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%
110.302853702857712854112857252855732855700.07
210.332850452853072851760.07
单位质量响应值RSD%判断
27725.2427606.580.31数据可信
供试品溶液-20220126批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118368-183685.9573.4862.545.963.4862.57
214112-141124.5774.58
317474-174745.6675.67
46731-67312.1832.18
53901-39011.2651.27
63836-38361.2441.24
10min184786-8478627.49922.9417.5027.5322.9617.54
276169-7616924.70424.73
381939-8193926.57626.61
468638-6863822.26222.27
556581-5658118.35118.36
656293-5629318.25818.26
15min1142502-14250246.21843.276.4246.4043.426.47
2137070-13707044.45744.62
3142889-14288946.34446.52
4129184-12918441.89942.03
5124088-12408840.24640.36
6124709-12470940.44840.56
20min1168739-16873954.72852.394.1155.1752.784.16
2162264-16226452.62853.04
3170188-17018855.19855.63
4156278-15627850.68751.06
5155735-15573550.51050.84
6155957-15595750.58250.92
30min1194471-19447163.07461.303.0963.8261.983.14
2188737-18873761.21461.92
3197340-19734064.00464.75
4182034-18203459.04059.69
5185324-18532460.10760.72
6186075-18607560.35160.96
45min1209106-20910667.82166.502.9368.9267.522.98
2205757-20575766.73467.78
3214458-21445869.55670.66
4198287-19828764.31265.29
5200946-20094665.17466.12
6201616-20161665.39166.34
60min1217376-21737670.50369.312.9271.9870.702.96
2210825-21082568.37869.79
3224822-22482272.91874.40
4208956-20895667.77269.11
5209591-20959167.97869.29
6210691-21069168.33569.65
极限1240536-24053678.01477.072.1379.8878.842.18
2234174-23417475.95177.74
3246653-24665379.99881.89
4235422-23542276.35678.07
5234467-23446776.04677.73
6234425-23442576.03277.72
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%
114.937226572048721077206171991720940.15
214.987196671834719000.13
单位质量响应值RSD%判断
4828.804799.730.43数据可信
供试品溶液-20220126批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119616-1961626.41723.1223.5026.4223.1323.50
223890-2389032.17332.17
313348-1334817.97617.98
413369-1336918.00418.00
516273-1627321.91521.92
616533-1653322.26522.27
10min154690-5469073.65272.335.5973.8072.465.61
257273-5727377.13177.31
348987-4898765.97266.07
456213-5621375.70375.80
552777-5277771.07671.20
652320-5232070.46070.58
15min165365-6536588.02887.503.2888.5888.023.30
267516-6751690.92591.53
361547-6154782.88783.35
466762-6676289.91090.43
564004-6400486.19586.71
664625-6462587.03287.55
20min167741-6774191.22891.922.0092.2792.932.03
269598-6959893.72994.84
365777-6577788.58389.51
469114-6911493.07794.10
568532-6853292.29393.29
668753-6875392.59193.59
30min168957-6895792.86694.611.9294.4296.141.94
271562-7156296.37498.01
368260-6826091.92793.35
470493-7049394.93496.47
570896-7089695.47796.99
671360-7136096.10297.61
45min168777-6877792.62394.681.8294.6996.731.83
271414-7141496.17598.34
368602-6860292.38894.32
470703-7070395.21797.28
571187-7118795.86997.91
671142-7114295.80897.86
60min169295-6929593.32195.131.3695.9097.711.35
270797-7079795.34498.05
369742-6974293.92396.37
470854-7085495.42098.01
571371-7137196.11798.69
671792-7179296.68499.26
极限168887-6888792.77194.121.5195.8797.231.54
271754-7175496.63399.87
368882-6888292.76595.73
469996-6999694.26597.39
570068-7006894.36297.47
669744-6974493.92697.04
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%
110.302847932854142850752853952851902851730.09
210.332852952852762852860.01
单位质量响应值RSD%判断
27686.7027617.230.18数据可信
供试品溶液-20220126批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121658-216587.0285.4935.177.035.5035.19
28132-81322.6392.64
321407-214076.9476.95
421782-217827.0687.07
517477-174775.6715.67
611132-111323.6123.61
10min191881-9188129.81527.5412.0129.8527.5712.05
272601-7260123.55923.57
395557-9555731.00831.05
492968-9296830.16830.21
582952-8295226.91826.95
673202-7320223.75423.77
15min1145816-14581647.31746.304.2047.5246.484.24
2138187-13818744.84144.99
3150534-15053448.84849.06
4145528-14552847.22447.43
5142121-14212146.11846.30
6133814-13381443.42243.57
20min1172673-17267356.03255.053.4056.5055.493.43
2167636-16763654.39854.79
3177807-17780757.69858.18
4169918-16991855.13855.61
5169431-16943154.98055.42
6160379-16037952.04352.44
30min1198514-19851464.41763.913.0965.2064.663.12
2196816-19681663.86664.56
3203713-20371366.10566.91
4196879-19687963.88764.66
5200142-20014264.94665.69
6185705-18570560.26160.94
45min1216050-21605070.10870.202.6971.2471.302.72
2216958-21695870.40271.45
3224932-22493272.99074.16
4216020-21602070.09871.23
5217329-21732970.52371.63
6206673-20667367.06568.08
60min1222533-22253372.21272.523.2273.7474.013.22
2224970-22497073.00274.45
3232005-23200575.28576.86
4222017-22201772.04473.56
5228373-22837374.10775.60
6211005-21100568.47169.86
极限1243727-24372779.08979.442.4281.0281.332.43
2247612-24761280.35082.20
3254718-25471882.65684.65
4242023-24202378.53680.46
5243459-24345979.00280.91
6237246-23724676.98678.76
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%
114.937187172129720767193571884719790.17
214.987186771950719080.09
单位质量响应值RSD%判断
4821.104800.270.31数据可信
供试品溶液-20220126批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129088-2908839.20236.5119.1439.2036.5119.15
218744-1874425.26225.26
324488-2448833.00333.00
434338-3433846.27846.28
527981-2798137.71037.71
627915-2791537.62237.62
10min157678-5767877.73475.107.2877.9575.307.31
248350-4835065.16265.30
355215-5521574.41474.60
458574-5857478.94179.20
559603-5960380.32880.54
654932-5493274.03374.24
15min164670-6467087.15788.212.7287.8188.832.75
263161-6316185.12385.63
364995-6499587.59588.19
465550-6555088.34389.04
568559-6855992.39893.05
665769-6576988.63889.26
20min165708-6570888.55691.191.8689.6992.301.85
267341-6734190.75791.73
367806-6780691.38392.47
467561-6756191.05392.24
569616-6961693.82394.99
667949-6794991.57692.69
30min167816-6781691.39792.991.7693.0294.601.77
268876-6887692.82594.30
368309-6830992.06193.65
468610-6861092.46794.16
571306-7130696.10097.79
669064-6906493.07994.70
45min168199-6819991.91393.861.5894.0595.991.55
270184-7018494.58896.58
368768-6876892.68094.78
469158-6915893.20595.41
570964-7096495.63997.86
670582-7058295.12597.26
60min167848-6784891.44092.892.2494.0895.542.21
269477-6947793.63596.16
368039-6803991.69794.31
467520-6752090.99893.72
571698-7169896.62999.38
668969-6896992.95195.62
极限168057-6805791.72293.381.4794.8796.541.45
269628-6962893.83996.88
369024-6902493.02596.15
468391-6839192.17295.40
570832-7083295.46298.75
669773-6977394.03497.22
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%
110.302855222855302854662856792855982855590.03
210.332855062854762854910.01
单位质量响应值RSD%判断
27724.1727637.080.23数据可信
供试品溶液-20220124批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114198-141984.6023.4242.224.603.4242.22
29523-95233.0873.09
35594-55941.8131.81
45374-53741.7421.74
515933-159335.1655.16
612624-126244.0924.09
10min189016-8901628.85623.8523.2128.8823.8723.21
245113-4511314.62414.64
364969-6496921.06121.07
471622-7162223.21723.23
590485-9048529.33229.36
680256-8025626.01626.04
15min1143810-14381046.61843.6010.3946.8043.7510.43
2110746-11074635.90036.00
3128906-12890641.78641.91
4133084-13308443.14143.28
5150775-15077548.87649.07
6139644-13964445.26745.43
20min1169128-16912854.82552.977.1255.2753.367.17
2144405-14440546.81147.11
3157225-15722550.96651.33
4163153-16315352.88853.27
5178199-17819957.76558.23
6168328-16832854.56654.98
30min1193582-19358262.75262.205.9763.5062.896.02
2175503-17550356.89257.45
3186458-18645860.44361.09
4191302-19130262.01362.69
5210591-21059168.26669.05
6193781-19378162.81763.54
45min1202871-20287165.76366.776.1966.8667.816.22
2189122-18912261.30662.18
3200693-20069365.05766.04
4207240-20724067.17968.20
5227952-22795273.89475.06
6208012-20801267.43068.50
60min1208344-20834467.53768.616.2069.0070.016.24
2192802-19280262.49963.71
3207528-20752867.27368.61
4214397-21439769.49970.89
5233192-23319275.59277.17
6213614-21361469.24670.69
极限1234560-23456076.03676.534.4377.8778.324.50
2221827-22182771.90873.47
3235626-23562676.38178.09
4232423-23242375.34377.12
5254042-25404282.35184.34
6238079-23807977.17679.01
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%
114.937201171735721917209672201720470.27
214.987207872002720400.08
单位质量响应值RSD%判断
4825.654809.080.25数据可信
供试品溶液-20220124批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133283-3328344.79422.2475.6544.7922.2475.64
2-0.0000.00
315424-1542420.75820.76
45094-50946.8566.86
519525-1952526.27826.28
625832-2583234.76634.77
10min161640-6164082.95873.6510.5783.2173.7710.64
251821-5182169.74369.74
346194-4619462.17062.29
451669-5166969.53869.58
558310-5831078.47678.62
658699-5869979.00079.19
15min166653-6665389.70587.064.0390.4187.594.12
261441-6144182.69083.08
361861-6186183.25583.72
464404-6440486.67887.10
567833-6783391.29391.87
665941-6594188.74689.38
20min168357-6835791.99890.992.5793.2192.012.66
265065-6506587.56788.41
365893-6589388.68289.61
468215-6821591.80792.71
569546-6954693.59894.69
668589-6858992.31093.44
30min169169-6916993.09192.741.7094.8194.261.77
267607-6760790.98992.32
367771-6777191.20992.63
469361-6936193.34994.77
570791-7079195.27496.88
668753-6875392.53194.17
45min167104-6710490.31291.431.8192.5593.461.81
267290-6729090.56292.40
366661-6666189.71591.64
468685-6868592.43994.37
569983-6998394.18696.32
667877-6787791.35293.50
60min167745-6774591.17491.121.4593.9193.671.50
266794-6679489.89492.24
366343-6634389.28791.71
468968-6896892.82095.27
568325-6832591.95594.62
668053-6805391.58994.25
极限169040-6904092.91792.121.0096.1695.171.09
267573-6757390.94393.78
368089-6808991.63794.55
468745-6874592.52095.48
569303-6930393.27196.44
667940-6794091.43794.61
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%
110.302846712846252848582845192848372847020.06
210.332846152846682846420.02
单位质量响应值RSD%判断
27640.9727554.890.23数据可信
供试品溶液-20220124批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117150-171505.5765.1934.595.585.2034.57
27713-77132.5082.51
310881-108813.5383.54
420350-203506.6166.62
517955-179555.8385.84
621807-218077.0907.09
10min184332-8433227.41928.3110.3727.4528.3410.39
279377-7937725.80825.82
375621-7562124.58724.61
492847-9284730.18830.22
590344-9034429.37429.41
699918-9991832.48732.53
15min1136543-13654344.39545.873.2744.5846.063.30
2138234-13823444.94545.10
3138923-13892345.16945.32
4140158-14015845.57045.77
5143428-14342846.63346.83
6149245-14924548.52548.74
20min1161733-16173352.58554.512.7053.0154.952.69
2171100-17110055.63056.04
3169460-16946055.09755.50
4162688-16268852.89553.35
5168124-16812454.66355.12
6172866-17286656.20556.69
30min1182373-18237359.29662.423.9360.0263.173.88
2193848-19384863.02763.74
3201885-20188565.64066.35
4183844-18384459.77460.53
5193301-19330162.84963.61
6196672-19667263.94564.75
45min1193150-19315062.80066.635.1963.8567.735.12
2207090-20709067.33268.40
3222275-22227572.26973.35
4194859-19485963.35564.44
5203395-20339566.13167.24
6208906-20890667.92269.08
60min1198001-19800164.37768.695.5765.7870.155.49
2213690-21369069.47870.92
3230648-23064874.99176.47
4200277-20027765.11766.55
5210333-21033368.38669.86
6214648-21464869.78971.32
极限1222143-22214372.22676.663.6473.9878.503.62
2238347-23834777.49579.32
3246968-24696880.29882.19
4231315-23131575.20877.01
5234858-23485876.36078.22
6241090-24109078.38780.31
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%
114.937185471890718457172571724718080.11
214.987180571754717800.06
单位质量响应值RSD%判断
4809.654791.720.27数据可信
供试品溶液-20220124批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116478-1647822.25424.8050.5822.2524.8050.57
230361-3036141.00341.00
32488-24883.3603.36
420936-2093628.27528.27
516798-1679822.68622.69
623110-2311031.21131.21
10min152233-5223370.54274.027.9170.6774.167.96
255248-5524874.61474.84
347846-4784664.61764.64
457486-5748677.63677.79
555691-5569175.21275.34
660329-6032981.47681.65
15min162484-6248484.38686.702.1484.9087.252.21
264900-6490087.64988.29
363316-6331685.51085.89
464480-6448087.08287.67
563615-6361585.91486.46
666383-6638389.65290.28
20min165102-6510287.92290.521.7288.9191.551.75
268095-6809591.96493.09
367468-6746891.11791.97
467009-6700990.49791.57
566374-6637489.64090.66
668105-6810591.97793.10
30min165662-6566288.67891.911.8590.1593.441.84
267993-6799391.82693.47
369089-6908993.30694.67
468238-6823892.15793.73
568290-6829092.22793.75
669056-6905693.26294.90
45min165631-6563188.63691.161.6590.6093.211.65
267370-6737090.98593.14
368408-6840892.38794.26
467867-6786791.65693.74
567027-6702790.52192.55
668716-6871692.80394.96
60min165226-6522688.08990.541.4090.5593.091.41
267205-6720590.76293.42
367213-6721390.77393.16
467938-6793891.75294.35
567448-6744891.09093.62
667199-6719990.75493.42
极限166670-6667090.03992.302.2392.9995.352.24
267641-6764191.35194.51
367582-6758291.27194.17
470280-7028094.91598.02
567662-6766291.37994.42
670218-7021894.83198.00
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%
110.302862932864242864162861692863242863250.04
210.332858242854252856240.10
单位质量响应值RSD%判断
27798.5427649.950.38数据可信
供试品溶液-555886批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17184-71842.3252.8343.462.332.8443.42
213440-134404.3504.35
310245-102453.3163.32
412061-120613.9043.90
53454-34541.1181.12
66160-61601.9941.99
10min172476-7247623.45727.9921.5923.4728.0121.60
2117331-11733137.97538.00
384046-8404627.20227.22
490646-9064629.33829.36
563070-6307020.41320.42
691374-9137429.57429.58
15min1163455-16345552.90356.877.4753.0557.047.51
2194458-19445862.93763.17
3176410-17641057.09657.27
4179012-17901257.93858.12
5158362-15836251.25451.37
6182507-18250759.06959.24
20min1212807-21280768.87670.692.4269.3171.182.49
2226561-22656173.32773.91
3219467-21946771.03171.52
4216195-21619569.97270.48
5213554-21355469.11869.52
6221894-22189471.81772.32
30min1248589-24858980.45781.120.6281.2882.000.64
2252242-25224281.63982.63
3249716-24971680.82281.70
4249575-24957580.77681.67
5252110-25211081.59682.38
6251576-25157681.42482.33
45min1261543-26154384.64985.400.7685.9286.720.71
2262660-26266085.01186.46
3263461-26346185.27086.60
4263301-26330185.21886.56
5267209-26720986.48387.72
6264912-26491285.74087.09
60min1267176-26717686.47386.600.8288.2188.400.75
2265331-26533185.87587.79
3268925-26892587.03988.84
4267439-26743986.55888.38
5271094-27109487.74189.46
6265463-26546385.91887.75
极限1271813-27181387.97388.741.2690.1991.031.20
2269381-26938187.18689.58
3278536-27853690.14992.44
4272759-27275988.28090.58
5276981-27698189.64691.86
6275619-27561989.20591.51
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%
114.937224372199723717261072298723440.23
214.987229472147722200.15
单位质量响应值RSD%判断
4845.554821.090.36数据可信
供试品溶液-555886批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16691-66918.97512.1069.098.9812.1069.09
214421-1442119.34419.34
317593-1759323.59923.60
48472-847211.36411.36
5-0.0000.00
66934-69349.3019.30
10min154363-5436372.92367.8913.8572.9767.9613.84
251248-5124868.74468.85
355044-5504473.83673.97
436558-3655849.03949.10
553550-5355071.83271.83
652914-5291470.97971.03
15min168729-6872992.19489.943.5792.6590.393.60
266504-6650489.20989.70
367743-6774390.87191.41
462496-6249683.83384.17
567944-6794491.14191.54
668885-6888592.40392.85
20min171182-7118295.48494.631.3896.4595.571.39
269094-6909492.68393.67
370867-7086795.06296.11
469561-6956193.31094.11
571410-7141095.79096.70
671141-7114195.42996.39
30min171930-7193096.48795.701.3097.9997.171.23
269905-6990593.77195.27
370663-7066394.78896.36
471927-7192796.48397.80
572355-7235597.05898.50
671271-7127195.60397.09
45min171456-7145695.85295.101.4997.8997.101.40
269424-6942493.12695.15
370398-7039894.43296.53
472422-7242297.14799.00
571339-7133995.69597.67
670329-7032994.34096.36
60min171473-7147395.87495.461.6798.4497.991.57
269727-6972793.53296.07
370567-7056794.65997.28
473177-7317798.160100.56
571460-7146095.85798.37
670596-7059694.69897.24
极限171148-7114895.43894.851.4398.5497.921.37
268833-6883392.33395.39
371005-7100595.24798.40
471832-7183296.35699.30
570784-7078494.95097.99
670670-7067094.79797.87
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%
110.302854842855302855912857152855682855780.04
210.332852832854942853880.06
单位质量响应值RSD%判断
27726.0227627.110.26数据可信
供试品溶液-555886批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15504-55041.7844.0141.641.784.0141.70
212011-120113.8943.89
311135-111353.6103.61
49071-90712.9412.94
517019-170195.5185.52
619548-195486.3386.34
10min184254-8425427.31630.018.2727.3330.048.29
291635-9163529.70929.73
393011-9301130.15530.18
484083-8408327.26127.28
5100915-10091532.71832.75
6101549-10154932.92332.96
15min1176011-17601157.06558.562.6357.2358.752.66
2180462-18046258.50858.69
3179746-17974658.27658.46
4175294-17529456.83257.00
5185418-18541860.11460.33
6186880-18688060.58860.81
20min1220644-22064471.53571.781.3772.0172.301.39
2220543-22054371.50272.01
3223251-22325172.38072.89
4216412-21641270.16370.65
5225266-22526673.03473.58
6222346-22234672.08772.64
30min1257329-25732983.42982.441.5084.3083.351.48
2255346-25534682.78683.69
3259380-25938084.09485.01
4249366-24936680.84781.72
5253175-25317582.08283.03
6251078-25107881.40282.36
45min1272016-27201688.19086.741.9789.5388.111.94
2266602-26660286.43587.80
3275225-27522589.23190.61
4261954-26195484.92886.25
5267048-26704886.58087.99
6262416-26241685.07886.49
60min1275074-27507489.18287.972.0391.0189.822.01
2273564-27356488.69290.54
3279079-27907990.48092.36
4264216-26421685.66287.46
5268605-26860587.08588.97
6267513-26751386.73088.61
极限1280956-28095691.08989.931.3393.4192.271.32
2276729-27672989.71892.06
3282310-28231091.52893.91
4272606-27260688.38290.65
5274645-27464589.04391.42
6276957-27695789.79292.15
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%
114.937234172338719607182072093721100.32
214.987222171898720600.32
单位质量响应值RSD%判断
4829.874810.410.29数据可信
供试品溶液-555886批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121612-2161229.07016.6542.3229.0716.6542.32
212237-1223716.46016.46
39234-923412.42012.42
414887-1488720.02420.02
58029-802910.80010.80
68275-827511.13011.13
10min161355-6135582.52769.7211.3582.6969.8111.38
248780-4878065.61365.70
343655-4365558.71958.79
453671-5367172.19172.30
550592-5059268.05068.11
652945-5294571.21571.28
15min170495-7049594.82190.844.2195.4491.324.25
264505-6450586.76487.22
364955-6495587.36987.76
469436-6943693.39693.91
565475-6547588.06988.51
670330-7033094.59995.06
20min171284-7128495.88294.583.4097.0395.563.41
265846-6584688.56889.51
369942-6994294.07794.96
471968-7196896.80297.83
570348-7034894.62395.55
672491-7249197.50698.49
30min172588-7258897.63696.033.1299.3297.543.14
267301-6730190.52591.95
371257-7125795.84697.25
473667-7366799.087100.66
571050-7105095.56797.02
672488-7248897.50299.03
45min172930-7293098.09696.043.51100.3298.083.51
266452-6645289.38391.32
371424-7142496.07098.01
473147-7314798.388100.51
572158-7215897.05899.04
672294-7229497.24199.31
60min172512-7251297.53496.153.13100.3098.733.14
267234-6723490.43592.86
370841-7084195.28697.76
473051-7305198.259100.92
572302-7230297.25199.77
672978-7297898.161100.77
极限171846-7184696.63895.613.5099.9598.723.50
266417-6641789.33692.27
370550-7055094.89597.89
473181-7318198.434101.65
571499-7149996.17199.23
672987-7298798.173101.32
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%
110.302870582874432874232872442867942871920.10
210.332857532858252857890.02
单位质量响应值RSD%判断
27882.7227665.920.56数据可信
供试品溶液-20220127批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14299-42991.3894.6358.211.394.6358.19
215001-150014.8464.85
325399-253998.2068.21
44696-46961.5171.52
518303-183035.9135.91
618255-182555.8985.90
10min171379-7137923.06127.0014.3023.0727.0214.34
278599-7859925.39325.42
3103137-10313733.32133.37
472583-7258323.45023.46
587715-8771528.33828.37
687997-8799728.42928.46
15min1135258-13525843.69845.254.3243.8345.434.39
2137098-13709844.29344.46
3149921-14992148.43548.67
4133471-13347143.12143.26
5142387-14238746.00146.19
6142245-14224545.95646.15
20min1166850-16685053.90553.313.1754.2853.733.20
2157284-15728450.81451.23
3172235-17223555.64456.14
4160921-16092151.98952.37
5166922-16692253.92854.37
6165778-16577853.55854.00
30min1194879-19487962.96061.283.0763.6462.003.08
2180220-18022058.22458.92
3194901-19490162.96763.78
4185303-18530359.86660.53
5191163-19116361.76062.51
6191528-19152861.87862.62
45min1212522-21252268.66065.084.0269.6966.143.99
2188964-18896461.04962.07
3207117-20711766.91468.07
4197888-19788863.93264.93
5202480-20248065.41666.50
6199658-19965864.50465.59
60min1219767-21976771.00166.893.8672.4168.323.82
2196218-19621863.39364.75
3211654-21165468.38069.91
4203256-20325665.66767.02
5205646-20564666.43967.89
6205799-20579966.48867.93
极限1240537-24053777.71175.362.8179.5177.152.81
2221222-22122271.47173.18
3237100-23710076.60178.51
4232891-23289175.24176.96
5233247-23324775.35677.18
6234502-23450275.76177.58
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%
114.937254572061723717219072395723120.27
214.987214171817719790.32
单位质量响应值RSD%判断
4843.404805.010.57数据可信
供试品溶液-20220127批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140401-4040154.29732.0840.9154.3032.0840.91
212223-1222316.42716.43
327462-2746236.90836.91
425592-2559234.39434.39
518528-1852824.90124.90
619023-1902325.56625.57
10min162189-6218983.57976.838.6583.8877.018.71
248662-4866265.40065.49
361187-6118782.23382.44
459338-5933879.74879.94
555773-5577374.95675.09
655860-5586075.07375.22
15min167611-6761190.86687.422.8891.6388.022.99
262291-6229183.71684.17
366077-6607788.80489.47
465914-6591488.58589.22
563995-6399586.00686.56
664378-6437886.52187.08
20min168618-6861892.21989.223.0793.4990.313.16
263017-6301784.69285.61
367227-6722790.35091.51
467999-6799991.38892.51
566058-6605888.77989.81
665381-6538187.86988.91
30min169623-6962393.57090.642.8595.3592.222.94
264036-6403686.06187.45
367433-6743390.62792.28
468868-6886892.55594.19
567221-6722190.34291.87
667473-6747390.68192.21
45min169492-6949293.39489.783.2695.7091.873.34
262981-6298184.64486.51
367052-6705290.11592.28
467972-6797291.35193.50
567084-6708490.15892.19
666214-6621488.98991.02
60min168906-6890692.60789.662.8395.4392.252.92
263298-6329885.07087.41
366958-6695889.98992.65
467804-6780491.12693.78
566758-6675889.72092.25
666550-6655089.44091.97
极限168236-6823691.70692.132.7395.0495.212.75
264963-6496387.30790.12
368845-6884592.52595.69
469816-6981693.83096.99
569485-6948593.38596.41
669941-6994193.99897.02
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%
110.302859682858702860962856892858322858910.06
210.332861512860442860980.03
单位质量响应值RSD%判断
27756.4127695.840.16数据可信
供试品溶液-20220127批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110566-105663.4193.8853.573.423.8853.56
218330-183305.9325.93
32596-25960.8400.84
417837-178375.7735.77
515811-158115.1175.12
66799-67992.2002.20
10min177974-7797425.23523.3320.0125.2523.3520.01
261407-6140719.87319.91
349730-4973016.09416.10
490140-9014029.17229.20
580136-8013625.93425.96
673154-7315423.67523.69
15min1140764-14076445.55543.167.7345.7143.317.77
2128652-12865241.63641.78
3115058-11505837.23637.33
4143501-14350146.44146.64
5135727-13572743.92544.10
6136466-13646644.16544.31
20min1170197-17019755.08152.514.6955.4952.904.74
2160838-16083852.05252.43
3148143-14814347.94448.24
4166313-16631353.82454.28
5163238-16323852.82953.25
6164855-16485553.35253.74
30min1192482-19248262.29360.312.6463.0161.002.68
2186495-18649560.35561.02
3179860-17986058.20858.78
4189351-18935161.28062.03
5181231-18123158.65259.36
6188737-18873761.08161.77
45min1211024-21102468.29465.672.8969.3666.682.90
2202245-20224565.45366.45
3197749-19774963.99864.89
4204615-20461566.22067.31
5195108-19510863.14364.18
6206681-20668166.88867.91
60min1215257-21525769.66467.482.3071.1168.862.30
2207239-20723967.06968.43
3206623-20662366.86968.12
4209194-20919467.70169.16
5201180-20118065.10866.49
6211554-21155468.46569.86
极限1240842-24084277.94475.802.0579.7777.562.05
2232302-23230275.18076.92
3232340-23234075.19276.81
4235211-23521176.12177.96
5227039-22703973.47775.23
6237517-23751776.86878.64
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%
114.937209272377722967204872211722050.20
214.987237372218722960.16
单位质量响应值RSD%判断
4836.244826.170.15数据可信
供试品溶液-20220127批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120959-2095928.12717.9872.6128.1317.9872.61
2-0.0000.00
319834-1983426.61726.62
424463-2446332.82932.83
56048-60488.1168.12
69087-908712.19512.19
10min151691-5169169.36967.8910.7769.5267.9910.77
252349-5234970.25270.25
342674-4267457.26857.42
459095-5909579.30579.49
550094-5009467.22667.27
647626-4762663.91463.98
15min163173-6317384.77783.715.2685.3284.195.29
263365-6336585.03585.43
357318-5731876.92077.39
467245-6724590.24290.86
560712-6071281.47581.89
662450-6245083.80784.23
20min165880-6588088.41089.432.9389.4290.372.95
266860-6686089.72590.59
364077-6407785.99186.88
468926-6892692.49893.62
565284-6528487.61088.48
668819-6881992.35493.24
30min166193-6619388.83089.373.5090.3390.813.52
267325-6732590.34991.71
368298-6829891.65593.03
469757-6975793.61395.25
564126-6412686.05687.41
663869-6386985.71187.11
45min166884-6688489.75890.323.3491.7592.253.35
267922-6792291.15193.01
369332-6933293.04394.92
470096-7009694.06896.23
564746-6474686.88888.72
664830-6483087.00188.88
60min166488-6648889.22690.183.7091.7292.623.71
267956-6795691.19693.57
369494-6949493.26095.66
470295-7029594.33597.02
564683-6468386.80489.12
664264-6426486.24288.60
极限167283-6728390.29391.502.2093.2894.442.25
267823-6782391.01893.89
369538-6953893.31996.23
470437-7043794.52697.73
567569-6756990.67793.48
666449-6644989.17492.01
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