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%
112.064611074611094590774597864596074601370.21
212.124595824593394594600.04
单位质量响应值RSD%判断
38153.9837909.240.46数据可信
加速3月-供试品溶液-2024082821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%
5min1304700-30470057.51254.417.4957.5154.417.49
2258420-25842048.77748.78
3319132-31913260.23660.24
4290912-29091254.91054.91
5276139-27613952.12152.12
6280342-28034252.91552.91
10min1416085-41608578.53675.894.5178.6375.984.51
2374539-37453970.69470.78
3425371-42537180.28980.39
4406458-40645876.71976.81
5391770-39177073.94774.03
6398226-39822675.16575.25
15min1450229-45022984.98183.433.1485.2183.643.14
2420883-42088379.44279.64
3462033-46203387.20987.44
4440545-44054583.15383.37
5442713-44271383.56283.77
6435592-43559282.21882.43
20min1464259-46425987.62986.572.6688.0086.922.66
2441433-44143383.32183.65
3477679-47767990.16290.54
4454146-45414685.72086.08
5460667-46066786.95187.30
6453680-45368085.63285.98
30min1478869-47886990.38789.882.1390.9090.382.14
2463231-46323187.43587.91
3493558-49355893.15993.69
4473050-47305089.28889.79
5477335-47733590.09790.59
6471106-47110688.92189.41
45min1495291-49529193.48693.261.9594.1593.911.96
2483694-48369491.29791.91
3511428-51142896.53297.22
4488589-48858992.22192.87
5495581-49558193.54194.19
6489823-48982392.45493.10
60min1505439-50543995.40295.401.7496.2296.201.74
2497005-49700593.81094.58
3521836-52183698.49799.34
4499418-49941894.26595.07
5505811-50581195.47296.27
6502980-50298094.93895.73
极限1514944-51494497.19697.561.2198.1898.531.22
2509267-50926796.12497.05
3527284-52728499.525100.54
4520261-52026198.19999.16
5513577-51357796.93897.90
6515993-51599397.39498.35
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%
115.442905372904442898162898262899732901190.12
215.422899652901242900440.04
单位质量响应值RSD%判断
18790.0918809.600.08数据可信
加速3月-供试品溶液-2024082821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%
5min1114732-11473234.26032.107.8434.2632.107.84
297181-9718129.01929.02
3118931-11893135.51435.51
4110014-11001432.85132.85
5102298-10229830.54730.55
6101839-10183930.41030.41
10min1202134-20213460.35857.835.0760.4257.885.07
2177894-17789453.12053.17
3204481-20448161.05961.12
4196572-19657258.69858.75
5187776-18777656.07156.12
6193147-19314757.67557.73
15min1241814-24181472.20771.043.3172.3671.193.31
2224312-22431266.98167.12
3247562-24756273.92474.08
4239837-23983771.61771.77
5234731-23473170.09270.24
6239208-23920871.42971.58
20min1267265-26726579.80778.792.6880.0979.062.68
2251773-25177375.18175.43
3272508-27250881.37381.66
4262704-26270478.44578.72
5261849-26184978.19078.45
6267096-26709679.75780.02
30min1286064-28606485.42185.791.8785.8386.191.88
2278611-27861183.19583.57
3295131-29513188.12888.55
4288718-28871886.21386.62
5286328-28632885.49985.89
6288967-28896786.28786.69
45min1297539-29753988.84789.371.3989.4089.921.40
2294331-29433187.88988.40
3306850-30685091.62792.19
4299096-29909689.31289.86
5298431-29843189.11389.65
6299537-29953789.44489.99
60min1300184-30018489.63790.191.2790.3490.881.28
2298197-29819789.04389.70
3309209-30920992.33293.05
4302015-30201590.18490.88
5300282-30028289.66690.35
6302312-30231290.27290.96
极限1303678-30367890.68091.221.1491.5392.061.15
2302258-30225890.25691.06
3311166-31116692.91693.79
4308237-30823792.04292.89
5303151-30315190.52391.35
6304433-30443390.90691.75
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%
112.064596114603054603074598954599804600200.07
212.124578864588424583640.15
单位质量响应值RSD%判断
38144.2837818.810.61数据可信
加速3月-供试品溶液-2024082821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%
5min1322352-32235260.92552.8611.5560.9252.8511.55
2262708-26270849.65249.65
3260327-26032749.20249.20
4235270-23527044.46644.47
5302966-30296657.26157.26
6294306-29430655.62455.62
10min1444248-44424883.96377.785.1784.0677.875.18
2414006-41400678.24778.33
3417291-41729178.86878.95
4378680-37868071.57171.64
5412124-41212477.89277.99
6402907-40290776.15076.24
15min1484119-48411991.49986.803.1691.7487.023.17
2464594-46459487.80988.02
3458795-45879586.71286.93
4441548-44154883.45383.65
5456118-45611886.20786.43
6450321-45032185.11185.33
20min1496211-49621193.78490.262.1294.1890.622.13
2482094-48209491.11691.48
3474093-47409389.60489.96
4470499-47049988.92589.26
5471530-47153089.11989.49
6470860-47086088.99389.35
30min1508177-50817796.04692.881.8596.6093.391.86
2495548-49554893.65994.17
3485842-48584291.82492.33
4487845-48784592.20392.68
5484424-48442491.55692.07
6486769-48676992.00092.51
45min1520521-52052198.37995.681.6199.0996.351.62
2511275-51127596.63197.30
3499170-49917094.34395.00
4503022-50302295.07195.71
5501617-50161794.80695.48
6501817-50181794.84495.51
60min1526517-52651799.51297.241.45100.3998.071.46
2520403-52040398.35699.18
3507199-50719995.86196.68
4512800-51280096.91997.71
5510953-51095396.57097.40
6509252-50925296.24997.07
极限1528806-52880699.94598.431.16100.9899.421.16
2525639-52563999.346100.34
3513926-51392697.13298.11
4523333-52333398.91099.86
5515809-51580997.48898.48
6517143-51714397.74098.72
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%
115.442901142900652898262897012903002900010.09
215.422901102903072902080.05
单位质量响应值RSD%判断
18782.4518820.230.15数据可信
加速3月-供试品溶液-2024082821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%
5min1117482-11748235.07830.7711.5535.0830.7711.55
296200-9620028.72428.72
396380-9638028.77728.78
486402-8640225.79825.80
5112822-11282233.68733.69
6108983-10898332.54032.54
10min1208094-20809462.13357.845.3262.1957.895.32
2191610-19161057.21157.26
3194654-19465458.12058.17
4176553-17655352.71652.76
5198397-19839759.23859.29
6192893-19289357.59557.65
15min1255751-25575176.36373.012.7976.5273.162.80
2243322-24332272.65272.79
3245013-24501373.15773.30
4234779-23477970.10170.23
5246272-24627273.53373.69
6242041-24204172.26972.42
20min1281291-28129183.98981.351.7184.2881.621.72
2271726-27172681.13381.40
3272942-27294281.49681.76
4267903-26790379.99180.24
5270873-27087380.87881.16
6269932-26993280.59780.87
30min1304080-30408090.79388.681.3791.2289.081.37
2298856-29885689.23389.63
3294861-29486188.04088.44
4296683-29668388.58488.97
5292657-29265787.38287.79
6294874-29487488.04488.45
45min1314097-31409793.78491.981.1494.3692.531.14
2309582-30958292.43692.98
3305545-30554591.23091.78
4308487-30848792.10992.64
5304934-30493491.04891.61
6305673-30567391.26991.82
60min1315408-31540894.17592.391.2294.9193.101.21
2311507-31150793.01193.71
3306868-30686891.62592.33
4310499-31049992.71093.39
5305464-30546491.20691.92
6306850-30685091.62092.32
极限1316694-31669494.55992.871.1395.4593.731.13
2312558-31255893.32494.18
3308465-30846592.10292.96
4312417-31241793.28294.12
5307536-30753691.82592.69
6308514-30851492.11792.97
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%
112.064585394582534587734577134586554583870.10
212.124572124571664571890.01
单位质量响应值RSD%判断
38008.8737721.860.54数据可信
加速3月-供试品溶液-2024083021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%
5min1216276-21627641.00250.0812.4941.0050.0812.49
2273264-27326451.80551.81
3294344-29434455.80255.80
4261050-26105049.49049.49
5237796-23779645.08145.08
6302162-30216257.28457.28
10min1367799-36779969.72775.996.2769.8076.086.28
2382843-38284372.57972.67
3412586-41258678.21878.31
4415228-41522878.71978.80
5389969-38996973.93074.01
6436603-43660382.77182.87
15min1432679-43267982.02783.823.1282.2184.033.12
2424369-42436980.45280.66
3437067-43706782.85983.08
4461889-46188987.56587.78
5443339-44333984.04884.25
6453390-45339085.95486.19
20min1462029-46202987.59187.152.7787.9187.502.76
2447384-44738484.81585.16
3447061-44706184.75485.12
4481720-48172091.32491.68
5458135-45813586.85387.19
6461960-46196087.57887.95
30min1486895-48689592.30590.553.0692.7791.053.04
2475724-47572490.18890.67
3458680-45868086.95687.46
4500853-50085394.95295.46
5474186-47418689.89690.38
6469528-46952889.01389.54
45min1499630-49963094.72092.933.5395.3493.573.50
2499849-49984994.76195.39
3465398-46539888.23088.88
4512484-51248497.15797.83
5487239-48723992.37193.00
6476382-47638290.31290.98
60min1502894-50289495.33893.803.8796.1294.603.84
2509778-50977896.64497.43
3467959-46795988.71689.51
4518235-51823598.24799.08
5491040-49104093.09193.88
6478890-47889090.78891.61
极限1532139-532139100.88399.301.95101.82100.251.94
2534082-534082101.251102.20
3506126-50612695.95196.89
4526072-52607299.733100.73
5525505-52550599.625100.57
6518731-51873198.34199.31
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%
115.442904882906662908942909162905102906950.08
215.422902812902472902640.01
单位质量响应值RSD%判断
18827.4018823.870.02数据可信
加速3月-供试品溶液-2024083021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%
5min178369-7836923.36928.2311.5923.3728.2211.58
2100118-10011829.85529.85
3103934-10393430.99330.99
492522-9252227.59027.59
586278-8627825.72825.73
6106705-10670531.81931.82
10min1169451-16945150.53056.497.8450.5756.547.84
2182264-18226454.35154.40
3197065-19706558.76458.82
4191470-19147057.09657.14
5183489-18348954.71654.76
6212959-21295963.50463.56
15min1226735-22673567.61271.624.4867.7371.764.48
2229965-22996568.57568.72
3240510-24051071.71971.87
4246427-24642773.48473.62
5241367-24136771.97572.11
6256019-25601976.34476.50
20min1259768-25976877.46279.332.9777.7079.602.98
2256289-25628976.42576.68
3261843-26184378.08178.35
4274815-27481581.94982.21
5268853-26885380.17180.43
6274689-27468981.91182.20
30min1288671-28867186.08185.822.3186.4586.212.30
2283547-28354784.55384.93
3279410-27941083.31983.72
4299103-29910389.19289.59
5289158-28915886.22686.61
6286840-28684085.53585.96
45min1299558-29955889.32788.662.7489.8489.192.72
2300842-30084289.71090.23
3285663-28566385.18485.72
4309266-30926692.22292.77
5297140-29714088.60689.14
6291400-29140086.89587.46
60min1302505-30250590.20689.213.0490.8689.893.01
2306404-30640491.36992.04
3285997-28599785.28385.96
4310337-31033792.54293.24
5297284-29728488.64989.33
6292418-29241887.19887.91
极限1315767-31576794.16192.821.7494.9793.661.72
2316400-31640094.35095.17
3301861-30186190.01490.84
4312344-31234493.14094.00
5312710-31271093.24994.08
6308579-30857992.01792.87
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%
112.064573664570964564094569124568114569190.08
212.124570444570984570710.01
单位质量响应值RSD%判断
37887.1537712.130.33数据可信
加速3月-供试品溶液-2024083021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%
5min1265832-26583250.48455.3626.5250.4855.3526.52
2346056-34605665.71965.72
3236240-23624044.86444.86
4181454-18145434.45934.46
5329854-32985462.64262.64
6389465-38946573.96273.96
10min1448137-44813785.10580.4211.9885.1980.5112.00
2450571-45057185.56785.68
3388723-38872373.82173.90
4335649-33564963.74263.80
5451586-45158685.76085.86
6465995-46599588.49688.62
15min1478458-47845890.86387.026.4591.0987.256.47
2475840-47584090.36690.62
3432495-43249582.13482.33
4411024-41102478.05778.22
5467906-46790688.85989.11
6483758-48375891.86992.14
20min1484056-48405691.92689.524.1092.3089.894.13
2484154-48415491.94592.35
3452167-45216785.87086.20
4443674-44367484.25784.55
5472971-47297189.82190.22
6491301-49130193.30293.73
30min1490729-49072993.19392.132.3393.7292.652.37
2492642-49264293.55694.11
3471963-47196389.62990.11
4474572-47457290.12590.56
5480226-48022691.19991.74
6500596-50059695.06795.65
45min1495084-49508494.02093.841.5194.7194.521.53
2498017-49801794.57795.29
3489218-48921892.90693.53
4492828-49282893.59294.18
5484043-48404391.92392.62
6505690-50569096.03496.77
60min1495790-49579094.15494.551.4995.0095.381.48
2500843-50084395.11495.98
3493381-49338193.69794.48
4504516-50451695.81196.55
5486598-48659892.40993.26
6506107-50610796.11497.01
极限1526689-526689100.02299.231.45101.02100.221.46
2532876-532876101.197102.23
3521294-52129498.99899.94
4517852-51785298.34499.24
5511182-51118297.07798.08
6525355-52535599.769100.83
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%
115.442895542896242893502899662899442896880.10
215.422906332907262906800.03
单位质量响应值RSD%判断
18762.1818850.840.34数据可信
加速3月-供试品溶液-2024083021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%
5min193817-9381728.00530.9626.4128.0030.9626.41
2120773-12077336.05136.05
381566-8156624.34824.35
467618-6761820.18420.18
5117965-11796535.21335.21
6140652-14065241.98541.98
10min1209668-20966862.58660.8314.1262.6360.8814.13
2220977-22097765.96266.02
3178596-17859653.31153.35
4158996-15899647.46147.49
5221477-22147766.11166.17
6233044-23304469.56469.63
15min1263939-26393978.78675.498.1578.9475.648.16
2264560-26456078.97279.14
3232425-23242569.37969.51
4221576-22157666.14166.25
5262928-26292878.48578.65
6271876-27187681.15681.34
20min1286321-28632185.46782.465.0685.7582.745.09
2284301-28430184.86485.17
3259522-25952277.46877.71
4257716-25771676.92977.15
5280375-28037583.69383.99
6289221-28922186.33386.65
30min1302157-30215790.19487.962.4890.6288.382.50
2298543-29854389.11689.56
3282688-28268884.38384.76
4292644-29264487.35587.71
5291289-29128986.95087.39
6300646-30064689.74390.21
45min1306724-30672491.55889.901.9192.1390.461.91
2301919-30191990.12390.72
3293715-29371587.67588.19
4305711-30571191.25591.75
5294404-29440487.88088.46
6304508-30450890.89691.51
60min1306326-30632691.43990.231.8692.1790.951.85
2303196-30319690.50591.25
3295997-29599788.35689.02
4308710-30871092.15192.80
5294935-29493588.03988.77
6304551-30455190.90991.68
极限1313688-31368893.63792.981.4594.5293.841.45
2316910-31691094.59895.49
3310001-31000192.53693.34
4310452-31045292.67193.47
5303925-30392590.72291.60
6313986-31398693.72594.64
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