枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909949039842069846219853569852939868760.46
217.719838259836349837300.02
单位质量响应值RSD%判断
55132.7455546.580.53数据可信
供试品溶液-2022052001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%
5min11070258-107025897.92898.511.4297.9398.511.42
21060276-106027697.01497.01
31067739-106773997.69797.70
41087785-108778599.53199.53
51101637-1101637100.799100.80
61071870-107187098.07598.08
10min11079772-107977298.798100.301.0398.96100.471.03
21093117-1093117100.019100.18
31089826-108982699.71899.88
41102729-1102729100.899101.06
51112041-1112041101.751101.92
61099900-1099900100.640100.80
15min11079293-107929398.754100.701.0899.08101.041.08
21095938-1095938100.277100.61
31109507-1109507101.519101.85
41105158-1105158101.121101.46
51111733-1111733101.723102.06
61101849-1101849100.818101.15
20min11087530-108753099.508100.300.75100.00100.800.75
21094639-1094639100.159100.65
31087731-108773199.526100.02
41101907-1101907100.824101.33
51108294-1108294101.408101.92
61097234-1097234100.396100.90
30min11075052-107505298.366100.021.0299.02100.691.03
21092679-109267999.979100.64
31087881-108788199.540100.20
41100317-1100317100.678101.35
51107600-1107600101.344102.02
61095503-1095503100.238100.90
45min11072414-107241498.12599.800.9898.95100.630.98
21090426-109042699.773100.60
31087174-108717499.475100.31
41098319-1098319100.495101.33
51103232-1103232100.945101.79
61092467-109246799.960100.79
极限11071814-107181498.07099.631.0999.06100.631.09
21088571-108857199.603100.60
31081360-108136098.94499.94
41093021-1093021100.010101.02
51106984-1106984101.288102.30
61091612-109161299.882100.88
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909834619830009836049833609824899831830.05
217.719882399866099874240.12
单位质量响应值RSD%判断
54926.4255755.171.06数据可信
供试品溶液-2022052001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%
5min11070850-107085097.98497.781.7397.9897.781.73
21088048-108804899.55899.56
31035325-103532594.73394.73
41074125-107412598.28498.28
51062797-106279797.24797.25
61080646-108064698.88098.88
10min11080231-108023198.84299.100.9799.0199.260.97
21096894-1096894100.367100.53
31074282-107428298.29898.46
41084890-108489099.26999.43
51069612-106961297.87198.03
61092461-109246199.961100.13
15min11082685-108268599.06799.261.0099.3999.591.00
21096832-1096832100.361100.69
31078246-107824698.66198.98
41087165-108716599.47799.81
51068340-106834097.75498.08
61095731-1095731100.261100.59
20min11081624-108162498.97099.571.3699.46100.061.36
21098173-1098173100.484100.98
31109159-1109159101.489101.98
41084295-108429599.21499.71
51066016-106601697.54298.03
61089660-108966099.705100.20
30min11083926-108392699.18099.050.9699.8499.710.96
21093518-1093518100.058100.73
31074911-107491198.35699.01
41084582-108458299.24099.90
51066398-106639897.57798.23
61091701-109170199.892100.56
45min11074696-107469698.33698.761.0099.1699.591.00
21092395-109239599.955100.79
31072514-107251498.13698.96
41080626-108062698.87899.70
51064997-106499797.44898.26
61090970-109097099.825100.66
极限11075342-107534298.39598.750.7299.3899.740.72
21090009-109000999.737100.74
31068854-106885497.80198.78
41077586-107758698.60099.59
51077169-107716998.56299.54
61086419-108641999.409100.41
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909814809811629823999835209806689818460.12
217.719833629835319834460.02
单位质量响应值RSD%判断
54851.7355530.550.87数据可信
供试品溶液-EW4378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%
5min11064894-106489497.70192.507.5497.7092.507.54
2860123-86012378.91478.91
31040205-104020595.43695.44
41036636-103663695.10995.11
51049989-104998996.33496.33
6997630-99763091.53091.53
10min11077999-107799998.90499.211.3999.0799.361.38
21104946-1104946101.376101.51
31089358-108935899.946100.10
41076152-107615298.73498.89
51059866-105986697.24097.40
61079740-107974099.06499.22
15min11078594-107859498.95899.401.3999.2999.721.38
21102035-1102035101.109101.41
31096533-1096533100.604100.93
41082672-108267299.33399.66
51059319-105931997.19097.51
61081228-108122899.20099.52
20min11076466-107646698.76399.461.5499.2699.941.52
21103616-1103616101.254101.72
31103799-1103799101.271101.76
41078442-107844298.94499.43
51061652-106165297.40497.89
61080427-108042799.12799.61
30min11076263-107626398.74499.271.9399.4099.921.91
21109386-1109386101.783102.42
31101459-1101459101.056101.72
41076181-107618198.73799.39
51051344-105134496.45897.11
61077072-107707298.81999.47
45min11071261-107126198.28698.901.4799.1199.711.46
21096447-1096447100.596101.40
31095331-1095331100.494101.32
41075525-107552598.67799.49
51054559-105455996.75397.56
61074541-107454198.58799.40
极限11069093-106909398.08798.631.3099.0799.611.30
21093022-1093022100.282101.26
31090219-1090219100.025101.02
41069147-106914798.09299.07
51056631-105663196.94397.91
61071776-107177698.33399.31
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909816899855259823129814049820169825890.18
217.719808949824119816520.11
单位质量响应值RSD%判断
54893.2455429.250.69数据可信
供试品溶液-EW4378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%
5min11034412-103441294.95593.943.8194.9593.943.81
21034232-103423294.93894.94
3955022-95502287.66787.67
41069982-106998298.22098.22
51038944-103894495.37195.37
61007513-100751392.48692.49
10min11055514-105551496.89298.352.0297.0598.502.02
21052627-105262796.62796.79
31086491-108649199.73599.88
41087545-108754599.832100.00
51097827-1097827100.776100.94
61048089-104808996.21096.36
15min11055653-105565396.90598.472.0397.2298.792.03
21049668-104966896.35596.67
31091032-1091032100.152100.46
41086169-108616999.706100.04
51099147-1099147100.897101.22
61054761-105476196.82397.14
20min11049938-104993896.38098.342.1596.8698.822.15
21051339-105133996.50996.99
31090274-1090274100.083100.56
41087920-108792099.867100.36
51097905-1097905100.783101.28
61050253-105025396.40996.88
30min11052399-105239996.60698.381.9997.2599.031.99
21053617-105361796.71897.36
31087434-108743499.822100.47
41087072-108707299.789100.45
51097909-1097909100.784101.45
61051926-105192696.56397.20
45min11052007-105200796.57098.312.0497.3799.122.04
21054464-105446496.79697.60
31090407-1090407100.095100.91
41084239-108423999.529100.36
51096792-1096792100.681101.51
61048053-104805396.20797.00
极限11050885-105088596.46797.921.9997.4398.901.99
21048607-104860796.25897.22
31080129-108012999.151100.13
41079082-107908299.055100.05
51096434-1096434100.648101.65
61045454-104545495.96896.93
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