阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.952872402881702876652864042871362873230.23
211.052886812889102887960.06
单位质量响应值RSD%判断
26239.5426135.380.29数据可信
长期12月-供试品溶液-2023101221批-阿齐沙坦-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%
5min177129-7712926.42823.6223.3926.4323.6223.39
251068-5106817.49817.50
382129-8212928.14128.14
484540-8454028.96728.97
571783-7178324.59624.60
646872-4687216.06116.06
10min1228079-22807978.15072.769.4278.3072.909.43
2193501-19350166.30266.40
3198719-19871968.09068.25
4243588-24358883.46583.63
5213144-21314473.03373.17
6197077-19707767.52867.62
15min1279440-27944095.74991.984.3696.3392.514.38
2263547-26354790.30390.77
3258848-25884888.69389.23
4275244-27524494.31194.94
5280791-28079196.21296.75
6252698-25269886.58687.05
20min1292376-292376100.18296.264.46101.2997.314.48
2276480-27648094.73595.70
3268717-26871792.07593.10
4288537-28853798.866100.01
5294336-294336100.853101.93
6265223-26522390.87891.82
30min1284932-28493297.63195.232.3999.3096.802.36
2281529-28152996.46597.96
3271521-27152193.03694.57
4269331-26933192.28593.98
5284171-28417197.37099.01
6275983-27598394.56596.01
45min1291945-291945100.03498.872.12102.25100.982.13
2287078-28707898.366100.40
3276898-27689894.87896.93
4292328-292328100.165102.38
5293128-293128100.439102.62
6289895-28989599.331101.31
60min1284445-28444597.46498.422.04100.23101.082.00
2288766-28876698.945101.52
3283799-28379997.24399.83
4283066-28306696.99199.76
5298427-298427102.255104.99
6284845-28484597.601100.13
极限1302776-302776103.745102.682.18107.05105.882.10
2309758-309758106.137109.26
3295640-295640101.300104.42
4290493-29049399.536102.84
5300492-300492102.962106.27
6298827-298827102.392105.46
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.776988869782703077014070557701350.45
214.777085170943708970.10
单位质量响应值RSD%判断
4748.484800.070.77数据可信
长期12月-供试品溶液-2023101221批-氨氯地平-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%
5min150717-5071768.87564.3411.8968.8864.3411.89
248490-4849065.85165.85
345249-4524961.44961.45
438240-3824051.93151.93
554962-5496274.64074.64
646627-4662763.32163.32
10min160881-6088182.67881.989.3083.0682.349.31
264194-6419487.17787.54
361149-6114983.04283.38
449236-4923666.86467.15
563504-6350486.24086.65
663253-6325385.89986.25
15min163306-6330685.97187.306.4486.8188.116.45
267054-6705491.06191.91
366802-6680290.71991.52
456333-5633376.50277.16
565511-6551188.96689.86
666684-6668490.55991.39
20min164802-6480288.00389.504.7789.3290.804.81
267713-6771391.95693.31
367450-6745091.59992.91
459962-5996281.43082.52
568114-6811492.50193.89
667383-6738391.50892.84
30min163348-6334886.02888.746.7287.8490.546.72
266959-6695990.93292.80
367796-6779692.06993.88
457422-5742277.98179.52
566918-6691890.87792.78
669647-6964794.58396.42
45min166583-6658390.42292.974.2892.7195.254.32
269364-6936494.19896.57
370703-7070396.01798.34
463688-6368886.49088.46
568685-6868593.27695.68
671716-7171697.39299.76
60min165101-6510188.40992.284.8291.2095.094.85
269853-6985394.86297.76
370501-7050195.74298.60
462628-6262885.05187.50
569779-6977994.76297.69
669850-6985094.85897.77
极限167368-6736891.48895.362.4594.7798.682.45
271127-7112796.593100.01
372502-7250298.460101.85
469639-6963994.57297.50
570031-7003195.10498.56
670654-7065495.95099.38
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.952881662868102886912860992889262877380.43
211.052864352871472867910.18
单位质量响应值RSD%判断
26277.4425953.940.88数据可信
长期12月-供试品溶液-2024010621批-阿齐沙坦-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%
5min1116798-11679840.13245.6013.8540.1345.6013.85
2114316-11431639.27939.28
3149008-14900851.19951.20
4119606-11960641.09741.10
5157612-15761254.15554.16
6138894-13889447.72447.72
10min1229316-22931678.79382.984.4279.0283.244.44
2237342-23734281.55181.77
3240031-24003182.47582.76
4233680-23368080.29280.52
5256390-25639088.09688.40
6252318-25231886.69686.96
15min1253979-25397987.26790.202.9987.9390.923.01
2256978-25697888.29888.97
3260749-26074989.59390.34
4259639-25963989.21289.89
5274630-27463094.36395.15
6269179-26917992.49093.24
20min1262537-26253790.20892.142.9391.3593.362.95
2258199-25819988.71789.88
3264387-26438790.84392.08
4270540-27054092.95794.13
5279202-27920295.93497.25
6274129-27412994.19195.45
30min1266676-26667691.63094.482.8493.2896.212.83
2273533-27353393.98695.64
3265516-26551691.23192.98
4281817-28181796.83298.52
5284339-28433997.69999.55
6278013-27801395.52597.31
45min1277543-27754395.36495.731.5297.5297.991.54
2273806-27380694.08096.26
3274817-27481794.42796.68
4282207-28220796.96699.19
5284702-28470297.824100.21
6278656-27865695.74698.06
60min1277871-27787195.47696.211.7198.1699.001.73
2275253-27525394.57797.28
3275416-27541694.63397.41
4283212-28321297.312100.07
5287359-28735998.736101.67
6280943-28094396.53299.38
极限1300858-300858103.375104.160.96106.59107.480.91
2308336-308336105.944109.17
3303119-303119104.152107.45
4300881-300881103.383106.69
5301314-301314103.531107.01
6304413-304413104.596107.98
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.777099370885709367105470388708510.38
214.777109371184711380.10
单位质量响应值RSD%判断
4796.954816.380.29数据可信
长期12月-供试品溶液-2024010621批-氨氯地平-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%
5min156144-5614475.72980.806.5375.7380.806.53
254004-5400472.84372.84
360861-6086182.09282.09
462288-6228884.01784.02
563676-6367685.88985.89
662462-6246284.25184.25
10min164094-6409486.45393.103.6886.8793.553.68
270502-7050295.09695.50
368761-6876192.74893.20
470926-7092695.66896.13
569493-6949393.73594.21
670359-7035994.90395.37
15min166356-6635689.50494.713.6290.4095.683.61
271417-7141796.33097.26
367683-6768391.29492.27
471458-7145896.38697.38
572125-7212597.28598.28
672270-7227097.48198.48
20min168814-6881492.81995.691.9994.2297.182.01
269576-6957693.84795.32
371540-7154096.49697.97
471773-7177396.81098.34
571536-7153696.49198.03
672399-7239997.65599.19
30min168618-6861892.55597.542.6294.4799.562.62
273193-7319398.726100.72
372265-7226597.47499.49
473820-7382099.572101.64
573349-7334998.936101.01
672625-7262597.960100.04
45min171805-7180596.85498.451.1399.28101.011.16
272215-7221597.40799.94
373977-7397799.783102.34
473403-7340399.009101.63
573457-7345799.082101.71
673056-7305698.541101.16
60min171608-7160896.58898.681.2599.55101.801.30
272730-7273098.101101.18
373061-7306198.548101.66
473871-7387199.640102.82
573607-7360799.284102.46
674086-7408699.930103.10
极限172131-7213197.29398.030.91100.80101.690.92
273012-7301298.482102.11
371892-7189296.971100.63
473562-7356299.224102.95
573144-7314498.660102.39
672314-7231497.540101.27
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.952880712897332864972867652868812875890.47
211.052858482860422859450.05
单位质量响应值RSD%判断
26263.8425877.381.05数据可信
长期12月-供试品溶液-2024010721批-阿齐沙坦-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%
5min1103988-10398835.79345.4512.0935.7945.4512.09
2126601-12660143.57643.58
3134905-13490546.43446.43
4133004-13300445.78045.78
5148740-14874051.19651.20
6145003-14500349.91049.91
10min1259703-25970389.39083.045.0289.5983.304.99
2228674-22867478.71078.95
3246244-24624484.75785.02
4230176-23017679.22679.48
5247913-24791385.33285.62
6234870-23487080.84281.12
15min1285075-28507598.12390.214.9098.8290.924.86
2249037-24903785.71886.40
3267081-26708191.92992.66
4253916-25391687.39888.09
5260680-26068089.72690.48
6256712-25671288.36089.09
20min1285612-28561298.30891.783.7099.5592.993.67
2259468-25946889.30990.46
3268574-26857492.44393.68
4261476-26147690.00091.18
5260610-26061089.70290.96
6264098-26409890.90292.12
30min1282871-28287197.36493.802.9899.1595.522.95
2269594-26959492.79494.45
3282364-28236497.19098.94
4268866-26886692.54494.22
5263622-26362290.73992.49
6267744-26774492.15793.88
45min1277318-27731895.45394.683.4197.7896.923.36
2268369-26836992.37394.54
3291655-291655100.388102.68
4277480-27748095.50997.70
5268138-26813892.29394.55
6267397-26739792.03894.27
60min1287407-28740798.92595.342.67101.7898.112.65
2271391-27139193.41396.09
3282312-28231297.172100.02
4274591-27459194.51497.24
5267237-26723791.98394.76
6279030-27903096.04298.79
极限1300647-300647103.483101.382.49106.89104.682.44
2294214-294214101.268104.47
3298645-298645102.794106.18
4302173-302173104.008107.26
5286548-28654898.630101.91
6284973-28497398.088101.37
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.777092971083705007051670519707090.40
214.777043370466704500.04
单位质量响应值RSD%判断
4787.344769.800.26数据可信
长期12月-供试品溶液-2024010721批-氨氯地平-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%
5min143133-4313358.52276.7713.3858.5276.7713.38
256751-5675176.99877.00
358831-5883179.82079.82
460630-6063082.26182.26
554628-5462874.11874.12
665539-6553988.92188.92
10min163966-6396686.78789.784.8387.1190.214.84
265405-6540588.74089.17
367956-6795692.20192.64
470264-7026495.33295.79
561459-6145983.38683.80
667993-6799392.25192.75
15min165730-6573089.18191.113.9789.9992.044.00
265808-6580889.28690.21
368290-6829092.65493.61
470255-7025595.32096.31
563282-6328285.85986.73
669547-6954794.35995.37
20min166228-6622889.85692.253.4591.1693.683.48
268913-6891393.49994.92
367836-6783692.03893.51
470375-7037595.48397.00
564411-6441187.39188.74
670202-7020295.24896.78
30min166685-6668590.47693.973.5992.2895.913.62
270371-7037195.47797.41
370849-7084996.12698.11
471649-7164997.21199.26
565593-6559388.99590.83
670412-7041295.53397.59
45min165086-6508688.30794.714.4190.6197.174.42
270369-7036995.47597.94
372529-7252998.405100.92
472687-7268798.620101.21
567078-6707891.01093.34
671063-7106396.41699.01
60min169398-6939894.15795.883.0496.9598.883.07
272495-7249598.359101.36
370493-7049395.64398.71
471528-7152897.047100.18
567177-6717791.14493.98
672924-7292498.941102.07
极限173693-7369399.98596.722.49103.30100.242.34
272176-7217697.926101.47
370919-7091996.22199.81
472150-7215097.891101.56
570098-7009895.10798.45
668685-6868593.19096.87
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.952859782859272860752860042859662859900.02
211.052868522871182869850.07
单位质量响应值RSD%判断
26117.8125971.490.40数据可信
长期12月-供试品溶液-2024010921批-阿齐沙坦-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%
5min1156383-15638353.87856.3013.4853.8856.3013.48
2143379-14337949.39849.40
3145120-14512049.99850.00
4202498-20249869.76669.77
5159798-15979855.05555.05
6173313-17331359.71159.71
10min1243351-24335183.84194.497.5284.1494.807.52
2276736-27673695.34395.62
3258529-25852989.07089.35
4295831-295831101.922102.31
5275755-27575595.00595.31
6295392-295392101.770102.10
15min1260624-26062489.79298.245.1590.5699.085.17
2290251-29025199.999100.80
3274798-27479894.67595.45
4297784-297784102.594103.55
5289355-28935599.690100.52
6297999-297999102.669103.57
20min1263979-26397990.94898.214.4192.2199.604.42
2296237-296237102.061103.42
3278457-27845795.93697.23
4290455-290455100.069101.59
5284226-28422697.92399.31
6297081-297081102.352103.82
30min1258566-25856689.08397.615.0690.8599.545.08
2284188-28418897.91099.84
3276625-27662595.30597.14
4295107-295107101.672103.75
5287466-28746699.040100.97
6297917-297917102.640104.68
45min1271992-27199293.70899.593.6895.97102.063.71
2299782-299782103.283105.75
3283693-28369397.740100.10
4295301-295301101.739104.38
5285748-28574898.448100.93
6297939-297939102.648105.25
60min1270895-27089593.33098.984.1096.12102.014.10
2299038-299038103.026106.07
3284163-28416397.902100.81
4294166-294166101.348104.56
5277088-27708895.46498.49
6298423-298423102.815105.99
极限1298866-298866102.967102.630.78106.27106.210.73
2301255-301255103.790107.41
3298987-298987103.009106.46
4296994-296994102.322106.10
5294528-294528101.473105.03
6296769-296769102.245105.99
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.777047770430704897037170376704290.08
214.777073770545706410.20
单位质量响应值RSD%判断
4768.384782.740.22数据可信
长期12月-供试品溶液-2024010921批-氨氯地平-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%
5min159359-5935980.58778.6814.2480.5978.6814.24
241784-4178456.72756.73
360554-6055482.21082.21
459070-5907080.19580.19
561492-6149283.48383.48
665455-6545588.86388.86
10min166121-6612189.76889.832.7090.2290.272.75
262961-6296185.47885.79
367434-6743491.55092.01
465504-6550488.93089.38
567400-6740091.50491.97
667582-6758291.75192.24
15min167765-6776592.00091.661.8792.9592.601.91
266219-6621989.90190.69
368705-6870593.27694.24
466143-6614389.79790.74
567101-6710191.09892.07
669168-6916893.90494.91
20min168492-6849292.98792.242.2494.4493.682.25
267483-6748391.61792.91
369352-6935294.15495.64
465330-6533088.69490.13
567592-6759291.76593.24
669397-6939794.21595.74
30min166650-6665090.48692.832.5592.4694.792.57
266680-6668090.52792.32
368823-6882393.43695.44
467647-6764791.83993.77
569341-6934194.13996.13
671140-7114096.58298.63
45min169884-6988494.87694.931.4297.3597.401.44
269796-6979694.75797.06
370891-7089196.24398.77
468443-6844392.92095.36
569394-6939494.21196.72
671139-7113996.58099.17
60min169962-6996294.98294.732.4797.9997.742.44
269863-6986394.84897.68
371069-7106996.48599.55
467988-6798892.30295.26
567675-6767591.87794.91
672110-7211097.898101.02
极限170289-7028995.42694.071.6798.9697.601.68
268312-6831292.74296.10
370705-7070595.99199.59
467652-6765291.84695.32
569512-6951294.37197.92
669266-6926694.03797.70
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