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%
110.712828012828232828982830932825462828320.07
210.742827142828122827630.03
单位质量响应值RSD%判断
26408.2226328.030.22数据可信
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%
5min1109709-10970937.33438.0552.9337.3338.0552.93
2113076-11307638.48038.48
352422-5242217.83917.84
482465-8246528.06328.06
5224102-22410276.26176.26
689184-8918430.34930.35
10min1277444-27744494.41494.263.6394.6294.473.74
2272641-27264192.77992.99
3268498-26849891.36991.47
4271746-27174692.47592.63
5296559-296559100.918101.34
6275092-27509293.61393.78
15min1291981-29198199.361100.581.26100.09101.321.25
2289845-28984598.63499.36
3298294-298294101.509102.12
4297437-297437101.217101.89
5297341-297341101.185102.17
6298513-298513101.583102.27
20min1292555-29255599.556100.851.05100.84102.141.01
2293369-29336999.833101.11
3296720-296720100.973102.14
4299593-299593101.951103.18
5295897-295897100.693102.24
6300022-300022102.097103.35
30min1291565-29156599.219100.571.09101.06102.421.04
2292387-29238799.499101.33
3297886-297886101.370103.10
4297160-297160101.123102.92
5294644-294644100.267102.37
6299578-299578101.946103.77
45min1287581-28758197.86399.721.43100.25102.131.38
2288405-28840598.144100.53
3295816-295816100.666102.96
4295847-295847100.676103.04
5293055-29305599.726102.39
6297521-297521101.246103.63
60min1287675-28767597.89598.961.09100.83101.921.07
2286357-28635797.447100.38
3291760-29176099.285102.14
4294605-294605100.254103.17
5291418-29141899.169102.39
6292919-29291999.680102.63
极限1285461-28546197.14298.821.39100.62102.341.33
2286195-28619597.392100.86
3292473-29247399.528102.93
4293977-293977100.040103.52
5289340-28934098.462102.23
6294921-294921100.361103.86
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%
114.726782867833674706752967649676620.25
214.836762167422675220.21
单位质量响应值RSD%判断
4596.604553.070.68数据可信
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%
5min144590-4459063.19467.7314.6263.1967.7314.62
251150-5115072.49172.49
336950-3695052.36652.37
452169-5216973.93573.94
556682-5668280.33180.33
645187-4518764.04064.04
10min162014-6201487.88890.314.3488.2490.694.38
264845-6484591.90092.30
359571-5957184.42584.72
466215-6621593.84194.25
566857-6685794.75195.20
662845-6284589.06589.42
15min164522-6452291.44293.442.9492.2894.312.99
265906-6590693.40394.32
363270-6327089.66890.43
468317-6831796.82097.75
567901-6790196.23197.20
665654-6565493.04693.90
20min164582-6458291.52794.012.9492.8795.412.97
267621-6762195.83497.27
364312-6431291.14492.40
469471-6947198.45699.93
566167-6616793.77395.28
665858-6585893.33594.70
30min164841-6484191.89495.483.5893.7597.403.61
269079-6907997.90099.86
364550-6455091.48293.25
469868-6986899.018101.04
569498-6949898.494100.52
666387-6638794.08595.97
45min165000-6500092.11995.243.0594.4997.693.09
268450-6845097.00999.52
364895-6489591.97194.24
469528-6952898.537101.10
568960-6896097.732100.31
666383-6638394.07996.49
60min164729-6472991.73594.713.7494.6197.693.77
268647-6864797.288100.34
363753-6375390.35293.14
469393-6939398.345101.46
569115-6911597.951101.07
665335-6533592.59495.53
极限164307-6430791.13794.563.5294.5398.073.55
268618-6861897.247100.83
364051-6405190.77494.06
468854-6885497.581101.24
568967-6896797.742101.40
665556-6555692.90796.35
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%
110.712833282837092834442828832829562832640.13
210.742824152821272822710.08
单位质量响应值RSD%判断
26448.5526282.220.45数据可信
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%
5min1140685-14068547.88036.0217.0947.8836.0217.09
293298-9329831.75331.75
3108036-10803636.76936.77
497511-9751133.18733.19
5103042-10304235.06935.07
692404-9240431.44831.45
10min1278411-27841194.75393.950.7595.0294.150.76
2278050-27805094.63094.81
3276427-27642794.07894.28
4274643-27464393.47193.66
5272998-27299892.91193.11
6275698-27569893.83094.00
15min1291250-29125099.12399.660.8199.92100.380.79
2296546-296546100.925101.63
3295043-295043100.414101.14
4291510-29151099.21199.92
5291492-29149299.20599.92
6291145-29114599.08799.78
20min1291675-29167599.268100.191.00100.61101.470.97
2299436-299436101.909103.17
3295926-295926100.714102.00
4292806-29280699.652100.91
5294336-294336100.173101.44
6292188-29218899.442100.69
30min1291420-29142099.181100.221.35101.08102.061.32
2299157-299157101.814103.64
3294913-294913100.370102.21
4288335-28833598.13199.94
5297330-297330101.192103.01
6295760-295760100.658102.46
45min1286300-28630097.43898.901.1499.88101.291.10
2293407-29340799.857102.25
3292560-29256099.569101.97
4286668-28666897.56399.92
5291267-29126799.129101.51
6293402-29340299.855102.21
60min1284634-28463496.87198.581.3499.86101.521.31
2295341-295341100.515103.46
3292786-29278699.646102.60
4287674-28767497.906100.80
5289837-28983798.642101.57
6287660-28766097.901100.81
极限1285613-28561397.20498.440.95100.73101.930.93
2293150-29315099.769103.28
3290326-29032698.808102.32
4286728-28672897.584101.02
5290449-29044998.850102.33
6289274-28927498.450101.91
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%
114.726775567804677656716967617676220.39
214.836735467504674290.16
单位质量响应值RSD%判断
4593.894546.800.73数据可信
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%
5min151510-5151073.07373.635.4973.0773.635.49
255339-5533978.50578.51
351775-5177573.44973.45
451208-5120872.64572.64
554373-5437377.13577.13
647216-4721666.98266.98
10min161612-6161287.40493.734.3687.8194.144.35
269623-6962398.76999.20
364745-6474591.84992.26
464994-6499492.20292.61
568246-6824696.81597.24
667209-6720995.34495.72
15min163535-6353590.13296.723.9891.0297.653.97
270885-70885100.559101.54
367418-6741895.64196.56
467287-6728795.45596.37
570045-7004599.367100.33
669923-6992399.194100.10
20min163846-6384690.57397.574.5691.9799.044.53
272386-72386102.688104.23
367390-6739095.60197.05
467492-6749295.74697.19
570570-70570100.112101.63
670976-70976100.688102.14
30min164845-6484591.99098.124.4593.89100.134.43
271276-71276101.114103.23
368223-6822396.78398.76
466644-6664494.54396.52
572671-72671103.093105.17
671333-71333101.194103.21
45min164589-6458991.62797.904.0294.03100.454.02
271726-71726101.752104.43
368265-6826596.84299.36
467400-6740095.61598.12
570724-70724100.331102.98
671348-71348101.216103.79
60min164465-6446591.45197.593.8594.37100.683.85
271807-71807101.867105.11
368229-6822996.79199.85
467610-6761095.91398.95
570946-70946100.645103.85
669679-6967998.848101.98
极限164380-6438091.33197.704.0994.75101.344.08
271718-71718101.741105.55
367879-6787996.29599.89
467482-6748295.73199.30
571196-71196101.000104.76
670570-70570100.112103.80
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%
110.712826712827132826092824482824662825810.05
210.742824692824052824370.02
单位质量响应值RSD%判断
26384.7826297.670.24数据可信
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%
5min1163263-16326355.61554.919.3455.6154.919.35
2167126-16712656.93156.93
3132526-13252645.14445.14
4173545-17354559.11759.12
5158905-15890554.13054.13
6171868-17186858.54658.55
10min1287053-28705397.78399.161.1298.0999.461.13
2292232-29223299.54899.86
3289282-28928298.54398.79
4296325-296325100.942101.27
5289377-28937798.57598.88
6292265-29226599.55999.88
15min1289433-28943398.594100.171.1099.45101.021.11
2295178-295178100.551101.42
3293832-293832100.093100.89
4298505-298505101.684102.57
5291499-29149999.298100.15
6295839-295839100.776101.65
20min1286720-28672097.67099.481.2899.07100.891.28
2296449-296449100.984102.41
3292883-29288399.769101.12
4294604-294604100.356101.81
5288420-28842098.24999.65
6293090-29309099.840101.28
30min1301805-301805102.809100.091.58104.75102.061.56
2292910-29291099.779101.77
3289811-28981198.723100.63
4296536-296536101.014103.03
5289903-28990398.754100.70
6292007-29200799.471101.46
45min1282575-28257596.25897.911.2198.77100.431.22
2291166-29116699.184101.73
3284976-28497697.07699.53
4291379-29137999.257101.83
5286457-28645797.580100.07
6287937-28793798.084100.63
60min1282865-28286596.35797.241.2599.41100.301.25
2289613-28961398.655101.75
3281037-28103795.73498.73
4289501-28950198.617101.74
5286051-28605197.442100.48
6283619-28361996.61499.70
极限1280191-28019195.44696.631.4199.03100.231.41
2285695-28569597.321100.96
3281571-28157195.91699.44
4289564-28956498.639102.31
5279189-27918995.10598.68
6285728-28572897.332100.96
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%
114.726733567568674806756567323674540.18
214.836785767281675690.61
单位质量响应值RSD%判断
4582.474556.240.41数据可信
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%
5min149357-4935770.03375.866.6970.0375.866.70
254069-5406976.71976.72
349043-4904369.58769.59
457360-5736081.38881.39
554067-5406776.71676.72
656873-5687380.69780.70
10min161367-6136787.07492.923.1487.4693.343.14
266322-6632294.10494.53
366397-6639794.21194.60
466443-6644394.27694.73
565636-6563693.13193.56
666757-6675794.72295.17
15min164406-6440691.38695.472.3292.2696.402.32
267005-6700595.07396.02
368626-6862697.37498.28
467461-6746195.72096.70
567559-6755995.86096.80
668644-6864497.39998.37
20min164914-6491492.10796.372.3893.4997.842.38
268205-6820596.77698.25
369654-6965498.832100.28
468097-6809796.62398.13
567808-6780896.21397.69
668826-6882697.65799.17
30min167825-6782596.23797.681.1998.1399.681.21
267839-6783996.25798.27
369541-6954198.672100.67
469614-6961498.775100.82
569311-6931198.345100.36
668920-6892097.79199.85
45min166559-6655994.44197.141.5796.8799.691.57
268390-6839097.03999.59
368670-6867097.43699.98
468753-6875397.554100.15
569859-6985999.123101.68
668543-6854397.25699.86
60min167143-6714395.26995.901.0298.2298.991.02
267034-6703495.11598.20
367050-6705095.13798.23
467647-6764795.98499.12
568794-6879497.612100.72
667878-6787896.31299.45
极限166910-6691094.93996.080.8798.4299.700.90
267114-6711495.22898.85
367727-6772796.09899.72
468050-6805096.556100.22
568378-6837897.022100.67
668117-6811796.651100.33
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%
110.712825092825472822752825032822812824230.05
210.742825532822452823990.08
单位质量响应值RSD%判断
26370.0326294.130.21数据可信
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%
5min1165230-16523056.30457.418.1656.3057.418.15
2173512-17351259.12759.13
3177019-17701960.32260.32
4187404-18740463.86063.86
5158703-15870354.08054.08
6148977-14897750.76650.77
10min1288292-28829298.23999.452.3698.5599.772.33
2288393-28839398.27498.60
3294081-294081100.212100.55
4282698-28269896.33396.69
5295292-295292100.625100.93
6302354-302354103.031103.31
15min1296210-296210100.938100.422.19101.80101.292.15
2290616-29061699.03199.91
3293524-293524100.022100.91
4285081-28508197.14598.04
5299633-299633102.104102.96
6303012-303012103.256104.11
20min1298435-298435101.696100.952.00103.12102.381.98
2297637-297637101.424102.85
3295086-295086100.555102.00
4285374-28537497.24598.67
5297859-297859101.500102.93
6303053-303053103.269104.70
30min1294318-294318100.29399.521.92102.28101.511.89
2288891-28889198.444100.43
3289261-28926198.570100.58
4284164-28416496.83398.80
5296255-296255100.953102.94
6299375-299375102.016104.02
45min1289838-28983898.76699.302.48101.31101.842.44
2286380-28638097.588100.12
3291403-29140399.300101.85
4281598-28159895.95898.47
5298911-298911101.858104.41
6300334-300334102.343104.91
60min1293030-29303099.85498.872.19102.94101.962.16
2287296-28729697.900100.98
3291067-29106799.185102.29
4278938-27893895.05298.09
5293419-29341999.987103.10
6297046-297046101.223104.36
极限1289728-28972898.72998.673.21102.37102.323.13
2285227-28522797.195100.82
3287406-28740697.938101.59
4277073-27707394.41697.99
5305077-305077103.959107.63
6292860-29286099.796103.50
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%
114.726795567602674176720767621675600.41
214.836762467592676080.04
单位质量响应值RSD%判断
4589.674558.870.48数据可信
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%
5min154489-5448977.23275.397.2177.2375.397.21
247673-4767367.57167.57
352235-5223574.03774.04
450832-5083272.04872.05
555135-5513578.14778.15
658766-5876683.29483.29
10min165200-6520092.41391.413.9492.8491.833.95
262665-6266588.82089.20
364912-6491292.00592.42
460569-6056985.84986.25
565783-6578393.24093.67
667833-6783396.14596.61
15min167429-6742995.57394.033.1496.5294.963.16
264704-6470491.71092.58
366577-6657794.36595.29
463058-6305889.37790.25
567661-6766195.90196.85
668613-6861397.25198.25
20min168755-6875597.45295.882.2598.9397.342.27
267309-6730995.40296.78
366970-6697094.92296.37
465210-6521092.42793.80
568134-6813496.57298.06
669519-6951998.535100.07
30min168567-6856797.18695.772.7899.2097.752.80
265953-6595393.48195.39
367600-6760095.81597.79
464740-6474091.76193.65
568920-6892097.68699.71
669613-6961398.668100.75
45min168136-6813696.57596.212.6499.1398.722.66
266689-6668994.52496.95
367772-6777296.05998.57
465316-6531692.57894.97
568824-6882497.550100.11
670524-7052499.959102.59
60min169299-6929998.22396.512.43101.3199.562.45
267415-6741595.55398.51
368122-6812296.55599.59
465187-6518792.39595.31
568781-6878197.489100.59
669756-6975698.871102.06
极限168951-6895197.73096.823.14101.37100.413.11
267319-6731995.41798.90
368378-6837896.918100.49
465029-6502992.17195.60
571586-71586101.465105.11
668600-6860097.232100.97
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%
110.712849582854292851762849662851692851400.07
210.742848692852342850520.10
单位质量响应值RSD%判断
26623.7226541.150.22数据可信
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%
5min1176948-17694859.73060.7613.0659.7360.7613.07
2163809-16380955.29455.29
3165357-16535755.81755.82
4201758-20175868.10468.10
5156668-15666852.88452.88
6215481-21548172.73772.74
10min1292656-29265698.78798.151.1299.1298.481.12
2284667-28466796.09196.40
3291758-29175898.48498.79
4291236-29123698.30898.69
5293985-29398599.23699.53
6290222-29022297.96698.37
15min1295749-29574999.83199.291.24100.71100.171.24
2287666-28766697.10397.94
3294686-29468699.473100.33
4292617-29261798.77499.70
5297962-297962100.578101.42
6296135-29613599.962100.91
20min1294000-29400099.24198.761.04100.68100.201.03
2287493-28749397.04598.43
3293068-29306898.926100.34
4290792-29079298.15899.63
5296074-29607499.941101.34
6294030-29403099.251100.75
30min1293195-29319598.96998.430.87100.96100.420.88
2286614-28661496.74898.67
3291600-29160098.431100.39
4292530-29253098.745100.76
5293133-29313398.948100.91
6292575-29257598.760100.82
45min1292004-29200498.56797.651.36101.10100.181.35
2282436-28243695.33897.79
3289266-28926697.643100.15
4288821-28882197.493100.06
5294029-29402999.251101.76
6289145-28914597.602100.21
60min1290160-29016097.94597.211.47101.03100.281.45
2280831-28083194.79697.78
3290238-29023897.971101.02
4285385-28538596.33399.44
5292567-29256798.757101.82
6288750-28875097.469100.61
极限1287635-28763597.09296.841.33100.72100.461.32
2280440-28044094.66498.18
3288707-28870797.454101.05
4284671-28467196.09299.74
5291207-29120798.298101.91
6288747-28874797.468101.16
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%
114.726940369535696316930769186694120.26
214.836958969498695440.10
单位质量响应值RSD%判断
4715.494689.410.40数据可信
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%
5min156366-5636677.71480.983.2177.7180.983.21
256925-5692578.48578.48
361245-6124584.44184.44
458562-5856280.74280.74
560294-6029483.13083.13
659027-5902781.38381.38
10min166168-6616891.22993.082.3191.6693.532.31
265716-6571690.60591.04
369179-6917995.38095.85
468511-6851194.45994.91
569014-6901495.15295.61
666483-6648391.66392.11
15min167887-6788793.59995.241.8794.5496.201.87
267128-6712892.55293.49
370181-7018196.76197.76
469986-6998696.49397.47
570076-7007696.61797.61
669192-6919295.39896.36
20min168013-6801393.77295.811.6295.2397.311.62
268866-6886694.94896.40
370809-7080997.62799.16
470079-7007996.62198.13
570484-7048497.17998.71
668702-6870294.72296.21
30min168499-6849994.44296.491.5796.4298.521.58
269358-6935895.62797.61
370985-7098597.87099.95
471434-7143498.489100.54
570195-7019596.78198.85
669448-6944895.75197.77
45min168830-6883094.89996.831.6197.4099.391.62
269064-6906495.22197.73
371314-7131498.323100.95
470858-7085897.695100.29
571408-7140898.453101.06
669906-6990696.38298.93
60min168603-6860394.58696.661.8297.6299.761.82
269164-6916495.35998.40
371732-7173298.900102.07
470861-7086197.699100.84
571065-7106597.980101.13
669213-6921395.42798.51
极限168428-6842894.34496.991.8997.90100.631.89
269501-6950195.82499.39
371594-7159498.710102.43
470197-7019796.783100.46
572035-7203599.318103.01
670338-7033896.978100.59
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%
110.712848152850752850962850752848902849900.05
210.742851242847732849480.09
单位质量响应值RSD%判断
26609.7126531.470.21数据可信
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%
5min1147149-14714949.69351.3017.7449.6951.3017.74
2188314-18831463.59563.59
3172577-17257758.28058.28
4137481-13748146.42846.43
5111439-11143937.63337.63
6154425-15442552.15052.15
10min1296802-296802100.23199.761.36100.51100.051.39
2296172-296172100.019100.37
3299165-299165101.029101.35
4290900-29090098.23898.50
5290136-29013697.98098.19
6299277-299277101.067101.36
15min1301589-301589101.848100.941.48102.68101.781.46
2292885-29288598.90999.82
3301975-301975101.978102.86
4294345-29434599.402100.21
5298857-298857100.925101.68
6303741-303741102.575103.43
20min1299645-299645101.192100.450.76102.59101.850.75
2296024-29602499.969101.43
3295829-29582999.903101.35
4294686-29468699.517100.87
5298359-298359100.757102.07
6300141-300141101.359102.78
30min1298535-298535100.817100.080.75102.78102.040.75
2295488-29548899.788101.80
3294595-29459599.486101.49
4293586-29358699.145101.05
5296675-296675100.189102.06
6299213-299213101.046103.03
45min1297746-297746100.55099.500.93103.07102.010.93
2292209-29220998.680101.25
3294920-29492099.596102.16
4291888-29188898.572101.03
5292973-29297398.938101.37
6298023-298023100.644103.19
60min1291470-29147098.43198.892.20101.51101.962.18
2293488-29348899.112102.23
3303479-303479102.486105.60
4285413-28541396.38599.39
5287588-28758897.120100.10
6295589-29558999.822102.93
极限1290517-29051798.10998.160.99101.74101.780.98
2289590-28959097.796101.46
3288617-28861797.467101.15
4290973-29097398.263101.81
5288230-28823097.337100.86
6296120-296120100.001103.66
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%
114.726941869266694626921069073692860.23
214.836939469384693890.02
单位质量响应值RSD%判断
4706.934678.960.43数据可信
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%
5min158639-5863981.01280.325.1581.0180.325.15
257550-5755079.50779.51
360741-6074183.91683.92
453932-5393274.50974.51
555970-5597077.32577.32
662006-6200685.66385.66
10min167302-6730292.98093.773.1593.4394.223.16
266765-6676592.23892.68
370134-7013496.89397.36
464757-6475789.46489.88
567888-6788893.79094.22
670413-7041397.27897.75
15min169079-6907995.43596.033.1296.4097.003.12
268264-6826494.30995.26
370958-7095898.03199.04
465995-6599591.17492.09
571061-7106198.17399.12
671713-7171399.074100.09
20min169221-6922195.63196.402.5097.1397.902.51
269039-6903995.38096.86
370511-7051197.41398.96
466938-6693892.47793.89
571449-7144998.709100.21
671487-7148798.762100.33
30min166656-6665692.08897.203.7194.1299.243.67
270475-7047597.36499.37
371095-7109598.220100.31
467987-6798793.92695.86
573486-73486101.523103.57
672444-72444100.084102.20
45min169900-6990096.56997.962.6899.11100.542.69
269993-6999396.69899.25
371708-7170899.067101.70
468110-6811094.09696.55
572914-72914100.733103.34
672830-72830100.617103.29
60min168801-6880195.05197.322.8198.13100.442.81
270599-7059997.535100.62
371755-7175599.132102.32
467341-6734193.03496.01
572078-7207899.578102.75
672099-7209999.607102.84
极限168861-6886195.13497.462.1498.74101.122.15
269622-6962296.18599.81
370748-7074897.741101.48
469426-6942695.91499.41
572547-72547100.226103.95
672070-7207099.567103.35
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%
110.712825462819602822652815072817502820060.15
210.742822272822192822230.01
单位质量响应值RSD%判断
26331.0926277.750.15数据可信
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%
5min1136238-13623846.47456.7916.4346.4756.7816.43
2184986-18498663.10363.10
3208927-20892771.27071.27
4142865-14286548.73448.73
5169770-16977057.91257.91
6156016-15601653.22053.22
10min1297431-297431101.460101.510.56101.72101.820.54
2294863-294863100.584100.93
3297600-297600101.518101.91
4298242-298242101.737102.01
5297299-297299101.415101.74
6299951-299951102.320102.62
15min1299153-299153102.048102.320.76102.87103.200.72
2298136-298136101.701102.61
3296849-296849101.262102.22
4302228-302228103.097103.93
5301138-301138102.725103.61
6302273-302273103.112103.98
20min1298477-298477101.817101.860.69103.21103.310.65
2296986-296986101.308102.78
3295861-295861100.925102.45
4299682-299682102.228103.64
5298987-298987101.991103.45
6301635-301635102.894104.33
30min1299251-299251102.081101.900.72104.04103.910.68
2295255-295255100.718102.76
3297198-297198101.381103.46
4299334-299334102.109104.09
5301100-301100102.712104.73
6300097-300097102.370104.38
45min1290780-29078099.191100.270.77101.71102.850.76
2292846-29284699.896102.49
3292340-29234099.724102.37
4296017-296017100.978103.52
5296273-296273101.065103.66
6295357-295357100.753103.33
60min1284774-28477497.14398.731.32100.22101.861.29
2285767-28576797.481100.63
3288089-28808998.273101.47
4291119-29111999.307102.41
5294276-294276100.384103.54
6292520-29252099.785102.92
极限1291107-29110799.30399.150.93102.92102.840.89
2287268-28726897.993101.69
3289000-28900098.584102.33
4290109-29010998.962102.62
5291166-29116699.323103.04
6295269-295269100.723104.41
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%
114.726773867719678626785867798677950.10
214.836806267728678950.35
单位质量响应值RSD%判断
4605.644578.220.43数据可信
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%
5min145845-4584564.73074.827.3864.7374.827.38
253131-5313175.01775.02
352289-5228973.82873.83
453852-5385276.03576.04
556920-5692080.36780.37
655918-5591878.95278.95
10min161331-6133186.59590.943.4786.9591.353.49
263803-6380390.08590.50
362585-6258588.36588.78
465210-6521092.07292.49
567017-6701794.62395.07
666496-6649693.88794.33
15min162081-6208187.65493.294.2688.4994.214.27
265792-6579292.89393.81
363493-6349389.64790.55
467609-6760995.45996.39
569151-6915197.63698.61
668301-6830196.43697.40
20min163646-6364689.86394.613.9391.1996.053.94
265730-6573092.80694.24
365057-6505791.85693.25
467770-6777095.68697.15
570272-7027299.219100.73
669567-6956798.22499.72
30min164541-6454191.12795.713.3692.9597.673.39
267007-6700794.60996.56
366415-6641593.77395.68
468531-6853196.76198.76
570988-70988100.230102.30
669231-6923197.74999.79
45min163277-6327789.34295.094.0591.6897.594.06
266815-6681594.33896.81
365483-6548392.45794.89
468475-6847596.68299.22
570792-7079299.953102.58
669257-6925797.786100.37
60min162597-6259788.38293.554.3491.2196.574.33
264878-6487891.60394.60
364133-6413390.55193.50
467290-6729095.00998.08
570222-7022299.148102.33
668407-6840796.58699.71
极限163708-6370889.95194.383.3793.2797.933.40
266110-6611093.34296.85
365605-6560592.62996.08
466824-6682494.35197.95
569722-6972298.442102.17
669109-6910997.577101.24
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%
110.712850832848552848992849132848092849120.04
210.742846852845242846040.05
单位质量响应值RSD%判断
26602.4326499.440.28数据可信
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%
5min1159033-15903353.74654.387.1153.7554.387.11
2179532-17953260.67460.67
3152377-15237751.49751.50
4159553-15955353.92253.92
5167620-16762056.64856.65
6147345-14734549.79649.80
10min1299702-299702101.286101.010.86101.58101.310.85
2297271-297271100.464100.80
3297888-297888100.673100.96
4303347-303347102.518102.82
5296027-296027100.044100.36
6299052-299052101.066101.34
15min1300760-300760101.643101.890.49102.50102.750.47
2300676-300676101.615102.51
3301836-301836102.007102.85
4303154-303154102.453103.32
5299490-299490101.214102.08
6303046-303046102.416103.25
20min1299459-299459101.204101.390.40102.63102.820.40
2299739-299739101.298102.76
3299463-299463101.205102.62
4301976-301976102.054103.49
5298606-298606100.916102.35
6300816-300816101.662103.07
30min1298193-298193100.776100.950.43102.76102.940.42
2298350-298350100.829102.85
3298786-298786100.976102.95
4300699-300699101.623103.63
5296905-296905100.341102.33
6299305-299305101.152103.12
45min1295478-29547899.858100.000.76102.41102.560.74
2296351-296351100.153102.74
3296928-296928100.348102.88
4298558-298558100.899103.47
5291888-29188898.645101.20
6296256-296256100.121102.66
60min1293986-29398699.35499.570.33102.46102.680.32
2293857-29385799.311102.45
3295214-29521499.769102.86
4296214-296214100.107103.24
5293822-29382299.299102.40
6294691-29469199.592102.68
极限1293632-29363299.23599.190.67102.89102.850.65
2291762-29176298.603102.29
3294583-29458399.556103.20
4296377-296377100.162103.85
5290984-29098498.340101.99
6293582-29358299.218102.86
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%
114.726941069356693736945869619694430.16
214.836971169714697120.01
单位质量响应值RSD%判断
4717.604700.740.26数据可信
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%
5min157275-5727578.85479.256.0278.8579.256.03
255479-5547976.38276.38
363612-6361287.57987.58
459181-5918181.47881.48
553824-5382474.10374.10
656014-5601477.11877.12
10min165681-6568190.42791.552.7290.8791.992.70
265504-6550490.18490.61
365254-6525489.84090.33
469133-6913395.18095.63
564957-6495789.43189.84
668433-6843394.21694.64
15min166873-6687392.06993.692.4593.0194.642.44
267499-6749992.93093.86
367344-6734492.71793.70
469634-6963495.87096.85
566385-6638591.39792.31
670577-7057797.16898.12
20min167502-6750292.93594.462.5394.3995.922.52
267913-6791393.50094.94
367782-6778293.32094.82
470320-7032096.81498.33
566910-6691092.12093.54
671211-7121198.04199.53
30min168750-6875094.65395.722.5596.6297.722.54
269043-6904395.05697.02
367965-6796593.57295.59
471915-7191599.010101.06
567927-6792793.52095.45
671565-7156598.528100.56
45min168999-6899994.99695.702.4697.4998.232.45
268909-6890994.87297.36
368315-6831594.05496.59
471873-7187398.952101.55
567631-6763193.11295.56
671350-7135098.232100.82
60min167191-6719192.50694.642.5095.5397.702.48
268932-6893294.90397.92
367999-6799993.61996.68
469906-6990696.24499.40
566992-6699292.23295.20
671442-7144298.359101.49
极限168382-6838294.14694.782.8197.6898.362.78
268205-6820593.90297.45
367206-6720692.52796.11
471363-7136398.250101.94
566831-6683192.01195.49
671054-7105497.825101.50
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