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%
112.213831863832243832223827013832383831140.07
212.133812883823223818050.20
单位质量响应值RSD%判断
31377.0731476.090.23数据可信
长期24月25℃-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%
5min1226086-22608654.53055.613.2854.5355.613.28
2241427-24142758.23058.23
3235163-23516356.71956.72
4229520-22952055.35855.36
5219461-21946152.93252.93
6231793-23179355.90655.91
10min1257564-25756462.12261.522.4962.2461.642.49
2261369-26136963.03963.17
3250705-25070560.46760.59
4260101-26010162.73462.86
5244614-24461458.99859.12
6256045-25604561.75561.88
15min1273461-27346165.95665.953.5966.2266.213.58
2287989-28798969.46069.73
3275184-27518466.37166.63
4274031-27403166.09366.36
5257201-25720162.03462.28
6272668-27266865.76566.03
20min1278280-27828067.11868.823.0667.5269.233.05
2287998-28799869.46269.89
3293217-29321770.72171.13
4285995-28599568.97969.39
5272074-27207465.62166.01
6294469-29446971.02371.43
30min1306841-30684174.00773.782.1174.5674.342.10
2309481-30948174.64475.22
3308787-30878774.47675.04
4313801-31380175.68576.25
5299894-29989472.33172.86
6296586-29658671.53372.10
45min1317719-31771976.63076.762.0777.3577.482.04
2325875-32587578.59879.34
3309577-30957774.66775.40
4311563-31156375.14675.88
5321251-32125177.48278.18
6323511-32351178.02778.75
60min1341725-34172582.42081.221.6383.3182.121.62
2337931-33793181.50582.42
3339840-33984081.96682.86
4337684-33768481.44682.34
5326144-32614478.66279.53
6337211-33721181.33282.23
90min1346619-34661983.60184.441.4884.6785.521.47
2352662-35266285.05886.16
3347738-34773883.87184.95
4359576-35957686.72687.80
5347820-34782083.89084.93
6346231-34623183.50784.59
120min1356600-35660086.00885.641.3187.2786.901.31
2359142-35914286.62187.91
3361342-36134287.15288.42
4350862-35086284.62485.90
5350294-35029484.48785.71
6352104-35210484.92486.19
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1370466-37046689.35288.642.0190.8090.091.99
2364964-36496488.02589.51
3362341-36234187.39388.85
4379822-37982291.60993.07
5358761-35876186.52987.94
6368761-36876188.94190.39
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%
112.213827123820793833043841203845733833580.27
212.133818213824733821470.13
单位质量响应值RSD%判断
31397.0531504.290.25数据可信
长期24月25℃-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%
5min1252204-25220460.78259.762.2060.7859.762.20
2255218-25521861.50961.51
3246717-24671759.46059.46
4249308-24930860.08460.08
5244218-24421858.85858.86
6240214-24021457.89357.89
10min1264764-26476463.80964.712.2663.9464.842.25
2266867-26686764.31664.45
3276219-27621966.57066.70
4259926-25992662.64362.78
5274262-27426266.09866.23
6269032-26903264.83864.97
15min1283889-28388968.41968.460.8668.7068.740.86
2286490-28649069.04569.33
3285134-28513468.71969.00
4280877-28087767.69367.97
5281524-28152467.84968.13
6286526-28652669.05469.33
20min1296865-29686571.54671.460.5671.9771.890.55
2296360-29636071.42471.86
3293375-29337570.70571.14
4297379-29737971.67072.09
5298126-29812671.85072.28
6296918-29691871.55971.98
30min1313930-31393075.65974.851.3076.2575.441.29
2307304-30730474.06274.65
3312145-31214575.22875.82
4313193-31319375.48176.06
5303961-30396173.25673.84
6312866-31286675.40275.99
45min1323190-32319077.89079.451.6478.6580.201.62
2329235-32923579.34780.10
3324794-32479478.27779.03
4335285-33528580.80581.56
5328895-32889579.26580.02
6336531-33653181.10681.86
60min1339285-33928581.76981.331.1482.7082.261.13
2332731-33273180.19081.12
3339713-33971381.87282.80
4343034-34303482.67383.60
5335014-33501480.74081.67
6334994-33499480.73581.67
90min1344684-34468483.07084.251.1984.1885.361.18
2350068-35006884.36885.48
3344431-34443183.00984.12
4352089-35208984.85585.97
5351651-35165184.75085.86
6354544-35454485.44786.56
120min1355369-35536985.64685.780.6886.9487.080.67
2355757-35575785.73987.04
3355529-35552985.68486.98
4360444-36044486.86988.17
5355283-35528385.62586.92
6353172-35317285.11686.42
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1363543-36354387.61688.020.6489.1089.500.63
2365495-36549588.08689.57
3367471-36747188.56290.05
4366072-36607288.22589.72
5367185-36718588.49389.98
6361439-36143987.10888.60
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%
112.213824163817303840533822213836033828050.26
212.133807833808593808210.02
单位质量响应值RSD%判断
31351.7631394.970.10数据可信
长期24月30℃-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%
5min1198340-19834047.91951.128.5847.9251.138.58
2216878-21687852.39752.40
3223432-22343253.98153.98
4211828-21182851.17751.18
5184132-18413244.48644.49
6235048-23504856.78756.79
10min1232248-23224856.11157.896.9156.2258.006.91
2246460-24646059.54459.66
3230417-23041755.66855.79
4237754-23775457.44157.55
5221787-22178753.58353.68
6268972-26897264.98365.11
15min1250104-25010460.42563.175.7560.6663.415.75
2262053-26205363.31163.56
3253542-25354261.25561.50
4265564-26556464.16064.40
5248596-24859660.06060.28
6288920-28892069.80270.07
20min1267324-26732464.58566.824.8964.9567.204.89
2277418-27741867.02467.41
3266968-26696864.49964.88
4281667-28166768.05068.43
5265334-26533464.10464.46
6300678-30067872.64373.07
30min1288121-28812169.60972.844.5070.1273.374.51
2298160-29816072.03572.57
3302900-30290073.18073.70
4302213-30221373.01473.55
5291227-29122770.36070.85
6326384-32638478.85479.44
45min1306226-30622673.98477.254.0174.6577.954.02
2319479-31947977.18577.88
3318029-31802976.83577.52
4320981-32098177.54878.25
5310664-31066475.05675.71
6343160-34316082.90783.67
60min1321915-32191577.77481.193.2478.6082.053.25
2330794-33079479.91980.79
3345331-34533183.43184.29
4336787-33678781.36782.24
5329914-32991479.70780.52
6351564-35156484.93785.88
90min1346018-34601883.59785.052.1584.6086.102.18
2345881-34588183.56484.61
3352278-35227885.11086.15
4356095-35609586.03287.08
5346929-34692983.81784.81
6365049-36504988.19589.33
120min1349398-34939884.41487.753.1685.6088.983.16
2356913-35691386.22987.46
3368177-36817788.95190.18
4375541-37554190.73091.97
5353557-35355785.41986.60
6375645-37564590.75592.09
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1365306-36530688.25789.992.2589.6391.422.27
2363843-36384387.90489.33
3375610-37561090.74792.18
4375892-37589290.81592.26
5368101-36810188.93290.30
6386016-38601693.26194.79
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%
112.213819423824913813583811483836813821240.27
212.133813373813143813260.01
单位质量响应值RSD%判断
31295.9931436.600.32数据可信
长期24月30℃-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%
5min1224761-22476154.31455.313.2654.3155.313.26
2239895-23989557.97157.97
3233728-23372856.48156.48
4227049-22704954.86754.87
5218288-21828852.75052.75
6229569-22956955.47655.48
10min1255313-25531361.69761.042.5461.8261.162.55
2259267-25926762.65362.78
3248005-24800559.93160.06
4257042-25704262.11562.24
5242031-24203158.48858.60
6253801-25380161.33261.46
15min1271630-27163065.64065.623.9365.9065.883.92
2287887-28788769.56969.84
3273949-27394966.20166.46
4269960-26996065.23765.50
5254473-25447361.49461.74
6271456-27145665.59865.86
20min1278405-27840567.27868.682.7267.6869.082.72
2287315-28731569.43169.85
3290384-29038470.17270.58
4283201-28320168.43768.84
5272619-27261965.87966.26
6293231-29323170.86071.27
30min1304297-30429773.53473.392.5174.0973.952.50
2307679-30767974.35274.93
3307813-30781374.38474.95
4312911-31291175.61676.17
5297295-29729571.84272.37
6292282-29228270.63171.19
45min1316334-31633476.44376.422.1977.1677.142.17
2323536-32353678.18478.93
3307075-30707574.20674.93
4308704-30870474.59975.32
5320005-32000577.33078.02
6321664-32166477.73178.45
60min1340581-34058182.30380.941.3183.1981.841.31
2335228-33522881.00981.92
3337287-33728781.50782.40
4334992-33499280.95281.84
5327305-32730579.09479.96
6334385-33438580.80581.70
90min1344859-34485983.33684.221.4484.4185.291.43
2350205-35020584.62885.72
3346720-34672083.78684.86
4357867-35786786.48087.55
5346819-34681983.81084.85
6344550-34455083.26284.33
120min1368464-36846489.04187.081.9590.3088.341.93
2366843-36684388.64989.93
3363577-36357787.86089.12
4351010-35101084.82386.09
5354925-35492585.76986.99
6357232-35723286.32687.58
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1372038-37203889.90490.700.7891.3692.150.77
2377536-37753691.23392.71
3371906-37190689.87291.33
4374530-37453090.50691.96
5377581-37758191.24492.66
6378432-37843291.44992.90
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