氢氯噻嗪坎地沙坦酯片项目信息
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100309-201404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2000
标示量(mg)6.25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%
112.132396062396072394962393692394492395050.05
212.152384722383622384170.04
单位质量响应值RSD%判断
19744.8519622.800.44数据可信
中间条件24月-供试品溶液-2023021121批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1138240-13824050.41550.674.4750.4150.674.47
2139303-13930350.80250.80
3134198-13419848.94148.94
4133172-13317248.56648.57
5138088-13808850.35950.36
6150583-15058354.91654.92
10min1256355-25635593.49094.211.4593.5794.301.45
2254949-25494992.97793.06
3255818-25581893.29493.38
4262061-26206195.57195.65
5256858-25685893.67393.76
6263992-26399296.27596.37
15min1269418-26941898.25498.701.1698.4998.941.16
2266336-26633697.13097.37
3272511-27251199.38299.62
4273771-27377199.841100.08
5268153-26815397.79298.03
6273676-27367699.807100.06
20min1269456-26945698.26898.761.1498.6799.171.14
2266967-26696797.36097.76
3272564-27256499.40199.80
4273780-27378099.844100.25
5268029-26802997.74798.15
6274084-27408499.955100.37
30min1268997-26899798.10098.601.0598.6799.171.05
2266689-26668997.25897.82
3272347-27234799.32299.89
4273168-27316899.621100.19
5267946-26794697.71798.28
6273017-27301799.566100.15
45min1268807-26880798.03198.671.2798.7699.411.27
2266175-26617597.07197.80
3272162-27216299.25499.99
4275136-275136100.339101.08
5268043-26804397.75298.48
6273071-27307199.586100.34
60min1268108-26810897.77698.261.0898.6799.161.08
2265621-26562196.86997.76
3271454-27145498.99699.90
4272175-27217599.259100.17
5266997-26699797.37198.26
6272256-27225699.289100.21
极限1267413-26741397.52398.091.1498.5899.161.14
2265193-26519396.71397.76
3270937-27093798.80899.87
4271834-27183499.135100.21
5266309-26630997.12098.17
6272187-27218799.264100.35
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.827564375671757767555675563756420.12
215.887541775365753910.05
单位质量响应值RSD%判断
4781.424747.540.51数据可信
中间条件24月-供试品溶液-2023021121批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118813-1881322.16722.494.4422.1722.494.44
219149-1914922.56322.56
318368-1836821.64221.64
418626-1862621.94621.95
518822-1882222.17722.18
620733-2073324.42924.43
10min147668-4766856.16656.491.9756.2056.531.97
247599-4759956.08456.12
346869-4686955.22455.26
448045-4804556.61056.65
547789-4778956.30856.35
649693-4969358.55258.59
15min162569-6256973.72374.311.4373.8574.441.43
262210-6221073.30073.43
362993-6299374.22274.35
463780-6378075.15075.28
562344-6234473.45873.59
664483-6448375.97876.12
20min169285-6928581.63682.671.9381.8982.921.93
269009-6900981.31181.56
369860-6986082.31482.57
471926-7192684.74885.00
569089-6908981.40581.66
671802-7180284.60284.87
30min175356-7535688.78989.821.5389.1890.221.52
275106-7510688.49588.88
376637-7663790.29990.69
477544-7754491.36791.76
575202-7520288.60889.00
677552-7755291.37791.78
45min178417-7841792.39693.401.4992.9393.941.49
277802-7780291.67192.21
379789-7978994.01394.55
480038-8003894.30694.86
578634-7863492.65293.19
680941-8094195.37095.93
60min179128-7912893.23494.401.5493.9395.101.54
278615-7861592.62993.32
381033-8103395.47896.17
480848-8084895.26095.97
579410-7941093.56694.26
681680-8168096.24196.96
极限179490-7949093.66094.581.5194.5195.441.50
278602-7860292.61493.46
381122-8112295.58396.44
481049-8104995.49796.36
579639-7963993.83694.68
681730-8173096.30097.18
氢氯噻嗪坎地沙坦酯片项目信息
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100309-201404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2000
标示量(mg)6.25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%
112.132389842390182395282394542391772392320.11
212.152384182383722383950.02
单位质量响应值RSD%判断
19722.3419620.990.37数据可信
中间条件24月-供试品溶液-2023021221批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133841-13384148.84048.212.7748.8448.212.77
2137640-13764050.22750.23
3126841-12684146.28646.29
4132849-13284948.47848.48
5130017-13001747.44547.44
6131511-13151147.99047.99
10min1251969-25196991.94795.472.0392.0395.552.03
2267024-26702497.44197.52
3262437-26243795.76795.84
4264258-26425896.43196.51
5264272-26427296.43696.52
6259821-25982194.81294.89
15min1263106-26310696.01199.432.0296.2599.672.02
2278312-278312101.560101.81
3277620-277620101.307101.54
4272425-27242599.41199.65
5272512-27251299.44399.68
6270861-27086198.84199.08
20min1262825-26282595.90899.452.0696.3099.852.06
2278481-278481101.621102.04
3277612-277612101.304101.71
4272188-27218899.32599.73
5272816-27281699.55499.96
6271222-27122298.97299.38
30min1262603-26260395.82799.292.0596.3899.862.05
2278044-278044101.462102.05
3277232-277232101.166101.74
4271352-27135299.02099.59
5272552-27255299.458100.03
6270803-27080398.82099.39
45min1261608-26160895.46499.082.1096.1899.822.09
2277525-277525101.273102.03
3276549-276549100.916101.66
4270887-27088798.85099.59
5272018-27201899.263100.00
6270530-27053098.72099.45
60min1260310-26031094.99198.822.2295.8699.722.22
2276739-276739100.986101.91
3276350-276350100.844101.75
4269954-26995498.51099.41
5272014-27201499.261100.16
6269461-26946198.33099.23
极限1260997-26099795.24198.612.0496.2799.682.03
2276099-276099100.752101.84
3275136-275136100.401101.48
4268974-26897498.15299.22
5271702-27170299.148100.22
6268485-26848597.97499.03
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.827541175559754477557875499754990.10
215.887578475716757500.07
单位质量响应值RSD%判断
4772.384770.150.04数据可信
中间条件24月-供试品溶液-2023021221批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117780-1778020.92020.494.4620.9220.494.45
218190-1819021.40221.40
316469-1646919.37719.38
418239-1823921.46021.46
516607-1660719.53919.54
617212-1721220.25120.25
10min146898-4689855.17956.571.9555.2156.601.95
249374-4937458.09258.13
348275-4827556.79956.83
448839-4883957.46357.50
547778-4777856.21456.25
647315-4731555.67055.70
15min161799-6179972.71174.991.9872.8475.121.97
265255-6525576.77776.91
364839-6483976.28876.41
463894-6389475.17675.31
563642-6364274.88075.01
662971-6297174.09074.22
20min168025-6802580.03783.032.2780.2883.292.27
272257-7225785.01685.28
372140-7214084.87885.13
470443-7044382.88183.14
570924-7092483.44783.70
669644-6964481.94182.19
30min173572-7357286.56390.062.2386.9490.452.23
278146-7814691.94592.35
378068-7806891.85392.25
476590-7659090.11490.51
577033-7703390.63591.03
675847-7584789.24089.63
45min176140-7614089.58493.562.3990.1194.102.39
281202-8120295.54096.10
381345-8134595.70996.26
479278-7927893.27793.82
579969-7996994.09094.63
679164-7916493.14293.68
60min177151-7715190.77494.522.2591.4595.222.25
281816-8181696.26396.98
382103-8210396.60097.31
480205-8020594.36795.07
580988-8098895.28895.99
679744-7974493.82594.52
极限177361-7736191.02194.552.2191.8595.412.21
281848-8184896.30097.18
382303-8230396.83697.70
480213-8021394.37795.23
580813-8081395.08395.94
679636-7963693.69894.54
氢氯噻嗪坎地沙坦酯片项目信息
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100309-201404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2000
标示量(mg)6.25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%
112.132390392387882389132389592389262389250.04
212.152400702400972400840.01
单位质量响应值RSD%判断
19697.0319760.000.23数据可信
中间条件24月-供试品溶液-2023021321批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146832-14683253.42648.609.1753.4348.609.17
2128944-12894446.91846.92
3149726-14972654.47954.48
4124838-12483845.42445.42
5118984-11898443.29443.29
6132144-13214448.08248.08
10min1260750-26075094.87794.990.9494.9795.070.94
2263890-26389096.01996.10
3261197-26119795.03995.13
4261432-26143295.12595.20
5262404-26240495.47895.55
6256649-25664993.38493.46
15min1276560-276560100.62999.360.83100.8899.600.84
2271422-27142298.76099.00
3274273-27427399.797100.05
4273608-27360899.55599.79
5272384-27238499.11099.34
6270156-27015698.29998.53
20min1276681-276681100.67399.510.85101.0999.910.85
2271089-27108998.63899.04
3275321-275321100.178100.59
4274068-27406899.722100.12
5272811-27281199.26599.66
6270939-27093998.58498.98
30min1276163-276163100.48599.480.86101.07100.050.87
2270861-27086198.55599.12
3275503-275503100.245100.83
4274126-27412699.743100.31
5273260-27326099.42899.99
6270500-27050098.42498.99
45min1276282-276282100.52899.600.84101.28100.340.84
2271213-27121398.68499.42
3276075-276075100.453101.20
4274106-27410699.736100.47
5273820-27382099.632100.36
6270923-27092398.57899.31
60min1275941-275941100.40499.330.91101.32100.230.91
2270990-27099098.60299.50
3275166-275166100.122101.04
4273276-27327699.434100.33
5273078-27307899.362100.26
6269432-26943298.03698.93
极限1274781-27478199.98299.080.82101.07100.150.82
2270453-27045398.40799.47
3274418-27441899.850100.93
4272407-27240799.118100.18
5272629-27262999.199100.26
6269108-26910897.91898.97
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.827531075062753367517775118752010.16
215.887553775573755550.04
单位质量响应值RSD%判断
4753.544757.870.07数据可信
中间条件24月-供试品溶液-2023021321批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120624-2062424.34521.869.7224.3521.869.73
218131-1813121.40221.40
320368-2036824.04324.04
417647-1764720.83120.83
515794-1579418.64418.64
618556-1855621.90421.90
10min150560-5056059.68258.352.1659.7258.382.16
249429-4942958.34758.38
350879-5087960.05960.10
448598-4859857.36657.40
548752-4875257.54857.58
648357-4835757.08257.12
15min166138-6613878.07176.331.4678.2176.461.46
264602-6460276.25876.39
365394-6539477.19377.33
464178-6417875.75775.89
564021-6402175.57275.70
663644-6364475.12775.26
20min172255-7225585.29284.410.7585.5684.680.75
271784-7178484.73685.00
371693-7169384.62884.90
471262-7126284.11984.38
571384-7138484.26384.52
670695-7069583.45083.71
30min178893-7889393.12791.741.0293.5492.141.02
277960-7796092.02692.43
377857-7785791.90492.31
477497-7749791.47991.88
577633-7763391.64092.03
676460-7646090.25590.65
45min181798-8179896.55695.240.7997.1295.790.79
280364-8036494.86495.42
380558-8055895.09395.66
480752-8075295.32295.87
580723-8072395.28795.83
679882-7988294.29594.84
60min182096-8209696.90895.880.7697.6496.590.76
281164-8116495.80896.52
381679-8167996.41697.14
481196-8119695.84696.55
580850-8085095.43796.14
680360-8036094.85995.56
极限182141-8214196.96195.760.7397.8596.630.74
281182-8118295.82996.70
381315-8131595.98696.87
480697-8069795.25796.12
580966-8096695.57496.44
680443-8044394.95795.82
氢氯噻嗪坎地沙坦酯片项目信息
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100309-201404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2000
标示量(mg)6.25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%
112.132395112394332393382396112393792394540.05
212.152393552395742394640.07
单位质量响应值RSD%判断
19740.6419708.970.12数据可信
中间条件24月-供试品溶液-FK011批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112939-11293941.10245.3713.9941.1045.3713.99
2113873-11387341.44241.44
3107729-10772939.20639.21
4151543-15154355.15155.15
5140415-14041551.10151.10
6121548-12154844.23544.23
10min1203752-20375274.15187.437.9074.2287.517.89
2245409-24540989.31189.38
3244833-24483389.10289.17
4259781-25978194.54294.63
5241651-24165187.94488.03
6246041-24604189.54189.61
15min1252664-25266491.95197.152.9492.1497.372.95
2265704-26570496.69796.91
3274899-274899100.043100.26
4272896-27289699.31499.56
5267009-26700997.17297.40
6268541-26854197.73097.95
20min1268495-26849597.71398.361.4498.0698.741.44
2266441-26644196.96597.34
3276840-276840100.750101.13
4272934-27293499.32899.74
5268789-26878997.82098.21
6268139-26813997.58397.97
30min1270139-27013998.31198.491.4898.8299.031.48
2266705-26670597.06197.60
3277465-277465100.977101.53
4273029-27302999.36399.94
5267975-26797597.52498.08
6268395-26839597.67698.22
45min1270990-27099098.62198.381.3999.2999.091.38
2266215-26621596.88397.59
3276602-276602100.663101.38
4271995-27199598.98799.73
5268212-26821297.61098.33
6267932-26793297.50898.22
60min1270398-27039898.40598.291.3699.2499.161.36
2266250-26625096.89697.76
3276374-276374100.580101.46
4271714-27171498.88499.80
5268117-26811797.57598.46
6267591-26759197.38498.26
极限1270610-27061098.48298.051.2299.4899.081.21
2265776-26577696.72397.75
3274887-274887100.039101.09
4270277-27027798.36199.44
5267872-26787297.48698.53
6267036-26703697.18298.22
氢氯噻嗪坎地沙坦酯片项目信息
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%
115.827517875141752867521175211752050.08
215.887528575355753200.07
单位质量响应值RSD%判断
4753.794743.070.16数据可信
中间条件24月-供试品溶液-FK011批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115509-1550918.33521.2815.5518.3421.2815.53
216255-1625519.21719.22
316042-1604218.96518.97
421313-2131325.19725.20
521775-2177525.74325.74
617102-1710220.21920.22
10min141329-4132948.86156.958.2348.8956.988.23
249010-4901057.94157.97
348001-4800156.74856.78
453622-5362263.39463.44
549194-4919458.15958.20
647866-4786656.58956.62
15min159290-5929070.09577.465.2070.2177.595.20
267266-6726679.52479.65
366696-6669678.85078.98
469307-6930781.93782.08
565545-6554577.49077.63
665025-6502576.87577.00
20min170963-7096383.89587.172.7184.1287.432.72
274264-7426487.79788.06
375129-7512988.82089.08
476466-7646690.40190.68
573393-7339386.76887.04
672176-7217685.32985.59
30min178785-7878593.14294.101.6893.5194.511.69
279294-7929493.74494.15
380982-8098295.74096.15
481483-8148396.33296.77
578930-7893093.31493.73
678104-7810492.33792.74
45min181496-8149696.34796.421.5296.8796.981.52
280513-8051395.18595.75
383181-8318198.33998.90
482854-8285497.95398.55
581192-8119295.98896.56
680114-8011494.71395.27
60min181785-8178596.68996.331.4397.3797.051.43
280178-8017894.78995.51
382998-8299898.12398.85
482584-8258497.63498.39
580923-8092395.67096.40
680414-8041495.06895.78
极限181145-8114595.93295.790.8696.7896.670.86
280628-8062895.32196.20
382053-8205397.00697.90
481380-8138096.21097.13
580913-8091395.65896.55
680013-8001394.59495.46
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