盐酸伐地那非口崩片项目信息
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%
112.073814963806933814863800413802883808010.18
212.153820933821413821170.01
单位质量响应值RSD%判断
31549.3831449.960.23数据可信
长期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%
5min1257076-25707661.86062.582.8461.8662.582.84
2264779-26477963.71463.71
3269992-26999264.96864.97
4261365-26136562.89262.89
5248250-24825059.73659.74
6258918-25891862.30362.30
10min1282915-28291568.07868.332.2168.2268.472.21
2288278-28827869.36869.51
3289579-28957969.68169.83
4288692-28869269.46869.61
5273317-27331765.76865.90
6280895-28089567.59267.73
15min1297204-29720471.51671.241.9471.8071.531.94
2298246-29824671.76772.06
3301394-30139472.52472.82
4298775-29877571.89472.19
5285046-28504668.59168.87
6295621-29562171.13571.42
20min1307017-30701773.87773.652.2674.3374.102.26
2310117-31011774.62375.08
3313252-31325275.37875.84
4309074-30907474.37274.83
5293680-29368070.66871.10
6303378-30337873.00273.45
30min1322850-32285077.68777.842.3578.3078.452.35
2332001-33200179.88980.51
3332770-33277080.07480.70
4322012-32201277.48678.10
5314086-31408675.57876.17
6317221-31722176.33376.94
45min1343995-34399582.77581.782.0483.5682.562.04
2342224-34222482.34983.15
3347202-34720283.54784.35
4341418-34141882.15582.95
5327649-32764978.84279.60
6336568-33656880.98881.77
60min1356174-35617485.70684.772.4386.6785.742.43
2357921-35792186.12687.11
3359762-35976286.56987.56
4352952-35295284.93185.90
5336190-33619080.89781.83
6350658-35065884.37985.34
90min1372121-37212189.54388.731.8690.7089.881.86
2372470-37247089.62790.80
3378977-37897791.19392.38
4362996-36299687.34888.51
5361458-36145886.97888.09
6364410-36441087.68888.83
120min1381069-38106991.69790.441.8193.0591.791.82
2379272-37927291.26492.64
3383202-38320292.21093.60
4376375-37637590.56791.92
5367268-36726888.37689.68
6367843-36784388.51489.85
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1390839-39083994.04792.732.2395.6194.292.23
2391401-39140194.18395.76
3392662-39266294.48696.08
4386032-38603292.89194.45
5370213-37021389.08490.59
6381031-38103191.68793.23
盐酸伐地那非口崩片项目信息
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%
112.073803493807603812853812243796353806510.18
212.153803653793553798600.19
单位质量响应值RSD%判断
31536.9531264.200.62数据可信
长期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%
5min1249736-24973660.28562.313.6460.2862.313.64
2268976-26897664.92964.93
3270870-27087065.38665.39
4255893-25589361.77161.77
5252257-25225760.89360.89
6251044-25104460.60060.60
10min1264904-26490463.94668.184.6164.0868.324.61
2302027-30202772.90773.05
3292593-29259370.63070.78
4277301-27730166.93967.08
5278220-27822067.16067.30
6279697-27969767.51767.65
15min1282437-28243768.17871.502.9968.4571.792.99
2307104-30710474.13374.44
3304187-30418773.42973.73
4296564-29656471.58871.87
5292311-29231170.56270.85
6294707-29470771.14071.42
20min1290808-29080870.19973.643.0870.6374.093.08
2315361-31536176.12676.60
3315340-31534076.12176.59
4304203-30420373.43273.88
5300140-30014072.45272.89
6304581-30458173.52473.97
30min1309721-30972174.76477.492.5775.3578.102.57
2330972-33097279.89480.53
3329982-32998279.65580.29
4320609-32060977.39378.00
5315893-31589376.25476.86
6318788-31878876.95377.56
45min1328833-32883379.37881.662.2080.1382.442.21
2347650-34765083.92084.74
3346857-34685783.72984.54
4335298-33529880.93981.72
5334722-33472280.80081.57
6336295-33629581.17981.96
60min1339786-33978682.02284.352.1082.9585.312.11
2358536-35853686.54887.55
3356271-35627186.00187.00
4346782-34678283.71184.67
5343634-34363482.95183.90
6351487-35148784.84785.80
90min1353496-35349685.33187.651.5986.4488.801.60
2369192-36919289.12090.32
3367017-36701788.59589.78
4359262-35926286.72387.87
5365053-36505388.12189.26
6364541-36454187.99889.14
120min1365617-36561788.25789.201.4889.5690.551.49
2377595-37759591.14992.54
3374734-37473490.45891.84
4364333-36433387.94789.29
5365937-36593788.33589.67
6368915-36891589.05490.40
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1378989-37898991.48592.221.2792.9893.761.29
2391556-39155694.51996.12
3381419-38141992.07293.66
4379298-37929891.56093.09
5378983-37898391.48493.01
6381824-38182492.17093.71
盐酸伐地那非口崩片项目信息
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%
112.073794863783333795943797103809273796100.25
212.153815653792203803920.44
单位质量响应值RSD%判断
31450.7031307.980.33数据可信
长期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%
5min1260896-26089663.02060.783.5863.0260.783.58
2248826-24882660.10560.10
3242603-24260358.60158.60
4261400-26140063.14263.14
5240654-24065458.13158.13
6255329-25532961.67561.68
10min1286776-28677669.27267.502.7069.4167.642.70
2282814-28281468.31568.45
3271112-27111265.48865.62
4285459-28545968.95369.09
5269031-26903164.98565.11
6281498-28149867.99768.13
15min1299286-29928672.29370.422.7472.5970.702.75
2297379-29737971.83372.12
3285023-28502368.84869.12
4297589-29758971.88472.18
5279552-27955267.52767.80
6290246-29024670.11070.40
20min1306458-30645874.02672.891.8574.4873.341.86
2306690-30669074.08274.53
3296516-29651671.62472.05
4305548-30554873.80674.26
5293568-29356870.91271.34
6301866-30186672.91773.36
30min1321563-32156377.67576.561.5578.2977.171.56
2320538-32053877.42778.04
3311105-31110575.14875.74
4319389-31938977.14977.77
5310386-31038674.97575.56
6318769-31876977.00077.61
45min1340675-34067582.29180.701.8483.0881.481.84
2337192-33719281.45082.23
3331959-33195980.18680.94
4335123-33512380.95081.74
5323049-32304978.03378.78
6336648-33664881.31882.10
60min1352358-35235885.11383.391.9286.0984.341.91
2348320-34832084.13885.10
3337488-33748881.52182.45
4340870-34087082.33883.31
5339951-33995182.11683.04
6352320-35232085.10486.06
90min1364517-36451788.05086.601.5889.2187.741.59
2358255-35825586.53887.69
3353951-35395185.49886.61
4359946-35994686.94688.10
5350180-35018084.58785.69
6364169-36416987.96689.11
120min1371058-37105889.63088.541.3090.9989.881.30
2365182-36518288.21189.55
3359893-35989386.93388.24
4368951-36895189.12190.47
5362739-36273987.62188.91
6371563-37156389.75291.09
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1383590-38359092.65791.441.3394.2292.971.33
2378395-37839591.40292.94
3376760-37676091.00892.50
4375497-37549790.70292.25
5371913-37191389.83791.32
6385174-38517493.04094.58
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