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100309-202205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%
111.784590574581814579214572194570854578930.18
211.784570854569434570140.03
单位质量响应值RSD%判断
38870.3738795.760.14数据可信
加速6月-供试品溶液-2024090121批-氢氯噻嗪-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%
5min1387758-38775871.67866.7112.8171.6866.7112.81
2411409-41140976.05076.05
3397917-39791773.55673.56
4349768-34976864.65664.66
5326059-32605960.27360.27
6292321-29232154.03654.04
10min1481375-48137588.98487.863.4089.1087.973.41
2482195-48219589.13589.26
3483115-48311589.30589.43
4480752-48075288.86888.98
5481833-48183389.06889.17
6442413-44241381.78181.87
15min1500188-50018892.46192.761.8692.7393.021.86
2503757-50375793.12193.40
3497548-49754891.97392.24
4505247-50524793.39693.65
5516237-51623795.42895.68
6488004-48800490.20990.44
20min1500670-50067092.55093.541.4492.9793.951.44
2502217-50221792.83693.27
3503722-50372293.11493.54
4507606-50760693.83294.24
5520043-52004396.13196.54
6501836-50183692.76693.14
30min1501483-50148392.70194.471.6793.2895.041.65
2505201-50520193.38893.97
3505990-50599093.53494.11
4515418-51541895.27795.84
5524670-52467096.98797.55
6513541-51354194.93095.46
45min1500409-50040992.50294.842.1093.2395.562.07
2505717-50571793.48394.22
3504766-50476693.30794.04
4521663-52166396.43197.16
5526578-52657897.33998.07
6519087-51908795.95596.64
60min1504290-50429093.21995.102.0994.1095.982.07
2505794-50579493.49894.39
3504069-50406993.17994.07
4524942-52494297.03797.92
5525603-52560397.15998.05
6522004-52200496.49497.34
极限1522306-52230696.55096.781.0997.5997.821.09
2518017-51801795.75796.81
3523470-52347096.76597.81
4534413-53441398.78899.84
5523054-52305496.68897.74
6520167-52016796.15497.16
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(%)99.80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%
115.642968312979972966692964482964582968810.22
215.642970812972642971720.05
单位质量响应值RSD%判断
18982.1619000.770.07数据可信
加速6月-供试品溶液-2024090121批-坎地沙坦酯-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%
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
10min12064-20640.6100.8120.430.610.8120.40
23038-30380.8980.90
33182-31820.9410.94
42368-23680.7000.70
53492-34921.0321.03
62372-23720.7010.70
15min14073-40731.2041.1621.941.201.1621.97
24414-44141.3051.31
33384-33841.0001.00
44694-46941.3881.39
54590-45901.3571.36
62463-24630.7280.73
20min14624-46241.3671.4610.761.371.4610.69
25609-56091.6581.66
35195-51951.5361.54
45360-53601.5841.59
54511-45111.3331.34
64282-42821.2661.27
30min14705-47051.3911.6111.761.401.6211.74
26118-61181.8081.81
36021-60211.7801.79
44661-46611.3781.38
55482-54821.6201.63
65792-57921.7121.72
45min15278-52781.5601.9310.581.571.9410.54
27191-71912.1262.14
36626-66261.9591.97
47008-70082.0722.08
56784-67842.0052.01
66265-62651.8521.86
60min17535-75352.2272.166.612.242.176.67
27632-76322.2562.27
37450-74502.2022.21
47512-75122.2202.23
57379-73792.1812.19
66336-63361.8731.88
极限17202-72022.1292.184.212.142.204.23
27568-75682.2372.25
37801-78012.3062.32
47428-74282.1962.21
56895-68952.0382.05
67398-73982.1872.20
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100309-202205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%
111.784547054538744550934552724554704548830.14
211.784551214560724555960.15
单位质量响应值RSD%判断
38614.8638675.380.12数据可信
加速6月-供试品溶液-2024090121批-氢氯噻嗪-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%
5min1309451-30945157.48160.786.2057.4860.786.20
2310693-31069357.71257.71
3327686-32768660.86860.87
4339506-33950663.06463.06
5314737-31473758.46358.46
6361286-36128667.11067.11
10min1451622-45162283.89084.013.1283.9984.123.13
2449249-44924983.44983.55
3461447-46144785.71585.82
4460942-46094285.62185.73
5426200-42620079.16779.26
6464311-46431186.24786.36
15min1491506-49150691.29890.732.3391.5390.972.33
2490650-49065091.13991.37
3492348-49234891.45591.70
4498117-49811792.52692.77
5465946-46594686.55086.78
6492083-49208391.40591.66
20min1501678-50167893.18892.611.7793.5893.001.77
2504526-50452693.71794.10
3501844-50184493.21893.62
4506370-50637094.05994.46
5482647-48264789.65390.03
6494363-49436391.82992.24
30min1512821-51282195.25794.192.3695.8094.732.35
2519273-51927396.45697.00
3509568-50956894.65395.21
4515861-51586195.82296.38
5489788-48978890.97991.50
6494988-49498891.94592.51
45min1521557-52155796.88095.182.7197.5895.882.70
2521000-52100096.77797.48
3519245-51924596.45197.16
4523426-52342697.22797.95
5493668-49366891.70092.37
6495606-49560692.06092.77
60min1522544-52254497.06495.442.8197.9396.302.80
2526244-52624497.75198.62
3518344-51834496.28397.15
4524573-52457397.44098.32
5494509-49450991.85692.68
6496514-49651492.22893.10
极限1522895-52289597.12997.360.3898.1598.380.38
2527151-52715197.91998.95
3521277-52127796.82897.86
4524771-52477197.47798.52
5524155-52415597.36398.34
6524527-52452797.43298.45
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(%)99.80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%
115.642957292952602960842964102958352958640.15
215.642966972969122968040.06
单位质量响应值RSD%判断
18917.1418977.240.23数据可信
加速6月-供试品溶液-2024090121批-坎地沙坦酯-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%
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
10min12733-27330.8100.7711.110.810.7711.36
22410-24100.7140.71
32998-29980.8880.89
42207-22070.6540.65
52767-27670.8200.82
62455-24550.7270.73
15min13140-31400.9301.1616.000.931.1615.94
23069-30690.9090.91
34463-44631.3221.32
44295-42951.2731.27
54261-42611.2621.26
64169-41691.2351.24
20min15200-52001.5411.555.301.541.555.20
25318-53181.5761.58
34975-49751.4741.48
45490-54901.6271.63
55533-55331.6391.64
64842-48421.4351.44
30min15600-56001.6591.677.861.661.687.98
25641-56411.6711.68
36309-63091.8691.88
45856-58561.7351.74
54951-49511.4671.47
65517-55171.6351.64
45min17156-71562.1202.006.402.132.016.37
26933-69332.0542.06
37156-71562.1202.13
46497-64971.9251.93
56763-67632.0042.01
66037-60371.7891.80
60min16675-66751.9782.108.881.992.118.89
27657-76572.2692.28
37375-73752.1852.20
46904-69042.0462.06
56143-61431.8201.83
67777-77772.3042.32
极限16634-66341.9662.196.151.982.216.18
27611-76112.2552.27
37799-77992.3112.33
47842-78422.3232.34
57281-72812.1572.17
67208-72082.1362.15
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100309-202205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%
111.784544254551264546744546094556484548960.11
211.784527374539384533380.19
单位质量响应值RSD%判断
38615.9638483.700.25数据可信
中间条件6月-供试品溶液-2024090121批-氢氯噻嗪-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%
5min1241944-24194445.05357.8915.9845.0557.8915.98
2293200-29320054.59754.60
3308207-30820757.39257.39
4287998-28799853.62953.63
5352257-35225765.59465.59
6381732-38173271.08371.08
10min1428522-42852279.79684.766.6479.8784.856.65
2430020-43002080.07580.17
3453592-45359284.46484.56
4434938-43493880.99081.08
5484776-48477690.27190.38
6499144-49914492.94693.06
15min1488048-48804890.88092.812.1291.0993.052.14
2491109-49110991.45091.67
3496850-49685092.51992.76
4491532-49153291.52991.75
5510399-51039995.04295.30
6512601-51260195.45295.73
20min1502814-50281493.63095.041.4293.9995.441.43
2502405-50240593.55493.93
3514764-51476495.85596.25
4507028-50702894.41494.79
5518189-51818996.49396.91
6517221-51722196.31296.74
30min1512305-51230595.39796.591.1695.9197.141.17
2511412-51141295.23195.76
3523470-52347097.47698.03
4521287-52128797.07097.60
5526096-52609697.96598.54
6517676-51767696.39796.99
45min1521134-52113497.04197.661.2497.7298.371.23
2517465-51746596.35897.05
3528356-52835698.38699.10
4530415-53041598.76999.47
5531705-53170599.01099.75
6517683-51768396.39997.15
60min1520469-52046996.91797.541.4597.7598.411.44
2516440-51644096.16797.02
3528367-52836798.38899.26
4531334-53133498.94099.80
5531526-53152698.97699.88
6514719-51471995.84796.76
极限1519672-51967296.76997.891.2597.7798.921.26
2515496-51549695.99197.00
3527275-52727598.18599.23
4530046-53004698.70199.73
5530610-53061098.80699.88
6530932-53093298.86699.94
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(%)99.80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%
115.642962732967812967592965712973962967560.14
215.642958002965572961780.19
单位质量响应值RSD%判断
18974.1718937.210.14数据可信
中间条件6月-供试品溶液-2024090121批-坎地沙坦酯-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%
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
10min12301-23010.6810.4578.440.680.4578.45
2-0.0000.00
32060-20600.6100.61
42636-26360.7810.78
52211-22110.6550.65
6-0.0000.00
15min13678-36781.0891.2416.291.091.2416.40
23286-32860.9730.97
34717-47171.3971.40
44532-45321.3421.34
55025-50251.4881.49
63815-38151.1301.13
20min15214-52141.5441.616.341.551.626.35
25031-50311.4901.49
35857-58571.7351.74
45329-53291.5781.58
55875-58751.7401.74
65395-53951.5981.60
30min16000-60001.7771.849.431.781.849.57
25432-54321.6091.61
36584-65841.9501.96
46865-68652.0332.04
56691-66911.9821.99
65696-56961.6871.69
45min16956-69562.0602.157.862.072.167.84
28303-83032.4592.47
37221-72212.1392.15
46869-68692.0342.04
56742-67421.9972.01
67394-73942.1902.20
60min17160-71602.1202.407.102.132.417.16
27880-78802.3342.34
38742-87422.5892.60
48200-82002.4282.44
58617-86172.5522.57
67945-79452.3532.36
极限18819-88192.6122.497.632.632.507.66
28921-89212.6422.66
38242-82422.4412.46
48807-88072.6082.63
57213-72132.1362.15
68373-83732.4802.49
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100309-202205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%
111.784518354521714528394537134529444527000.17
211.784515164520534517840.09
单位质量响应值RSD%判断
38429.5438351.780.15数据可信
中间条件6月-供试品溶液-2024090121批-氢氯噻嗪-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%
5min1372562-37256269.66359.1411.3269.6659.1311.32
2341114-34111463.78363.78
3316898-31689859.25559.25
4286003-28600353.47853.48
5276780-27678051.75351.75
6304197-30419756.88056.88
10min1484430-48443090.58083.265.4690.7083.365.47
2466496-46649687.22787.33
3436080-43608081.54081.64
4431304-43130480.64780.74
5425431-42543179.54879.63
6428013-42801380.03180.13
15min1499126-49912693.32890.302.6393.6090.542.64
2498254-49825493.16593.42
3472785-47278588.40388.64
4470238-47023887.92788.15
5480227-48022789.79490.01
6477113-47711389.21289.44
20min1505112-50511294.44792.391.9294.8792.781.93
2504918-50491894.41194.82
3485825-48582590.84191.22
4482325-48232590.18790.56
5492855-49285592.15692.52
6493713-49371392.31692.69
30min1514070-51407096.12294.681.6596.7095.231.66
2514440-51444096.19296.76
3496280-49628092.79693.33
4496040-49604092.75193.27
5507123-50712394.82395.35
6510291-51029195.41695.95
45min1518016-51801696.86095.881.7497.6096.581.74
2522195-52219597.64298.37
3503196-50319694.08994.78
4500503-50050393.58694.26
5514273-51427396.16096.84
6518612-51861296.97297.66
60min1518370-51837096.92696.311.9797.8397.161.97
2523721-52372197.92798.81
3504723-50472394.37595.22
4501924-50192493.85194.68
5514443-51444396.19297.03
6527139-52713998.56699.42
极限1523881-52388197.95797.500.6199.0298.520.62
2523630-52363097.91098.96
3519649-51964997.16698.17
4521706-52170697.55098.54
5516028-51602896.48997.49
6523830-52383097.94798.96
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(%)99.80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%
115.642954412957792963542968062964972961750.19
215.642961462961612961540.01
单位质量响应值RSD%判断
18937.0218935.680.01数据可信
中间条件6月-供试品溶液-2024090121批-坎地沙坦酯-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%
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
10min12493-24930.7390.6150.970.740.6150.92
22166-21660.6420.64
32478-24780.7350.73
42985-29850.8850.88
52226-22260.6600.66
6-0.0000.00
15min14157-41571.2321.2812.011.231.2811.97
24733-47331.4031.40
34944-49441.4661.47
44433-44331.3141.32
54228-42281.2531.25
63460-34601.0261.03
20min16392-63921.8951.777.791.901.777.78
26334-63341.8781.88
36403-64031.8981.90
45661-56611.6781.68
55313-53131.5751.58
65737-57371.7011.70
30min17425-74252.2011.9910.192.212.0010.21
26170-61701.8291.84
37262-72622.1532.16
47361-73612.1822.19
55983-59831.7741.78
66169-61691.8291.83
45min17906-79062.3442.324.322.352.334.45
27991-79912.3692.38
38217-82172.4362.45
47834-78342.3222.33
57797-77972.3112.32
67207-72072.1372.14
60min19020-90202.6742.504.612.692.524.61
28312-83122.4642.48
38705-87052.5812.60
48304-83042.4622.48
58453-84532.5062.52
67880-78802.3362.35
极限19510-95102.8192.538.782.842.558.72
28560-85602.5382.56
38197-81972.4302.45
48128-81282.4102.43
59287-92872.7532.77
67530-75302.2322.25
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