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%
113.079571895790957959573495781957640.04
212.839633496276963050.05
单位质量响应值RSD%判断
7327.017506.241.71数据可信
供试品溶液-GA4705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%
5min118782-1878220.20221.687.7420.2021.677.74
221751-2175123.39523.39
318939-1893920.37020.37
420121-2012121.64221.64
522352-2235224.04124.04
618967-1896720.40120.40
10min171059-7105976.43073.865.2976.5373.965.29
266929-6692971.98772.10
365202-6520270.13070.23
470997-7099776.36376.47
573367-7336778.91279.03
664461-6446169.33369.43
15min181989-8198988.18691.192.4788.6791.672.47
285521-8552191.98592.46
385380-8538091.83392.29
487464-8746494.07494.56
585791-8579192.27592.79
682563-8256388.80389.25
20min184050-8405090.40292.841.8691.3393.781.85
286609-8660993.15594.09
386916-8691693.48594.40
488869-8886995.58696.55
585532-8553291.99692.97
685934-8593492.42993.32
30min183616-8361689.93693.892.5491.3195.292.51
288353-8835395.03196.43
388780-8878095.49096.87
489054-8905495.78597.22
585499-8549991.96193.40
688474-8847495.16196.52
45min185066-8506691.49594.171.9993.3296.041.96
287665-8766594.29196.17
389503-8950396.26898.12
488787-8878795.49797.41
585871-8587192.36194.26
688452-8845295.13796.97
60min185756-8575692.23794.591.7294.5296.931.70
288865-8886595.58197.93
389801-8980196.58898.93
488750-8875095.45897.85
586689-8668993.24195.60
687788-8778894.42396.73
极限185930-8593092.42595.482.1295.1798.302.10
290657-9065797.509100.34
389268-8926896.01598.84
490801-9080197.664100.54
588413-8841395.09597.92
687561-8756194.17996.96
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%
115.222631722633202630942634642633852632870.06
215.102642052644062643060.06
单位质量响应值RSD%判断
17298.7517503.710.84数据可信
供试品溶液-GA4705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%
5min124839-248399.51710.226.899.5210.236.89
228881-2888111.06511.07
324997-249979.5779.58
427297-2729710.45810.46
528652-2865210.97710.98
625436-254369.7459.75
10min1103802-10380239.76938.455.4839.8238.505.48
297364-9736437.30337.36
394902-9490236.36036.41
4102073-10207339.10739.16
5108774-10877441.67441.73
695200-9520036.47436.52
15min1143573-14357355.00756.072.9455.2556.312.95
2145424-14542455.71655.96
3145929-14592955.90956.14
4150011-15001157.47357.72
5152468-15246858.41558.68
6140618-14061853.87554.11
20min1166881-16688163.93764.811.7064.4665.341.71
2167694-16769464.24864.77
3169288-16928864.85965.37
4172714-17271466.17266.71
5172452-17245266.07166.63
6165945-16594563.57864.08
30min1190005-19000572.79674.751.3673.6475.601.35
2195662-19566274.96475.81
3196611-19661175.32776.16
4197620-19762075.71476.58
5195286-19528674.82075.71
6195399-19539974.86375.68
45min1210826-21082680.77382.010.9581.9883.230.94
2212692-21269281.48882.70
3216299-21629982.87084.08
4215602-21560282.60383.85
5214032-21403282.00283.26
6214805-21480582.29883.49
60min1222100-22210085.09385.940.6886.7087.570.69
2224574-22457486.04187.66
3226152-22615286.64588.27
4224500-22450086.01287.67
5225503-22550386.39788.07
6223023-22302385.44687.05
极限1227229-22722987.05888.831.2589.0990.901.24
2234111-23411189.69491.75
3232557-23255789.09991.16
4232947-23294789.24991.34
5234719-23471989.92792.03
6229617-22961787.97390.00
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%
113.079614696336962249633996137962360.11
212.839638496451964180.05
单位质量响应值RSD%判断
7363.127515.041.45数据可信
供试品溶液-GA4705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%
5min125665-2566527.52024.0512.0727.5224.0512.07
225538-2553827.38427.38
320965-2096522.48022.48
422371-2237123.98823.99
518866-1886620.23020.23
621152-2115222.68122.68
10min169720-6972074.76076.382.9674.9076.502.96
272243-7224377.46577.60
374063-7406379.41779.53
469808-6980874.85474.97
572820-7282078.08478.19
668712-6871273.67973.79
15min180718-8071886.55391.613.3787.0692.113.35
286120-8612092.34592.87
387534-8753493.86294.37
483907-8390789.97290.47
585458-8545891.63692.13
688877-8887795.30295.78
20min184147-8414790.23092.161.4091.1793.121.39
285995-8599592.21193.20
386789-8678993.06394.04
486937-8693793.22194.17
586967-8696793.25494.20
684840-8484090.97391.93
30min182955-8295588.95292.082.0690.3593.502.05
286214-8621492.44693.89
387790-8779094.13695.58
486577-8657792.83594.25
587041-8704193.33394.75
684670-8467090.79192.20
45min183225-8322589.24192.432.0991.0894.312.07
285719-8571991.91593.82
387818-8781894.16696.08
487613-8761393.94695.82
587502-8750293.82795.71
685299-8529991.46593.33
60min183174-8317489.18692.181.9091.4794.521.88
285842-8584292.04794.42
387595-8759593.92796.31
486206-8620692.43894.78
587523-8752393.85096.20
685448-8544891.62593.95
极限185052-8505291.20093.601.9293.9396.401.91
286573-8657392.83195.66
389337-8933795.79598.65
488179-8817994.55397.36
588626-8862695.03397.85
685977-8597792.19294.97
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%
115.222644592641152642702645362644282643620.07
215.102648122647512647820.02
单位质量响应值RSD%判断
17369.3817535.230.68数据可信
供试品溶液-GA4705批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133259-3325912.70511.2510.8412.7111.2510.85
233272-3327212.71012.71
327355-2735510.45010.45
429444-2944411.24811.25
525704-257049.8199.82
627628-2762810.55410.55
10min1105677-10567740.36940.462.3240.4340.522.31
2109285-10928541.74741.81
3107536-10753641.07941.13
4104370-10437039.87039.93
5106369-10636940.63340.68
6102265-10226539.06539.12
15min1143174-14317454.69357.593.1754.9657.853.16
2154158-15415858.88959.16
3152587-15258758.28958.55
4148298-14829856.65056.91
5149721-14972157.19457.45
6156643-15664359.83860.09
20min1168903-16890364.52165.761.4765.0666.311.47
2175056-17505666.87267.44
3171977-17197765.69666.24
4174123-17412366.51567.05
5173395-17339566.23766.78
6169421-16942164.71965.27
30min1188563-18856372.03174.712.0772.8975.582.06
2199116-19911676.06376.96
3198683-19868375.89776.77
4196792-19679275.17576.05
5197201-19720175.33176.20
6193064-19306473.75174.62
45min1206770-20677078.98781.911.8680.2183.161.84
2216330-21633082.63983.92
3215676-21567682.38983.65
4217835-21783583.21384.46
5216128-21612882.56183.81
6213735-21373581.64782.89
60min1216077-21607782.54285.692.4584.1687.352.42
2225593-22559386.17787.87
3232838-23283888.94590.61
4222858-22285885.13286.80
5226046-22604686.35088.01
6222499-22249984.99586.64
极限1225184-22518486.02188.251.4388.0590.341.43
2231792-23179288.54590.67
3233781-23378189.30591.42
4233377-23337789.15091.24
5232825-23282588.94091.03
6229212-22921287.55989.63
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%
113.079634596155963389649496318963300.13
212.839659896502965500.08
单位质量响应值RSD%判断
7370.317525.331.48数据可信
供试品溶液-FA4456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%
5min134060-3406036.47930.2412.7036.4830.2412.70
224799-2479926.56126.56
325847-2584727.68327.68
428958-2895831.01531.01
525417-2541727.22227.22
630320-3032032.47432.47
10min178386-7838683.95485.222.9284.1485.372.92
280273-8027385.97586.11
378345-7834583.91084.05
481731-8173187.53787.69
576273-7627381.69181.83
682381-8238188.23388.40
15min182239-8223988.08192.762.8888.6893.342.87
286498-8649892.64293.20
386588-8658892.73993.30
489120-8912095.45096.04
586241-8624192.36792.91
688966-8896695.28695.89
20min184874-8487490.90394.482.2591.9595.522.24
287586-8758693.80794.83
387887-8788794.13095.15
490220-9022096.62997.70
588513-8851394.80095.81
690189-9018996.59597.68
30min184115-8411590.09095.323.0091.5996.842.96
288446-8844694.72996.22
389499-8949995.85697.35
490056-9005696.45398.01
592034-9203498.571100.05
689865-8986596.24897.81
45min184743-8474390.76395.502.6692.7197.492.63
288561-8856194.85296.82
389411-8941195.76297.73
490441-9044196.86598.90
591225-9122597.70599.68
690623-9062397.06099.10
60min184007-8400789.97495.233.0092.3897.702.96
290402-9040296.82499.27
387731-8773193.96396.41
489739-8973996.11398.63
591035-9103597.50199.96
690556-9055696.98899.52
极限188957-8895795.27696.340.9198.1399.280.91
290162-9016296.56699.49
389978-8997896.36999.29
491186-9118697.663100.66
590279-9027996.69299.64
689136-8913695.46898.48
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%
115.222646112645082644862647692644102645570.06
215.102645722644772645240.03
单位质量响应值RSD%判断
17382.1917518.150.56数据可信
供试品溶液-FA4456批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139583-3958315.12312.6413.4215.1212.6413.41
228193-2819310.77110.77
330443-3044311.63111.63
434183-3418313.05913.06
529568-2956811.29611.30
636504-3650413.94613.95
10min1108158-10815841.32140.673.3941.4040.733.40
2105050-10505040.13440.19
3104358-10435839.87039.93
4109479-10947941.82641.89
5101035-10103538.60038.66
6110595-11059542.25242.32
15min1137021-13702152.34853.552.0152.6353.812.01
2138803-13880353.02953.28
3139750-13975053.39153.65
4143852-14385254.95855.23
5138214-13821452.80453.05
6143336-14333654.76155.04
20min1165406-16540663.19361.801.9063.7462.341.91
2157997-15799760.36260.88
3159794-15979461.04961.57
4164331-16433162.78263.33
5159444-15944460.91561.43
6163621-16362162.51163.07
30min1177880-17788067.95870.382.0168.8271.231.99
2181893-18189369.49170.31
3185262-18526270.77971.61
4186689-18668971.32472.19
5187852-18785271.76872.59
6185799-18579970.98471.85
45min1196871-19687175.21477.521.9576.4178.711.94
2199123-19912376.07477.24
3203842-20384277.87779.06
4205446-20544678.49079.71
5205967-20596778.68979.87
6206184-20618478.77279.99
60min1204076-20407677.96681.512.3479.5483.092.31
2213572-21357281.59483.14
3212418-21241881.15382.73
4214990-21499082.13683.75
5217470-21747083.08484.65
6217589-21758983.12984.75
极限1221154-22115484.49185.201.1086.4687.191.09
2219431-21943183.83385.79
3225726-22572686.23888.22
4224742-22474285.86287.88
5224677-22467785.83787.82
6222338-22233884.94386.98
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%
113.079679296625965089648496546965910.13
212.839628296347963140.05
单位质量响应值RSD%判断
7390.287506.941.11数据可信
供试品溶液-FA4456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%
5min127627-2762729.58530.1313.9729.5830.1313.97
233012-3301235.35235.35
325586-2558627.39927.40
428238-2823830.23930.24
531896-3189634.15634.16
622436-2243624.02624.03
10min172682-7268277.83384.284.1077.9884.444.11
280963-8096386.70186.88
378325-7832583.87684.01
479011-7901184.61084.76
581855-8185587.65687.83
679401-7940185.02885.15
15min181864-8186487.66692.193.4488.2092.763.45
290122-9012296.50997.12
384080-8408090.03990.60
486846-8684693.00193.57
588212-8821294.46495.07
685430-8543091.48492.03
20min183186-8318689.08195.516.2990.0696.546.27
291422-9142297.90198.99
385014-8501491.03992.05
489920-8992096.29397.33
598807-98807105.809106.89
686778-8677892.92893.93
30min184535-8453590.52694.712.9791.9596.223.00
291473-9147397.95699.54
387687-8768793.90195.36
490110-9011096.49698.02
590262-9026296.65998.27
686604-8660492.74294.21
45min185296-8529691.34195.342.5193.2197.322.54
291837-9183798.345100.42
388739-8873995.02896.96
490454-9045496.86498.87
589592-8959295.94198.04
688254-8825494.50996.44
60min185149-8514991.18395.623.5593.5198.083.55
294677-94677101.387103.95
388617-8861794.89797.30
489253-8925395.57898.07
590309-9030996.70999.28
687722-8772293.93996.34
极限184378-8437890.35895.063.1193.1498.003.12
291548-9154898.036101.11
386378-8637892.50095.38
490200-9020096.59299.56
590071-9007196.45499.51
690027-9002796.40799.28
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%
115.222652342653112651322651232651902651980.03
215.102643962643782643870.01
单位质量响应值RSD%判断
17424.3117509.070.35数据可信
供试品溶液-FA4456批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131199-3119911.90812.5113.3311.9112.5113.33
238471-3847114.68414.68
330983-3098311.82611.83
433098-3309812.63312.63
536607-3660713.97213.97
626261-2626110.02310.02
10min196582-9658236.86440.084.8836.9240.144.88
2108732-10873241.50141.57
3104754-10475439.98340.04
4104449-10444939.86639.93
5111658-11165842.61842.69
6103858-10385839.64139.69
15min1130302-13030249.73452.773.7149.9853.033.72
2144048-14404854.98055.26
3136567-13656752.12552.38
4138618-13861852.90853.17
5143549-14354954.79055.07
6136426-13642652.07152.32
20min1149243-14924356.96360.965.1457.4661.495.14
2165638-16563863.22163.78
3154751-15475159.06659.59
4160089-16008961.10361.63
5172199-17219965.72566.28
6156334-15633459.67060.18
30min1173223-17322366.11669.152.9366.8969.982.96
2187108-18710871.41672.29
3179171-17917168.38669.20
4181836-18183669.40370.24
5186841-18684171.31472.20
6178785-17878568.23969.05
45min1192350-19235073.41676.652.4974.5277.832.52
2207457-20745779.18280.41
3200080-20008076.36777.52
4201367-20136776.85878.04
5203604-20360477.71278.95
6200082-20008276.36877.52
60min1202995-20299577.47980.993.4378.9582.543.43
2224319-22431985.61887.24
3211593-21159380.76182.30
4208969-20896979.76081.32
5215897-21589782.40484.03
6209347-20934779.90481.43
极限1208625-20862579.62883.242.6081.4985.202.61
2222939-22293985.09287.14
3214323-21432381.80383.75
4218264-21826483.30785.27
5222197-22219784.80886.85
6222122-22212284.78086.71
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