厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.609293992906926869296592993928980.14
2 12.679229892464923810.13
单位质量响应值RSD%判断
7372.867291.320.79数据可信
供试品溶液-HA0117批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130659-3065933.35334.3814.4533.3534.3814.46
232206-3220635.03535.04
336179-3617939.35739.36
423077-2307725.10425.10
533617-3361736.57036.57
633912-3391236.89136.89
10min171903-7190378.22078.983.4178.3979.163.43
272080-7208078.41378.59
376632-7663283.36483.56
469009-6900975.07275.20
573424-7342479.87580.06
672589-7258978.96679.15
15min179887-7988786.90587.120.5087.4687.680.51
279585-7958586.57787.14
380458-8045887.52788.14
480171-8017187.21487.72
579782-7978286.79187.37
680598-8059887.67988.26
20min183053-8305390.35090.891.3291.3491.891.32
285198-8519892.68393.68
382904-8290490.18891.24
482426-8242689.66890.60
583063-8306390.36091.38
684643-8464392.07993.10
30min182609-8260989.86792.232.8891.3193.692.83
288993-8899396.81198.28
385278-8527892.77094.27
485591-8559193.11194.50
583720-8372091.07592.54
682503-8250389.75191.23
45min185167-8516792.64977.7946.5394.5479.7145.38
286102-8610293.66695.61
33647-36473.9675.93
486371-8637193.95995.81
584701-8470192.14294.07
683085-8308590.38492.31
60min186397-8639793.98793.340.9496.3495.651.04
286273-8627393.85296.27
384923-8492392.38494.37
484641-8464192.07794.40
586474-8647494.07196.46
686096-8609693.66096.04
极限186134-8613493.70194.611.7696.5397.391.73
289647-8964797.523100.41
387201-8720194.86297.31
486638-8663894.25097.03
585061-8506192.53495.39
687154-8715494.81197.66
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.682584002580152577632583102583852581750.11
214.772580722580742580730.01
单位质量响应值RSD%判断
17586.8517472.780.47数据可信
供试品溶液-HA0117批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13500-35001.3311.4412.111.331.4412.27
23812-38121.4501.45
34257-42571.6191.62
43007-30071.1441.14
54119-41191.5661.57
63944-39441.5001.50
10min18403-84033.1963.4410.293.203.4410.31
29248-92483.5173.52
310730-107304.0814.09
48064-80643.0673.07
58869-88693.3733.38
68883-88833.3783.39
15min110891-108914.1424.161.754.164.191.79
210993-109934.1814.21
311175-111754.2504.28
410609-106094.0354.06
511053-110534.2044.23
610933-109334.1584.18
20min112250-122504.6594.741.854.704.781.93
212700-127004.8304.88
312534-125344.7674.82
412104-121044.6034.64
512584-125844.7864.83
612573-125734.7824.83
30min113686-136865.2055.392.995.275.463.02
214800-148005.6295.70
314536-145365.5285.60
413938-139385.3015.36
514153-141535.3835.45
613898-138985.2865.35
45min115437-154375.87110.36103.895.9610.46102.93
216227-162276.1716.27
384991-8499132.32332.42
415740-157405.9866.08
515668-156685.9596.06
615363-153635.8435.94
60min116516-165166.2816.341.216.406.491.47
216941-169416.4436.57
316673-166736.3416.60
416394-163946.2356.36
516829-168296.4006.53
616734-167346.3646.49
极限116774-167746.3796.483.076.536.663.31
217323-173236.5886.75
317230-172306.5536.85
416308-163086.2026.35
516808-168086.3926.55
617803-178036.7716.93
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.609253292430922809253092534924610.12
2 12.679215691974920650.14
单位质量响应值RSD%判断
7338.177266.380.70数据可信
供试品溶液-3批-氢氯噻嗪-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%
5min156725-5672561.96044.6522.6261.9644.6522.62
236563-3656339.93739.94
337183-3718340.61540.61
447329-4732951.69751.70
533837-3383736.96036.96
633623-3362336.72636.73
10min183051-8305190.71690.151.4691.0390.371.46
284445-8444592.23892.44
382940-8294090.59490.80
481324-8132488.82989.09
581327-8132788.83389.02
682091-8209189.66789.85
15min188630-8863096.81094.562.1297.5795.232.13
288451-8845196.61497.27
387437-8743795.50696.16
484392-8439292.18092.88
585101-8510192.95593.58
685413-8541393.29693.93
20min189256-8925697.49395.481.9098.7496.631.90
289541-8954197.80598.95
385723-8572393.63494.77
485968-8596893.90295.07
587453-8745395.52496.62
686532-8653294.51895.62
30min189742-8974298.02494.932.3099.7696.562.30
285568-8556893.46595.10
388422-8842296.58298.18
484702-8470292.51994.15
587675-8767595.76697.34
685364-8536493.24294.81
45min186238-8623894.19793.791.1696.4295.891.15
285718-8571893.62995.73
386927-8692794.94997.03
485164-8516493.02495.12
586799-8679994.81096.86
684356-8435692.14194.18
60min187799-8779995.90293.632.1698.6096.202.13
283713-8371391.43994.01
384207-8420791.97894.54
485445-8544593.33195.89
588149-8814996.28498.81
685015-8501592.86195.36
极限185936-8593693.86792.801.0397.0495.831.03
284920-8492092.75795.78
385725-8572593.63696.66
484568-8456892.37395.40
583527-8352791.23694.24
685067-8506792.91895.88
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.682581292579392578662580322582382580410.06
214.772573952569872571910.12
单位质量响应值RSD%判断
17577.7217413.070.67数据可信
供试品溶液-3批-厄贝沙坦-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%
5min160331-6033122.99017.0021.7322.9917.0021.73
243637-4363716.62816.63
339277-3927714.96714.97
451513-5151319.63019.63
534056-3405612.97712.98
638786-3878614.78014.78
10min1129721-12972149.43245.056.1749.5545.146.20
2122421-12242146.65046.73
3117494-11749444.77244.85
4118022-11802244.97445.07
5109033-10903341.54841.61
6112683-11268342.93943.01
15min1161354-16135461.48658.784.0761.8559.094.09
2160108-16010861.01161.33
3155702-15570259.33259.63
4151073-15107357.56857.89
5144383-14438355.01955.29
6152912-15291258.26958.56
20min1183070-18307069.76167.283.1870.4367.883.20
2183772-18377270.02870.65
3173520-17352066.12266.72
4173519-17351966.12166.73
5170037-17003764.79465.34
6175373-17537366.82867.41
30min1209094-20909479.67876.422.6880.7077.362.69
2199597-19959776.05977.03
3204783-20478378.03578.96
4194801-19480174.23175.17
5197072-19707275.09675.97
6197919-19791975.41976.33
45min1220144-22014483.88883.011.3285.3184.341.34
2219530-21953083.65485.01
3221292-22129284.32685.64
4215747-21574782.21383.53
5216208-21620882.38883.64
6214111-21411181.58982.88
60min1235535-23553589.75388.941.6891.5990.681.65
2231948-23194888.38690.16
3232862-23286288.73590.47
4234902-23490289.51291.24
5238299-23829990.80692.47
6226819-22681986.43288.13
极限1237337-23733790.44089.591.1292.7291.771.14
2235685-23568589.81092.02
3238102-23810290.73192.91
4235130-23513089.59991.77
5230918-23091887.99490.11
6233506-23350688.98091.11
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.609215291966920189217391944920510.12
2 12.679227092278922740.01
单位质量响应值RSD%判断
7305.637282.870.23数据可信
供试品溶液-HA0117批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122498-2249824.60127.6013.6324.6027.6013.63
222069-2206924.13224.13
328258-2825830.89930.90
422395-2239524.48824.49
530099-3009932.91232.91
626104-2610428.54428.54
10min176274-7627483.40382.901.4083.5383.041.39
275761-7576182.84282.96
375548-7554882.60982.76
475965-7596583.06583.19
574055-7405580.97781.14
677293-7729384.51784.66
15min182299-8229989.99190.482.2890.5391.032.27
284200-8420092.07092.60
380690-8069088.23288.80
481026-8102688.59989.14
582636-8263690.36090.93
685622-8562293.62594.19
20min184261-8426192.13793.002.8793.1394.002.84
289073-8907397.39898.39
383332-8333291.12192.13
483196-8319690.97291.95
583422-8342291.21992.24
686999-8699995.13096.16
30min186558-8655894.64894.402.3596.1095.872.33
288776-8877697.07498.56
384691-8469192.60794.07
485182-8518293.14494.58
584093-8409391.95393.43
688669-8866996.95798.47
45min187229-8722995.38294.282.1597.3196.222.13
287740-8774095.94197.91
383575-8357591.38693.31
485148-8514893.10695.01
585241-8524193.20895.15
688383-8838396.64498.64
60min186078-8607894.12394.242.0696.5296.662.04
287384-8738495.55198.00
384499-8449992.39794.78
486780-8678094.89197.26
583841-8384191.67794.08
688547-8854796.82399.30
极限186798-8679894.91194.852.0397.7897.732.01
289662-8966298.042100.97
384300-8430092.17995.03
485937-8593793.96996.81
586495-8649594.57997.44
687239-8723995.39398.35
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.682573742570462572472572242571592572100.05
214.772579102579122579110.01
单位质量响应值RSD%判断
17521.1217461.810.24数据可信
供试品溶液-HA0117批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164623-6462324.63027.7213.6424.6327.7213.64
262860-6286023.95823.96
381873-8187331.20531.21
465349-6534924.90724.91
586287-8628732.88732.89
675308-7530828.70328.70
10min1217349-21734982.84082.500.9982.9682.640.98
2215273-21527382.04982.17
3216187-21618782.39782.55
4218204-21820483.16683.29
5212982-21298281.17681.34
6218756-21875683.37783.52
15min1240071-24007191.50192.221.7692.0492.771.75
2244415-24441593.15693.69
3237185-23718590.40190.97
4238165-23816590.77491.31
5243554-24355492.82893.40
6248359-24835994.65995.22
20min1247691-24769194.40595.312.2995.4096.322.26
2260033-26003399.109100.10
3245651-24565193.62794.65
4245441-24544193.54794.54
5247989-24798994.51895.55
6253593-25359396.65497.69
30min1253027-25302796.43996.201.5697.9197.701.54
2257476-25747698.13499.63
3248353-24835394.65796.15
4249581-24958195.12596.59
5249446-24944695.07496.58
6256575-25657597.79199.31
45min1252683-25268396.30795.431.7298.2697.401.70
2253253-25325396.52598.51
3243357-24335792.75394.71
4247371-24737194.28396.22
5250731-25073195.56397.55
6254846-25484697.13299.14
60min1248780-24878094.82095.191.4497.2597.641.42
2251836-25183695.98598.45
3245132-24513293.42995.85
4251510-25151095.86098.27
5246577-24657793.98096.44
6254716-25471697.08299.57
极限1249547-24954795.11295.211.8498.0298.141.81
2257224-25722498.038100.98
3243241-24324192.70995.60
4247794-24779494.44497.33
5249615-24961595.13898.07
6251427-25142795.82998.81
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.609225192070921779217792122921590.08
2 12.679192991944919360.02
单位质量响应值RSD%判断
7314.217256.200.57数据可信
供试品溶液-HA0117批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121653-2165323.70725.069.0723.7125.069.06
223410-2341025.63025.63
319243-1924321.06821.07
424646-2464626.98326.98
524141-2414126.43126.43
624222-2422226.51926.52
10min175239-7523982.37580.721.3482.4980.851.34
273661-7366180.64780.78
372426-7242679.29579.40
474343-7434381.39481.53
573059-7305979.98880.12
673661-7366180.64780.78
15min183193-8319391.08390.580.8491.6191.110.83
281867-8186789.63190.16
383187-8318791.07691.58
482263-8226390.06590.61
582274-8227490.07790.61
683612-8361291.54292.08
20min182986-8298690.85691.201.7591.8492.181.73
282536-8253690.36491.34
383922-8392291.88192.84
481080-8108088.77089.76
583906-8390691.86492.85
685349-8534993.44394.44
30min185585-8558593.70293.390.8795.1494.820.86
283956-8395691.91893.35
385465-8546593.57094.99
485922-8592294.07195.51
585002-8500293.06494.51
685848-8584893.99095.45
45min185640-8564093.76293.701.1195.6795.601.10
285894-8589494.04095.93
385534-8553493.64695.53
484699-8469992.73294.64
584555-8455592.57494.48
687183-8718395.45197.38
60min187044-8704495.29993.551.2197.6895.921.18
285309-8530993.40095.76
386310-8631094.49696.85
484570-8457092.59194.96
584443-8444392.45294.82
684986-8498693.04695.45
极限188431-8843196.81894.411.5299.6797.251.48
284419-8441992.42595.25
385989-8598994.14496.97
485972-8597294.12696.96
586640-8664094.85797.69
685957-8595794.10996.98
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.682575332574562575262576062576302575500.03
214.772570932569612570270.04
单位质量响应值RSD%判断
17544.2817401.960.58数据可信
供试品溶液-HA0117批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162258-6225823.75425.088.7023.7525.088.70
267325-6732525.68725.69
355777-5577721.28121.28
470975-7097527.08027.08
568715-6871526.21826.22
669352-6935226.46126.46
10min1216097-21609782.45180.271.8382.5780.401.83
2210513-21051380.32080.45
3206791-20679178.90079.01
4213314-21331481.38981.52
5206056-20605678.62078.75
6209571-20957179.96180.09
15min1244040-24404093.11291.941.1593.6492.471.14
2238146-23814690.86391.39
3241668-24166892.20792.71
4241880-24188092.28892.83
5237082-23708290.45790.98
6243009-24300992.71993.25
20min1244258-24425893.19593.281.3694.1994.261.35
2242352-24235292.46893.45
3246225-24622593.94694.91
4240161-24016191.63292.64
5244018-24401893.10494.08
6249839-24983995.32596.32
30min1249499-24949995.19595.090.9696.6696.540.95
2245895-24589593.82095.27
3249514-24951495.20196.63
4252713-25271396.42197.88
5247340-24734094.37195.81
6250333-25033395.51396.99
45min1248264-24826494.72494.941.0496.6696.861.03
2249697-24969795.27197.19
3248914-24891494.97296.88
4247311-24731194.36096.30
5245549-24554993.68895.60
6253181-25318196.60098.55
60min1251238-25123895.85994.431.0398.2796.841.00
2247110-24711094.28496.68
3249892-24989295.34597.73
4246263-24626393.96096.38
5244767-24476793.39095.77
6245762-24576293.76996.20
极限1253002-25300296.53294.601.3199.4297.481.27
2243434-24343492.88195.74
3247749-24774994.52797.39
4247140-24714094.29597.18
5249794-24979495.30898.16
6246545-24654594.06896.97
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