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%
112.184727584726744724274722034721374724400.06
212.204686864692344689600.09
单位质量响应值RSD%判断
38788.1838439.340.64数据可信
供试品溶液-2批-氢噻-含35%SDS的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%
5min1388437-38843772.21366.097.3872.2166.097.37
2324073-32407360.24760.25
3377740-37774070.22470.22
4327477-32747760.88060.88
5363664-36366467.60767.61
6351640-35164065.37265.37
10min1467644-46764486.93886.473.1387.0686.583.13
2440451-44045181.88381.98
3466134-46613486.65786.77
4474776-47477688.26488.37
5482767-48276789.74989.86
6458932-45893285.31885.43
15min1485042-48504290.17289.781.9690.4490.031.96
2470102-47010287.39587.63
3482721-48272189.74190.00
4491881-49188191.44491.69
5493714-49371491.78592.05
6473979-47397988.11688.37
20min1493202-49320291.68991.131.7892.1091.541.78
2482041-48204189.61590.00
3488388-48838890.79491.21
4497602-49760292.50792.91
5501012-50101293.14193.56
6478913-47891389.03389.43
30min1501459-50145993.22492.831.6893.7993.391.68
2494456-49445691.92392.45
3498271-49827192.63293.19
4508591-50859194.55095.11
5507162-50716294.28594.86
6486184-48618490.38590.93
45min1508958-50895894.61994.531.9895.3495.241.97
2506577-50657794.17694.86
3507568-50756894.36095.08
4519567-51956796.59197.30
5517091-51709196.13196.86
6491122-49112291.30392.00
60min1513568-51356895.47695.812.1696.3696.682.15
2516415-51641596.00596.85
3514294-51429495.61196.48
4528476-52847698.24799.12
5523404-52340497.30498.19
6496027-49602792.21593.06
极限1552007-552007102.622101.081.04103.66102.111.02
2545823-545823101.472102.47
3535444-53544499.542100.58
4545677-545677101.445102.48
5540362-540362100.457101.51
6543045-543045100.956101.96
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%
116.513158233157713159193158583159653158670.03
216.173097013098093097550.03
单位质量响应值RSD%判断
19131.8619156.150.09数据可信
供试品溶液-2批-坎地-含35%SDS的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%
5min1162502-16250247.65243.666.8547.6543.666.85
2136654-13665440.07240.07
3158130-15813046.37046.37
4139304-13930440.84940.85
5150111-15011144.01844.02
6146683-14668343.01343.01
10min1247358-24735872.53571.543.1572.6171.613.15
2229422-22942267.27567.34
3244062-24406271.56871.65
4250121-25012173.34573.41
5249639-24963973.20473.28
6243192-24319271.31371.38
15min1285564-28556483.73883.151.9683.9483.341.96
2275631-27563180.82681.00
3280374-28037482.21682.41
4290016-29001685.04485.23
5288829-28882984.69684.89
6280912-28091282.37482.56
20min1305463-30546389.57389.341.8989.9189.671.88
2300290-30029088.05688.37
3300961-30096188.25388.59
4314150-31415092.12192.45
5308001-30800190.31890.65
6299172-29917287.72988.06
30min1325536-32553695.46094.881.6195.9595.361.60
2323362-32336294.82295.28
3318333-31833393.34793.83
4331516-33151697.21397.70
5325176-32517695.35495.84
6317489-31748993.10093.57
45min1335958-33595898.51697.981.4599.1698.621.45
2336067-33606798.54899.17
3329675-32967596.67397.31
4340583-34058399.872100.52
5335340-33534098.33498.98
6327258-32725895.96596.59
60min1337210-33721098.88398.321.4099.7099.121.40
2337039-33703998.83399.62
3330886-33088697.02897.83
4341229-341229100.061100.88
5336886-33688698.78899.60
6328506-32850696.33097.12
极限1345210-345210101.22999.751.04102.21100.711.04
2341682-341682100.194101.14
3335204-33520498.29599.25
4342078-342078100.310101.29
5338599-33859999.290100.26
6338214-33821499.177100.13
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%
112.184703514703064705824705284705374704610.03
212.204659804661484660640.03
单位质量响应值RSD%判断
38625.7038201.970.78数据可信
供试品溶液-24073102批-氢噻
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1283733-28373353.02360.7324.2153.0260.7324.21
2258526-25852648.31248.31
3235634-23563444.03444.03
4376191-37619170.30170.30
5355527-35552766.43966.44
6440263-44026382.27582.27
10min1404661-40466175.62182.408.2675.7182.508.27
2429806-42980680.32080.40
3395689-39568973.94574.02
4472670-47267088.33188.45
5459546-45954685.87885.99
6483111-48311190.28290.42
15min1443630-44363082.90487.654.2483.1287.894.26
2468970-46897087.63987.85
3447281-44728183.58683.78
4484733-48473390.58590.85
5477327-47732789.20189.45
6492206-49220691.98192.27
20min1463817-46381786.67689.482.6687.0389.862.69
2476879-47687989.11789.48
3464612-46461286.82587.16
4486840-48684090.97991.39
5485552-48555290.73891.14
6495107-49510792.52492.96
30min1483367-48336790.33091.351.5190.8391.881.55
2484884-48488490.61391.12
3480280-48028089.75390.23
4490069-49006991.58292.15
5494703-49470392.44893.00
6499637-49963793.37093.97
45min1500271-50027193.48992.780.9894.1493.460.99
2491817-49181791.90992.57
3492934-49293492.11792.75
4491555-49155591.86092.58
5501353-50135393.69194.40
6500882-50088293.60394.35
60min1509886-50988695.28593.521.3396.0994.361.32
2495706-49570692.63593.45
3497872-49787293.04093.82
4491529-49152991.85592.73
5503617-50361794.11494.98
6503883-50388394.16495.07
极限1525967-52596798.291100.191.1999.25101.181.19
2539362-539362100.794101.76
3539646-539646100.847101.79
4530450-53045099.128100.15
5542017-542017101.290102.31
6539337-539337100.789101.85
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%
116.513157193155873156973155663157293156600.03
216.173088043085783086910.06
单位质量响应值RSD%判断
19119.3219090.350.11数据可信
供试品溶液-24073102批-坎地
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114274-11427433.57838.9524.5933.5838.9524.58
2106041-10604131.15931.16
397084-9708428.52728.53
4151973-15197344.65644.66
5143152-14315242.06442.06
6182789-18278953.71153.71
10min1204395-20439560.05966.7210.5760.1266.7810.59
2215588-21558863.34863.40
3199417-19941758.59758.64
4244327-24432771.79371.87
5239774-23977470.45570.53
6258830-25883076.05476.14
15min1251419-25141973.87780.135.9674.0380.305.99
2270092-27009279.36479.52
3256633-25663375.40975.55
4283674-28367483.35583.55
5281429-28142982.69582.88
6292852-29285286.05186.27
20min1281762-28176282.79387.323.8783.0787.633.89
2296903-29690387.24287.53
3286007-28600784.04084.31
4303595-30359589.20889.54
5302481-30248188.88189.21
6312232-31223291.74692.11
30min1310517-31051791.24293.281.9291.6693.741.95
2317080-31708093.17193.61
3310757-31075791.31391.72
4320030-32003094.03794.52
5320145-32014594.07194.54
6326227-32622795.85896.37
45min1325176-32517695.55096.101.0396.1296.721.06
2327801-32780196.32196.91
3322462-32246294.75295.32
4325964-32596495.78196.42
5328705-32870596.58697.22
6332254-33225497.62998.30
60min1328400-32840096.49796.500.8697.2397.270.89
2329061-32906196.69197.44
3325127-32512795.53596.26
4325857-32585795.75096.55
5328901-32890196.64497.44
6333076-33307697.87198.71
极限1333013-33301397.85299.961.2898.74100.891.29
2343215-343215100.850101.76
3341593-341593100.373101.25
4336654-33665498.92299.88
5343749-343749101.007101.96
6342819-342819100.734101.73
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%
112.184679644680104680714691254691274684590.14
212.204652474651444651960.02
单位质量响应值RSD%判断
38461.3338130.820.62数据可信
供试品溶液-24073103批-氢噻
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1402842-40284275.51265.7411.4975.5165.7411.49
2342014-34201464.11064.11
3296287-29628755.53855.54
4317577-31757759.52959.53
5384825-38482572.13572.13
6360729-36072967.61867.62
10min1469870-46987088.07681.675.2688.2081.785.27
2426364-42636479.92180.03
3416024-41602477.98378.08
4409544-40954476.76876.87
5452468-45246884.81484.93
6440018-44001882.48182.59
15min1477759-47775989.55584.753.3989.8385.003.40
2443564-44356483.14583.39
3439022-43902282.29482.52
4440579-44057982.58682.81
5463152-46315286.81787.08
6448775-44877584.12284.37
20min1481196-48119690.19986.272.7090.6286.662.72
2454975-45497585.28485.66
3450689-45068984.48184.84
4454917-45491785.27385.64
5469465-46946588.00088.41
6450248-45024884.39884.79
30min1484794-48479490.87488.212.0291.4588.742.03
2466849-46684987.51088.03
3468845-46884587.88488.38
4468043-46804387.73488.24
5477559-47755989.51890.07
6457367-45736785.73386.26
45min1486884-48688491.26690.042.0391.9990.722.03
2481625-48162590.28090.95
3483405-48340590.61391.26
4481565-48156590.26990.92
5487468-48746891.37592.08
6461182-46118286.44887.12
60min1488392-48839291.54891.162.1392.4291.982.11
2492664-49266492.34993.17
3489934-48993491.83792.64
4489414-48941491.74092.54
5491977-49197792.22093.07
6465473-46547387.25288.07
极限1533951-533951100.08899.160.79101.12100.140.81
2530599-53059999.460100.43
3530549-53054999.451100.40
4523134-52313498.06199.02
5531007-53100799.536100.54
6524616-52461698.33899.30
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%
116.513146603143793144093151743150693147380.12
216.173079633079763079700.01
单位质量响应值RSD%判断
19063.4819045.760.07数据可信
供试品溶液-24073103批-坎地
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1197902-19790258.30550.7711.1358.3050.7711.12
2175505-17550551.70651.71
3145876-14587642.97742.98
4154457-15445745.50545.51
5184154-18415454.25454.25
6176023-17602351.85951.86
10min1283531-28353183.53278.435.8283.6378.515.83
2269298-26929879.33979.43
3248868-24886873.32073.39
4245479-24547972.32172.40
5276271-27627181.39381.48
6273803-27380380.66680.75
15min1309758-30975891.25987.663.5091.5087.883.51
2299424-29942488.21488.43
3285747-28574784.18584.38
4284155-28415583.71683.91
5305049-30504989.87290.10
6301207-30120788.74088.96
20min1319446-31944694.11391.542.3894.5091.902.39
2313554-31355492.37792.74
3302616-30261689.15589.49
4301437-30143788.80789.14
5316680-31668093.29893.67
6310456-31045691.46591.83
30min1325051-32505195.76494.821.2396.3195.341.25
2323644-32364495.35095.87
3317755-31775593.61594.10
4316148-31614893.14293.63
5325552-32555295.91296.44
6322981-32298195.15595.68
45min1328653-32865396.82696.011.0297.5396.681.03
2328319-32831996.72797.41
3325181-32518195.80396.44
4321582-32158294.74295.38
5329090-32909096.95497.65
6322523-32252395.02095.70
60min1329913-32991397.19796.290.9698.0697.120.97
2329485-32948597.07197.91
3326220-32622096.10996.91
4322393-32239394.98195.78
5328949-32894996.91397.77
6324106-32410695.48696.32
极限1337443-33744399.41598.770.82100.4499.760.83
2336159-33615999.037100.04
3336764-33676499.215100.17
4331472-33147297.65698.61
5337539-33753999.444100.46
6332133-33213397.85198.85
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