厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.066159761653615626157261721616210.11
210.016199362020620060.04
单位质量响应值RSD%判断
6125.356194.410.80数据可信
供试品溶液-2026051421批-厄贝沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13744-37445.4665.979.455.475.989.43
24463-44636.5166.52
33862-38625.6385.64
44489-44896.5546.55
54355-43556.3586.36
63636-36365.3085.31
10min115146-1514622.11240.2548.5422.1740.3248.47
235430-3543051.72651.80
338623-3862356.38756.45
415543-1554322.69222.76
544425-4442564.85864.93
616252-1625223.72723.79
15min126752-2675239.05656.0134.3239.3656.5234.40
245505-4550566.43567.08
349392-4939272.11072.80
425903-2590337.81738.14
555221-5522180.62081.41
627415-2741540.02440.35
20min134723-3472350.69465.7026.2551.4366.8426.46
251642-5164275.39476.78
353744-5374478.46379.95
433939-3393949.54950.29
560857-6085788.84890.53
635116-3511651.26752.03
30min145015-4501565.71977.5216.8067.0279.3817.19
258433-5843385.30987.53
360576-6057688.43890.80
444036-4403664.29065.59
564099-6409993.58196.26
646411-4641167.75869.09
45min154066-5406678.93387.129.8580.9789.8510.39
263664-6366492.94696.12
364954-6495494.82998.17
453157-5315777.60679.62
566140-6614096.561100.27
656057-5605781.84083.93
60min158117-5811784.84888.865.6687.7692.566.32
263648-6364892.92397.13
363256-6325692.35096.75
455962-5596281.70184.57
564473-6447394.12798.91
659746-5974687.22690.23
90min164093-6409393.57292.551.3097.4397.241.85
262911-6291191.84797.08
363620-6362092.88298.31
462057-6205790.60094.38
564302-6430293.87799.71
663378-6337892.52896.50
120min165039-6503994.95394.321.9099.85100.031.08
263761-6376193.08899.34
362967-6296791.92898.39
465948-6594896.280101.07
563991-6399193.423100.30
665919-6591996.238101.23
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164131-6413193.62892.951.8099.5899.710.95
262981-6298191.94999.24
362169-6216990.76398.24
464908-6490894.762100.62
562914-6291491.85199.76
664899-6489994.749100.81
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.96458586465236462876463636466696463400.05
214.96513426517316515360.05
单位质量响应值RSD%判断
43378.5243727.250.57数据可信
供试品溶液-2026051421批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190842-19084226.29117.0342.6026.2917.0342.59
2185831-18583125.60125.60
389310-8931012.30412.30
4121157-12115716.69116.69
574658-7465810.28510.29
680057-8005711.02911.03
10min1514186-51418670.83770.836.3571.1371.026.37
2558827-55882776.98777.27
3541060-54106074.54074.68
4471673-47167364.98065.17
5513070-51307070.68370.80
6486022-48602266.95767.08
15min1646136-64613689.01588.531.4990.0989.511.56
2650031-65003189.55290.69
3654669-65466990.19191.16
4641584-64158488.38889.30
5632214-63221487.09788.00
6631016-63101686.93287.80
20min1659756-65975690.89291.521.0792.9693.481.04
2666832-66683291.86794.00
3660026-66002690.92992.90
4675341-67534193.03994.93
5655964-65596490.36992.24
6667886-66788692.01293.84
30min1668077-66807792.03892.171.6195.1295.151.57
2670396-67039692.35895.51
3665878-66587891.73594.71
4682235-68223593.98996.91
5650887-65088789.67092.54
6676828-67682893.24496.10
45min1670141-67014192.32292.641.3696.4296.641.31
2672266-67226692.61596.80
3671518-67151892.51296.51
4680873-68087393.80197.77
5657318-65731890.55694.42
6682761-68276194.06197.95
60min1664265-66426591.51390.081.4296.6495.111.42
2656178-65617890.39995.61
3648288-64828889.31294.34
4653988-65398890.09795.11
5638847-63884788.01192.89
6661471-66147191.12896.06
90min1654075-65407590.10989.831.2396.2595.861.15
2642813-64281388.55894.77
3654301-65430190.14096.16
4660129-66012990.94396.95
5641605-64160588.39194.24
6659215-65921590.81796.77
120min1645977-64597788.99490.592.4396.1497.622.25
2653560-65356090.03897.24
3648118-64811889.28896.31
4681303-68130393.860100.88
5643076-64307688.59495.43
6673539-67353992.79199.75
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1669937-66993792.29493.310.63100.43101.340.54
2679930-67993093.671101.87
3676122-67612293.146101.16
4676201-67620193.157101.22
5680078-68007893.691101.51
6681433-68143393.878101.87
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.066160461554615956147961530615520.09
210.016137761419613980.05
单位质量响应值RSD%判断
6118.496133.670.18数据可信
供试品溶液-2026051421批-厄贝沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13232-32324.7446.1218.554.746.1218.56
23889-38895.7095.71
34973-49737.3007.30
43370-33704.9474.95
54856-48567.1287.13
64694-46946.8916.89
10min119572-1957228.73128.8842.2228.7828.9542.14
216972-1697224.91424.98
315600-1560022.90022.98
414854-1485421.80521.86
514819-1481921.75421.83
636233-3623353.18853.27
15min130160-3016044.27445.7330.2644.6546.1230.30
230225-3022544.36944.71
326482-2648238.87439.21
425354-2535437.21937.52
524881-2488136.52436.85
649794-4979473.09573.76
20min137161-3716154.55157.2321.5455.4158.1221.70
239007-3900757.26158.09
334445-3444550.56451.33
434662-3466250.88251.59
533076-3307648.55449.28
655561-5556181.56183.04
30min148508-4850871.20871.5313.1372.6873.0713.43
249964-4996473.34574.81
345467-4546766.74468.07
444771-4477165.72267.00
542969-4296963.07764.34
660705-6070589.11291.50
45min155238-5523881.08782.097.2283.3584.427.63
257666-5766684.65186.94
353780-5378078.94781.02
453564-5356478.63080.64
552078-5207876.44878.42
663204-6320492.78196.16
60min159890-5989087.91687.904.2991.0891.144.67
262873-6287392.29595.52
357722-5772284.73387.68
457634-5763484.60487.48
557990-5799085.12787.94
663151-6315192.70397.11
90min163028-6302892.52292.421.8896.6696.632.16
264418-6441894.56398.81
362549-6254991.81995.71
460900-6090089.39993.22
563290-6329092.90796.67
663553-6355393.29398.73
120min164598-6459894.82794.410.9599.9999.651.16
264125-6412594.13399.43
364266-6426694.34099.25
463302-6330292.92597.74
565150-6515095.637100.43
664448-6444894.607101.08
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164302-6430294.39393.971.91100.61100.261.83
264039-6403994.006100.35
366249-6624997.251103.21
462864-6286492.28298.13
563109-6310992.64198.50
663515-6351593.237100.76
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.96482056482376484486484666483966483500.02
214.96484066480356482200.05
单位质量响应值RSD%判断
43513.4243504.700.02数据可信
供试品溶液-2026051421批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123808-12380817.07318.8114.4517.0718.8114.46
2136701-13670118.85118.85
3109310-10931015.07415.07
4136354-13635418.80418.80
5167760-16776023.13423.13
6144531-14453119.93119.93
10min1497249-49724968.57268.437.3468.7668.647.33
2538090-53809074.20474.41
3461624-46162463.65963.83
4451953-45195362.32562.53
5490932-49093267.70167.96
6537346-53734674.10174.32
15min1640212-64021288.28786.814.5389.2487.784.53
2677914-67791493.48694.52
3605472-60547283.49684.37
4602983-60298383.15384.05
5613478-61347884.60085.61
6636884-63688487.82888.87
20min1668229-66822992.15090.393.5294.0892.323.51
2692485-69248595.49597.57
3628082-62808286.61488.42
4659362-65936290.92892.75
5641074-64107488.40690.35
6643451-64345188.73390.75
30min1687358-68735894.78890.573.8297.7493.513.77
2687891-68789194.86298.00
3637227-63722787.87590.64
4655887-65588790.44893.28
5635824-63582487.68290.61
6636605-63660587.78990.80
45min1684536-68453694.39989.883.9098.4193.823.85
2677516-67751693.43197.62
3622948-62294885.90689.65
4656710-65671090.56294.40
5637405-63740587.90091.81
6631315-63131587.06091.04
60min1689895-68989595.13889.524.94100.2094.464.85
2684212-68421294.35499.58
3620118-62011885.51690.21
4620202-62020285.52790.37
5654550-65455090.26495.15
6625997-62599786.32691.28
90min1674519-67451993.01889.223.2099.1395.163.20
2666202-66620291.87198.15
3620808-62080885.61191.26
4644028-64402888.81394.61
5646982-64698289.22095.11
6629375-62937586.79292.70
120min1671462-67146292.59689.492.8899.7596.412.89
2660750-66075091.11998.41
3617361-61736185.13691.73
4655016-65501690.32897.11
5647148-64714889.24396.12
6641693-64169388.49195.36
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1674593-67459393.02893.890.87101.21101.810.66
2678702-67870293.595101.90
3689311-68931195.058102.60
4674855-67485593.064100.85
5682101-68210194.063101.93
6685398-68539894.518102.37
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.066157161628615496159861550615790.06
210.016162561664616440.05
单位质量响应值RSD%判断
6121.176158.240.43数据可信
供试品溶液-2026051421批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130034-3003443.99137.4827.6043.9937.4827.60
224650-2465036.10536.11
333472-3347249.02749.03
419151-1915128.05128.05
530616-3061644.84444.84
615600-1560022.84922.85
10min161061-6106189.43788.052.7289.9388.472.82
260136-6013688.08288.48
360213-6021388.19488.74
458914-5891486.29286.60
562530-6253091.58892.09
657842-5784284.72284.98
15min164535-6453594.52593.951.7096.0195.351.79
264114-6411493.90895.29
363840-6384093.50795.03
463482-6348292.98394.25
566040-6604096.72998.25
662857-6285792.06793.26
20min164489-6448994.45894.722.3296.9997.162.34
263806-6380693.45795.88
365016-6501695.22997.79
466350-6635097.18399.49
566049-6604996.74399.33
662302-6230291.25493.47
30min164487-6448794.45594.231.9098.0497.721.94
263305-6330592.72396.19
363927-6392793.63497.26
464263-6426394.12797.51
566624-6662497.585101.25
663389-6338992.84696.08
45min164628-6462894.66193.751.2399.2998.281.31
262922-6292292.16296.65
364294-6429494.17298.83
463416-6341692.88697.32
565019-6501995.23499.98
663751-6375193.37797.64
60min163204-6320492.57591.631.0398.2697.211.08
261804-6180490.52596.04
362190-6219091.09096.80
462099-6209990.95796.42
563403-6340392.86798.67
662650-6265091.76497.07
90min161641-6164190.28689.981.1097.0096.581.09
260317-6031788.34794.87
361247-6124789.70996.43
461221-6122189.67196.14
562188-6218891.08797.93
661995-6199590.80597.13
120min161754-6175490.45290.491.6998.1798.091.70
260177-6017788.14295.65
363051-6305192.351100.07
461774-6177490.48197.95
562731-6273191.88399.73
661213-6121389.65996.99
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162441-6244191.45890.841.10100.1899.441.15
262288-6228891.23499.72
362836-6283692.036100.78
461002-6100289.35097.82
562122-6212290.99199.86
661435-6143589.98498.31
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.96447616448776449786444706446596447490.04
214.96447486445936446700.02
单位质量响应值RSD%判断
43271.7443266.440.01数据可信
供试品溶液-2026051421批-非奈利酮-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112465-124651.7281.5219.511.731.5219.54
29613-96131.3331.33
312256-122561.7001.70
47766-77661.0771.08
510175-101751.4111.41
613466-134661.8671.87
10min127535-275353.8183.733.563.843.753.63
226252-262523.6403.66
327542-275423.8193.84
425369-253693.5183.53
526975-269753.7413.76
627900-279003.8693.89
15min133958-339584.7094.681.914.774.741.97
232916-329164.5644.62
334063-340634.7234.78
433025-330254.5794.63
533875-338754.6974.75
634572-345724.7944.86
20min136371-363715.0435.122.095.165.242.01
236309-363095.0355.14
338003-380035.2705.38
437479-374795.1975.30
537407-374075.1875.30
636155-361555.0145.13
30min140289-402895.5875.681.965.765.841.91
239973-399735.5435.70
341233-412335.7185.89
441703-417035.7835.94
541903-419035.8115.98
640442-404425.6085.78
45min144230-442306.1336.181.816.376.411.81
243344-433446.0106.23
345754-457546.3456.58
444807-448076.2136.44
544896-448966.2266.46
644346-443466.1496.38
60min145587-455876.3216.391.386.626.681.41
245031-450316.2446.53
346594-465946.4616.77
446681-466816.4736.77
546297-462976.4206.72
646106-461066.3936.70
90min148158-481586.6786.681.667.057.051.65
246665-466656.4716.83
348894-488946.7807.16
448665-486656.7487.11
548318-483186.7007.07
648517-485176.7287.10
120min149967-499676.9296.971.837.377.411.84
248982-489826.7927.22
351723-517237.1727.63
450399-503996.9897.43
550573-505737.0137.46
649756-497566.9007.35
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150099-500996.9476.991.697.477.521.64
250200-502006.9617.47
352118-521187.2277.76
450333-503336.9807.50
550099-500996.9477.47
649729-497296.8967.42
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.066168161614615776168661640616400.08
210.016161761546615820.09
单位质量响应值RSD%判断
6127.246152.050.29数据可信
供试品溶液-2026051421批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118332-1833226.85129.4028.9926.8529.4028.99
229289-2928942.90042.90
323190-2319033.96733.97
421295-2129531.19131.19
514382-1438221.06621.07
613934-1393420.40920.41
10min158844-5884486.19087.702.1286.4988.022.22
261891-6189190.65391.13
360404-6040488.47588.85
460290-6029088.30888.65
559440-5944087.06387.30
658365-5836585.48885.71
15min164225-6422594.07194.100.8895.3395.400.83
263823-6382393.48394.97
363597-6359793.15294.51
464957-6495795.14496.47
564892-6489295.04896.25
663978-6397893.71094.89
20min165194-6519495.49194.862.1797.7997.202.08
263581-6358193.12895.65
364311-6431194.19796.59
464917-6491795.08597.47
567224-6722498.464100.72
663353-6335392.79495.01
30min164789-6478994.89895.051.5498.2698.461.42
263906-6390693.60497.16
363749-6374993.37496.82
465110-6511095.36898.81
566435-6643597.308100.66
665385-6538595.77199.02
45min165084-6508495.33095.261.7099.7599.721.57
264167-6416793.98698.58
363395-6339592.85697.34
465236-6523695.552100.05
566351-6635197.185101.62
665975-6597596.635100.95
60min163807-6380793.45992.401.7598.9497.921.62
261766-6176690.47096.11
361888-6188890.64896.16
463490-6349092.99598.56
564565-6456594.569100.08
663008-6300892.28997.68
90min163745-6374593.36892.641.3599.8899.181.25
262420-6242091.42898.07
362520-6252091.57498.09
462963-6296392.22398.82
564687-6468794.748101.31
663154-6315492.50398.91
120min164090-6409093.87492.301.61101.4399.881.54
263428-6342892.904100.57
361517-6151790.10597.64
463377-6337792.829100.45
563676-6367693.267100.88
662022-6202290.84598.28
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163383-6338392.83892.331.49101.43100.921.30
261541-6154190.14098.84
363656-6365693.238101.78
462194-6219491.09799.75
563590-6359093.141101.79
663835-6383593.500101.95
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.96447096442606448616449916449566447550.05
214.96450736448286449500.03
单位质量响应值RSD%判断
43272.1543285.230.03数据可信
供试品溶液-2026051421批-非奈利酮-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17262-72621.0071.3334.241.011.3334.28
211146-111461.5451.55
38533-85331.1831.18
47502-75021.0401.04
57404-74041.0261.03
615555-155552.1562.16
10min124693-246933.4233.656.883.433.677.02
227473-274733.8093.83
326279-262793.6433.66
425281-252813.5053.52
524981-249813.4633.47
629411-294114.0774.10
15min132696-326964.5334.623.074.584.683.24
233439-334394.6364.70
333125-331254.5924.65
432489-324894.5044.55
533017-330174.5774.63
635321-353214.8974.97
20min136620-366205.0775.131.925.185.241.94
236452-364525.0545.16
337125-371255.1475.25
436249-362495.0255.13
537983-379835.2665.37
637727-377275.2305.35
30min140490-404905.6135.732.075.775.892.12
240640-406405.6345.80
341606-416065.7685.93
440637-406375.6345.79
542187-421875.8496.01
642409-424095.8796.06
45min144536-445366.1746.271.856.396.501.89
244692-446926.1966.43
344528-445286.1736.40
445047-450476.2456.46
545973-459736.3746.60
646507-465076.4486.69
60min145946-459466.3706.431.386.666.721.37
245616-456166.3246.62
346510-465106.4486.74
446001-460016.3776.67
547367-473676.5676.86
646746-467466.4816.80
90min149604-496046.8776.880.827.237.240.81
249133-491336.8127.18
349583-495836.8747.24
449294-492946.8347.19
550318-503186.9767.34
649601-496016.8777.27
120min152071-520717.2197.121.317.657.561.15
251984-519847.2077.65
350407-504076.9887.43
451310-513107.1137.55
551530-515307.1447.59
650715-507157.0317.50
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151667-516677.1637.121.557.687.651.50
250773-507737.0397.56
352435-524357.2697.79
450174-501746.9567.47
551662-516627.1627.69
651630-516307.1587.70
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