氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.703416493419423417073416813415873417130.04
214.703418843424603421720.12
单位质量响应值RSD%判断
23245.7823277.010.10数据可信
供试品溶液-J428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%
5min1161990-16199040.41038.295.6340.4138.305.63
2160570-16057040.05640.06
3137771-13777134.36834.37
4154677-15467738.58638.59
5152289-15228937.99037.99
6153731-15373138.35038.35
10min1361339-36133990.13987.573.3690.2187.643.36
2341585-34158585.21185.28
3332704-33270482.99683.05
4358813-35881389.50989.57
5350770-35077087.50387.57
6361032-36103290.06390.13
15min1398678-39867899.45499.321.3699.6799.521.36
2397254-39725499.09999.31
3398628-39862899.44199.64
4398342-39834299.37099.58
5389425-38942597.14697.35
6406410-406410101.383101.60
20min1396861-39686199.00199.401.2499.3899.781.24
2397800-39780099.23599.61
3398304-39830499.36199.72
4400530-40053099.916100.29
5391145-39114597.57597.95
6406226-406226101.337101.72
30min1402808-402808100.48499.581.38101.03100.121.38
2398105-39810599.31199.85
3396433-39643398.89499.42
4402265-402265100.349100.89
5390137-39013797.32397.86
6405372-405372101.124101.68
45min1396157-39615798.82599.061.3199.5499.771.30
2396771-39677198.97899.68
3397749-39774999.22299.91
4399890-39989099.756100.47
5388199-38819996.84097.54
6403827-403827100.738101.46
极限1396154-39615498.82498.941.2999.7099.811.29
2396461-39646198.90199.77
3396829-39682998.99399.85
4398807-39880799.486100.37
5387891-38789196.76397.62
6403596-403596100.681101.57
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.703412473416173415893418263409513414460.11
214.703408043414983411510.15
单位质量响应值RSD%判断
23227.6223207.550.07数据可信
供试品溶液-J428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%
5min1150023-15002337.49539.896.2737.5039.896.26
2157841-15784139.44939.45
3162040-16204040.49940.50
4156203-15620339.04039.04
5178226-17822644.54444.54
6153228-15322838.29638.30
10min1357020-35702089.23089.561.7089.2989.631.70
2350424-35042487.58187.65
3361165-36116590.26690.33
4367408-36740891.82691.89
5360720-36072090.15590.23
6353360-35336088.31588.38
15min1395161-39516198.76299.840.8398.97100.060.83
2396986-39698699.21999.43
3400634-400634100.130100.35
4403471-403471100.839101.06
5402564-402564100.613100.84
6398028-39802899.47999.69
20min1395933-39593398.95599.720.5099.33100.100.51
2398016-39801699.47699.85
3398596-39859699.621100.01
4400503-400503100.098100.48
5401657-401657100.386100.78
6399136-39913699.756100.13
30min1395057-39505798.736100.141.1499.28100.691.14
2396954-39695499.21199.75
3399376-39937699.816100.37
4401924-401924100.453101.01
5402856-402856100.686101.25
6407790-407790101.919102.46
45min1396005-39600598.97399.750.6199.68100.470.61
2396918-39691899.20299.91
3401693-401693100.395101.11
4400800-400800100.172100.89
5401185-401185100.268101.00
6398132-39813299.505100.22
极限1394889-39488998.69499.290.6099.56100.170.60
2393998-39399898.47299.35
3398166-39816699.513100.40
4398182-39818299.517100.40
5400241-400241100.032100.93
6398216-39821699.526100.40
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.703410653411143407613414473410913410960.08
214.703413723418413416060.10
单位质量响应值RSD%判断
23203.8123238.500.11数据可信
供试品溶液-J428批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1173107-17310743.25841.107.2643.2641.107.26
2168601-16860142.13242.13
3150777-15077737.67837.68
4148602-14860237.13437.13
5177314-17731444.30944.31
6168377-16837742.07642.08
10min1360160-36016090.00190.522.1590.0790.592.15
2367518-36751891.84091.91
3358858-35885889.67589.74
4349197-34919787.26187.32
5369112-36911292.23892.31
6368615-36861592.11492.18
15min1410712-410712102.633101.731.08102.86101.941.08
2406107-406107101.483101.71
3402657-402657100.620100.83
4406448-406448101.568101.78
5402841-402841100.666100.89
6413705-413705103.381103.60
20min1404976-404976101.200101.470.90101.59101.850.90
2405893-405893101.429101.82
3402731-402731100.639101.02
4406872-406872101.674102.05
5403020-403020100.711101.11
6412733-412733103.138103.53
30min1406052-406052101.469101.450.97102.03102.010.97
2405370-405370101.298101.86
3402461-402461100.572101.12
4405667-405667101.373101.92
5402967-402967100.698101.26
6413433-413433103.313103.88
45min1403165-403165100.747101.061.02101.48101.781.02
2403975-403975100.950101.68
3400973-400973100.200100.91
4405013-405013101.209101.92
5401182-401182100.252100.98
6412142-412142102.991103.73
极限1403468-403468100.823101.071.08101.72101.961.08
2404053-404053100.969101.87
3400360-400360100.046100.93
4405621-405621101.361102.24
5400779-400779100.151101.05
6412362-412362103.046103.96
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.703428373426463431713430433418233427040.16
214.703422893426083424480.07
单位质量响应值RSD%判断
23313.2023295.780.06数据可信
供试品溶液-J428批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1166510-16651041.46140.476.1741.4640.466.17
2165429-16542941.19141.19
3165122-16512241.11541.11
4176382-17638243.91943.92
5152448-15244837.95937.96
6149210-14921037.15337.15
10min1361525-36152590.01989.811.7890.0989.881.78
2362900-36290090.36190.43
3349133-34913386.93387.00
4368654-36865491.79491.87
5360123-36012389.67089.73
6361882-36188290.10890.17
15min1405203-405203100.895100.940.34101.11101.160.34
2406970-406970101.335101.55
3404193-404193100.643100.86
4406231-406231101.151101.38
5403469-403469100.463100.68
6406291-406291101.166101.38
20min1405934-405934101.077101.200.35101.46101.590.35
2407412-407412101.445101.83
3406466-406466101.209101.59
4407256-407256101.406101.80
5403881-403881100.565100.95
6407708-407708101.518101.90
30min1405309-405309100.921100.780.51101.48101.340.51
2406867-406867101.309101.87
3405853-405853101.056101.61
4405921-405921101.073101.64
5402793-402793100.295100.84
6401694-401694100.021100.57
45min1404964-404964100.835100.700.42101.56101.420.41
2405778-405778101.038101.76
3405085-405085100.865101.58
4404438-404438100.704101.44
5401142-40114299.883100.60
6405079-405079100.864101.58
极限1404470-404470100.712100.550.42101.60101.440.42
2404830-404830100.802101.70
3402918-402918100.326101.21
4404537-404537100.729101.63
5400865-40086599.814100.70
6405348-405348100.931101.82
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