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%
112.474760144759064756744758214755744757980.04
212.534749124752444750780.05
单位质量响应值RSD%判断
38155.4137915.240.45数据可信
加速3月-供试品溶液-2024082321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%
5min1237687-23768744.85964.0417.5144.8664.0417.51
2378105-37810571.36071.36
3401731-40173175.81975.82
4375021-37502170.77870.78
5324401-32440161.22561.22
6318945-31894560.19560.20
10min1455028-45502885.87887.123.1285.9587.233.12
2470192-47019288.74088.86
3480649-48064990.71490.84
4467919-46791988.31188.43
5439644-43964482.97583.08
6456244-45624486.10886.21
15min1480793-48079390.74190.621.5290.9690.871.53
2483287-48328791.21291.48
3491066-49106692.68092.96
4481683-48168390.90991.17
5471031-47103188.89889.14
6473019-47301989.27489.52
20min1488723-48872392.23891.971.0392.6192.381.03
2488162-48816292.13292.55
3493997-49399793.23393.66
4485585-48558591.64592.06
5488666-48866692.22792.62
6478841-47884190.37290.77
30min1493985-49398593.23193.411.3293.7593.961.32
2497710-49771093.93494.51
3501752-50175294.69795.28
4491011-49101192.66993.24
5500546-50054694.46995.01
6484520-48452091.44491.99
45min1501797-50179794.70594.661.5995.3895.381.58
2504151-50415195.14995.88
3503515-50351595.02995.77
4496123-49612393.63494.36
5513689-51368996.94997.65
6490204-49020492.51793.21
60min1502609-50260994.85895.061.9595.6995.931.94
2504843-50484395.28096.17
3503269-50326994.98395.89
4499807-49980794.32995.21
5520847-52084798.30099.16
6490645-49064592.60093.45
极限1530212-530212100.06899.730.85101.06100.760.85
2533450-533450100.679101.73
3529740-52974099.979101.04
4528276-52827699.702100.74
5528591-52859199.762100.79
6520127-52012798.16499.17
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%
116.621509881507331510981507921510021509230.11
216.551512181511101511640.06
单位质量响应值RSD%判断
9080.819133.780.42数据可信
加速3月-供试品溶液-2024082321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%
5min140921-4092125.22440.3019.9725.2240.3019.98
272515-7251544.69944.70
377472-7747247.75447.75
471839-7183944.28244.28
562076-6207638.26438.26
667494-6749441.60441.60
10min1108409-10840966.82470.733.9666.8770.793.98
2117109-11710972.18772.26
3118924-11892473.30673.39
4116892-11689272.05372.13
5109517-10951767.50767.57
6117577-11757772.47572.54
15min1128220-12822079.03681.351.9979.1981.542.01
2133332-13333282.18782.38
3133661-13366182.39082.59
4133200-13320082.10582.30
5129084-12908479.56879.74
6134375-13437582.83083.02
20min1138233-13823385.20886.840.9885.4987.161.00
2140913-14091386.86087.19
3141601-14160187.28487.62
4141212-14121287.04487.37
5142220-14222087.66587.97
6141139-14113986.99987.33
30min1145874-14587489.91891.150.9290.3491.610.93
2148604-14860491.60192.08
3148938-14893891.80692.29
4147569-14756990.96391.44
5149393-14939392.08792.54
6146849-14684990.51990.99
45min1150619-15061992.84393.310.8593.4293.930.85
2151552-15155293.41894.05
3150855-15085592.98893.63
4150302-15030292.64793.27
5153841-15384194.82995.44
6151082-15108293.12893.75
60min1151712-15171293.51693.990.9194.2594.760.90
2153300-15330094.49595.28
3152312-15231293.88694.68
4151728-15172893.52694.31
5154806-15480695.42396.19
6150999-15099993.07793.86
极限1155832-15583296.05696.170.8496.9497.100.84
2158298-15829897.57698.52
3155734-15573495.99696.94
4156209-15620996.28897.23
5155790-15579096.03096.96
6154240-15424095.07596.01
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%
112.474744974737744743994745724742344742950.07
212.534726814733174729990.10
单位质量响应值RSD%判断
38034.8837749.320.54数据可信
加速3月-供试品溶液-2024082321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%
5min1407405-40740577.18170.439.3677.1870.439.36
2322273-32227361.05361.05
3365808-36580869.30169.30
4387406-38740673.39273.39
5405756-40575676.86976.87
6341968-34196864.78464.78
10min1472368-47236889.48884.984.4489.6285.104.44
2420300-42030079.62479.73
3443401-44340184.00084.12
4458476-45847686.85686.98
5464055-46405587.91388.04
6432831-43283181.99882.11
15min1486119-48611992.09388.842.4492.3789.102.45
2454484-45448486.10086.33
3461185-46118587.37087.63
4470706-47070689.17389.44
5476838-47683890.33590.61
6464321-46432187.96488.21
20min1496507-49650794.06191.041.9194.4991.441.92
2475568-47556890.09490.47
3469178-46917888.88489.28
4477922-47792290.54090.96
5481696-48169691.25591.68
6482398-48239891.38891.78
30min1505698-50569895.80293.471.9896.3994.021.98
2497384-49738494.22794.76
3477684-47768490.49591.04
4488752-48875292.59293.16
5491358-49135893.08693.66
6499318-49931894.59495.14
45min1514716-51471697.51195.382.2798.2696.102.26
2512154-51215497.02597.71
3486398-48639892.14692.85
4496405-49640594.04294.76
5498584-49858494.45595.19
6512689-51268997.12797.83
60min1517349-51734998.01096.312.5298.9297.192.50
2517256-51725697.99298.84
3487549-48754992.36493.22
4503740-50374095.43196.31
5502963-50296395.28496.17
6521481-52148198.79299.66
极限1524819-52481999.42599.940.90100.50100.970.88
2528870-528870100.192101.20
3531079-531079100.611101.62
4519342-51934298.38799.42
5531955-531955100.777101.83
6529062-529062100.229101.26
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%
116.621505371505291506001508031508151506570.10
216.551505381512251508820.33
单位质量响应值RSD%判断
9064.809116.740.41数据可信
加速3月-供试品溶液-2024082321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%
5min176044-7604446.95944.229.1946.9644.229.19
261979-6197938.27438.27
369394-6939442.85342.85
475727-7572746.76346.76
579449-7944949.06249.06
667090-6709041.43041.43
10min1114793-11479370.88868.996.2470.9769.066.24
2100616-10061662.13362.20
3111905-11190569.10469.18
4116058-11605871.66971.75
5119963-11996374.08074.16
6106947-10694766.04366.11
15min1131358-13135881.11779.614.1681.3179.794.16
2119795-11979573.97774.14
3128692-12869279.47179.66
4130541-13054180.61380.81
5135875-13587583.90684.11
6127202-12720278.55178.73
20min1140530-14053086.78185.142.3487.1185.462.36
2131919-13191981.46481.75
3137539-13753984.93485.25
4137959-13795985.19385.53
5140871-14087186.99287.34
6138410-13841085.47285.78
30min1148206-14820691.52190.261.5092.0090.721.50
2144115-14411588.99589.42
3143802-14380288.80289.26
4145137-14513789.62690.10
5146624-14662490.54491.03
6149123-14912392.08792.54
45min1151733-15173393.69992.951.3694.3393.571.35
2151560-15156093.59294.17
3147460-14746091.06191.67
4149167-14916792.11592.74
5150080-15008092.67893.32
6153150-15315094.57495.18
60min1152687-15268794.28894.171.5995.0794.941.58
2153477-15347794.77695.51
3147997-14799791.39292.15
4151896-15189693.80094.58
5154237-15423795.24696.04
6154636-15463695.49296.26
极限1155013-15501395.72596.450.8396.6797.380.82
2156704-15670496.76997.66
3157334-15733497.15898.07
4154170-15417095.20496.14
5157249-15724997.10698.06
6156630-15663096.72397.65
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%
112.474728614732654729724732744738254732390.08
212.534734484733224733850.02
单位质量响应值RSD%判断
37950.2037780.130.32数据可信
加速3月-供试品溶液-2024082521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%
5min1267884-26788450.78553.2612.8550.7953.2612.85
2302769-30276957.39957.40
3306969-30696958.19558.19
4276027-27602752.32952.33
5314584-31458459.63859.64
6217422-21742241.21941.22
10min1432160-43216081.92881.924.1082.0182.014.11
2450734-45073485.45085.55
3447104-44710484.76184.86
4434499-43449982.37282.46
5427252-42725280.99881.10
6401006-40100676.02276.09
15min1491310-49131093.14291.321.7893.3691.551.78
2478193-47819390.65590.89
3479797-47979790.95991.20
4493209-49320993.50293.73
5475331-47533190.11390.35
6472500-47250089.57689.77
20min1505720-50572095.87494.241.8696.2594.621.85
2485600-48560092.06092.45
3492736-49273693.41293.80
4509511-50951196.59396.97
5490444-49044492.97893.36
6498577-49857794.52094.86
30min1513982-51398297.44096.241.3797.9896.771.36
2497305-49730594.27994.82
3506962-50696296.10996.65
4515963-51596397.81698.36
5502965-50296595.35295.89
6508666-50866696.43296.93
45min1516882-51688297.99098.030.9798.6998.730.97
2509743-50974396.63797.34
3519710-51971098.52699.23
4524815-52481599.494100.20
5514971-51497197.62898.33
6516427-51642797.90498.57
60min1518871-51887198.36798.801.1099.2399.661.10
2511615-51161596.99197.85
3525561-52556199.635100.51
4527648-527648100.031100.90
5523334-52333499.213100.07
6519927-51992798.56799.39
极限1525281-52528199.582100.321.24100.61101.341.23
2522273-52227399.012100.03
3533776-533776101.193102.23
4539805-539805102.336103.37
5525266-52526699.579100.61
6528474-528474100.188101.18
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%
116.621507121512691509061508471508321509130.14
216.551511021512431511720.07
单位质量响应值RSD%判断
9080.209134.260.42数据可信
加速3月-供试品溶液-2024082521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%
5min150193-5019330.94032.5114.1930.9432.5214.18
257508-5750835.44935.45
357724-5772435.58235.58
452042-5204232.07932.08
559619-5961936.75036.75
639399-3939924.28624.29
10min199616-9961661.40462.947.0761.4663.007.08
2108920-10892067.14067.20
3109390-10939067.42967.49
4101008-10100862.26262.32
5103860-10386064.02064.08
689847-8984755.38355.42
15min1125644-12564477.44878.492.7977.6078.652.81
2129326-12932679.71879.89
3131202-13120280.87481.05
4127840-12784078.80278.96
5128844-12884479.42179.59
6121114-12111474.65674.79
20min1139900-13990086.23686.461.2186.5286.751.21
2138202-13820285.18985.49
3141364-14136487.13887.44
4142545-14254587.86688.15
5141040-14104086.93987.24
6138565-13856585.41385.67
30min1150572-15057292.81492.871.2193.2493.301.21
2147715-14771591.05391.50
3152045-15204593.72294.17
4153038-15303894.33494.77
5150497-15049792.76893.21
6150109-15010992.52992.93
45min1153818-15381894.81595.660.7195.4096.250.71
2155046-15504695.57296.17
3156173-15617396.26796.87
4156664-15666496.56997.16
5154235-15423595.07295.67
6155202-15520295.66896.22
60min1155078-15507895.59296.081.2996.3396.831.28
2152600-15260094.06494.82
3157658-15765897.18297.95
4157981-15798197.38198.13
5155231-15523195.68696.44
6156678-15667896.57897.29
极限1156959-15695996.75197.492.1497.6598.402.12
2154463-15446395.21396.13
3158795-15879597.88398.81
4164360-164360101.313102.23
5156439-15643996.43197.35
6157959-15795997.36898.24
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%
112.474718184718334719174725124721854720530.07
212.534711454706274708860.08
单位质量响应值RSD%判断
37855.0937580.690.52数据可信
加速3月-供试品溶液-2024082521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%
5min1258594-25859449.21651.8714.4249.2251.8714.41
2220728-22072842.00942.01
3314787-31478759.91059.91
4299794-29979457.05757.06
5304548-30454857.96257.96
6236754-23675445.05945.06
10min1384036-38403673.09074.786.0873.1774.866.08
2361467-36146768.79568.86
3399418-39941876.01876.12
4429316-42931681.70881.80
5405883-40588377.24877.34
6377329-37732971.81471.89
15min1450447-45044785.72984.783.1985.9384.993.20
2426972-42697281.26281.45
3441485-44148584.02484.25
4468696-46869689.20389.43
5448365-44836585.33385.56
6436728-43672883.11883.31
20min1470556-47055689.55788.991.8289.9089.341.84
2457500-45750087.07287.39
3460082-46008287.56387.93
4479503-47950391.25991.64
5473842-47384290.18290.55
6463905-46390588.29188.62
30min1494933-49493394.19693.211.2094.6993.711.18
2490373-49037393.32893.79
3478312-47831291.03391.55
4491991-49199193.63694.17
5492259-49225993.68794.20
6490598-49059893.37193.85
45min1514906-51490697.99796.721.4098.6597.381.39
2509732-50973297.01397.63
3495455-49545594.29594.96
4507028-50702896.49897.19
5514628-51462897.94498.62
6507566-50756696.60097.24
60min1527315-527315100.35998.551.69101.1899.371.67
2523599-52359999.652100.43
3502062-50206295.55396.37
4516281-51628198.25999.11
5520045-52004598.97599.81
6517613-51761398.51299.31
极限1535190-535190101.858100.481.37102.84101.461.34
2534949-534949101.812102.76
3516593-51659398.31899.30
4523382-52338299.610100.62
5530364-530364100.939101.94
6527170-527170100.331101.29
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%
116.621509071508841509711511531511721510170.10
216.551507291510201508740.14
单位质量响应值RSD%判断
9086.469116.250.24数据可信
加速3月-供试品溶液-2024082521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%
5min147969-4796929.58832.1515.3329.5932.1615.33
241879-4187925.83125.83
361229-6122937.76637.77
457617-5761735.53835.54
558521-5852136.09636.10
645566-4556628.10528.11
10min192985-9298557.35459.758.5757.4059.818.58
285685-8568552.85152.89
3102644-10264463.31163.37
4106965-10696565.97766.04
5102330-10233063.11863.18
690655-9065555.91655.96
15min1122511-12251175.56575.155.0475.7175.305.04
2112167-11216769.18569.32
3125138-12513877.18677.35
4129464-12946479.85480.02
5124285-12428576.66076.82
6117489-11748972.46872.61
20min1135586-13558683.63083.203.4183.9083.483.42
2128449-12844979.22879.47
3132795-13279581.90982.21
4140718-14071886.79687.10
5139304-13930485.92386.22
6132524-13252481.74182.00
30min1148465-14846591.57490.511.6291.9890.921.62
2145276-14527689.60789.99
3142852-14285288.11288.55
4148746-14874691.74792.19
5148691-14869191.71392.15
6146373-14637390.28490.68
45min1154646-15464695.38694.742.1895.9595.302.17
2153540-15354094.70495.23
3148456-14845691.56892.15
4152982-15298294.36094.96
5158843-15884397.97598.56
6153104-15310494.43594.98
60min1156220-15622096.35795.151.3997.0895.881.37
2155511-15551195.92096.61
3150293-15029392.70293.43
4153635-15363594.76395.52
5155231-15523195.74796.50
6154713-15471395.42896.13
极限1158335-15833597.66296.621.0098.5497.500.98
2157586-15758697.20098.05
3154008-15400894.99395.88
4155764-15576496.07696.99
5157441-15744197.11098.02
6156728-15672896.67197.53
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