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%
19.863265663261273267433263083266453264780.08
29.923293463291113292280.06
单位质量响应值RSD%判断
33111.3633188.310.17数据可信
长期6月-供试品溶液-2023091921批-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1118533-11853361.01575.8912.7561.0275.8812.75
2160803-16080382.77482.77
3154267-15426779.41079.41
4143744-14374473.99373.99
5136052-13605270.03370.03
6171134-17113488.09288.09
10min1179265-17926592.27796.142.5492.3896.272.54
2183749-18374994.58694.72
3191215-19121598.42998.56
4190221-19022197.91798.04
5185740-18574095.61095.73
6190442-19044298.03198.18
15min1189197-18919797.39098.442.7197.6598.722.70
2185230-18523095.34895.64
3192787-19278799.23899.53
4200361-200361103.137103.42
5188505-18850597.03497.31
6191306-19130698.47698.79
20min1191056-19105698.34798.031.4098.7698.481.39
2185431-18543195.45195.91
3193255-19325599.47999.94
4191738-19173898.69899.16
5190257-19025797.93698.37
6190946-19094698.29098.76
30min1192419-19241999.04998.191.4499.6398.801.43
2185345-18534595.40796.02
3192718-19271899.20299.83
4191604-19160498.62999.25
5191548-19154898.60099.20
6190849-19084998.24098.88
极限1193492-19349299.60198.391.49100.3599.161.48
2185628-18562895.55396.33
3192745-19274599.216100.01
4191526-19152698.58999.38
5192456-19245699.06899.83
6190949-19094998.29299.09
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%
19.863244763250023252313247743252613249490.11
29.923245883248473247180.06
单位质量响应值RSD%判断
32956.2932733.670.48数据可信
长期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%
5min1143239-14323974.41877.4812.7574.4277.4812.75
2167182-16718286.85786.86
3175187-17518791.01691.02
4149769-14976977.81177.81
5127303-12730366.13966.14
6132100-13210068.63168.63
10min1188434-18843497.89998.444.1698.0298.574.16
2187511-18751197.41997.56
3196576-196576102.129102.28
4189215-18921598.30498.43
5198683-198683103.223103.33
6176449-17644991.67291.79
15min1190601-19060199.024100.033.5299.31100.333.52
2188672-18867298.02298.33
3199240-199240103.513103.83
4194339-194339100.966101.26
5200116-200116103.968104.25
6182299-18229994.71194.98
20min1190745-19074599.099100.443.2199.55100.903.20
2188484-18848497.92498.39
3199185-199185103.484103.98
4195424-195424101.530101.99
5200912-200912104.381104.84
6185263-18526396.25196.68
30min1189862-18986298.640100.862.9099.26101.492.90
2188406-18840697.88498.52
3199470-199470103.632104.30
4197395-197395102.554103.19
5200646-200646104.243104.87
6189053-18905398.22098.81
极限1190802-19080299.129101.332.7199.91102.122.71
2188256-18825697.80698.60
3199768-199768103.787104.63
4198305-198305103.027103.83
5200887-200887104.368105.17
6192219-19221999.865100.61
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%
19.863256163258243254263254523256033255840.05
29.923252683252923252800.01
单位质量响应值RSD%判断
33020.6932790.320.50数据可信
长期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%
5min1141056-14105673.14978.5711.6773.1578.5711.68
2124829-12482964.73464.73
3175808-17580891.17191.17
4150397-15039777.99377.99
5153391-15339179.54679.55
6163620-16362084.85084.85
10min1191904-19190499.51899.493.5599.6499.623.55
2182965-18296594.88294.99
3189187-18918798.10998.26
4203570-203570105.568105.70
5189676-18967698.36398.50
6193747-193747100.474100.62
15min1195276-195276101.267100.862.67101.55101.162.67
2191196-19119699.15199.42
3190148-19014898.60798.92
4204294-204294105.943106.25
5191709-19170999.41799.71
6194345-194345100.784101.09
20min1196002-196002101.643101.162.49102.10101.622.48
2193764-193764100.483100.91
3189838-18983898.44798.93
4203994-203994105.788106.27
5192428-19242899.790100.25
6194344-194344100.783101.26
30min1195887-195887101.584101.252.58102.21101.892.57
2195748-195748101.511102.11
3188825-18882597.92198.57
4204074-204074105.829106.49
5193194-193194100.187100.82
6193777-193777100.489101.13
极限1197149-197149102.238101.612.64103.03102.422.62
2198942-198942103.168103.94
3188361-18836197.68198.49
4203471-203471105.516106.35
5194082-194082100.647101.44
6193651-193651100.424101.24
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%
19.863253283252793255863253833253353253820.04
29.923246553241103243820.12
单位质量响应值RSD%判断
33000.2032699.800.65数据可信
长期6月-供试品溶液-2023092121批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1350463-350463182.053147.4130.12182.05147.4130.12
2239947-239947124.644124.64
3304864-304864158.366158.37
4355136-355136184.480184.48
5131347-13134768.23068.23
6320860-320860166.675166.67
10min1382221-382221198.550184.8213.45198.85185.0713.47
2356726-356726185.306185.51
3384902-384902199.942200.21
4376176-376176195.409195.72
5260269-260269135.200135.31
6374502-374502194.540194.82
15min1383459-383459199.193193.355.29199.83193.915.33
2378484-378484196.608197.12
3385572-385572200.290200.89
4378868-378868196.808197.44
5332941-332941172.950173.29
6373991-373991194.274194.88
20min1383133-383133199.023196.082.58199.99196.962.62
2384683-384683199.829200.67
3384919-384919199.951200.88
4377113-377113195.896196.86
5359348-359348186.668187.30
6375613-375613195.117196.04
30min1382253-382253198.566198.381.06199.86199.591.03
2388050-388050201.578202.75
3383075-383075198.993200.26
4377617-377617196.158197.45
5383187-383187199.051199.99
6377231-377231195.958197.21
极限1380767-380767197.794200.602.14199.42202.132.06
2393230-393230204.268205.78
3384079-384079199.515201.11
4379991-379991197.391199.01
5399349-399349207.447208.72
6379573-379573197.174198.75
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