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%
110.972853622860202854882863792858132858120.15
211.002852802871522862160.47
单位质量响应值RSD%判断
26053.9726019.640.10数据可信
供试品溶液-20220127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%
5min150075-5007517.25715.4343.9117.2615.4443.90
210497-104973.6183.62
371405-7140524.60824.61
448132-4813216.58816.59
542180-4218014.53614.54
646434-4643416.00216.00
10min1212041-21204173.07572.138.4573.1772.228.49
2191096-19109665.85765.88
3241204-24120483.12683.26
4210113-21011372.41172.50
5206077-20607771.02071.10
6195297-19529767.30567.39
15min1291353-291353100.40899.221.63100.9199.701.63
2292433-292433100.781101.17
3289578-28957899.797100.40
4289918-28991899.914100.41
5283054-28305497.54898.02
6281041-28104196.85597.32
20min1296636-296636102.229100.561.88103.29101.591.82
2299143-299143103.093104.04
3285585-28558598.42199.57
4289819-28981999.880100.93
5286438-28643898.71499.73
6293049-293049100.993101.99
30min1295952-295952101.993101.291.31103.62102.881.27
2298632-298632102.917104.44
3292344-292344100.750102.45
4291496-291496100.458102.06
5288320-28832099.363100.93
6296685-296685102.246103.81
45min1290265-290265100.033100.871.24102.23103.031.18
2296293-296293102.111104.20
3289987-28998799.938102.20
4292765-292765100.895103.06
5289069-28906999.621101.74
6297759-297759102.616104.75
60min1291854-291854100.581101.391.46103.33104.111.40
2300339-300339103.505106.16
3290360-290360100.066102.88
4296683-296683102.245104.97
5289451-28945199.753102.42
6296559-296559102.202104.90
极限1302322-302322104.189104.411.09107.50107.691.06
2304331-304331104.881108.11
3301796-301796104.007107.38
4307663-307663106.029109.32
5297749-297749102.613105.84
6303859-303859104.718107.99
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%
114.937140171101712377126371489712980.22
214.987098771469712280.48
单位质量响应值RSD%判断
4775.494754.870.31数据可信
供试品溶液-20220127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%
5min126709-2670936.34041.6520.3236.3441.6420.32
229056-2905639.53339.53
335530-3553048.34248.34
436337-3633749.44049.44
520757-2075728.24228.24
635263-3526347.97847.98
10min153747-5374773.12773.723.2973.3373.963.33
251933-5193370.65970.88
354203-5420373.74874.02
457014-5701477.57277.85
552973-5297372.07472.23
655240-5524075.15975.43
15min162391-6239184.88884.712.7285.5085.352.72
259921-5992181.52882.14
360773-6077382.68783.37
464651-6465187.96388.67
563037-6303785.76786.32
662774-6277485.40986.09
20min165706-6570689.39987.882.2190.4888.992.20
264220-6422087.37788.44
362137-6213784.54385.68
466131-6613189.97791.17
564264-6426487.43788.47
665087-6508788.55789.72
30min167764-6776492.19990.531.9393.7892.131.91
266600-6660090.61592.17
364139-6413987.26788.87
467419-6741991.72993.42
566400-6640090.34391.86
666919-6691991.04992.70
45min166827-6682790.92491.581.6093.0193.681.60
266777-6677790.85692.91
365702-6570289.39391.49
468666-6866693.42695.63
568070-6807092.61594.64
667808-6780892.25994.42
60min167426-6742691.73992.352.1194.3394.962.10
267904-6790492.38994.95
365841-6584189.58292.17
470285-7028595.62998.35
568033-6803392.56595.10
667746-6774692.17494.84
极限168486-6848693.18192.861.8896.2895.991.90
267377-6737791.67294.74
366555-6655590.55493.64
470163-7016395.46398.72
567849-6784992.31495.36
669092-6909294.00697.19
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%
110.972863742841922858202862502855782856430.31
211.002847172847472847320.01
单位质量响应值RSD%判断
26038.5625884.730.42数据可信
供试品溶液-20220127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%
5min132480-3248011.22614.6633.6111.2314.6733.59
266325-6632522.92422.92
346973-4697316.23516.24
442035-4203514.52814.53
524376-243768.4258.43
642384-4238414.64914.65
10min1207205-20720571.61673.795.0871.6873.875.10
2235000-23500081.22381.35
3205678-20567871.08871.18
4212563-21256373.46873.55
5211140-21114072.97673.02
6209352-20935272.35872.44
15min1283606-28360698.022100.012.5998.48100.502.57
2286160-28616098.90599.48
3280119-28011996.81797.30
4290471-290471100.395100.88
5299354-299354103.465103.92
6296496-296496102.477102.96
20min1289856-289856100.182101.152.62101.19102.202.58
2286948-28694899.177100.31
3285730-28573098.75699.78
4289063-28906399.908100.95
5304458-304458105.229106.26
6299847-299847103.636104.69
30min1300052-300052103.706101.932.02105.27103.541.97
2287420-28742099.340101.02
3290408-290408100.373101.94
4291063-291063100.600102.20
5299274-299274103.438105.05
6301191-301191104.100105.73
45min1296768-296768102.571101.852.57104.71104.022.52
2286029-28602998.860101.09
3287826-28782699.481101.61
4291174-291174100.638102.80
5304393-304393105.207107.39
6301895-301895104.343106.55
60min1302147-302147104.431101.842.66107.14104.582.60
2284858-28485898.455101.24
3285650-28565098.729101.41
4294179-294179101.677104.40
5299292-299292103.444106.21
6301825-301825104.319107.11
极限1295258-295258102.050103.652.15105.34106.962.10
2290875-290875100.535103.86
3298814-298814103.279106.51
4300465-300465103.849107.13
5306158-306158105.817109.16
6307834-307834106.396109.76
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%
114.937136971293710637143371319712950.20
214.987149271674715830.18
单位质量响应值RSD%判断
4775.284778.570.05数据可信
供试品溶液-20220127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%
5min137117-3711750.37643.6914.9350.3843.7014.93
238384-3838452.09652.10
332008-3200843.44243.44
431312-3131242.49842.50
528062-2806238.08738.09
626279-2627935.66735.67
10min153490-5349072.59873.202.3072.8873.442.31
255501-5550175.32875.62
352748-5274871.59171.83
453604-5360472.75372.99
552822-5282271.69271.90
655444-5544475.25175.45
15min159492-5949280.74583.792.4081.4384.442.36
262140-6214084.33985.05
361159-6115983.00783.65
461809-6180983.88984.53
561772-6177283.83984.45
664050-6405086.93187.55
20min162365-6236584.64486.941.4285.7888.051.38
263712-6371286.47287.65
364286-6428687.25188.35
464530-6453087.58288.69
564786-6478687.93089.01
664644-6464487.73788.84
30min165216-6521688.51389.521.8090.1291.121.75
264627-6462787.71489.37
366687-6668790.51092.09
466082-6608289.68991.28
565284-6528488.60690.17
667868-6786892.11393.70
45min164599-6459987.67690.412.3589.7792.512.29
265810-6581089.32091.46
366452-6645290.19192.28
467204-6720491.21293.30
566356-6635690.06192.12
669267-6926794.01296.11
60min166534-6653490.30290.332.1392.8892.922.07
265412-6541288.77991.42
365515-6551588.91991.51
467208-6720891.21793.81
565596-6559689.02991.59
669054-6905493.72296.34
极限164153-6415387.07190.702.8990.1593.802.82
266404-6640490.12693.26
366629-6662990.43193.51
468192-6819292.55395.66
565873-6587389.40592.46
669728-6972894.63797.78
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%
110.972860922844402855352859012849182853770.25
211.002859992868552864270.22
单位质量响应值RSD%判断
26014.3126038.820.07数据可信
供试品溶液-555886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%
5min12515-25150.8673.8598.470.873.8598.42
231968-3196811.02111.02
312331-123314.2514.25
43305-33051.1391.14
55297-52971.8261.83
611638-116384.0124.01
10min1141452-14145248.76759.6915.8148.7759.7115.83
2214225-21422573.85773.92
3162603-16260356.06056.08
4197129-19712967.96367.97
5154520-15452053.27353.28
6168792-16879258.19358.22
15min1263590-26359090.87695.913.0791.1596.263.10
2282232-28223297.30397.77
3281194-28119496.94597.28
4286155-28615598.65699.04
5283483-28348397.73598.04
6272462-27246293.93594.28
20min1290019-29001999.98898.691.84100.7799.581.76
2276608-27660895.36496.38
3286218-28621898.67799.55
4290365-290365100.107101.04
5289633-28963399.855100.70
6284700-28470098.15499.02
30min1286258-28625898.69197.761.20100.0399.201.12
2277628-27762895.71697.26
3284936-28493698.23599.66
4282536-28253697.40898.90
5287029-28702998.957100.36
6282927-28292797.54398.96
45min1284805-28480598.19097.840.83100.0799.810.81
2284309-28430998.019100.09
3280904-28090496.84598.81
4283369-28336997.69599.72
5287479-28747999.112101.07
6281837-28183797.16799.12
60min1282995-28299597.56696.731.11100.0099.261.05
2277731-27773195.75198.37
3277478-27747895.66498.17
4279115-27911596.22998.80
5285302-28530298.362100.87
6280857-28085796.82999.32
极限1280814-28081496.81496.312.1699.7999.362.07
2270359-27035993.21096.36
3273512-27351294.29797.33
4283822-28382297.851100.96
5285330-28533098.371101.42
6282223-28222397.300100.33
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%
114.937130271275711707117471130712100.11
214.987162971673716510.05
单位质量响应值RSD%判断
4769.594783.110.21数据可信
供试品溶液-555886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%
5min114884-1488420.20417.8968.8920.2017.8968.89
29576-957612.99813.00
322248-2224830.19930.20
48364-836411.35311.35
5-0.0000.00
623994-2399432.56932.57
10min154657-5465774.19175.967.2374.3076.067.29
253394-5339472.47772.55
359373-5937380.59380.76
458645-5864579.60579.67
549748-4974867.52867.53
659954-5995481.38281.56
15min166059-6605989.66989.252.5790.1989.772.65
263691-6369186.45486.93
367265-6726591.30691.92
466075-6607589.69090.20
563766-6376686.55686.93
667638-6763891.81292.44
20min168292-6829292.70091.762.3793.7292.782.39
264362-6436287.36588.32
368176-6817692.54293.66
468510-6851092.99694.00
567871-6787192.12892.98
668383-6838392.82393.97
30min168496-6849692.97792.291.7694.5193.821.73
266316-6631690.01791.46
368092-6809292.42894.07
466949-6694990.87792.40
569670-6967094.57095.94
668405-6840592.85394.51
45min167714-6771491.91592.801.4893.9794.841.42
267644-6764491.82093.76
368430-6843092.88795.04
467537-6753791.67593.70
570199-7019995.28897.18
668659-6865993.19895.37
60min167532-6753291.66891.571.8494.2394.131.80
266052-6605289.65992.11
366965-6696590.89893.56
466411-6641190.14692.68
569155-6915593.87196.29
668659-6865993.19895.89
极限164422-6442287.44690.432.8290.5293.492.78
264520-6452087.58090.53
366611-6661190.41893.59
467005-6700590.95393.99
568046-6804692.36695.31
669101-6910193.79897.01
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%
110.972854412849532845132846612845462848230.14
211.002849702844352847020.14
单位质量响应值RSD%判断
25963.8125882.000.23数据可信
供试品溶液-555886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%
5min130527-3052710.5674.9472.6810.574.9472.70
223738-237388.2178.22
311042-110423.8223.82
48288-82882.8692.87
55631-56311.9491.95
66359-63592.2012.20
10min1199136-19913668.92961.2519.7168.9961.2719.73
2224897-22489777.84677.89
3159616-15961655.25055.27
4161687-16168755.96755.98
5126142-12614243.66343.67
6190142-19014265.81665.83
15min1284214-28421498.37996.864.7198.8297.224.74
2283506-28350698.13498.61
3274056-27405694.86295.19
4289350-289350100.156100.48
5256006-25600688.61588.87
6291743-291743100.985101.36
20min1289569-289569100.232100.241.44101.22101.141.46
2287791-28779199.617100.64
3287428-28742899.491100.35
4287223-28722399.420100.30
5287596-28759699.549100.29
6297889-297889103.112104.05
30min1290568-290568100.57899.470.76102.12100.930.77
2284726-28472698.556100.13
3287350-28735099.464100.87
4285463-28546398.811100.25
5287140-28714099.391100.69
6288994-288994100.033101.54
45min1288036-28803699.70299.002.13101.81101.022.16
2287628-28762899.560101.68
3281116-28111697.30699.27
4281831-28183197.55499.54
5280934-28093497.24399.09
6296538-296538102.644104.71
60min1281886-28188697.57398.041.24100.23100.611.24
2280388-28038897.05499.73
3284359-28435998.429100.93
4283244-28324498.043100.57
5280056-28005696.93999.33
6289569-289569100.232102.87
极限1284228-28422898.38397.900.98101.58101.011.02
2283413-28341398.101101.32
3278208-27820896.30099.35
4283147-28314798.009101.08
5281626-28162697.483100.41
6286378-28637899.128102.32
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%
114.937135771184710367076071450711570.39
214.987113771235711860.10
单位质量响应值RSD%判断
4766.044752.070.21数据可信
供试品溶液-555886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%
5min18240-824011.22624.5030.6211.2324.5030.62
221293-2129329.00829.01
320562-2056228.01228.01
422526-2252630.68830.69
514620-1462019.91719.92
620646-2064628.12728.13
10min150123-5012368.28475.048.4268.3575.188.42
255042-5504274.98675.15
358597-5859779.82979.98
449928-4992868.01968.19
555117-5511775.08875.20
661705-6170584.06384.22
15min165461-6546189.18091.922.5089.6292.482.53
266375-6637590.42591.00
369300-6930094.41095.01
466124-6612490.08390.63
568483-6848393.29793.82
669112-6911294.15494.78
20min169536-6953694.73195.221.7695.6796.281.77
268028-6802892.67793.76
371367-7136797.22698.35
469203-6920394.27895.33
570294-7029495.76496.81
670926-7092696.62597.77
30min170734-7073496.36395.511.1797.8397.101.16
269212-6921294.29095.88
371224-7122497.03198.69
469169-6916994.23195.80
570199-7019995.63497.21
670105-7010595.50697.19
45min169615-6961594.83994.642.1696.8496.762.13
271230-7123097.03999.16
368796-6879693.72395.93
468704-6870493.59895.69
567370-6737091.78093.89
671105-7110596.86999.08
60min168879-6887993.83694.551.7296.3697.201.72
269214-6921494.29396.95
370714-7071496.33699.06
467398-6739891.81994.43
570174-7017495.60098.22
670040-7004095.41898.17
极限169661-6966194.90294.390.9797.9597.570.94
269575-6957594.78497.97
368931-6893193.90797.17
468109-6810992.78795.91
569958-6995895.30698.46
669480-6948094.65597.94
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