氨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250
标示量(mg)40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%
114.326568576586016583796588926581806581820.12
214.326583026584356583680.02
单位质量响应值RSD%判断
45962.4345975.420.02数据可信
供试品溶液-24061701-2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119374-11937415.06931.7133.4815.0731.7133.48
2303455-30345538.30638.31
3315691-31569139.85039.85
4170564-17056421.53121.53
5299725-29972537.83537.83
6298362-29836237.66337.66
10min1317608-31760840.09264.1821.4840.1264.2421.48
2561323-56132370.85770.92
3591731-59173174.69674.76
4435655-43565554.99455.03
5575116-57511672.59872.66
6569331-56933171.86871.93
15min1478908-47890860.45484.2915.3660.5584.4615.37
2709004-70900489.49989.68
3742651-74265193.74793.94
4619907-61990778.25278.38
5729789-72978992.12392.31
6726326-72632691.68691.87
20min1598896-59889675.60091.868.8475.7992.168.87
2756321-75632195.47295.80
3763687-76368796.40296.75
4731631-73163192.35592.61
5765080-76508096.57896.92
6750670-75067094.75995.09
30min1743953-74395393.91195.561.1594.2396.011.19
2755275-75527595.34095.83
3764540-76454096.51097.02
4764367-76436796.48896.90
5763725-76372596.40796.91
6750088-75008894.68595.18
45min1773563-77356397.64995.801.1498.1296.411.07
2752022-75202294.92995.58
3759769-75976995.90796.58
4759660-75966095.89496.47
5759838-75983895.91696.58
6748579-74857994.49595.15
极限1772509-77250997.51695.881.1598.1596.651.09
2753890-75389095.16595.97
3762430-76243096.24397.07
4762003-76200396.18996.92
5759600-75960095.88696.71
6746670-74667094.25495.06
氨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250
标示量(mg)40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%
114.326562906578816582326559916576046572000.16
214.326548786557256553020.10
单位质量响应值RSD%判断
45893.8545761.310.21数据可信
供试品溶液-24061701-2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%
5min1283989-28398935.95935.723.2035.9635.723.20
2293487-29348737.16237.16
3267399-26739933.85933.86
4276514-27651435.01335.01
5286300-28630036.25236.25
6285048-28504836.09336.09
10min1519550-51955065.78666.282.5665.8566.342.56
2539241-53924168.28068.34
3502929-50292963.68263.74
4515442-51544265.26665.32
5529923-52992367.10067.16
6533510-53351067.55467.61
15min1673204-67320485.24286.052.0785.4186.222.07
2693918-69391887.86588.04
3660811-66081183.67383.84
4668944-66894484.70384.87
5685521-68552186.80286.97
6695017-69501788.00488.18
20min1737870-73787093.43094.341.6793.7494.651.67
2756128-75612895.74296.06
3731290-73129092.59792.90
4737471-73747193.38093.69
5743977-74397794.20494.52
6763654-76365496.69597.01
30min1739405-73940593.62594.581.6894.0995.051.69
2757104-75710495.86696.35
3735040-73504093.07293.53
4738637-73863793.52893.99
5744262-74426294.24094.71
6767159-76715997.13997.62
45min1736614-73661493.27194.331.8293.8994.961.82
2757267-75726795.88796.53
3732794-73279492.78893.40
4736446-73644693.25093.87
5740757-74075793.79694.43
6766170-76617097.01497.66
极限1739814-73981493.67794.331.7394.4695.111.72
2756116-75611695.74196.54
3730700-73070092.52393.29
4736007-73600793.19593.97
5742495-74249594.01694.80
6764481-76448196.80097.60
氨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250
标示量(mg)40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%
114.326592506603276612616610566610646605920.13
214.326537826526996532400.12
单位质量响应值RSD%判断
46130.7345617.320.80数据可信
供试品溶液-24061701-2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%
5min1296643-29664337.52537.094.1837.5237.094.19
2301400-30140038.12638.13
3274481-27448134.72134.72
4298596-29859637.77237.77
5282043-28204335.67835.68
6306151-30615138.72738.73
10min1567537-56753771.79270.963.7471.8571.023.75
2580883-58088373.48073.54
3534057-53405767.55767.61
4565840-56584071.57771.64
5536415-53641567.85567.91
6581207-58120773.52173.59
15min1716093-71609390.58490.512.7490.7790.692.74
2737015-73701593.23093.42
3686921-68692186.89487.06
4723122-72312291.47391.66
5697987-69798788.29488.47
6732000-73200092.59692.78
20min1752055-75205595.13395.711.3095.4796.041.30
2763576-76357696.59096.93
3742135-74213593.87894.19
4766127-76612796.91397.25
5750710-75071094.96395.28
6765158-76515896.79097.13
30min1747331-74733194.53595.641.3795.0396.131.37
2767076-76707697.03397.54
3746970-74697094.49094.96
4765966-76596696.89397.39
5745893-74589394.35494.83
6763102-76310296.53097.03
45min1745031-74503194.24495.491.4594.8996.141.45
2767419-76741997.07697.74
3745052-74505294.24794.88
4763912-76391296.63397.29
5744904-74490494.22894.86
6762843-76284396.49897.16
极限1750441-75044194.92995.631.3695.7496.441.36
2769452-76945297.33498.16
3748394-74839494.67095.46
4758897-75889795.99896.82
5743315-74331594.02794.82
6765236-76523696.80097.62
氨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250
标示量(mg)40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%
114.326586076588816580766575596581026582450.08
214.326595646587596591620.09
单位质量响应值RSD%判断
45966.8346030.870.10数据可信
供试品溶液-24061701-2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%
5min1260845-26084532.90633.666.4732.9133.666.47
2236863-23686329.88029.88
3272440-27244034.36834.37
4288837-28883736.43736.44
5269475-26947533.99433.99
6272261-27226134.34634.35
10min1518987-51898765.47066.024.6465.5366.074.64
2485016-48501661.18561.23
3525536-52553666.29666.35
4560927-56092770.76170.82
5520737-52073765.69165.75
6528692-52869266.69566.75
15min1686148-68614886.55886.423.2886.7286.583.28
2647226-64722681.64881.80
3687344-68734486.70986.88
4715337-71533790.24090.42
5678437-67843785.58585.75
6695647-69564787.75687.92
20min1753921-75392195.10795.301.7995.4295.611.79
2739810-73981093.32793.62
3751921-75192194.85595.17
4753973-75397395.11495.44
5752151-75215194.88495.19
6780752-78075298.49298.81
30min1754493-75449395.17995.731.7995.6596.201.78
2752838-75283894.97195.41
3752446-75244694.92195.39
4749623-74962394.56595.05
5757837-75783795.60196.07
6785888-78588899.14099.62
45min1753890-75389095.10395.571.7795.7396.201.76
2752584-75258494.93995.54
3749013-74901394.48895.12
4750834-75083494.71895.36
5754648-75464895.19995.83
6784515-78451598.96799.61
极限1752114-75211494.87995.241.8395.6696.031.83
2749287-74928794.52395.28
3749472-74947294.54695.33
4746197-74619794.13394.94
5749842-74984294.59395.38
6782887-78288798.76199.57
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