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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.143417983417243415813414003417983416600.05
210.143409443410833410140.03
单位质量响应值RSD%判断
33694.2833630.570.14数据可信
加速3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%
5min1161746-16174648.04948.8017.6848.0548.8017.68
2151144-15114444.90044.90
3171517-17151750.95250.95
4158439-15843947.06747.07
5127468-12746837.86737.87
6215220-21522063.93563.93
10min1293411-29341187.16387.173.6887.3187.323.70
2293186-29318687.09687.23
3296959-29695988.21788.37
4290876-29087686.41086.55
5276324-27632482.08782.20
6309818-30981892.03792.23
15min1320024-32002495.06994.711.3795.4795.121.40
2321474-32147495.49995.90
3320139-32013995.10395.52
4318729-31872994.68495.08
5310305-31030592.18192.54
6322317-32231795.75096.22
20min1322346-32234695.75895.620.8696.4596.320.88
2325872-32587296.80697.49
3320422-32042295.18795.89
4321021-32102195.36596.05
5317912-31791294.44195.08
6323757-32375796.17896.93
30min1323555-32355596.11895.950.7797.1096.920.76
2327288-32728897.22798.20
3320133-32013395.10196.09
4321416-32141695.48296.45
5322155-32215595.70296.62
6323323-32332396.04997.09
45min1323428-32342896.08096.220.9697.3597.480.94
2328530-32853097.59698.86
3320275-32027595.14396.42
4321024-32102495.36696.62
5325995-32599596.84298.05
6324074-32407496.27297.60
60min1323761-32376196.17996.241.1297.7397.801.10
2329530-32953097.89399.45
3320042-32004295.07496.63
4320679-32067995.26396.81
5326747-32674797.06698.56
6323084-32308495.97897.60
极限1335321-33532199.613100.050.50101.46101.900.50
2335575-33557599.688101.54
3335721-33572199.732101.58
4339133-339133100.745102.57
5336476-33647699.956101.74
6338617-338617100.592102.50
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.143410473411453410953411353410613410970.02
210.143413103409313411200.08
单位质量响应值RSD%判断
33638.7633641.030.01数据可信
加速3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%
5min1170329-17032950.63349.4812.9350.6349.4812.93
2154906-15490646.04846.05
3190830-19083056.72756.73
4190779-19077956.71256.71
5154028-15402845.78745.79
6137732-13773240.94340.94
10min1303571-30357190.24187.516.9790.3987.666.98
2295701-29570187.90288.04
3315116-31511693.67393.84
4312165-31216592.79692.97
5275494-27549481.89582.03
6264198-26419878.53778.66
15min1326588-32658897.08495.992.0697.5196.402.09
2323020-32302096.02396.42
3331058-33105898.41298.86
4326240-32624096.98097.43
5317718-31771894.44794.83
6312813-31281392.98993.35
20min1330849-33084998.35097.700.9799.0698.401.00
2327261-32726197.28497.97
3333753-33375399.21399.96
4328450-32845097.63798.38
5326765-32676597.13697.80
6324867-32486796.57297.21
30min1332716-33271698.90598.700.6899.9199.690.70
2330141-33014198.14099.12
3336038-33603899.893100.94
4330231-33023198.16699.20
5332274-33227498.77499.73
6330659-33065998.29499.22
45min1331144-33114498.43898.980.5299.74100.270.52
2331858-33185898.65099.93
3335041-33504199.596100.94
4331953-33195398.678100.01
5335161-33516199.632100.89
6332679-33267998.894100.12
60min1331876-33187698.65598.790.55100.26100.380.57
2330231-33023198.16699.74
3334728-33472899.503101.15
4332284-33228498.777100.40
5334154-33415499.333100.89
6330667-33066798.29699.81
极限1331693-33169398.60198.870.63100.50100.750.65
2329597-32959797.97899.84
3335047-33504799.598101.54
4334324-33432499.383101.30
5333530-33353099.147101.00
6331301-33130198.485100.30
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.143417043418033417823419673418693418250.03
210.143410123404823407470.11
单位质量响应值RSD%判断
33710.5533604.240.23数据可信
加速3月-供试品溶液-2024012521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%
5min1157114-15711446.68044.246.4546.6844.246.45
2158631-15863147.13147.13
3153498-15349845.60645.61
4139971-13997141.58741.59
5134857-13485740.06840.07
6149393-14939344.38644.39
10min1281994-28199483.78484.211.7183.9284.351.72
2290885-29088586.42586.57
3278624-27862482.78382.92
4278158-27815882.64482.77
5285016-28501684.68284.80
6285963-28596384.96385.10
15min1321443-32144395.50595.301.1495.9095.681.14
2323871-32387196.22696.63
3322166-32216695.71996.10
4319581-31958194.95195.32
5323472-32347296.10796.48
6313992-31399293.29193.68
20min1330354-33035498.15297.391.8598.8398.061.84
2328922-32892297.72798.42
3332715-33271598.85499.53
4329908-32990898.02098.68
5329040-32904097.76298.42
6315751-31575193.81394.48
30min1334815-33481599.47898.412.38100.4599.382.36
2329952-32995298.03399.02
3338424-338424100.550101.52
4335072-33507299.554100.51
5332902-33290298.90999.87
6316217-31621793.95294.90
45min1337236-337236100.19798.902.59101.47100.162.57
2332040-33204098.65399.93
3339242-339242100.793102.06
4337619-337619100.311101.56
5334973-33497399.525100.78
6316043-31604393.90095.13
60min1335247-33524799.60699.002.74101.18100.562.72
2331217-33121798.40999.98
3340076-340076101.041102.61
4339298-339298100.810102.36
5337694-337694100.333101.88
6315793-31579393.82695.34
极限1337211-337211100.190100.321.54102.06102.171.53
2332074-33207498.663100.53
3343076-343076101.932103.81
4342673-342673101.812103.67
5339789-339789100.955102.81
6330996-33099698.343100.14
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.143407693406203404233413093409793408200.10
210.143403313402953403130.01
单位质量响应值RSD%判断
33611.4433561.440.11数据可信
加速3月-供试品溶液-X013576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%
5min1151986-15198645.25241.0312.1345.2541.0212.13
2138072-13807241.10941.11
3136736-13673640.71240.71
4149669-14966944.56244.56
5144297-14429742.96342.96
6106015-10601531.56531.56
10min1257382-25738276.63381.435.3676.7781.555.36
2271503-27150380.83780.96
3281026-28102683.67383.79
4290783-29078386.57886.71
5284760-28476084.78484.91
6255485-25548576.06876.16
15min1291297-29129786.73189.661.7887.1090.031.78
2299538-29953889.18489.55
3303298-30329890.30490.68
4306097-30609791.13791.53
5304781-30478190.74591.13
6301858-30185889.87590.20
20min1303390-30339090.33191.831.1190.9692.471.09
2306968-30696891.39692.03
3307260-30726091.48392.13
4310281-31028192.38393.05
5309325-30932592.09892.75
6313412-31341293.31593.91
30min1313604-31360493.37293.220.9194.2794.130.88
2310805-31080592.53993.45
3310546-31054692.46293.38
4311947-31194792.87993.82
5313349-31334993.29694.23
6318286-31828694.76695.64
45min1316550-31655094.24994.410.9695.4395.610.93
2313966-31396693.48094.67
3316015-31601594.09095.29
4316294-31629494.17395.40
5316866-31686694.34395.56
6322906-32290696.14297.30
60min1318067-31806794.70195.080.8196.1696.550.79
2316917-31691794.35995.82
3320210-32021095.33996.82
4316568-31656894.25595.76
5321066-32106695.59497.09
6323129-32312996.20897.65
极限1319844-31984495.23097.522.0696.9799.282.04
2323519-32351996.32498.07
3328588-32858897.83499.60
4337753-337753100.562102.35
5332470-33247098.989100.77
6323028-32302896.17897.91
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