.7096.8298.201.70
2337685-33768598.612100.17
3329732-32973296.29097.81
4335082-33508297.85299.42
5334302-33430297.62499.16
6323080-32308094.34795.84
极限1330004-33000496.36997.820.9798.1299.640.99
2338626-33862698.887100.74
3332379-33237997.06398.87
4335750-33575098.04799.91
5337525-33752598.565100.39
6335590-33559098.00099.78
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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500
标示量(mg)10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%
110.103438293436923427483435933434123434550.13
210.013432293429553430920.06
单位质量响应值RSD%判断
34005.4534274.930.56数据可信
中间条件12月-供试品溶液-2025012521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%
5min1147409-14740943.07040.7814.3543.0740.7814.35
2140455-14045541.03841.04
3169100-16910049.40849.41
4124095-12409536.25836.26
5145067-14506742.38642.39
6111263-11126332.50932.51
10min1312383-31238391.27383.077.4491.4083.197.45
2258600-25860075.55875.68
3307538-30753889.85790.01
4276649-27664980.83280.94
5278884-27888481.48581.61
6271718-27171879.39179.49
15min1334980-33498097.87594.813.1298.2895.183.13
2307602-30760289.87690.23
3333336-33333697.39597.81
4325251-32525195.03395.38
5326769-32676995.47695.85
6318950-31895093.19293.53
20min1334905-33490597.85397.541.6598.5598.191.67
2325238-32523895.02995.65
3338269-33826998.83699.55
4337958-33795898.74599.38
5337683-33768398.66599.32
6328862-32886296.08896.70
30min1334359-33435997.69498.550.7398.6899.500.73
2335673-33567398.07898.98
3339286-33928699.133100.14
4338901-33890199.02199.95
5340184-34018499.396100.35
6335379-33537997.99298.90
45min1334252-33425297.66298.790.7798.95100.030.76
2336270-33627098.25299.45
3339808-33980899.286100.59
4339241-33924199.120100.35
5341337-34133799.733100.98
6337695-33769598.66899.87
60min1334417-33441797.71198.460.5999.29100.000.60
2336023-33602398.18099.67
3338626-33862698.940100.54
4338944-33894499.033100.56
5338618-33861898.938100.49
6335280-33528097.96399.46
极限1344399-344399100.62799.060.98102.50100.900.99
2334177-33417797.64199.43
3338451-33845198.889100.79
4340119-34011999.377101.20
5338941-33894199.033100.88
6338069-33806998.778100.57
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