坎地氢噻片项目信息
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100309-202205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%
112.354984114983934984414983654983544983930.01
212.324966394965344965860.02
单位质量响应值RSD%判断
40355.7140307.310.09数据可信
供试品溶液-2024083021批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1445651-44565179.31974.378.4079.3274.378.40
2427857-42785776.15276.15
3386763-38676368.83868.84
4405293-40529372.13672.14
5375242-37524266.78766.79
6466222-46622282.98182.98
10min1550195-55019597.92696.332.5098.0696.452.50
2542300-54230096.52196.65
3524097-52409793.28193.40
4558537-55853799.41199.53
5526446-52644693.69993.81
6545739-54573997.13397.27
15min1559409-55940999.56698.721.4299.8699.001.42
2554235-55423598.64698.93
3553511-55351198.51798.79
4567028-567028100.922101.21
5545060-54506097.01297.28
6548602-54860297.64397.94
20min1559328-55932899.55298.931.29100.0199.381.29
2555368-55536898.84799.30
3557325-55732599.19599.63
4566780-566780100.878101.33
5547560-54756097.45797.89
6548649-54864997.65198.11
30min1558910-55891099.47898.941.18100.1099.551.17
2555001-55500198.78299.40
3556915-55691599.12399.72
4566112-566112100.759101.38
5550635-55063598.00598.60
6547613-54761397.46798.09
45min1556941-55694199.12798.731.1099.9299.511.10
2553839-55383998.57599.36
3555657-55565798.89999.66
4564537-564537100.479101.27
5550715-55071598.01998.77
6546629-54662997.29298.08
60min1555981-55598198.95698.541.0699.9199.491.05
2553952-55395298.59599.54
3555506-55550698.87299.80
4562073-562073100.041101.00
5549188-54918897.74798.67
6545320-54532097.05998.01
极限1556305-55630599.01498.511.16100.1499.611.16
2557106-55710699.157100.27
3555414-55541498.85599.95
4560652-56065299.788100.91
5547227-54722797.39898.48
6543976-54397696.82097.93
坎地氢噻片项目信息
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%
115.512968782969382969962969702970652969690.03
215.472972952973592973270.02
单位质量响应值RSD%判断
19146.9419219.590.27数据可信
供试品溶液-2024083021批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154060-15406045.08443.217.8045.0843.217.79
2157954-15795446.22346.22
3138552-13855240.54640.55
4140346-14034641.07141.07
5133783-13378339.15039.15
6161307-16130747.20547.20
10min1245936-24593671.97070.652.9072.0570.722.90
2244886-24488671.66371.74
3231601-23160167.77567.84
4244553-24455371.56671.63
5233517-23351768.33668.40
6247972-24797272.56672.64
15min1279520-27952081.79881.211.1881.9981.401.19
2278678-27867881.55281.75
3274128-27412880.22180.40
4281007-28100782.23482.42
5272806-27280679.83480.01
6278916-27891681.62281.82
20min1295781-29578186.55786.240.7486.8986.570.74
2293908-29390886.00986.34
3293255-29325585.81886.13
4298376-29837687.31687.64
5292232-29223285.51885.83
6294691-29469186.23886.57
30min1308755-30875590.35490.080.7690.8390.550.76
2306944-30694489.82490.30
3307946-30794690.11790.57
4311785-31178591.24091.71
5305036-30503689.26589.72
6306521-30652189.70090.18
45min1313051-31305191.61191.510.8192.2492.130.81
2312045-31204591.31791.94
3313646-31364691.78592.39
4316892-31689292.73593.36
5309557-30955790.58891.19
6311079-31107991.03491.66
60min1314890-31489092.14991.870.9192.9392.640.91
2313013-31301391.60092.38
3315265-31526592.25993.02
4318382-31838293.17193.95
5310634-31063490.90491.66
6311486-31148691.15391.93
极限1315965-31596592.46492.200.9793.4093.130.96
2314732-31473292.10393.03
3316635-31663592.66093.57
4319543-31954393.51194.44
5310962-31096291.00091.91
6312633-31263391.48992.42
坎地氢噻片项目信息
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100309-202205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%
112.354960374953964955074957364955964956540.05
212.324944604946694945640.03
单位质量响应值RSD%判断
40133.9340143.180.02数据可信
供试品溶液-2024083021批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1387958-38795869.38375.699.2569.3875.699.25
2375542-37554267.16267.16
3473275-47327584.64184.64
4406476-40647672.69472.69
5440520-44052078.78378.78
6455690-45569081.49681.50
10min1529282-52928294.65797.011.9694.7797.131.97
2541917-54191796.91797.03
3553428-55342898.97599.12
4531882-53188295.12295.24
5555041-55504199.26499.40
6542937-54293797.09997.23
15min1539415-53941596.46998.071.3696.7498.361.36
2551689-55168998.66498.94
3555006-55500699.25899.56
4540471-54047196.65896.94
5556943-55694399.60499.90
6546677-54667797.76898.07
20min1539477-53947796.48098.151.3796.9198.601.38
2552681-55268198.84299.28
3555282-55528299.30799.78
4541655-54165596.87097.31
5557720-55772099.743100.21
6545997-54599797.64698.11
30min1539516-53951696.48798.221.4397.0898.841.44
2552041-55204198.72799.33
3559404-559404100.044100.68
4542675-54267597.05297.65
5556046-55604699.444100.07
6545639-54563997.58298.21
45min1543312-54331297.16698.671.1497.9299.441.14
2554016-55401699.08199.85
3558520-55852099.886100.69
4554630-55463099.19099.95
5555196-55519699.292100.09
6544490-54449097.37798.16
60min1548499-54849998.09498.690.9199.0199.630.91
2553346-55334698.96199.89
3557600-55760099.721100.69
4554688-55468899.201100.13
5553201-55320198.93599.89
6543509-54350997.20198.15
极限1552305-55230598.77599.030.3099.86100.140.30
2554845-55484599.229100.33
3555394-55539499.327100.46
4553244-55324498.942100.04
5551525-55152598.63599.76
6555204-55520499.293100.40
坎地氢噻片项目信息
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%
115.512971302967992968342969312968112969010.05
215.472971172967472969320.09
单位质量响应值RSD%判断
19142.5519194.050.19数据可信
供试品溶液-2024083021批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116348-11634834.07437.078.9834.0737.078.98
2113403-11340333.21233.21
3140274-14027441.08241.08
4119964-11996435.13335.13
5133861-13386139.20339.20
6135647-13564739.72739.73
10min1205490-20549060.18162.593.9660.2462.653.96
2208537-20853761.07461.13
3222010-22201065.01965.09
4204888-20488860.00560.06
5223779-22377965.53765.60
6217557-21755763.71563.78
15min1235999-23599969.11671.963.8769.2772.123.87
2238862-23886269.95570.11
3256364-25636475.08175.26
4237827-23782769.65269.81
5256987-25698775.26375.44
6248108-24810872.66372.84
20min1251857-25185773.76177.194.1874.0377.474.19
2255587-25558774.85375.13
3277648-27764881.31481.62
4255771-25577174.90775.18
5275592-27559280.71281.01
6264860-26486077.56977.86
30min1267268-26726878.27482.394.2478.6782.804.24
2273115-27311579.98680.38
3296074-29607486.71087.15
4274706-27470680.45280.85
5294822-29482286.34486.78
6281952-28195282.57483.00
45min1282169-28216982.63886.573.6983.1687.123.69
2286477-28647783.90084.43
3310068-31006890.80991.39
4296851-29685186.93887.47
5305924-30592489.59590.17
6292079-29207985.54086.10
60min1296089-29608986.71588.682.7387.3889.382.73
2295689-29568986.59787.27
3313462-31346291.80392.54
4307251-30725189.98490.66
5309547-30954790.65691.38
6294756-29475686.32487.03
极限1309627-30962790.67991.330.8091.4992.170.82
2310479-31047990.92991.74
3316293-31629392.63293.52
4312140-31214091.41592.24
5312500-31250091.52192.40
6309983-30998390.78491.63
坎地氢噻片项目信息
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100309-202205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%
112.354948294949574952044949034953294950440.05
212.324946124946484946300.01
单位质量响应值RSD%判断
40084.5340148.540.12数据可信
供试品溶液-505806批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1379466-37946667.90164.0813.9467.9064.0813.94
2413354-41335473.96573.97
3273395-27339548.92148.92
4373932-37393266.91166.91
5327088-32708858.52958.53
6381591-38159168.28168.28
10min1527030-52703094.30694.732.7594.4294.842.75
2541394-54139496.87697.00
3505114-50511490.38490.47
4524362-52436293.82993.94
5532389-53238995.26595.36
6546099-54609997.71897.83
15min1531162-53116295.04597.131.5095.3297.391.48
2543480-54348097.25097.53
3552212-55221298.81299.04
4538113-53811396.28996.56
5540384-54038496.69696.95
6551498-55149898.68498.96
20min1531797-53179795.15997.231.4695.5997.661.45
2544244-54424497.38697.83
3553000-55300098.95399.35
4539553-53955396.54796.98
5540287-54028796.67897.10
6551221-55122198.63599.08
30min1532842-53284295.34697.111.4895.9397.701.47
2545184-54518497.55598.16
3554345-55434599.19499.76
4536515-53651596.00396.59
5539027-53902796.45397.03
6548235-54823598.10198.71
45min1532703-53270395.32197.291.5596.0798.041.54
2547227-54722797.92098.69
3554426-55442699.20899.94
4534975-53497595.72896.48
5543584-54358497.26898.01
6549163-54916398.26799.04
60min1532105-53210595.21497.141.6996.1298.051.67
2545926-54592697.68798.62
3555989-55598999.488100.38
4532598-53259895.30296.21
5543766-54376697.30198.20
6546721-54672197.83098.76
极限1542048-54204896.99397.831.9198.0698.901.89
2556012-55601299.492100.59
3557105-55710599.688100.75
4529882-52988294.81695.88
5543273-54327397.21398.28
6552013-55201398.77799.87
坎地氢噻片项目信息
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%
115.512970332969772973852971532973502971800.07
215.472972072970772971420.04
单位质量响应值RSD%判断
19160.5419207.630.18数据可信
供试品溶液-505806批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189486-8948626.18626.1215.3026.1926.1215.29
2100719-10071929.47329.47
368103-6810319.92919.93
4102937-10293730.12230.12
578278-7827822.90622.91
695973-9597328.08428.08
10min1201618-20161858.99960.266.7559.0460.316.76
2219308-21930864.17564.22
3181874-18187453.22153.25
4213273-21327362.40962.46
5202557-20255759.27359.31
6217029-21702963.50863.56
15min1254689-25468974.52977.163.1874.6777.303.19
2270517-27051779.16079.32
3253343-25334374.13574.26
4269066-26906678.73678.89
5261654-26165476.56776.70
6272798-27279879.82879.98
20min1281150-28115082.27285.632.5982.5485.902.60
2297105-29710586.94187.23
3287385-28738584.09684.34
4298793-29879387.43587.72
5290581-29058185.03285.30
6300665-30066587.98288.27
30min1304264-30426489.03692.522.1389.4492.932.13
2317945-31794593.03993.47
3317278-31727892.84493.23
4320678-32067893.83994.27
5313427-31342791.71792.12
6323357-32335794.62395.05
45min1310814-31081490.95294.752.0991.5095.322.09
2323788-32378894.74995.34
3325447-32544795.23495.77
4325746-32574695.32295.91
5326331-32633195.49396.05
6330663-33066396.76197.35
60min1310103-31010390.74495.132.4591.4595.862.44
2323930-32393094.79095.54
3330215-33021596.62997.33
4325359-32535995.20895.95
5332215-33221597.21597.93
6328697-32869796.18596.94
极限1324267-32426794.88996.691.6795.7497.581.66
2332272-33227297.23198.14
3335385-33538598.14299.00
4323626-32362694.70195.61
5330207-33020796.62797.51
6336723-33672398.53499.45
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