枸橼酸西地那非片片项目信息
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%
110.219949039842069846219853569852939868760.46
210.219838259836349837300.02
单位质量响应值RSD%判断
96657.7996349.660.23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%
5min11070258-107025856.15656.491.4256.1656.491.42
21060276-106027655.63255.63
31067739-106773956.02356.02
41087785-108778557.07557.08
51101637-110163757.80257.80
61071870-107187056.24056.24
10min11079772-107977256.65557.521.0356.7557.611.02
21093117-109311757.35557.45
31089826-108982657.18257.28
41102729-110272957.85957.95
51112041-111204158.34858.44
61099900-109990057.71157.80
15min11079293-107929356.63057.751.0856.8257.941.08
21095938-109593857.50357.69
31109507-110950758.21558.40
41105158-110515857.98758.18
51111733-111173358.33258.53
61101849-110184957.81358.00
20min11087530-108753057.06257.520.7557.3457.800.74
21094639-109463957.43557.72
31087731-108773157.07257.36
41101907-110190757.81658.10
51108294-110829458.15158.44
61097234-109723457.57157.86
30min11075052-107505256.40757.361.0256.7857.741.03
21092679-109267957.33257.71
31087881-108788157.08057.46
41100317-110031757.73358.12
51107600-110760058.11558.50
61095503-109550357.48057.86
45min11072414-107241456.26957.230.9856.7457.700.98
21090426-109042657.21457.69
31087174-108717457.04357.52
41098319-109831957.62858.11
51103232-110323257.88658.37
61092467-109246757.32157.80
极限11071814-107181456.23757.131.0956.8057.711.09
21088571-108857157.11657.69
31081360-108136056.73857.31
41093021-109302157.35057.93
51106984-110698458.08358.66
61091612-109161257.27657.85
枸橼酸西地那非片片项目信息
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%
110.219834619830009836049833609824899831830.05
210.219882399866099874240.12
单位质量响应值RSD%判断
96296.0896711.460.31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%
5min11070850-107085056.18756.071.7356.1956.071.73
21088048-108804857.08957.09
31035325-103532554.32354.32
41074125-107412556.35956.36
51062797-106279755.76455.76
61080646-108064656.70156.70
10min11080231-108023156.67956.830.9756.7756.920.98
21096894-109689457.55357.65
31074282-107428256.36756.46
41084890-108489056.92357.02
51069612-106961256.12256.21
61092461-109246157.32157.42
15min11082685-108268556.80856.921.0057.0057.111.00
21096832-109683257.55057.74
31078246-107824656.57556.76
41087165-108716557.04357.23
51068340-106834056.05556.24
61095731-109573157.49257.68
20min11081624-108162456.75257.091.3657.0357.381.36
21098173-109817357.62057.91
31109159-110915958.19758.48
41084295-108429556.89257.18
51066016-106601655.93356.21
61089660-108966057.17457.46
30min11083926-108392656.87356.800.9657.2557.180.95
21093518-109351857.37657.76
31074911-107491156.40056.78
41084582-108458256.90757.29
51066398-106639855.95356.33
61091701-109170157.28157.66
45min11074696-107469656.38956.631.0056.8657.111.00
21092395-109239557.31757.80
31072514-107251456.27456.74
41080626-108062656.70057.17
51064997-106499755.88056.35
61090970-109097057.24257.72
极限11075342-107534256.42256.630.7256.9957.200.72
21090009-109000957.19257.77
31068854-106885456.08256.65
41077586-107758656.54057.11
51077169-107716956.51857.08
61086419-108641957.00457.58
枸橼酸西地那非片片项目信息
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%
110.219814809811629823999835209806689818460.12
210.219833629835319834460.02
单位质量响应值RSD%判断
96165.1396321.840.12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%
5min11064894-106489456.02553.047.5456.0353.057.54
2860123-86012345.25245.25
31040205-104020554.72654.73
41036636-103663654.53854.54
51049989-104998955.24155.24
6997630-99763052.48652.49
10min11077999-107799956.71556.891.3956.8156.981.38
21104946-110494658.13258.21
31089358-108935857.31257.40
41076152-107615256.61756.71
51059866-105986655.76155.85
61079740-107974056.80656.89
15min11078594-107859456.74657.001.3956.9357.181.38
21102035-110203557.97958.15
31096533-109653357.69057.88
41082672-108267256.96057.15
51059319-105931955.73255.92
61081228-108122856.88457.07
20min11076466-107646656.63457.031.5456.9257.311.52
21103616-110361658.06258.33
31103799-110379958.07258.35
41078442-107844256.73857.02
51061652-106165255.85556.13
61080427-108042756.84257.12
30min11076263-107626356.62356.921.9357.0057.301.91
21109386-110938658.36658.73
31101459-110145957.94958.33
41076181-107618156.61956.99
51051344-105134455.31255.68
61077072-107707256.66657.04
45min11071261-107126156.36056.711.4756.8357.181.47
21096447-109644757.68558.15
31095331-109533157.62658.10
41075525-107552556.58457.05
51054559-105455955.48155.94
61074541-107454156.53357.00
极限11069093-106909356.24656.561.3056.8157.121.29
21093022-109302257.50558.06
31090219-109021957.35757.93
41069147-106914756.24956.81
51056631-105663155.59056.15
61071776-107177656.38756.95
枸橼酸西地那非片片项目信息
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%
110.219816899855259823129814049820169825890.18
210.219808949824119816520.11
单位质量响应值RSD%判断
96237.9096146.130.07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%
5min11034412-103441254.45153.873.8154.4553.873.81
21034232-103423254.44154.44
3955022-95502250.27250.27
41069982-106998256.32356.32
51038944-103894454.68954.69
61007513-100751353.03553.03
10min11055514-105551455.56156.392.0255.6556.482.02
21052627-105262755.40955.50
31086491-108649157.19257.28
41087545-108754557.24757.34
51097827-109782757.78957.88
61048089-104808955.17055.26
15min11055653-105565355.56956.472.0355.7556.652.03
21049668-104966855.25455.44
31091032-109103257.43157.61
41086169-108616957.17557.36
51099147-109914757.85858.05
61054761-105476155.52255.70
20min11049938-104993855.26856.392.1555.5456.672.15
21051339-105133955.34255.62
31090274-109027457.39157.67
41087920-108792057.26757.55
51097905-109790557.79358.08
61050253-105025355.28455.56
30min11052399-105239955.39756.411.9955.7756.791.98
21053617-105361755.46155.83
31087434-108743457.24257.61
41087072-108707257.22257.60
51097909-109790957.79358.17
61051926-105192655.37255.74
45min11052007-105200755.37756.382.0455.8456.842.03
21054464-105446455.50655.97
31090407-109040757.39857.86
41084239-108423957.07357.55
51096792-109679257.73458.21
61048053-104805355.16955.63
极限11050885-105088555.31856.151.9955.8756.711.99
21048607-104860755.19855.75
31080129-108012956.85757.42
41079082-107908256.80257.37
51096434-109643457.71558.29
61045454-104545455.03255.58
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