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%
110.143387893390333389113389683386953388790.05
210.143378143376093377120.05
单位质量响应值RSD%判断
33420.0233304.930.25数据可信
中间条件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%
5min1124104-12410437.19944.7919.8637.2044.7919.86
2169732-16973250.87550.88
3139700-13970041.87441.87
4200238-20023860.01960.02
5128405-12840538.48838.49
6134339-13433940.26740.27
10min1239887-23988771.90380.559.2772.0280.689.29
2301040-30104090.23390.39
3249935-24993574.91575.04
4295069-29506988.44488.62
5255509-25550976.58676.70
6270924-27092481.20681.33
15min1290559-29055987.09290.643.2887.4291.023.31
2314460-31446094.25694.68
3291599-29159987.40487.75
4306834-30683491.97092.42
5300515-30051590.07690.42
6310486-31048693.06593.43
20min1315264-31526494.49793.711.5595.0994.361.53
2315542-31554294.58095.29
3309744-30974492.84293.45
4307759-30775992.24792.97
5307971-30797192.31192.93
6319505-31950595.76896.41
30min1327015-32701598.01995.262.2998.8996.192.24
2316030-31603094.72695.72
3319965-31996595.90696.80
4308058-30805892.33793.33
5311722-31172293.43594.33
6324138-32413897.15798.09
45min1329828-32982898.86295.532.60100.0396.752.54
2315189-31518994.47495.75
3323158-32315896.86398.04
4308049-30804992.33493.61
5312055-31205593.53594.71
6323997-32399797.11498.34
60min1330761-33076199.14295.532.72100.6097.032.65
2314608-31460894.30095.86
3323593-32359396.99398.46
4307905-30790592.29193.84
5311855-31185593.47594.93
6323617-32361797.00198.51
极限1335190-335190100.46998.632.04102.23100.422.02
2334219-334219100.178102.02
3332266-33226699.593101.35
4326988-32698898.01199.84
5317036-31703695.02896.76
6328579-32857998.488100.29
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%
110.143377883377573376213382083374753377700.09
210.143368523363483366000.11
单位质量响应值RSD%判断
33310.6533195.270.25数据可信
中间条件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%
5min1153267-15326746.09146.727.2846.0946.727.28
2154360-15436046.42046.42
3141572-14157242.57442.57
4172091-17209151.75251.75
5146427-14642744.03444.03
6164499-16449949.46949.47
10min1284835-28483585.65783.033.3785.8083.173.37
2269038-26903880.90781.05
3273477-27347782.24282.37
4272514-27251481.95282.11
5266611-26661180.17780.31
6290119-29011987.24687.39
15min1321366-32136696.64394.162.3197.0494.562.31
2316386-31638695.14695.53
3310627-31062793.41493.79
4303104-30310491.15191.55
5307501-30750192.47492.85
6319757-31975796.15996.57
20min1324793-32479397.67496.311.9798.3696.981.97
2326415-32641598.16198.83
3318585-31858595.80796.46
4310941-31094193.50894.18
5315368-31536894.83995.49
6325361-32536197.84598.54
30min1328583-32858398.81397.291.8199.7998.251.81
2328751-32875198.86499.83
3321051-32105196.54897.49
4315152-31515294.77495.73
5319186-31918695.98896.92
6328311-32831198.73299.72
45min1329793-32979399.17797.671.66100.4598.921.67
2329014-32901498.943100.20
3322247-32224796.90898.14
4317614-31761495.51596.75
5320255-32025596.30997.53
6329682-32968299.144100.43
60min1329930-32993099.21997.671.51100.7999.211.51
2328765-32876598.868100.42
3322154-32215496.88098.40
4319100-31910095.96297.49
5319985-31998596.22897.74
6328654-32865498.835100.42
极限1331377-33137799.65498.421.15101.52100.261.16
2329998-32999899.239101.09
3322193-32219396.89298.70
4327047-32704798.352100.17
5323442-32344297.26799.07
6329616-32961699.124101.01
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%
110.143373833376203375003373813374093374590.04
210.143367473392383379920.53
单位质量响应值RSD%判断
33279.9833332.540.12数据可信
中间条件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%
5min1139627-13962741.92249.8513.0641.9249.8613.06
2192263-19226357.72657.73
3141815-14181542.57942.58
4179164-17916453.79353.79
5163368-16336849.05049.05
6180050-18005054.05954.06
10min1271905-27190581.63888.726.0181.7688.886.02
2309005-30900592.77792.95
3276545-27654583.03183.16
4295121-29512188.60888.77
5305779-30577991.80891.96
6314689-31468994.48394.65
15min1313401-31340194.09795.782.0494.4796.202.04
2325046-32504697.59398.04
3323595-32359597.15797.53
4308759-30875992.70393.13
5320449-32044996.21396.64
6322779-32277996.91297.36
20min1323650-32365097.17496.772.3597.8397.472.32
2327735-32773598.40099.14
3330703-33070399.29299.96
4308888-30888892.74293.45
5320649-32064996.27396.98
6322178-32217896.73297.47
30min1327708-32770898.39296.962.7199.3497.962.68
2330151-33015199.126100.17
3331437-33143799.512100.48
4308281-30828192.56093.54
5319051-31905195.79396.79
6321045-32104596.39297.42
45min1328785-32878598.71697.152.9199.9698.432.88
2332502-33250299.832101.17
3331716-33171699.596100.86
4307924-30792492.45293.71
5320024-32002496.08597.37
6320385-32038596.19497.51
60min1327951-32795198.46597.502.91100.0099.072.89
2333138-333138100.023101.66
3332430-33243099.810101.37
4307931-30793192.45493.99
5320296-32029696.16797.74
6326650-32665098.07599.68
极限1330810-33081099.32499.691.91101.15101.561.91
2337259-337259101.260103.20
3332178-33217899.734101.60
4320546-32054696.24298.06
5333300-333300100.071101.94
6338134-338134101.523103.42
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%
110.143383163384733380243372053384253380890.16
210.143374173373143373660.03
单位质量响应值RSD%判断
33342.1133270.810.16数据可信
中间条件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%
5min1137492-13749241.28142.9616.6541.2842.9616.66
2112655-11265533.82433.82
3134536-13453640.39340.39
4132049-13204939.64739.65
5179241-17924153.81653.82
6162530-16253048.79848.80
10min1278334-27833483.56884.367.4883.6984.497.48
2279681-27968183.97284.07
3293458-29345888.10988.23
4247762-24776274.38974.51
5311149-31114993.42093.58
6275541-27554182.72982.88
15min1306058-30605891.89290.343.8092.2790.723.81
2299288-29928889.85990.21
3302078-30207890.69791.08
4282915-28291584.94385.29
5317754-31775495.40395.84
6297305-29730589.26489.66
20min1308070-30807092.49692.112.0893.1592.772.11
2306095-30609591.90392.53
3301382-30138290.48891.15
4298974-29897489.76590.36
5316974-31697495.16995.90
6309260-30926092.85393.52
30min1311453-31145393.51192.791.6494.4493.721.66
2311550-31155093.54194.44
3301403-30140390.49491.42
4304812-30481291.51792.38
5315261-31526194.65595.67
6309801-30980193.01593.96
45min1313533-31353394.13693.281.5195.3494.481.53
2313406-31340694.09895.28
3303260-30326091.05292.25
4306768-30676892.10593.25
5315495-31549594.72596.02
6311540-31154093.53894.76
60min1312890-31289093.94393.441.7995.4394.931.79
2314082-31408294.30195.76
3302235-30223590.74492.22
4307282-30728292.25993.68
5317778-31777895.41096.99
6313051-31305193.99195.49
极限1317218-31721895.24295.461.6597.0197.231.67
2321419-32141996.50498.25
3311115-31111593.41095.16
4313208-31320894.03895.73
5325262-32526297.65799.53
6319469-31946995.91897.70
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