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100309-202205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%
112.204789684787854788014787234784464787450.04
212.164775374776004775680.01
单位质量响应值RSD%判断
39241.3939273.680.06数据可信
供试品溶液-519819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%
5min1130787-13078723.91525.335.2523.9125.335.26
2138618-13861825.34725.35
3151274-15127427.66127.66
4140147-14014725.62625.63
5132285-13228524.18924.19
6137912-13791225.21825.22
10min1319194-31919458.36655.044.4358.4155.084.42
2305091-30509155.78755.83
3283625-28362551.86251.91
4296173-29617354.15654.20
5311279-31127956.91956.96
6290600-29060053.13753.18
15min1397175-39717572.62568.504.7372.7668.644.73
2381989-38198969.84869.98
3357338-35733865.34165.47
4369953-36995367.64767.78
5388773-38877371.08971.22
6352589-35258964.47264.60
20min1443319-44331981.06377.484.0981.3277.724.09
2431098-43109878.82879.08
3427485-42748578.16778.41
4413799-41379975.66575.91
5432358-43235879.05879.31
6394169-39416972.07572.31
30min1487901-48790189.21585.883.6489.6186.263.64
2479102-47910287.60687.99
3483877-48387788.47988.85
4459733-45973384.06484.44
5464370-46437084.91285.30
6443024-44302481.00981.37
45min1507000-50700092.70789.972.8293.2590.502.81
2496443-49644390.77791.31
3506750-50675092.66193.18
4481149-48114987.98088.49
5487937-48793789.22189.75
6473041-47304186.49786.99
60min1512521-51252193.71791.452.5394.4192.122.53
2500890-50089091.59092.27
3515620-51562094.28394.96
4488825-48882589.38490.04
5499379-49937991.31391.99
6483502-48350288.41089.05
极限1538833-53883398.52896.521.3799.3897.341.37
2526459-52645996.26597.10
3531563-53156397.19898.03
4529786-52978696.87497.68
5521528-52152895.36496.19
6518977-51897794.89795.68
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351550891548171547871549321549161549080.08
216.311546231545581545900.03
单位质量响应值RSD%判断
9474.509478.230.03数据可信
供试品溶液-519819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%
5min123065-2306513.66414.966.1613.6614.966.18
224734-2473414.65214.65
327576-2757616.33616.34
425808-2580815.28915.29
524351-2435114.42514.43
625971-2597115.38515.39
10min172890-7289043.18041.582.8643.2041.602.85
271209-7120942.18442.21
368285-6828540.45240.48
468812-6881240.76440.79
571721-7172142.48742.51
668219-6821940.41340.44
15min1108000-10800063.97960.484.3564.0760.574.34
2105001-10500162.20262.30
397856-9785657.96958.06
499975-9997559.22559.32
5104675-10467562.00962.10
697011-9701157.46957.56
20min1131930-13193078.15573.614.1978.3673.804.19
2125798-12579874.52274.72
3123546-12354673.18873.38
4122101-12210172.33272.52
5126026-12602674.65774.86
6116135-11613568.79868.99
30min1155341-15534192.02386.994.3592.3587.314.34
2150290-15029089.03189.35
3150516-15051689.16589.48
4142558-14255884.45184.76
5144591-14459185.65585.98
6137768-13776881.61381.92
45min1164090-16409097.20692.703.6297.6993.163.61
2157544-15754493.32893.80
3161848-16184895.87896.34
4151904-15190489.98790.44
5153470-15347090.91591.38
6150001-15000188.86089.30
60min1165711-16571198.16693.793.2298.8194.403.22
2158260-15826093.75294.38
3163113-16311396.62797.25
4153325-15332590.82991.43
5155724-15572492.25092.87
6153795-15379591.10791.69
极限1170056-170056100.74098.161.59101.5598.931.60
2165638-16563898.12398.91
3166811-16681198.81899.60
4165305-16530597.92698.68
5162275-16227596.13196.90
6164117-16411797.22297.96
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100309-202205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%
112.204773154769914769204773634771124771400.05
212.164754414756464755440.04
单位质量响应值RSD%判断
39109.8439107.240.01数据可信
供试品溶液-519819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%
5min1224571-22457141.22036.3411.8341.2236.3411.82
2177205-17720532.52632.53
3197772-19777236.30136.30
4226161-22616141.51241.51
5191794-19179435.20435.20
6170288-17028831.25631.26
10min1352314-35231464.66765.907.5064.7465.977.50
2347933-34793363.86363.92
3378901-37890169.54869.61
4398787-39878773.19873.27
5355587-35558765.26865.33
6320790-32079058.88158.93
15min1419118-41911876.92978.626.8977.1178.796.89
2409766-40976675.21375.37
3467684-46768485.84486.02
4458428-45842884.14584.34
5424623-42462377.94078.11
6390309-39030971.64171.79
20min1466661-46666185.65686.145.8385.9686.445.83
2447908-44790882.21482.50
3511739-51173993.93094.25
4490881-49088190.10290.43
5459428-45942884.32884.63
6439164-43916480.60980.88
30min1506946-50694693.05093.621.8993.5094.061.91
2509174-50917493.45993.88
3518595-51859595.18895.66
4523660-52366096.11896.60
5504656-50465692.63093.07
6497227-49722791.26691.67
45min1519058-51905895.27396.531.0695.8897.131.04
2533146-53314697.85998.44
3519839-51983995.41796.05
4529782-52978297.24297.88
5526425-52642596.62697.22
6527123-52712396.75497.31
60min1519457-51945795.34796.771.3596.1197.541.33
2537383-53738398.63799.38
3518753-51875395.21796.01
4530422-53042297.35998.16
5527458-52745896.81597.57
6529890-52989097.26297.98
极限1518659-51865995.20097.061.6096.1297.981.59
2539543-53954399.03499.94
3520789-52078995.59196.54
4537289-53728998.62099.59
5527531-52753196.82997.74
6528963-52896397.09297.97
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351545071544121543981545791545721544940.06
216.311539641540201539920.03
单位质量响应值RSD%判断
9449.179441.570.06数据可信
供试品溶液-519819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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min12149-21491.2771.3114.331.281.3114.45
22039-20391.2121.21
31914-19141.1381.14
42752-27521.6361.64
52405-24051.4291.43
61990-19901.1831.18
20min13416-34162.0301.9512.692.031.9512.57
22766-27661.6441.65
33781-37812.2472.25
43686-36862.1912.19
52958-29581.7581.76
63035-30351.8041.81
30min14767-47672.8332.825.182.842.825.19
24315-43152.5652.57
34634-46342.7542.76
44939-49392.9352.94
54999-49992.9712.98
64786-47862.8452.85
45min15319-53193.1613.577.663.173.587.61
26279-62793.7323.74
35628-56283.3453.36
46579-65793.9103.92
56080-60803.6143.62
66195-61953.6823.69
60min17281-72814.3274.203.694.344.213.67
27347-73474.3674.38
36657-66573.9573.97
47153-71534.2514.27
57060-70604.1964.21
66869-68694.0834.10
极限17573-75734.5014.554.754.524.574.75
27788-77884.6294.65
37694-76944.5734.60
48266-82664.9134.94
57269-72694.3204.34
67324-73244.3534.38
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100309-202205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%
112.204757914757494755264757444756484756920.03
212.164740874739814740340.02
单位质量响应值RSD%判断
38991.1538983.060.02数据可信
供试品溶液-519819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%
5min1168202-16820230.97034.8912.8430.9734.8912.84
2228712-22871242.11142.11
3199552-19955236.74236.74
4194204-19420435.75735.76
5185663-18566334.18534.18
6160723-16072329.59329.59
10min1316150-31615058.21061.688.3058.2661.748.31
2352271-35227164.86164.93
3382611-38261170.44770.51
4318398-31839858.62458.68
5331096-33109660.96261.02
6309428-30942856.97357.02
15min1395876-39587672.89073.576.9973.0473.736.99
2414412-41441276.30376.48
3448162-44816282.51782.70
4372448-37244868.57668.73
5379021-37902169.78669.94
6387584-38758471.36371.51
20min1436182-43618280.31180.896.2080.5881.186.21
2458136-45813684.35384.66
3482687-48268788.87489.19
4408694-40869475.25075.52
5417193-41719376.81577.09
6433204-43320479.76380.03
30min1476066-47606687.65488.893.5388.0689.313.55
2497532-49753291.60792.05
3505388-50538893.05393.52
4458962-45896284.50584.90
5472821-47282187.05787.46
6486014-48601489.48689.88
45min1505458-50545893.06693.961.2593.6294.531.27
2511833-51183394.24094.84
3520168-52016895.77596.39
4501655-50165592.36692.90
5510292-51029293.95694.50
6512564-51256494.37594.92
60min1514198-51419894.67595.671.1395.3896.391.15
2519763-51976395.70096.46
3529661-52966197.52298.30
4515644-51564494.94295.63
5515705-51570594.95395.66
6522599-52259996.22296.92
极限1526018-52601896.85297.521.4797.7198.401.48
2526273-52627396.89997.81
3542290-54229099.848100.79
4527684-52768497.15898.01
5520435-52043595.82496.69
6535093-53509398.52399.39
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351542101541061543001540951540451541510.07
216.311537901539151538520.06
单位质量响应值RSD%判断
9428.209432.990.04数据可信
供试品溶液-519819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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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100309-202205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%
112.204740784742754739794740444741784741110.03
212.164753114754064753580.02
单位质量响应值RSD%判断
38861.5639091.940.42数据可信
供试品溶液-519819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%
5min1288061-28806153.05349.799.0153.0549.799.01
2302754-30275455.75955.76
3256453-25645347.23247.23
4242196-24219644.60644.61
5283260-28326052.16952.17
6249214-24921445.89845.90
10min1447779-44777982.46974.767.7982.5674.847.79
2440674-44067481.16081.25
3380299-38029970.04170.12
4376942-37694269.42369.50
5407138-40713874.98475.07
6382698-38269870.48370.56
15min1500964-50096492.26485.426.2492.4985.636.25
2498984-49898491.89992.13
3443083-44308381.60481.80
4434811-43481180.08080.27
5457269-45726984.21784.43
6447781-44778182.46982.66
20min1519609-51960995.69890.514.1896.0890.874.19
2515852-51585295.00695.39
3481971-48197188.76689.10
4475116-47511687.50487.83
5478171-47817188.06688.42
6478058-47805888.04588.38
30min1531731-53173197.93095.512.3798.4796.012.38
2530021-53002197.61698.16
3526512-52651296.96997.45
4512206-51220694.33494.80
5506678-50667893.31693.82
6504328-50432892.88493.36
45min1533046-53304698.17398.160.5598.8898.820.55
2532466-53246698.06698.77
3538178-53817899.11899.76
4529420-52942097.50598.13
5533172-53317298.19698.85
6531442-53144297.87798.51
60min1532311-53231198.03798.370.4598.9099.190.44
2532799-53279998.12798.99
3534706-53470698.47899.28
4534090-53409098.36599.15
5538507-53850799.178100.00
6532342-53234298.04398.84
极限1532509-53250998.07498.500.5699.1099.490.56
2535307-53530798.58999.62
3533748-53374898.30299.27
4534250-53425098.39499.35
5540490-54049099.544100.53
6532575-53257598.08699.05
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.351538231538721538831539601536711538420.07
216.311536611538591537600.10
单位质量响应值RSD%判断
9409.309427.350.14数据可信
供试品溶液-519819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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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