盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.304007583951283948883946313946443960100.68
212.273924013924413924210.01
单位质量响应值RSD%判断
32195.9331982.150.48数据可信
加速6月-供试品溶液-2023120221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%
5min1204963-20496348.41551.163.8648.4151.163.86
2212396-21239650.17150.17
3219698-21969851.89551.90
4230152-23015254.36554.36
5215428-21542850.88750.89
6216977-21697751.25351.25
10min1244068-24406857.65260.253.4757.7660.363.47
2248015-24801558.58458.70
3253186-25318659.80659.92
4268740-26874063.48063.60
5255963-25596360.46260.57
6260435-26043561.51861.63
15min1269566-26956663.67565.642.8163.9165.882.81
2271665-27166564.17164.41
3274577-27457764.85865.11
4289576-28957668.40168.66
5277091-27709165.45265.70
6284766-28476667.26567.52
20min1283937-28393767.06969.322.6667.4569.722.67
2288069-28806968.04568.43
3289415-28941568.36368.76
4304943-30494372.03172.45
5295294-29529469.75270.14
6299226-29922670.68171.08
30min1311599-31159973.60375.063.4774.1375.603.46
2310851-31085173.42773.96
3311469-31146973.57374.12
4338490-33849079.95580.53
5312090-31209073.71974.27
6321991-32199176.05876.62
45min1334825-33482579.09079.742.0479.7880.452.05
2331643-33164378.33879.04
3330274-33027478.01578.72
4347687-34768782.12882.88
5337202-33720279.65180.36
6343786-34378681.20681.93
60min1348036-34803682.21083.071.8583.0883.971.86
2349074-34907482.45683.33
3343453-34345381.12882.01
4360080-36008085.05585.99
5350664-35066482.83183.72
6358834-35883484.76185.67
90min1365279-36527986.28386.931.8687.3388.011.87
2363882-36388285.95387.01
3361875-36187585.47986.54
4378083-37808389.30890.43
5363824-36382485.94087.01
6375196-37519688.62689.72
120min1372287-37228787.93988.871.8489.1890.141.85
2372071-37207187.88889.13
3370442-37044287.50388.75
4386094-38609491.20092.52
5372487-37248787.98689.25
6384001-38400190.70692.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1391366-39136692.44593.622.2293.8895.092.22
2391104-39110492.38493.83
3390131-39013192.15493.60
4407038-40703896.14797.67
5390186-39018692.16793.63
6408251-40825196.43497.93
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303936913938903937303937983938453937910.03
212.273948413948093948250.01
单位质量响应值RSD%判断
32015.5332178.080.36数据可信
加速6月-供试品溶液-2023120521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%
5min1227635-22763553.75752.353.7153.7652.363.71
2217905-21790551.45951.46
3223946-22394652.88652.89
4223689-22368952.82552.83
5229870-22987054.28554.28
6207133-20713348.91548.92
10min1263161-26316162.14760.722.9262.2760.842.92
2255664-25566460.37660.49
3257521-25752160.81560.93
4253942-25394259.96960.09
5266963-26696363.04463.16
6245491-24549157.97458.08
15min1284363-28436367.15366.092.4467.4166.342.44
2278140-27814065.68465.93
3278809-27880965.84266.09
4280359-28035966.20866.46
5288920-28892068.23068.49
6268686-26868663.45163.69
20min1299141-29914170.64369.882.3671.0570.282.37
2296284-29628469.96970.36
3292547-29254769.08669.49
4298214-29821470.42470.82
5304967-30496772.01972.43
6284316-28431667.14267.52
30min1320513-32051375.69074.862.1376.2575.412.13
2321299-32129975.87676.43
3312743-31274373.85574.41
4318317-31831775.17275.73
5323548-32354876.40776.98
6305452-30545272.13472.66
45min1339598-33959880.19779.401.9980.9380.121.99
2343186-34318681.04581.76
3333382-33338278.72979.45
4338294-33829479.88980.61
5338746-33874679.99680.74
6324234-32423476.56977.26
60min1353116-35311683.39082.472.0684.3083.372.06
2355615-35561583.98084.88
3344186-34418681.28182.17
4349624-34962482.56583.46
5355385-35538583.92684.85
6337523-33752379.70780.57
90min1368624-36862487.05286.191.7988.1587.271.79
2371825-37182587.80888.89
3359895-35989584.99186.06
4362940-36294085.71086.79
5370973-37097387.60788.71
6355661-35566183.99185.03
120min1378354-37835489.35087.981.9690.6489.251.96
2380941-38094189.96191.24
3367049-36704986.68087.94
4370627-37062787.52588.80
5376392-37639288.88690.19
6361962-36196285.47986.70
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1394768-39476893.22692.471.6294.7193.941.62
2398403-39840394.08495.56
3387484-38748491.50692.96
4387216-38721691.44392.91
5398110-39811094.01595.51
6383523-38352390.57091.98
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303931743931153933453932093932693932220.03
212.273951953950703951320.03
单位质量响应值RSD%判断
31969.2732203.100.52数据可信
加速6月-供试品溶液-2023120621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%
5min1228431-22843153.96353.966.7453.9653.966.74
2240045-24004556.70756.71
3216696-21669651.19151.19
4238863-23886356.42756.43
5203944-20394448.17848.18
6242605-24260557.31157.31
10min1259885-25988561.39461.175.6461.5161.285.64
2273879-27387964.69964.83
3247143-24714358.38458.50
4273660-27366064.64864.77
5237141-23714156.02156.13
6261796-26179661.84561.97
15min1283348-28334866.93666.344.7767.1966.594.77
2296750-29675070.10270.37
3267891-26789163.28563.53
4291814-29181468.93669.21
5262302-26230261.96562.20
6282742-28274266.79367.06
20min1300741-30074171.04569.984.5871.4570.384.59
2310354-31035473.31673.74
3282274-28227466.68367.07
4308591-30859172.90073.32
5277541-27754165.56565.93
6297828-29782870.35770.77
30min1318102-31810275.14675.074.0475.7175.644.05
2333185-33318578.71079.30
3304383-30438371.90672.44
4331286-33128678.26178.85
5302866-30286671.54772.06
6316970-31697074.87975.45
45min1335250-33525079.19779.383.6779.9380.103.68
2350682-35068282.84383.61
3323828-32382876.49977.19
4351174-35117482.95983.72
5324293-32429376.60977.28
6330893-33089378.16878.90
60min1350125-35012582.71182.983.8483.6283.883.85
2366123-36612386.49187.44
3335545-33554579.26780.13
4367024-36702486.70387.65
5337479-33747979.72480.57
6351307-35130782.99183.90
90min1369753-36975387.34886.623.9288.4487.703.92
2381799-38179990.19491.33
3349057-34905782.45983.50
4383748-38374890.65491.79
5353929-35392983.61084.63
6361620-36162085.42786.52
120min1373873-37387388.32188.463.5989.6189.743.60
2388270-38827091.72293.06
3358907-35890784.78686.01
4391942-39194292.59093.93
5362040-36204085.52686.73
6371717-37171787.81289.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1389515-38951592.01792.923.0093.5094.393.01
2405725-40572595.84697.39
3379391-37939189.62591.03
4409758-40975896.79998.34
5387333-38733391.50192.90
6388283-38828391.72693.20
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303944593945243946963946443946163945880.03
212.273944283942733943500.03
单位质量响应值RSD%判断
32080.3332139.360.13数据可信
加速6月-供试品溶液-2205008609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%
5min1248971-24897158.77158.513.4458.7758.513.44
2247273-24727358.37058.37
3252983-25298359.71859.72
4250689-25068959.17759.18
5255753-25575360.37260.37
6231586-23158654.66754.67
10min1277894-27789465.59966.532.6165.7366.672.61
2281404-28140466.42766.56
3284438-28443867.14367.28
4280784-28078466.28166.41
5294302-29430269.47269.61
6272338-27233864.28764.41
15min1293232-29323269.21970.092.7169.5070.372.71
2295561-29556169.76970.05
3298219-29821970.39770.68
4295340-29534069.71770.00
5311580-31158073.55173.84
6287501-28750167.86768.13
20min1304421-30442171.86172.532.3672.2972.962.36
2309349-30934973.02473.46
3308365-30836572.79273.23
4303682-30368271.68672.12
5319573-31957375.43775.89
6298079-29807970.36470.78
30min1321912-32191275.98976.642.0276.5877.232.03
2330986-33098678.13178.73
3325168-32516876.75877.36
4322796-32279676.19876.79
5332492-33249278.48779.11
6314553-31455374.25274.82
45min1340838-34083880.45781.571.7481.2282.331.74
2351849-35184983.05683.82
3346798-34679881.86482.63
4343500-34350081.08581.85
5352584-35258483.23084.02
6337630-33763079.70080.44
60min1354256-35425683.62484.872.0884.5685.822.08
2367650-36765086.78687.74
3358698-35869884.67385.63
4355394-35539483.89384.84
5369645-36964587.25788.24
6351463-35146382.96583.88
90min1370755-37075587.51988.591.8388.6489.721.83
2382790-38279090.36091.51
3378184-37818489.27390.41
4369409-36940987.20188.33
5382842-38284290.37291.55
6367764-36776486.81387.91
120min1378257-37825789.29089.722.3990.6191.052.36
2393385-39338592.86194.21
3387179-38717991.39692.74
4378081-37808189.24990.57
5367350-36735086.71588.09
6376158-37615888.79590.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1387210-38721091.40492.232.3292.9293.762.28
2404523-40452395.49097.04
3396742-39674293.65495.20
4390482-39048292.17693.70
5378184-37818489.27390.84
6387163-38716391.39292.88
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