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%
114.326602716604296602216598936603106602250.04
214.326563896563546563720.01
单位质量响应值RSD%判断
46105.1045836.030.42数据可信
供试品溶液-24062002-2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%
5min1319873-31987340.37736.7325.2240.3836.7325.23
2144118-14411818.19218.19
3336089-33608942.42442.42
4313775-31377539.60739.61
5334907-33490742.27542.27
6297082-29708237.50037.50
10min1598872-59887275.59570.2020.2875.6670.2620.29
2331826-33182641.88641.92
3629053-62905379.40579.48
4584996-58499673.84373.91
5628565-62856579.34379.41
6563249-56324971.09871.16
15min1723095-72309591.27587.3915.5891.4787.5615.59
2475250-47525059.99060.09
3753625-75362595.12995.33
4717230-71723090.53590.72
5760609-76060996.01196.21
6724014-72401491.39191.57
20min1744371-74437193.96191.869.7794.3192.189.80
2586079-58607973.98074.18
3756901-75690195.54395.90
4734027-73402792.65593.00
5772630-77263097.52897.89
6772231-77223197.47897.81
30min1758934-75893495.79994.793.3296.3095.263.37
2710761-71076189.71990.04
3754130-75413095.19395.71
4733164-73316492.54693.04
5774935-77493597.81998.34
6773744-77374497.66998.16
45min1752505-75250594.98895.092.3395.6595.732.36
2736596-73659692.98093.45
3754729-75472995.26995.95
4730872-73087292.25792.91
5772575-77257597.52198.21
6772677-77267797.53498.19
极限1755926-75592695.42095.382.0996.2496.182.11
2745358-74535894.08694.71
3752268-75226894.95895.80
4733468-73346892.58593.39
5773346-77334697.61998.47
6773346-77334697.61998.44
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%
114.326604456608396607586608446606736607120.03
214.326593536594396593960.01
单位质量响应值RSD%判断
46139.1146047.210.15数据可信
供试品溶液-24062002-2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%
5min1296164-29616437.28535.827.2437.2835.827.23
2273502-27350234.43234.43
3271632-27163234.19634.20
4311394-31139439.20239.20
5297931-29793137.50737.51
6256389-25638932.27732.28
10min1544749-54474968.58067.924.0668.6467.984.07
2525143-52514366.11166.17
3540493-54049368.04468.10
4565571-56557171.20171.27
5556389-55638970.04570.11
6504948-50494863.56963.62
15min1706720-70672088.97187.922.1889.1588.102.19
2684099-68409986.12386.29
3700422-70042288.17888.35
4708801-70880189.23389.42
5714485-71448589.94890.13
6675729-67572985.06985.23
20min1760728-76072895.77095.801.3096.0996.111.30
2753104-75310494.81095.12
3756352-75635295.21995.54
4751436-75143694.60094.93
5777920-77792097.93498.26
6766033-76603396.43896.74
30min1760909-76090995.79296.091.4396.2896.561.42
2757825-75782595.40495.87
3757011-75701195.30295.78
4750779-75077994.51795.01
5778984-77898498.06898.56
6773916-77391697.43097.89
45min1760825-76082595.78295.961.5096.4396.601.49
2756157-75615795.19495.82
3754783-75478395.02195.66
4749473-74947394.35395.00
5778124-77812497.96098.62
6773970-77397097.43798.06
极限1758376-75837695.47495.681.5496.2896.481.54
2754499-75449994.98695.77
3752988-75298894.79595.59
4746030-74603093.91994.72
5776081-77608197.70398.52
6772178-77217897.21198.00
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%
114.326562756571736572406570376567866569020.06
214.326554926559546557230.05
单位质量响应值RSD%判断
45873.0445790.710.13数据可信
供试品溶液-24062002-2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%
5min1256812-25681232.51537.149.5032.5137.149.51
2262117-26211733.18733.19
3297308-29730837.64237.64
4318825-31882540.36640.37
5303100-30310038.37538.38
6321833-32183340.74740.75
10min1508868-50886864.42871.037.3064.4871.097.30
2516731-51673165.42365.48
3564910-56491071.52371.59
4608136-60813676.99677.06
5568994-56899472.04072.10
6598339-59833975.75675.82
15min1670455-67045584.88690.485.1785.0590.665.17
2683197-68319786.49986.66
3708559-70855989.71189.89
4762237-76223796.50796.70
5709668-70966889.85190.03
6753905-75390595.45295.65
20min1747155-74715594.59795.733.1794.9096.073.17
2741632-74163293.89894.21
3740590-74059093.76694.10
4799065-799065101.169101.53
5738751-73875193.53393.87
6769576-76957697.43697.79
30min1754133-75413395.48195.783.3295.9496.273.32
2742484-74248494.00694.47
3740842-74084293.79894.29
4800325-800325101.329101.85
5731705-73170592.64193.13
6769303-76930397.40197.92
45min1752896-75289695.32495.783.1695.9496.433.17
2741232-74123293.84794.47
3739135-73913593.58294.23
4798335-798335101.077101.77
5737325-73732593.35394.00
6770139-77013997.50798.19
极限1750940-75094095.07695.453.1695.8696.263.17
2740096-74009693.70394.48
3738181-73818193.46194.26
4794993-794993100.654101.52
5731322-73132292.59393.39
6767645-76764597.19198.03
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%
114.326547066551276552606551726555586551650.05
214.326538096547206542640.10
单位质量响应值RSD%判断
45751.7545688.830.10数据可信
供试品溶液-24062002-2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%
5min1123658-12365815.69534.7327.2215.6934.7327.23
2302092-30209238.34138.34
3280593-28059335.61335.61
4312523-31252339.66539.67
5313709-31370939.81639.82
6309269-30926939.25239.25
10min1308440-30844039.14767.9421.0239.1768.0021.03
2583530-58353074.06174.12
3546632-54663269.37869.44
4594899-59489975.50475.57
5591195-59119575.03475.10
6587256-58725674.53474.60
15min1455849-45584957.85687.4816.7757.9587.6516.78
2735354-73535493.33093.52
3704829-70482989.45689.63
4751523-75152395.38295.57
5739510-73951093.85894.05
6748561-74856195.00695.20
20min1568452-56845272.14794.2011.6472.3494.5211.67
2772146-77214698.00098.34
3761748-76174896.68097.00
4789492-789492100.201100.55
5763011-76301196.84097.19
6798610-798610101.359101.71
30min1714768-71476890.71897.313.8091.0397.783.86
2770717-77071797.81898.32
3764303-76430397.00497.49
4787747-78774799.980100.50
5763382-76338296.88897.40
6799364-799364101.454101.97
45min1772876-77287698.09398.301.7398.5598.941.74
2770043-77004397.73398.40
3762219-76221996.74097.39
4786769-78676999.856100.54
5761055-76105596.59297.26
6794176-794176100.796101.48
极限1775861-77586198.47198.191.8799.0998.991.86
2766503-76650397.28498.12
3760212-76021296.48597.29
4783626-78362699.457100.31
5759587-75958796.40697.24
6796172-796172101.049101.90
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