盐酸伐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
10min1244068-24406857.65260.253.4757.6560.253.47
2248015-24801558.58458.58
3253186-25318659.80659.81
4268740-26874063.48063.48
5255963-25596360.46260.46
6260435-26043561.51861.52
15min1269566-26956663.67565.642.8163.6765.642.81
2271665-27166564.17164.17
3274577-27457764.85864.86
4289576-28957668.40168.40
5277091-27709165.45265.45
6284766-28476667.26567.27
20min1283937-28393767.06969.322.6667.0769.322.66
2288069-28806968.04568.05
3289415-28941568.36368.36
4304943-30494372.03172.03
5295294-29529469.75269.75
6299226-29922670.68170.68
30min1311599-31159973.60375.063.4773.6075.063.47
2310851-31085173.42773.43
3311469-31146973.57373.57
4338490-33849079.95579.96
5312090-31209073.71973.72
6321991-32199176.05876.06
45min1334825-33482579.09079.742.0479.0979.742.05
2331643-33164378.33878.34
3330274-33027478.01578.01
4347687-34768782.12882.13
5337202-33720279.65179.65
6343786-34378681.20681.21
60min1348036-34803682.21083.071.8582.2183.081.85
2349074-34907482.45682.46
3343453-34345381.12881.13
4360080-36008085.05585.06
5350664-35066482.83182.83
6358834-35883484.76184.76
90min1365279-36527986.28386.931.8686.2886.931.86
2363882-36388285.95385.95
3361875-36187585.47985.48
4378083-37808389.30889.31
5363824-36382485.94085.94
6375196-37519688.62688.63
120min1372287-37228787.93988.871.8487.9488.871.84
2372071-37207187.88887.89
3370442-37044287.50387.50
4386094-38609491.20091.20
5372487-37248787.98687.99
6384001-38400190.70690.71
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1391366-39136692.44593.622.2292.4593.622.22
2391104-39110492.38492.38
3390131-39013192.15492.15
4407038-40703896.14796.15
5390186-39018692.16792.17
6408251-40825196.43496.43
盐酸伐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
10min1263161-26316162.14760.722.9262.1560.722.92
2255664-25566460.37660.38
3257521-25752160.81560.81
4253942-25394259.96959.97
5266963-26696363.04463.04
6245491-24549157.97457.97
15min1284363-28436367.15366.092.4467.1566.092.44
2278140-27814065.68465.68
3278809-27880965.84265.84
4280359-28035966.20866.21
5288920-28892068.23068.23
6268686-26868663.45163.45
20min1299141-29914170.64369.882.3670.6469.882.36
2296284-29628469.96969.97
3292547-29254769.08669.09
4298214-29821470.42470.42
5304967-30496772.01972.02
6284316-28431667.14267.14
30min1320513-32051375.69074.862.1375.6974.862.13
2321299-32129975.87675.88
3312743-31274373.85573.86
4318317-31831775.17275.17
5323548-32354876.40776.41
6305452-30545272.13472.13
45min1339598-33959880.19779.401.9980.2079.401.99
2343186-34318681.04581.04
3333382-33338278.72978.73
4338294-33829479.88979.89
5338746-33874679.99680.00
6324234-32423476.56976.57
60min1353116-35311683.39082.472.0683.3982.482.06
2355615-35561583.98083.98
3344186-34418681.28181.28
4349624-34962482.56582.57
5355385-35538583.92683.93
6337523-33752379.70779.71
90min1368624-36862487.05286.191.7987.0586.191.79
2371825-37182587.80887.81
3359895-35989584.99184.99
4362940-36294085.71085.71
5370973-37097387.60787.61
6355661-35566183.99183.99
120min1378354-37835489.35087.981.9689.3587.981.96
2380941-38094189.96189.96
3367049-36704986.68086.68
4370627-37062787.52587.53
5376392-37639288.88688.89
6361962-36196285.47985.48
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1394768-39476893.22692.471.6293.2392.481.62
2398403-39840394.08494.08
3387484-38748491.50691.51
4387216-38721691.44391.44
5398110-39811094.01594.02
6383523-38352390.57090.57
盐酸伐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
10min1259885-25988561.39461.175.6461.3961.165.64
2273879-27387964.69964.70
3247143-24714358.38458.38
4273660-27366064.64864.65
5237141-23714156.02156.02
6261796-26179661.84561.85
15min1283348-28334866.93666.344.7766.9466.344.77
2296750-29675070.10270.10
3267891-26789163.28563.28
4291814-29181468.93668.94
5262302-26230261.96561.96
6282742-28274266.79366.79
20min1300741-30074171.04569.984.5871.0569.984.59
2310354-31035473.31673.32
3282274-28227466.68366.68
4308591-30859172.90072.90
5277541-27754165.56565.56
6297828-29782870.35770.36
30min1318102-31810275.14675.074.0475.1575.084.04
2333185-33318578.71078.71
3304383-30438371.90671.91
4331286-33128678.26178.26
5302866-30286671.54771.55
6316970-31697074.87974.88
45min1335250-33525079.19779.383.6779.2079.383.67
2350682-35068282.84382.84
3323828-32382876.49976.50
4351174-35117482.95982.96
5324293-32429376.60976.61
6330893-33089378.16878.17
60min1350125-35012582.71182.983.8482.7182.983.84
2366123-36612386.49186.49
3335545-33554579.26779.27
4367024-36702486.70386.70
5337479-33747979.72479.72
6351307-35130782.99182.99
90min1369753-36975387.34886.623.9287.3586.623.91
2381799-38179990.19490.19
3349057-34905782.45982.46
4383748-38374890.65490.65
5353929-35392983.61083.61
6361620-36162085.42785.43
120min1373873-37387388.32188.463.5988.3288.463.59
2388270-38827091.72291.72
3358907-35890784.78684.79
4391942-39194292.59092.59
5362040-36204085.52685.53
6371717-37171787.81287.81
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1389515-38951592.01792.923.0092.0292.923.00
2405725-40572595.84695.85
3379391-37939189.62589.62
4409758-40975896.79996.80
5387333-38733391.50191.50
6388283-38828391.72691.73
盐酸伐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
10min1277894-27789465.59966.532.6165.6066.542.61
2281404-28140466.42766.43
3284438-28443867.14367.14
4280784-28078466.28166.28
5294302-29430269.47269.47
6272338-27233864.28764.29
15min1293232-29323269.21970.092.7169.2270.092.71
2295561-29556169.76969.77
3298219-29821970.39770.40
4295340-29534069.71769.72
5311580-31158073.55173.55
6287501-28750167.86767.87
20min1304421-30442171.86172.532.3671.8672.532.36
2309349-30934973.02473.02
3308365-30836572.79272.79
4303682-30368271.68671.69
5319573-31957375.43775.44
6298079-29807970.36470.36
30min1321912-32191275.98976.642.0275.9976.642.03
2330986-33098678.13178.13
3325168-32516876.75876.76
4322796-32279676.19876.20
5332492-33249278.48778.49
6314553-31455374.25274.25
45min1340838-34083880.45781.571.7480.4681.571.74
2351849-35184983.05683.06
3346798-34679881.86481.86
4343500-34350081.08581.09
5352584-35258483.23083.23
6337630-33763079.70079.70
60min1354256-35425683.62484.872.0883.6284.872.08
2367650-36765086.78686.79
3358698-35869884.67384.67
4355394-35539483.89383.89
5369645-36964587.25787.26
6351463-35146382.96582.97
90min1370755-37075587.51988.591.8387.5288.591.83
2382790-38279090.36090.36
3378184-37818489.27389.27
4369409-36940987.20187.20
5382842-38284290.37290.37
6367764-36776486.81386.81
120min1378257-37825789.29089.722.3989.2989.722.39
2393385-39338592.86192.86
3387179-38717991.39691.40
4378081-37808189.24989.25
5367350-36735086.71586.72
6376158-37615888.79588.79
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1387210-38721091.40492.232.3291.4092.232.32
2404523-40452395.49095.49
3396742-39674293.65493.65
4390482-39048292.17692.18
5378184-37818489.27389.27
6387163-38716391.39291.39
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