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(%)99.70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%
111.974728344721784730724730684726084727520.08
211.994723104728244725670.08
单位质量响应值RSD%判断
39494.7439413.430.15数据可信
供试品溶液-505806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%
5min1334861-33486160.92646.0219.3460.9346.0219.34
2253403-25340346.10546.10
3237214-23721443.16043.16
4278717-27871750.71150.71
5212360-21236038.63738.64
6201132-20113236.59536.59
10min1514383-51438393.58973.5513.6193.6973.6213.61
2394230-39423071.72871.80
3377469-37746968.67868.75
4393171-39317171.53571.62
5365792-36579266.55366.62
6380388-38038869.20969.27
15min1523039-52303995.16385.297.6695.4285.497.67
2447526-44752681.42481.62
3453366-45336682.48782.67
4501025-50102591.15891.36
5427755-42775577.82778.00
6459989-45998983.69283.87
20min1525289-52528995.57389.415.1595.9989.755.17
2477740-47774086.92287.25
3482691-48269187.82288.15
4515750-51575093.83794.19
5456816-45681683.11583.42
6490132-49013289.17689.49
30min1524549-52454995.43893.072.1896.0193.562.21
2502993-50299391.51691.99
3514237-51423793.56294.03
4522802-52280295.12095.63
5496282-49628290.29590.74
6508289-50828992.48092.94
45min1526596-52659695.81195.721.6296.5596.371.62
2525122-52512295.54296.17
3541239-54123998.47599.10
4525217-52521795.56096.23
5515141-51514193.72694.32
6523310-52331095.21395.83
60min1525764-52576495.65996.371.6696.5597.171.65
2529776-52977696.38997.18
3544553-54455399.07899.87
4528964-52896496.24197.07
5517576-51757694.17094.92
6531256-53125696.65897.44
极限1538480-53848097.97398.420.9699.0399.380.96
2543696-54369698.92299.87
3547430-54743099.601100.56
4543462-54346298.87999.87
5532530-53253096.89097.80
6539865-53986598.22599.16
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(%)99.80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%
116.123129603130433127793127123128753128740.05
216.223120993127223124100.15
单位质量响应值RSD%判断
19409.0619260.790.55数据可信
供试品溶液-505806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%
5min1104979-10497930.48022.9419.2930.4822.9419.30
276162-7616222.11322.11
375574-7557421.94321.94
487068-8706825.28025.28
568035-6803519.75419.75
662237-6223718.07018.07
10min1234261-23426168.01752.7614.8468.0752.8014.84
2179081-17908151.99652.03
3168727-16872748.98949.03
4181886-18188652.81052.85
5161300-16130046.83346.87
6164960-16496047.89647.93
15min1291767-29176784.71472.5310.0084.8872.6610.01
2239879-23987969.64869.77
3235491-23549168.37468.49
4267826-26782677.76277.89
5225185-22518565.38265.49
6238735-23873569.31669.43
20min1318084-31808492.35583.157.2392.6683.397.24
2276384-27638480.24780.49
3275824-27582480.08580.32
4304374-30437488.37488.63
5262472-26247276.20876.43
6281072-28107281.60881.83
30min1332461-33246196.52992.163.4696.9992.553.49
2311320-31132090.39190.76
3314933-31493391.44091.81
4327987-32798795.23095.64
5302798-30279887.91688.26
6315064-31506491.47891.84
45min1337401-33740197.96396.661.8798.5897.201.88
2330041-33004195.82696.35
3341457-34145799.14199.66
4334766-33476697.19897.76
5324177-32417794.12494.62
6329578-32957895.69296.21
60min1334908-33490897.23997.291.6798.0297.991.66
2334805-33480597.21097.89
3344507-344507100.026100.71
4334662-33466297.16897.90
5326993-32699394.94195.59
6334656-33465697.16697.84
极限1339570-33957098.59398.991.1199.5499.861.12
2343115-34311599.622100.47
3345858-345858100.419101.27
4343269-34326999.667100.56
5335711-33571197.47398.28
6338151-33815198.18199.02
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(%)99.70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%
111.974715674717144719374725154726904720850.11
211.994703974691994697980.19
单位质量响应值RSD%判断
39439.0139182.490.47数据可信
供试品溶液-506993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%
5min1243674-24367444.49745.8611.4544.5045.8611.44
2263614-26361448.13848.14
3272171-27217149.70149.70
4196317-19631735.84935.85
5270813-27081349.45349.45
6260098-26009847.49647.50
10min1376426-37642668.73974.576.7568.8174.646.75
2402723-40272373.54173.62
3422869-42286977.21977.30
4381319-38131969.63269.69
5416729-41672976.09876.18
6449952-44995282.16582.24
15min1436194-43619479.65385.716.3579.8485.916.35
2466270-46627085.14585.35
3471802-47180286.15586.37
4446950-44695081.61781.79
5472679-47267986.31586.52
6522287-52228795.37495.59
20min1473991-47399186.55590.943.9686.8891.293.96
2490470-49047089.56489.91
3499201-49920191.15891.51
4496364-49636490.64090.95
5494231-49423190.25190.60
6533914-53391497.49797.87
30min1508866-50886692.92395.182.0693.3995.682.06
2513805-51380593.82594.32
3529297-52929796.65497.16
4529383-52938396.67097.13
5512370-51237093.56394.07
6533644-53364497.44897.99
45min1525813-52581396.01897.241.3696.6497.891.35
2528528-52852896.51497.16
3540861-54086198.76699.43
4540009-54000998.61099.23
5524452-52445295.76996.43
6535267-53526797.74498.44
60min1529396-52939696.67297.591.0297.4598.411.01
2531489-53148997.05497.87
3540334-54033498.67099.50
4540887-54088798.77199.56
5528652-52865296.53697.36
6535752-53575297.83398.70
极限1537083-53708398.07698.580.7499.0299.560.73
2537036-53703698.06799.04
3544598-54459899.448100.45
4545133-54513399.546100.50
5539145-53914598.45299.43
6536213-53621397.91798.94
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(%)99.80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%
116.123115483121023122293122033123043120770.10
216.223134043123023128530.25
单位质量响应值RSD%判断
19359.6219288.100.27数据可信
供试品溶液-506993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%
5min181376-8137623.64123.928.9723.6423.928.96
284495-8449524.54724.55
388985-8898525.85125.85
468210-6821019.81619.82
586797-8679725.21525.22
684074-8407424.42424.42
10min1172637-17263750.15354.047.2750.1954.087.28
2185286-18528653.82753.87
3193548-19354856.22856.27
4167914-16791448.78148.81
5193745-19374556.28556.33
6203064-20306458.99259.03
15min1231935-23193567.37973.076.4967.5073.206.49
2249305-24930572.42672.56
3256776-25677674.59674.73
4236738-23673868.77568.89
5257076-25707674.68374.82
6277318-27731880.56480.70
20min1271381-27138178.83984.185.0979.0784.445.09
2285684-28568482.99483.25
3292594-29259485.00185.26
4282034-28203481.93482.16
5291505-29150584.68584.95
6315474-31547491.64891.92
30min1312415-31241590.76094.112.7091.1394.502.70
2318040-31804092.39492.78
3328958-32895895.56695.97
4327135-32713595.03695.40
5320337-32033793.06193.46
6336756-33675697.83198.26
45min1333202-33320296.79898.361.6697.3298.911.66
2334388-33438897.14397.69
3345019-345019100.231100.79
4345023-345023100.233100.76
5333585-33358596.91097.47
6340227-34022798.83999.43
60min1336513-33651397.76098.761.2398.4499.471.22
2337131-33713197.94098.65
3345439-345439100.353101.08
4344707-344707100.141100.83
5336215-33621597.67498.39
6339710-33971098.68999.44
极限1341856-34185699.31399.631.01100.15100.510.99
2341861-34186199.314100.18
3346255-346255100.590101.49
4346551-346551100.676101.53
5343921-34392199.912100.79
6337324-33732497.99698.91
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(%)99.70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%
111.974695254703854706484715014716094707340.19
211.994694004694054694020.01
单位质量响应值RSD%判断
39326.1539149.460.32数据可信
供试品溶液-506993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%
5min1281218-28121851.44848.658.5751.4548.658.57
2273356-27335650.01050.01
3285330-28533052.20052.20
4249803-24980345.70145.70
5227102-22710241.54841.55
6278680-27868050.98450.98
10min1417513-41751376.38377.833.1276.4777.913.12
2420953-42095377.01277.10
3436772-43677279.90679.99
4407423-40742374.53774.61
5426055-42605577.94578.01
6443882-44388281.20781.29
15min1471671-47167186.29188.043.3786.5088.253.37
2473986-47398686.71486.93
3510153-51015393.33193.55
4478765-47876587.58987.79
5464670-46467085.01085.21
6488242-48824289.32289.54
20min1501597-50159791.76692.272.5392.1292.632.53
2499872-49987291.45091.81
3527076-52707696.42796.80
4502409-50240991.91492.26
5488404-48840489.35289.69
6506827-50682792.72293.09
30min1533455-53345597.59497.131.1598.1097.641.15
2528207-52820796.63497.14
3537436-53743698.32298.86
4537534-53753498.34098.84
5523765-52376595.82196.31
6525121-52512196.06996.59
45min1541518-54151899.06998.551.1199.7499.221.10
2535711-53571198.00798.68
3539293-53929398.66299.36
4546941-546941100.061100.72
5539524-53952498.70499.35
6529106-52910696.79897.48
60min1541923-54192399.14398.551.1099.9899.391.09
2534812-53481297.84298.68
3539062-53906298.62099.48
4546198-54619899.925100.76
5540861-54086198.94999.76
6529380-52938096.84897.69
极限1541868-54186899.13398.311.17100.1499.311.16
2534287-53428797.74698.74
3538034-53803498.43299.46
4545109-54510999.726100.72
5537917-53791798.41099.39
6527027-52702796.41897.42
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(%)99.80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%
116.123122413125083126783133763134793128560.18
216.223124123129093126600.12
单位质量响应值RSD%判断
19407.9419276.200.49数据可信
供试品溶液-506993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%
5min191026-9102626.41924.608.2226.4224.618.22
288681-8868125.73925.74
388429-8842925.66625.67
479455-7945523.06123.06
573102-7310221.21721.22
687946-8794625.52525.53
10min1189934-18993455.12655.013.2855.1755.053.28
2190139-19013955.18655.23
3195762-19576256.81856.86
4179134-17913451.99252.03
5186617-18661754.16354.20
6195569-19556956.76256.80
15min1251821-25182173.08873.742.8773.2273.872.87
2250346-25034672.66072.79
3266105-26610577.23477.37
4248908-24890872.24372.37
5247498-24749871.83371.96
6259691-25969175.37275.51
20min1289044-28904483.89284.472.7184.1584.732.71
2286900-28690083.26983.53
3304904-30490488.49588.76
4287730-28773083.51083.76
5282724-28272482.05782.30
6295000-29500085.62085.88
30min1328742-32874295.41494.891.5495.8195.281.55
2323830-32383093.98894.38
3335489-33548997.37297.79
4327617-32761795.08795.47
5320958-32095893.15493.54
6324923-32492394.30594.71
45min1344581-344581100.01199.391.05100.5799.951.04
2340471-34047198.81899.37
3343463-34346399.686100.26
4346736-346736100.636101.18
5342996-34299699.551100.09
6336486-33648697.66198.22
60min1345179-345179100.18499.491.08100.91100.211.07
2340759-34075998.90199.62
3343010-34301099.555100.30
4346888-346888100.680101.39
5344320-34432099.935100.64
6336512-33651297.66998.39
极限1344002-34400299.84398.971.39100.7399.861.37
2339321-33932198.48499.36
3341548-34154899.130100.04
4345775-345775100.357101.24
5342829-34282999.502100.37
6332485-33248596.50097.39
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