精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.183382673377153375263367063364323373290.23
210.073374573377243375900.06
单位质量响应值RSD%判断
33136.4433524.330.83数据可信
加速6月-供试品溶液-2023091921批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1138710-13871071.01776.925.8071.0276.925.80
2149091-14909176.33276.33
3150390-15039076.99777.00
4163047-16304783.47783.48
5143727-14372773.58673.59
6156439-15643980.09480.09
10min1183026-18302693.70695.862.2793.8295.992.27
2189734-18973497.14197.27
3193539-19353999.08999.22
4186095-18609595.27795.42
5188628-18862896.57496.70
6182407-18240793.38993.52
15min1186007-18600795.23296.711.8595.5197.001.85
2190798-19079897.68597.97
3194198-19419899.42699.72
4187206-18720695.84696.14
5190286-19028697.42397.71
6184913-18491394.67294.96
20min1186671-18667195.57296.801.7096.0197.251.69
2190743-19074397.65798.11
3194135-19413599.39499.85
4187510-18751096.00296.46
5190008-19000897.28197.73
6185368-18536894.90595.35
30min1187876-18787696.18996.981.3696.7897.591.37
2190640-19064097.60498.22
3193837-19383799.24199.87
4187463-18746395.97896.60
5189677-18967797.11197.72
6186990-18699095.73696.34
极限1188722-18872296.62297.111.2297.3897.881.22
2191125-19112597.85398.63
3193544-19354499.09199.88
4187617-18761796.05796.83
5189440-18944096.99097.76
6187594-18759496.04596.81
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.183350153347073348463351403352273349870.07
210.073364513365873365190.03
单位质量响应值RSD%判断
32906.3933417.971.10数据可信
加速6月-供试品溶液-2023092021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1151920-15192078.17781.8410.8178.1881.8410.81
2148384-14838476.35776.36
3155045-15504579.78579.79
4179086-17908692.15692.16
5181049-18104993.16693.17
6138772-13877271.41171.41
10min1198924-198924102.36599.521.85102.5099.661.85
2190677-19067798.12198.25
3190488-19048898.02498.16
4196813-196813101.279101.43
5191438-19143898.51398.67
6192023-19202398.81498.93
15min1199621-199621102.724100.311.79103.02100.611.78
2197258-197258101.508101.80
3191747-19174798.67298.97
4196974-196974101.361101.68
5191133-19113398.35698.68
6192797-19279799.21299.50
20min1199107-199107102.459100.221.56102.93100.691.55
2195392-195392100.547101.01
3192488-19248899.05399.51
4196534-196534101.135101.63
5190513-19051398.03798.52
6194483-194483100.080100.53
30min1199579-199579102.702100.101.87103.34100.731.86
2196459-196459101.096101.72
3192409-19240999.01299.64
4196751-196751101.247101.91
5190073-19007397.81098.46
6191837-19183798.71899.33
极限1199895-199895102.865100.212.07103.68101.012.06
2198017-198017101.898102.69
3193170-19317099.404100.19
4196381-196381101.056101.88
5189445-18944597.48798.30
6191469-19146998.52999.31
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.183365443360863362023358623359273361240.09
210.073362693362713362700.01
单位质量响应值RSD%判断
33018.0733393.250.80数据可信
加速6月-供试品溶液-2023092022批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1152347-15234778.29280.4110.1978.2980.4110.19
2159987-15998782.21882.22
3142657-14265773.31273.31
4167154-16715485.90185.90
5136771-13677170.28770.29
6179858-17985892.43092.43
10min1191737-19173798.53598.382.7098.6798.522.71
2185052-18505295.09995.24
3186425-18642595.80595.93
4196285-196285100.872101.01
5191067-19106798.19098.31
6198066-198066101.787101.94
15min1193279-19327999.327100.292.3899.62100.592.38
2191580-19158098.45498.75
3188842-18884297.04797.33
4197430-197430101.460101.77
5199150-199150102.344102.62
6200637-200637103.108103.43
20min1193836-19383699.613100.281.88100.07100.741.88
2193220-19322099.29799.76
3189300-18930097.28297.73
4197848-197848101.675102.16
5198653-198653102.089102.54
6197931-197931101.718102.21
30min1194180-19418099.790100.291.64100.42100.921.64
2193768-19376899.578100.20
3189833-18983397.55698.16
4197628-197628101.562102.21
5197942-197942101.723102.34
6197533-197533101.513102.18
极限1194270-19427099.836101.461.40100.63102.261.38
2195410-195410100.422101.21
3202251-202251103.938104.71
4197297-197297101.392102.21
5198081-198081101.795102.59
6197231-197231101.358102.19
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.183351173346433345053344503342613345950.10
210.073365353361493363420.09
单位质量响应值RSD%判断
32867.8833400.401.14数据可信
加速6月-供试品溶液-716277批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1106923-10692355.06948.2712.2555.0748.2712.26
293840-9384048.33048.33
3104669-10466953.90853.91
494519-9451948.68048.68
586270-8627044.43244.43
676152-7615239.22139.22
10min1173200-17320089.20383.823.3589.3083.903.35
2161832-16183283.34883.43
3163620-16362084.26984.36
4159925-15992582.36682.45
5158459-15845981.61181.69
6159478-15947882.13682.20
15min1195101-195101100.48399.371.87100.7299.591.87
2196681-196681101.297101.52
3194458-194458100.152100.38
4189900-18990097.80498.02
5187247-18724796.43896.65
6194297-194297100.069100.27
20min1196983-196983101.452100.201.67101.86100.591.67
2195089-195089100.477100.87
3197605-197605101.773102.17
4191267-19126798.50898.89
5189828-18982897.76798.14
6196545-196545101.227101.60
30min1196575-196575101.242100.261.33101.82100.811.33
2194716-194716100.285100.84
3196933-196933101.427101.99
4190419-19041998.07298.62
5192846-19284699.32299.86
6196473-196473101.190101.73
极限1196401-196401101.15399.711.75101.90100.431.75
2194078-19407899.956100.68
3196549-196549101.229101.96
4189714-18971497.70998.42
5189060-18906097.37298.07
6195789-195789100.837101.54
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