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%
110.482781122777752778142779932776722778730.07
210.532763852768302766080.12
单位质量响应值RSD%判断
26514.6026268.570.66数据可信
中间条件6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%
5min159189-5918920.12424.7424.4520.1224.7424.45
285046-8504628.91628.92
349228-4922816.73816.74
489725-8972530.50730.51
563065-6306521.44221.44
690412-9041230.74030.74
10min1208565-20856570.91373.4713.6071.0273.6113.62
2244892-24489283.26483.42
3169321-16932157.57057.66
4238972-23897281.25181.42
5198501-19850167.49167.61
6236291-23629180.33980.51
15min1244445-24444583.11288.287.0883.6288.827.13
2281848-28184895.82996.45
3239942-23994281.58181.99
4266442-26644290.59191.21
5246535-24653583.82284.32
6278574-27857494.71695.33
20min1256280-25628087.13691.904.5888.1092.944.65
2284672-28467296.78997.94
3259516-25951688.23689.10
4277241-27724194.26395.39
5262305-26230589.18490.14
6281817-28181795.81896.96
30min1274429-27442993.30695.263.4994.7696.803.57
2292779-29277999.545101.24
3272282-27228292.57693.93
4283779-28377996.48598.13
5268738-26873891.37192.83
6288987-28898798.25699.93
45min1273843-27384393.10796.242.8895.0898.312.93
2291994-29199499.279101.52
3284250-28425096.64698.52
4282121-28212195.92298.11
5273978-27397893.15395.12
6292085-29208599.310101.53
60min1276896-27689694.14597.753.4596.63100.363.43
2292547-29254799.467102.26
3297051-297051100.998103.41
4282900-28290096.18798.90
5276798-27679894.11296.59
6298757-298757101.578104.35
极限1296734-296734100.890100.860.94103.90104.021.01
2301552-301552102.528105.88
3293548-29354899.807102.78
4297190-297190101.045104.30
5296389-296389100.773103.78
6294455-294455100.115103.45
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%
115.267237772376727637240472554724950.24
215.327231072367723380.06
单位质量响应值RSD%判断
4750.664721.800.44数据可信
中间条件6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%
5min148831-4883166.84576.638.6866.8576.638.68
260251-6025182.47882.48
352356-5235671.67171.67
460105-6010582.27882.28
554369-5436974.42674.43
659952-5995282.06982.07
10min162654-6265485.76891.763.6886.1492.193.69
269335-6933594.91395.37
366797-6679791.43991.84
469241-6924194.78595.24
567763-6776392.76193.17
666405-6640590.90291.36
15min163791-6379187.32493.883.7888.1794.813.79
270538-7053896.56097.55
369051-6905194.52595.43
468919-6891994.34495.33
571075-7107597.29598.22
668091-6809193.21094.17
20min164642-6464288.48994.673.5089.8296.133.50
269755-6975595.48897.01
369877-6987795.65597.09
471019-7101997.21998.73
571152-7115297.40198.87
668491-6849193.75895.24
30min166477-6647791.00195.492.5492.8397.472.57
270465-7046596.46098.51
370443-7044396.43098.39
471309-7130997.61699.66
570781-7078196.89398.90
669069-6906994.54996.55
45min163637-6363787.11395.144.3289.4497.664.30
269356-6935694.94297.53
370844-7084496.97999.48
471611-7161198.029100.62
571498-7149897.874100.42
670073-7007395.92498.45
60min164688-6468888.55295.693.7191.3798.733.71
270741-7074196.83899.95
371378-7137897.710100.75
470942-7094297.113100.25
570219-7021996.12399.22
671428-7142897.779100.84
极限165691-6569189.92595.443.4493.2399.013.45
271376-7137697.707101.36
368800-6880094.18197.76
472165-7216598.787102.46
571274-7127497.568101.19
669015-6901594.47598.08
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%
110.482767832763922768172764612766022766110.07
210.532765942761962763950.11
单位质量响应值RSD%判断
26394.1826248.340.40数据可信
中间条件6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%
5min1192716-19271665.69855.0423.1765.7055.0423.17
2181316-18131661.81261.81
3202185-20218568.92668.93
4147266-14726650.20450.20
5103295-10329535.21435.21
6141967-14196748.39748.40
10min1262729-26272989.56685.867.9189.9386.167.96
2275664-27566493.97594.32
3265964-26596490.66991.05
4249612-24961285.09485.37
5231127-23112778.79378.99
6226058-22605877.06477.33
15min1277860-27786094.72492.046.4095.5992.836.44
2289735-28973598.77299.64
3284876-28487697.11698.00
4263133-26313389.70490.46
5260402-26040288.77389.41
6243963-24396383.16883.87
20min1278142-27814294.82092.565.1796.2193.865.22
2288208-28820898.25299.67
3281431-28143195.94197.37
4267323-26732391.13292.38
5264873-26487390.29791.42
6249156-24915684.93986.10
30min1281072-28107295.81993.893.8297.7395.703.90
2286178-28617897.56099.52
3283861-28386196.77098.73
4270933-27093392.36394.12
5272485-27248592.89294.52
6257970-25797087.94389.57
45min1284648-28464897.03894.174.0299.4996.504.08
2286716-28671697.743100.25
3283362-28336296.60099.10
4266852-26685290.97193.24
5276698-27669894.32896.47
6259055-25905588.31390.43
60min1280645-28064595.67392.283.7298.6695.143.79
2284031-28403196.82899.87
3272041-27204192.74095.77
4263763-26376389.91892.69
5265220-26522090.41593.08
6258518-25851888.13090.74
极限1294826-294826100.50898.602.13104.03101.962.07
2292525-29252599.723103.31
3279794-27979495.38398.93
4286916-28691697.811101.09
5295578-295578100.764103.93
6285693-28569397.394100.49
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%
115.267230272267723067226772315722910.04
215.327235172310723300.05
单位质量响应值RSD%判断
4737.294721.280.24数据可信
中间条件6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%
5min158749-5874980.54075.015.9280.5475.005.92
255003-5500375.40475.40
358461-5846180.14580.14
451684-5168470.85470.85
552093-5209371.41571.41
652292-5229271.68871.69
10min166579-6657991.27489.921.5991.7290.341.58
263614-6361487.20987.63
365787-6578790.18890.63
466227-6622790.79191.18
565839-6583990.25990.66
665513-6551389.81390.21
15min168902-6890294.45994.100.9195.4195.010.92
268304-6830493.63994.54
369272-6927294.96695.91
468479-6847993.87994.78
569223-6922394.89995.80
667643-6764392.73393.63
20min168400-6840093.77095.823.7095.2597.263.64
269077-6907794.69896.12
368739-6873994.23595.71
469818-6981895.71497.13
575048-75048102.884104.31
668277-6827793.60295.01
30min169730-6973095.59495.881.2697.5997.851.22
269299-6929995.00396.95
369611-6961195.43197.43
471610-7161098.171100.12
569241-6924194.92396.92
670137-7013796.15298.08
45min170046-7004696.02796.090.6398.5698.590.60
270304-7030496.38198.86
369851-6985195.76098.29
470776-7077697.02899.52
569477-6947795.24797.77
670088-7008896.08498.55
60min167548-6754892.60293.692.4095.6796.732.31
269117-6911794.75397.77
366751-6675191.51094.57
470529-7052996.68999.72
566513-6651391.18394.24
669588-6958895.39998.40
极限169344-6934495.06494.432.3698.6497.982.26
270151-7015196.17199.71
365914-6591490.36293.93
468223-6822393.52897.10
569435-6943595.18998.75
670207-7020796.24899.78
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%
110.482766802766242762622767722764272765530.08
210.532764882763452764160.04
单位质量响应值RSD%判断
26388.6526250.330.38数据可信
中间条件6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%
5min1189757-18975764.69457.5611.8464.6957.5611.84
2173855-17385559.27259.27
3180005-18000561.36961.37
4133000-13300045.34345.34
5176047-17604760.01960.02
6160288-16028854.64754.65
10min1274468-27446893.57488.524.0293.9388.844.05
2257689-25768987.85488.18
3267083-26708391.05691.40
4247786-24778684.47784.73
5262098-26209889.35789.69
6248755-24875584.80885.11
15min1282896-28289696.44793.692.7297.3394.502.75
2271191-27119192.45793.27
3285022-28502297.17298.02
4266170-26617090.74591.47
5273054-27305493.09293.92
6270495-27049592.21992.99
20min1286522-28652297.68395.302.2499.1096.632.28
2277993-27799394.77696.11
3285023-28502397.17298.56
4269773-26977391.97393.20
5281847-28184796.09097.44
6275942-27594294.07695.36
30min1282937-28293796.46196.422.0698.4298.282.08
2280332-28033295.57397.43
3288871-28887198.484100.41
4272989-27298993.07094.81
5288113-28811398.226100.11
6283627-28362796.69798.51
45min1288296-28829698.28897.881.84100.78100.281.87
2290896-29089699.175101.56
3291477-29147799.373101.85
4278738-27873895.03097.28
5290647-29064799.090101.52
6282525-28252596.32198.67
60min1282925-28292596.45797.921.4599.50100.861.44
2292839-29283999.837102.78
3291255-29125599.297102.32
4283568-28356896.67699.46
5287857-28785798.139101.12
6284788-28478897.09299.97
极限1299010-299010101.941102.520.87105.52106.000.79
2301944-301944102.941106.44
3296235-296235100.995104.57
4301568-301568102.813106.13
5302398-302398103.096106.62
6303068-303068103.324106.75
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%
115.267241172457723017234172284723590.11
215.327230472295723000.01
单位质量响应值RSD%判断
4741.744719.320.34数据可信
中间条件6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%
5min159153-5915381.07279.1015.8381.0779.1015.83
263969-6396987.67387.67
353705-5370573.60673.61
441168-4116856.42356.42
562921-6292186.23786.24
665384-6538489.61289.61
10min165651-6565189.97891.974.1990.4392.414.22
269403-6940395.12195.61
362853-6285386.14386.55
466065-6606590.54690.86
568096-6809693.32993.81
670556-7055696.70197.20
15min167198-6719892.09894.203.0393.0595.163.04
270069-7006996.03397.05
365629-6562989.94890.84
469561-6956195.33796.15
568540-6854093.93894.94
671405-7140597.86498.90
20min168822-6882294.32495.613.1695.7997.083.17
271804-7180498.41199.96
365839-6583990.23691.62
470521-7052196.65398.00
570057-7005796.01797.54
671517-7151798.01899.60
30min169162-6916294.79096.822.8196.7898.822.82
271879-7187998.514100.61
367520-6752092.54094.43
471832-7183298.450100.33
570628-7062896.79998.85
672837-7283799.827101.95
45min171790-7179098.39297.182.49100.9099.722.43
268682-6868294.13296.78
368876-6887694.39896.80
472788-7278899.760102.19
570921-7092197.20199.79
672365-7236599.180101.86
60min170923-7092397.20498.812.61100.26101.892.58
274233-74233101.740104.91
369575-6957595.35698.28
473902-73902101.287104.27
570960-7096097.254100.39
672972-72972100.012103.24
极限172292-7229299.08098.822.22102.68102.452.18
272874-7287499.878103.61
369973-6997395.90299.36
474316-74316101.854105.40
570543-7054396.683100.35
672627-7262799.539103.32
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%
110.482764662765372764512759712762332763320.09
210.532764442762332763380.06
单位质量响应值RSD%判断
26367.5626242.920.34数据可信
中间条件6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%
5min1178641-17864160.93752.5822.2660.9452.5822.25
2186080-18608063.47463.47
3165609-16560956.49156.49
4154962-15496252.85952.86
5149489-14948950.99350.99
690052-9005230.71830.72
10min1252520-25252086.13885.445.1286.4885.745.16
2267052-26705291.09591.45
3261189-26118989.09589.41
4250220-25022085.35385.65
5234125-23412579.86380.15
6237798-23779881.11681.29
15min1265612-26561290.60490.174.3491.4290.944.37
2275436-27543693.95594.81
3280180-28018095.57396.38
4258094-25809488.03988.81
5253075-25307586.32787.05
6253648-25364886.52387.14
20min1267550-26755091.26592.163.9692.5993.423.99
2282657-28265796.41897.80
3282354-28235496.31597.65
4268515-26851591.59492.85
5255057-25505787.00388.21
6264825-26482590.33591.44
30min1278076-27807694.85594.103.1096.6895.883.15
2284901-28490197.18399.10
3284394-28439497.01098.89
4274880-27488093.76595.53
5262837-26283789.65791.35
6270073-27007392.12593.73
45min1278306-27830694.93494.562.6897.2996.862.74
2284475-28447597.03899.49
3285831-28583197.50199.91
4275951-27595194.13096.42
5266051-26605190.75392.94
6272618-27261892.99395.11
60min1274240-27424093.54795.002.7896.4397.822.82
2288717-28871798.485101.48
3286688-28668897.793100.75
4277638-27763894.70697.52
5268767-26876791.68094.37
6274875-27487593.76396.40
极限1305290-305290104.138102.290.93107.54105.640.91
2298139-298139101.699105.24
3297862-297862101.604105.10
4299984-299984102.328105.66
5298511-298511101.826105.03
6299381-299381102.123105.28
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%
115.267245772455724247229172391724040.10
215.327247372407724400.07
单位质量响应值RSD%判断
4744.694728.460.25数据可信
中间条件6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%
5min159467-5946781.39869.2826.1281.4069.2826.12
234982-3498247.88347.88
359134-5913480.94380.94
459172-5917280.99580.99
558746-5874680.41280.41
632195-3219544.06944.07
10min164854-6485488.77284.078.9889.2284.459.05
254341-5434174.38274.65
364732-6473288.60589.05
466407-6640790.89891.35
563725-6372587.22787.67
654441-5444174.51974.76
15min166661-6666191.24687.196.5992.1988.046.68
258738-5873880.40181.08
367327-6732792.15793.10
465878-6587890.17491.13
565628-6562889.83290.76
657967-5796779.34580.00
20min165873-6587390.16788.294.1491.6289.634.25
261480-6148084.15485.28
366884-6688491.55193.00
467562-6756292.47993.93
563718-6371887.21788.65
661508-6150884.19285.29
30min167846-6784692.86891.183.5594.8293.013.68
263806-6380687.33888.93
368630-6863093.94195.90
468750-6875094.10596.07
567145-6714591.90893.82
663521-6352186.94888.51
45min167818-6781892.82992.092.7195.3094.422.86
265419-6541989.54691.62
368967-6896794.40296.89
469257-6925794.79997.29
567390-6739092.24394.67
664826-6482688.73490.78
60min167476-6747692.36192.942.5995.3595.792.71
267097-6709791.84294.42
369373-6937394.95897.97
470162-7016296.03899.06
568102-6810293.21896.16
665202-6520289.24991.79
极限169733-6973395.45194.881.1798.9598.241.11
268540-6854093.81896.90
369614-6961495.28898.82
469109-6910994.59698.15
568372-6837293.58897.04
670536-7053696.55099.59
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