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%
110.293236953239033242933241803241893240520.08
210.343195143194653194900.02
单位质量响应值RSD%判断
31491.9330898.451.35数据可信
长期12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%
5min1129462-12946270.82369.4312.2970.8269.4312.29
2108778-10877859.50859.51
3122778-12277867.16767.17
4111406-11140660.94560.95
5143344-14334478.41778.42
6145710-14571079.71279.71
10min1180969-18096999.00097.373.1499.1297.493.15
2166658-16665891.17191.27
3180625-18062598.81298.92
4180642-18064298.82198.92
5179416-17941698.15198.28
6179677-17967798.29498.43
15min1181721-18172199.41299.731.0199.69100.010.99
2182729-18272999.963100.21
3182221-18222199.68599.96
4185657-185657101.565101.83
5180519-18051998.75499.05
6180994-18099499.01499.31
20min1182530-18253099.854100.091.35100.30100.541.33
2185956-185956101.729102.15
3182238-18223899.695100.14
4185937-185937101.718102.15
5180537-18053798.76499.22
6180573-18057398.78499.25
30min1183543-183543100.408100.511.87101.02101.121.85
2189429-189429103.628104.22
3182388-18238899.777100.39
4185852-185852101.672102.28
5180439-18043998.71099.33
6180684-18068498.84499.47
极限1184327-184327100.837100.411.88101.62101.181.85
2188879-188879103.328104.09
3182247-18224799.699100.47
4185608-185608101.538102.31
5179996-17999698.46899.26
6180169-18016998.56399.35
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%
110.293203953205503203133204323200883203560.06
210.343203203203473203340.01
单位质量响应值RSD%判断
31132.7530980.080.35数据可信
长期12月-供试品溶液-2023092021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%
5min1147456-14745681.02074.1614.4481.0274.1614.44
2109041-10904159.91359.91
3111762-11176261.40861.41
4151524-15152483.25683.26
5150279-15027982.57282.57
6139748-13974876.78576.79
10min1177503-17750397.530100.281.8797.66100.401.88
2179057-17905798.38498.48
3184762-184762101.518101.62
4183729-183729100.951101.09
5183893-183893101.041101.18
6186074-186074102.239102.37
15min1180895-18089599.394101.411.0999.69101.701.09
2183768-183768100.972101.24
3185370-185370101.852102.12
4185246-185246101.784102.09
5185757-185757102.065102.37
6186386-186386102.411102.71
20min1181886-18188699.938101.670.95100.40102.130.95
2184429-184429101.335101.77
3185687-185687102.027102.47
4185404-185404101.871102.35
5185875-185875102.130102.61
6186975-186975102.734103.20
30min1182662-182662100.365101.790.76100.99102.420.76
2184892-184892101.590102.19
3185677-185677102.021102.63
4185608-185608101.983102.63
5186125-186125102.267102.91
6186598-186598102.527103.17
极限1181498-18149899.725101.510.90100.52102.310.90
2184980-184980101.638102.41
3185169-185169101.742102.52
4184939-184939101.616102.43
5185937-185937102.164102.98
6185981-185981102.188103.00
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%
110.293209773206643207203204963201443206000.10
210.343207563205143206350.06
单位质量响应值RSD%判断
31156.4631009.190.34数据可信
长期12月-供试品溶液-2023092022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%
5min1107100-10710058.79777.1117.7658.8077.1117.76
2155976-15597685.62985.63
3112628-11262861.83161.83
4169490-16949093.04893.05
5149406-14940682.02282.02
6148184-14818481.35181.35
10min1174603-17460395.85598.522.9995.9598.642.99
2179863-17986398.74398.89
3184058-184058101.046101.15
4183074-183074100.505100.66
5171290-17129094.03694.17
6183820-183820100.915101.05
15min1180943-18094399.336101.522.5399.59101.822.52
2183501-183501100.740101.05
3192571-192571105.719105.99
4187420-187420102.891103.21
5179792-17979298.70499.00
6185334-185334101.746102.05
20min1179176-17917698.365101.481.9898.79101.941.98
2184703-184703101.400101.87
3189101-189101103.814104.26
4183041-183041100.487100.98
5184627-184627101.358101.82
6188470-188470103.468103.94
30min1183270-183270100.613101.801.30101.20102.431.29
2185320-185320101.738102.38
3189353-189353103.953104.57
4182649-182649100.272100.93
5186363-186363102.311102.94
6185673-185673101.932102.58
极限1183367-183367100.666101.611.50101.42102.411.48
2185220-185220101.684102.50
3189090-189090103.808104.60
4181085-18108599.413100.24
5186850-186850102.578103.38
6184896-184896101.506102.32
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%
110.293219393218313220443219573218143219170.03
210.343197613197153197380.02
单位质量响应值RSD%判断
31284.4530922.440.83数据可信
长期12月-供试品溶液-716277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%
5min190378-9037849.58545.415.7949.5845.405.79
285600-8560046.96446.96
378314-7831442.96642.97
480384-8038444.10244.10
578070-7807042.83242.83
683817-8381745.98545.99
10min1156787-15678786.02084.311.7686.1084.391.76
2155010-15501085.04585.12
3151222-15122282.96683.04
4153258-15325884.08384.16
5149944-14994482.26582.34
6155837-15583785.49885.57
15min1181835-18183599.762100.380.7999.99100.600.79
2183867-183867100.877101.10
3181234-18123499.43299.64
4183844-183844100.864101.08
5182100-18210099.907100.12
6184899-184899101.443101.66
20min1182069-18206999.890100.970.80100.28101.350.80
2185966-185966102.028102.42
3184706-184706101.337101.71
4184528-184528101.239101.62
5182543-182543100.150100.53
6184407-184407101.173101.56
30min1180780-18078099.183100.680.9899.74101.230.97
2185838-185838101.958102.52
3184032-184032100.967101.51
4183246-183246100.536101.09
5182421-182421100.083100.63
6184740-184740101.356101.91
极限1180495-18049599.027100.400.8699.75101.120.86
2184709-184709101.339102.07
3183147-183147100.482101.19
4183418-183418100.630101.35
5181901-18190199.798100.51
6184292-184292101.110101.84
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