坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404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)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.314836924838684836674834734833964836190.04
212.334839974839024839500.02
单位质量响应值RSD%判断
39286.6839249.800.07数据可信
供试品溶液-24041001批-氢氯噻嗪-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1315433-31543357.66357.6314.1857.6657.6314.18
2254068-25406846.44546.44
3375702-37570268.68068.68
4289610-28961052.94252.94
5300261-30026154.88954.89
6356572-35657265.18365.18
10min1477292-47729287.25184.057.9887.3584.157.98
2393932-39393272.01272.09
3499180-49918091.25291.37
4447423-44742381.79181.88
5462141-46214184.48184.57
6478886-47888687.54287.65
15min1490291-49029189.62789.753.9889.8789.984.00
2456004-45600483.35983.56
3513335-51333593.84094.11
4492573-49257390.04490.27
5489199-48919989.42889.66
6504217-50421792.17392.43
20min1493330-49333090.18391.592.4190.5791.972.43
2483021-48302188.29888.63
3517195-51719594.54594.97
4500968-50096891.57991.95
5501457-50145791.66892.05
6510073-51007393.24493.65
30min1496777-49677790.81392.781.4391.3593.321.44
2502047-50204791.77692.26
3506396-50639692.57193.15
4510597-51059793.33993.87
5513881-51388193.94094.47
6515695-51569594.27194.83
45min1501011-50101191.58794.461.6492.2895.161.64
2514593-51459394.07094.71
3524942-52494295.96296.70
4517988-51798894.69095.37
5521812-52181295.38996.08
6520081-52008195.07395.79
60min1503254-50325491.99795.301.7792.8496.151.76
2521741-52174195.37696.17
3528175-52817596.55397.45
4522471-52247195.51096.35
5526825-52682596.30697.16
6525356-52535696.03796.92
极限1539221-53922198.572100.631.0699.57101.641.06
2553219-553219101.131102.08
3554599-554599101.383102.44
4550375-550375100.611101.61
5554803-554803101.420102.43
6550585-550585100.649101.69
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.133060723067243056793074983080843068110.33
216.093088483090983089730.06
单位质量响应值RSD%判断
19021.1419202.800.68数据可信
供试品溶液-24041001批-坎地沙坦酯-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195653-9565328.09728.3311.4128.1028.3311.41
279777-7977723.43323.43
3111053-11105332.62032.62
491331-9133126.82726.83
595154-9515427.95027.95
6105682-10568231.04331.04
10min1195255-19525557.35355.389.1157.4055.439.11
2157654-15765446.30946.35
3206238-20623860.58060.63
4181622-18162253.34953.39
5191897-19189756.36756.41
6198648-19864858.35058.40
15min1244624-24462471.85570.615.9972.0070.756.00
2212747-21274762.49162.61
3252729-25272974.23674.39
4238518-23851870.06170.19
5244263-24426371.74971.89
6249530-24953073.29673.44
20min1268958-26895879.00378.824.0279.2679.084.03
2247703-24770372.75972.98
3277659-27765981.55881.84
4267860-26786078.68078.93
5272499-27249980.04380.30
6275303-27530380.86681.14
30min1288890-28889084.85785.442.1185.2585.822.12
2282094-28209482.86183.20
3286514-28651484.16084.57
4293036-29303686.07586.46
5297627-29762787.42487.82
6296988-29698887.23687.64
45min1299057-29905787.84489.671.7488.3890.201.75
2298467-29846787.67188.15
3309570-30957090.93291.49
4306107-30610789.91590.44
5310787-31078791.28991.83
6307564-30756490.34390.89
60min1303017-30301789.00791.011.4789.6991.691.48
2305626-30562689.77390.40
3313329-31332992.03692.74
4310992-31099291.35092.02
5314563-31456392.39993.09
6311462-31146291.48892.19
极限1311935-31193591.62794.001.3492.4694.831.33
2320753-32075394.21794.99
3323429-32342995.00395.86
4321497-32149794.43595.26
5323274-32327494.95795.80
6319199-31919993.76094.61
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404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)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.314806184809144813374809644812314810130.06
212.334850634851604851120.02
单位质量响应值RSD%判断
39074.9839344.040.49数据可信
供试品溶液-1批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1386424-38642470.74763.6710.2570.7563.6710.25
2383285-38328570.17270.17
3293836-29383653.79653.80
4359805-35980565.87365.87
5334370-33437061.21761.22
6328811-32881160.19960.20
10min1483896-48389688.59282.355.5688.7182.465.57
2478678-47867887.63687.75
3428154-42815478.38778.48
4443118-44311881.12681.24
5435776-43577679.78279.88
6429337-42933778.60378.70
15min1493804-49380490.40686.363.4090.6786.603.41
2489440-48944089.60789.87
3459284-45928484.08684.31
4469044-46904485.87386.12
5460942-46094284.38984.62
6457570-45757083.77284.00
20min1498006-49800691.17588.322.4891.5988.712.50
2494380-49438090.51190.92
3472908-47290886.58086.94
4485705-48570588.92389.31
5471958-47195886.40686.78
6471525-47152586.32786.70
30min1504423-50442392.35090.181.6992.9290.711.71
2498337-49833791.23691.80
3489844-48984489.68190.19
4494668-49466890.56491.10
5481539-48153988.16088.68
6486492-48649289.06789.58
45min1510106-51010693.39091.811.3294.1192.501.33
2502953-50295392.08192.80
3506499-50649992.73093.38
4499466-49946691.44292.13
5491279-49127989.94390.61
6498671-49867191.29791.96
60min1513805-51380594.06892.571.3894.9593.401.37
2504685-50468592.39893.27
3513242-51324293.96494.77
4502005-50200591.90792.75
5495662-49566290.74691.56
6504198-50419892.30993.12
极限1540843-54084399.01898.780.44100.0599.770.45
2542001-54200199.230100.25
3540427-54042798.94199.91
4535868-53586898.10799.10
5540736-54073698.99899.97
6537409-53740998.38999.36
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.133113863120073118443119973124673119400.13
216.093149973151583150780.04
单位质量响应值RSD%判断
19339.1219582.220.89数据可信
供试品溶液-1批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113415-11341532.71831.777.6232.7231.777.61
2117343-11734333.85133.85
396294-9629427.77927.78
4119087-11908734.35434.35
5108138-10813831.19531.20
6106508-10650830.72530.73
10min1204277-20427758.92955.745.1458.9855.795.14
2204556-20455659.01059.07
3181225-18122552.27952.33
4195314-19531456.34456.40
5189537-18953754.67754.73
6184322-18432253.17353.22
15min1249206-24920671.89068.583.4572.0468.723.45
2245969-24596970.95771.11
3229421-22942166.18366.32
4236097-23609768.10968.26
5235579-23557967.95968.10
6230046-23004666.36366.50
20min1271836-27183678.41975.872.4278.6976.132.42
2268866-26886677.56277.83
3256859-25685974.09874.34
4262813-26281375.81676.08
5261611-26161175.46975.73
6256014-25601473.85474.10
30min1290526-29052683.81082.241.2884.2182.621.29
2287665-28766582.98583.39
3282745-28274581.56681.93
4284948-28494882.20182.59
5284380-28438082.03782.42
6280175-28017580.82481.20
45min1299172-29917286.30485.401.0586.8585.921.06
2296793-29679385.61886.16
3299510-29951086.40286.91
4295533-29553385.25585.78
5293415-29341584.64485.16
6291709-29170984.15284.66
60min1302653-30265387.30986.491.0688.0087.161.05
2299874-29987486.50787.19
3304291-30429187.78188.43
4298849-29884986.21186.88
5296165-29616585.43786.10
6297097-29709785.70686.35
极限1313451-31345190.42490.280.5291.2691.100.52
2314413-31441390.70191.53
3315050-31505090.88591.68
4312242-31224290.07590.89
5311594-31159489.88890.69
6311030-31103089.72590.52
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404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)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.314870094868654870094870364870814870000.02
212.334836364835244835800.02
单位质量响应值RSD%判断
39561.3339219.790.62数据可信
供试品溶液-2批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1266637-26663748.59248.9714.5648.5948.9814.56
2257841-25784146.98946.99
3332893-33289360.66660.67
4239182-23918243.58943.59
5223965-22396540.81540.82
6291911-29191153.19853.20
10min1427887-42788777.97878.874.9678.0678.964.96
2426809-42680977.78277.86
3457704-45770483.41283.51
4409587-40958774.64374.72
5414680-41468075.57175.64
6460146-46014683.85783.95
15min1473236-47323686.24387.112.2086.4587.322.21
2473960-47396086.37486.58
3488162-48816288.96389.20
4463556-46355684.47884.68
5476817-47681786.89587.09
6492131-49213189.68689.91
20min1486634-48663488.68489.201.7889.0489.561.80
2485964-48596488.56288.91
3497249-49724990.61991.01
4476417-47641786.82287.16
5489714-48971489.24589.58
6500778-50077891.26291.64
30min1500677-50067791.24391.741.6291.7592.241.63
2500328-50032891.18091.68
3508933-50893392.74893.29
4490818-49081889.44789.93
5505102-50510292.05092.54
6514395-51439593.74394.27
45min1516143-51614394.06294.321.3494.7294.981.35
2515760-51576093.99294.64
3522202-52220295.16695.86
4506485-50648592.30292.93
5517781-51778194.36095.00
6526960-52696096.03396.72
60min1528253-52825396.26996.201.1797.0897.021.18
2526644-52664495.97696.78
3532268-53226897.00197.85
4517798-51779894.36395.15
5526489-52648995.94796.75
6535930-53593097.66898.51
极限1543208-54320898.99498.730.8699.9799.710.87
2541705-54170598.72099.69
3541772-54177298.73399.75
4533444-53344497.21598.16
5542757-54275798.91299.87
6547672-54767299.808100.82
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.133158353159943155103162503158443158870.09
216.093134113137683135900.09
单位质量响应值RSD%判断
19583.8219489.750.35数据可信
供试品溶液-2批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185443-8544324.55224.8310.4924.5524.8310.49
284773-8477324.35924.36
3101538-10153829.17629.18
481163-8116323.32223.32
574886-7488621.51821.52
690585-9058526.02926.03
10min1173550-17355049.86950.475.9949.9150.515.99
2174615-17461550.17550.22
3188122-18812254.05654.10
4166231-16623147.76647.80
5163388-16338846.94946.98
6187982-18798254.01654.06
15min1230279-23027966.16966.332.9666.2966.452.97
2227222-22722265.29165.42
3238113-23811368.42068.56
4223111-22311164.11064.23
5226177-22617764.99165.10
6240089-24008968.98869.12
20min1261324-26132475.09075.332.0675.3275.572.07
2258598-25859874.30774.54
3265722-26572276.35476.61
4255947-25594773.54573.77
5260408-26040874.82775.05
6270964-27096477.86078.11
30min1292137-29213783.94484.291.3484.3084.651.35
2291319-29131983.70984.07
3294665-29466584.67085.05
4288085-28808582.78083.13
5294031-29403184.48884.84
6299804-29980486.14786.53
45min1308224-30822488.56688.741.0489.0789.241.05
2308338-30833888.59989.10
3309067-30906788.80989.33
4303540-30354087.22087.71
5310442-31044289.20489.69
6313317-31331790.03090.55
60min1311637-31163789.54790.041.0290.1990.691.03
2313089-31308989.96490.61
3314081-31408190.24990.92
4308434-30843488.62789.26
5314897-31489790.48491.12
6317929-31792991.35592.03
极限1315993-31599390.79990.950.8991.6091.750.89
2316970-31697091.08091.87
3315957-31595790.78891.61
4311688-31168889.56290.34
5318939-31893991.64592.43
6319580-31958091.82992.65
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