枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164841264844204839894843514841964842160.04
214.074849904849904849900.00
单位质量响应值RSD%判断
34196.0534469.790.57数据可信
供试品溶液-2024041221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1173311-17331131.95142.4915.3331.9542.4915.33
2240751-24075144.38444.38
3262241-26224148.34548.35
4248023-24802345.72445.72
5201530-20153037.15337.15
6257077-25707747.39347.39
5min1282101-28210152.00758.477.5352.0158.477.53
2321897-32189759.34359.34
3355980-35598065.62665.63
4318623-31862358.74058.74
5316671-31667158.38058.38
6307705-30770556.72756.73
10min1305656-30565656.34956.627.1856.3556.627.19
2340901-34090162.84762.85
3302824-30282455.82755.83
4320024-32002458.99859.00
5298400-29840055.01155.01
6275093-27509350.71550.71
15min1306614-30661456.52655.824.6756.5355.824.68
2276286-27628650.93550.93
3309576-30957657.07257.07
4309276-30927657.01657.02
5316169-31616958.28758.29
6298908-29890855.10555.11
20min1313464-31346457.78855.913.1857.7955.913.18
2298783-29878355.08255.08
3300697-30069755.43555.43
4308575-30857556.88756.89
5287475-28747552.99753.00
6310633-31063357.26757.27
30min1280698-28069851.74853.602.8051.7553.602.80
2298919-29891955.10755.11
3290252-29025253.50953.51
4296416-29641654.64654.65
5281253-28125351.85051.85
6297027-29702754.75854.76
45min1277959-27795951.24353.282.5751.2453.282.57
2296490-29649054.65954.66
3285519-28551952.63752.64
4288496-28849653.18653.19
5298033-29803354.94454.94
6287388-28738852.98152.98
极限1267900-26790049.38950.433.6349.3950.433.63
2265468-26546848.94048.94
3269010-26901049.59349.59
4292121-29212153.85453.85
5277177-27717751.09951.10
6269527-26952749.68849.69
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164855924853824851154849384851364852330.06
214.074820414821714821060.02
单位质量响应值RSD%判断
34267.8734264.820.01数据可信
供试品溶液-2024041221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1215584-21558439.82043.4210.7239.8243.4210.72
2203614-20361437.60937.61
3263881-26388148.74148.74
4265632-26563249.06549.06
5229541-22954142.39842.40
6232229-23222942.89542.89
5min1291162-29116253.78053.272.7853.7853.272.78
2273225-27322550.46750.47
3290367-29036753.63453.63
4296548-29654854.77554.78
5291819-29181953.90253.90
6287278-28727853.06353.06
10min1294146-29414654.33251.516.1454.3351.506.14
2260321-26032148.08448.08
3295232-29523254.53254.53
4291956-29195653.92753.93
5258650-25865047.77547.78
6272774-27277450.38450.38
15min1270681-27068149.99751.938.0550.0051.938.06
2249878-24987846.15546.15
3310418-31041857.33757.34
4304258-30425856.19956.20
5272329-27232950.30250.30
6279315-27931551.59251.59
20min1254423-25442346.99451.358.4246.9951.358.43
2250905-25090546.34546.34
3279244-27924451.57951.58
4286088-28608852.84352.84
5282595-28259552.19852.20
6314851-31485158.15658.16
30min1279248-27924851.58052.433.8951.5852.433.89
2296101-29610154.69354.69
3289058-28905853.39253.39
4266150-26615049.16049.16
5292716-29271654.06754.07
6279795-27979551.68151.68
45min1296664-29666454.79751.573.8454.8051.573.84
2276184-27618451.01451.01
3274538-27453850.71050.71
4286737-28673752.96352.96
5274651-27465150.73150.73
6266507-26650749.22649.23
极限1272868-27286850.40150.462.9250.4050.462.92
2275811-27581150.94550.94
3273280-27328050.47750.48
4284940-28494052.63152.63
5272075-27207550.25550.25
6260110-26011048.04548.04
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164850664850284851464849084846144849520.05
214.074854604857174855880.04
单位质量响应值RSD%判断
34248.0234512.300.55数据可信
供试品溶液-B736402批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1235823-23582343.41545.702.8243.4245.712.82
2252578-25257846.50046.50
3247785-24778545.61745.62
4246279-24627945.34045.34
5255932-25593247.11747.12
6251163-25116346.23946.24
5min1280947-28094751.72353.084.9551.7253.084.95
2307170-30717056.55056.55
3265998-26599848.97048.97
4285132-28513252.49352.49
5296043-29604354.50254.50
6294658-29465854.24754.25
10min1307864-30786456.67854.397.9956.6854.407.99
2321960-32196059.27359.27
3279265-27926551.41351.41
4256526-25652647.22747.23
5306655-30665556.45556.46
6300467-30046755.31655.32
15min1249231-24923145.88451.598.8945.8851.598.89
2298762-29876255.00255.00
3247891-24789145.63745.64
4288063-28806353.03353.03
5299842-29984255.20155.20
6297723-29772354.81154.81
20min1249397-24939745.91451.288.9945.9151.288.99
2294284-29428454.17854.18
3266371-26637149.03949.04
4253788-25378846.72346.72
5302737-30273755.73455.73
6304715-30471556.09856.10
30min1258556-25855647.60050.456.2147.6050.456.21
2289319-28931953.26453.26
3251380-25138046.27946.28
4274668-27466850.56750.57
5295486-29548654.39954.40
6274723-27472350.57750.58
45min1286186-28618652.68750.904.6552.6950.904.65
2277495-27749551.08751.09
3255335-25533547.00747.01
4267421-26742149.23249.23
5283525-28352552.19752.20
6288808-28880853.17053.17
极限1241323-24132344.42848.435.9144.4348.435.91
2271860-27186050.05050.05
3253655-25365546.69846.70
4254097-25409746.77946.78
5279102-27910251.38351.38
6278207-27820751.21851.22
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164867214857514860604857924853564859360.11
214.074850394833264841820.26
单位质量响应值RSD%判断
34317.5134412.370.20数据可信
供试品溶液-B736402批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1242520-24252044.66745.245.6644.6745.245.65
2236587-23658743.57543.57
3262130-26213048.27948.28
4250780-25078046.18946.19
5224645-22464541.37541.38
6257149-25714947.36247.36
5min1301125-30112555.46149.159.5855.4649.159.58
2240776-24077644.34644.35
3257444-25744447.41647.42
4288972-28897253.22353.22
5273898-27389850.44750.45
6238859-23885943.99343.99
10min1240128-24012844.22749.315.6444.2349.305.63
2260784-26078448.03148.03
3276251-27625150.88050.88
4271873-27187350.07450.07
5278970-27897051.38151.38
6278220-27822051.24351.24
15min1292291-29229153.83449.286.8553.8349.286.85
2251494-25149446.32046.32
3261296-26129648.12648.13
4288936-28893653.21653.22
5259658-25965847.82447.82
6251709-25170946.36046.36
20min1300942-30094255.42849.577.3955.4349.577.39
2262706-26270648.38548.39
3258965-25896547.69647.70
4266334-26633449.05349.05
5282062-28206251.95051.95
6243772-24377244.89844.90
30min1268238-26823849.40450.577.0849.4050.577.09
2248707-24870745.80745.81
3304512-30451256.08556.09
4287507-28750752.95352.95
5274678-27467850.59050.59
6263773-26377348.58248.58
45min1265625-26562548.92348.563.5448.9248.563.54
2259725-25972547.83647.84
3278725-27872551.33651.34
4268110-26811049.38149.38
5257313-25731347.39247.39
6252379-25237946.48346.48
极限1243060-24306044.76746.915.7444.7746.915.74
2271841-27184150.06850.07
3258937-25893747.69147.69
4270450-27045049.81249.81
5246903-24690345.47545.47
6237029-23702943.65643.66
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