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%
112.694715674713874716404712824714584714670.04
212.714699714696164697940.06
单位质量响应值RSD%判断
37152.6436962.550.37数据可信
供试品溶液-2024082821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%
5min1380120-38012073.63368.1115.7873.6368.1115.78
2445949-44594986.38586.39
3290873-29087356.34556.35
4321087-32108762.19862.20
5319312-31931261.85461.85
6352372-35237268.25868.26
10min1476534-47653492.31088.765.6692.4388.875.67
2501511-50151197.14897.29
3431073-43107383.50383.60
4446533-44653386.49886.60
5444385-44438586.08286.19
6449083-44908386.99287.11
15min1494802-49480295.84893.603.1096.1293.863.12
2506501-50650198.11598.42
3465806-46580690.23290.46
4473271-47327191.67891.93
5477205-47720592.44092.69
6481631-48163193.29793.56
20min1498585-49858596.58195.272.2997.0295.692.31
2505454-50545497.91298.38
3476572-47657292.31792.70
4481344-48134493.24193.64
5489779-48977994.87595.28
6499264-49926496.71397.13
30min1498564-49856496.57796.431.6797.1797.011.68
2504439-50443997.71598.35
3490261-49026194.96995.51
4485932-48593294.13094.69
5500123-50012396.87997.44
6507622-50762298.33298.91
45min1498505-49850596.56696.881.8497.3297.621.85
2503023-50302397.44198.24
3496093-49609396.09896.79
4485888-48588894.12294.83
5503685-50368597.56998.29
6513564-51356499.483100.22
60min1497824-49782496.43497.021.7497.3597.921.74
2501208-50120897.08998.05
3498949-49894996.65297.51
4487891-48789194.51095.38
5505061-50506197.83698.72
6514298-51429899.625100.53
极限1520516-520516100.829100.020.41101.91101.080.41
2514900-51490099.742100.86
3516446-516446100.041101.06
4515484-51548499.855100.88
5515835-51583599.923100.97
6514965-51496599.754100.83
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%
116.343036623037783041463041443040833039630.08
216.283037733039273038500.04
单位质量响应值RSD%判断
18602.3918664.000.24数据可信
供试品溶液-2024082821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
10min12416-24160.7280.6913.440.730.6913.11
22868-28680.8640.86
32110-21100.6360.64
42144-21440.6460.65
52055-20550.6190.62
62163-21630.6520.65
15min14458-44581.3431.458.051.341.458.20
25523-55231.6641.67
34535-45351.3661.37
44942-49421.4891.49
54650-46501.4011.40
64806-48061.4481.45
20min16017-60171.8131.837.131.821.847.00
26800-68002.0492.05
36253-62531.8841.89
45759-57591.7351.74
55549-55491.6721.68
66132-61321.8471.85
30min17448-74482.2442.242.322.252.252.21
27625-76252.2972.30
37444-74442.2432.25
47165-71652.1592.17
57619-76192.2952.30
67349-73492.2142.22
45min17890-78902.3772.454.142.392.464.08
28133-81332.4502.46
38022-80222.4172.43
48702-87022.6222.63
57772-77722.3422.35
68335-83352.5112.52
60min18724-87242.6282.603.302.642.623.36
28159-81592.4582.47
38677-86772.6142.63
48931-89312.6912.71
58878-88782.6752.69
68487-84872.5572.57
极限19015-90152.7162.793.552.732.813.55
29631-96312.9022.92
39470-94702.8532.87
49568-95682.8832.90
59050-90502.7272.74
68862-88622.6702.69
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%
112.694694744690714692964693444691684692710.04
212.714673404676074674740.05
单位质量响应值RSD%判断
36979.5936780.020.39数据可信
供试品溶液-2024083021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%
5min1313262-31326260.97560.577.7060.9760.567.70
2335300-33530065.26465.26
3322927-32292762.85662.86
4305410-30541059.44659.45
5323229-32322962.91562.91
6266833-26683351.93851.94
10min1463322-46332290.18385.624.8590.2885.724.85
2448882-44888287.37287.48
3451673-45167387.91688.02
4436488-43648884.96085.06
5437504-43750485.15885.26
6401338-40133878.11878.20
15min1497226-49722696.78294.072.4497.0394.312.44
2485210-48521094.44394.70
3495925-49592596.52996.78
4478528-47852893.14393.38
5467655-46765591.02691.27
6475137-47513792.48392.70
20min1505420-50542098.37797.062.2998.7997.462.29
2501246-50124697.56597.98
3505366-50536698.36798.78
4502877-50287797.88298.28
5475636-47563692.58092.98
6501234-50123497.56297.93
30min1510413-51041399.34998.982.2499.9399.542.23
2510721-51072199.40999.98
3514229-514229100.092100.67
4514389-514389100.123100.68
5485682-48568294.53595.09
6515629-515629100.364100.90
45min1512869-51286999.827100.112.50100.57100.842.49
2518247-518247100.874101.61
3520232-520232101.260102.00
4521216-521216101.452102.18
5489307-48930795.24195.95
6524188-524188102.030102.73
60min1511884-51188499.635100.302.87100.54101.192.85
2519492-519492101.116102.02
3522957-522957101.791102.70
4522774-522774101.755102.65
5487113-48711394.81495.68
6527582-527582102.691103.56
极限1526115-526115102.405101.651.04103.48102.711.03
2520399-520399101.293102.37
3520109-520109101.236102.32
4525149-525149102.217103.28
5513399-51339999.930100.96
6528223-528223102.816103.86
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%
116.343041813041453041723042813040323041620.03
216.283032563032943032750.01
单位质量响应值RSD%判断
18614.5718628.690.06数据可信
供试品溶液-2024083021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
10min13941-39411.1881.118.181.191.118.16
23834-38341.1561.16
33562-35621.0741.07
43258-32580.9820.98
53468-34681.0451.05
64029-40291.2151.21
15min15846-58461.7621.796.441.761.796.49
26310-63101.9021.90
36072-60721.8301.83
45344-53441.6111.61
56354-63541.9161.92
65735-57351.7291.73
20min17306-73062.2022.0510.452.212.0510.34
26683-66832.0152.02
37393-73932.2292.23
45448-54481.6421.65
56919-69192.0862.09
67027-70272.1182.12
30min18481-84812.5572.493.112.572.503.13
28227-82272.4802.49
38501-85012.5632.57
47958-79582.3992.41
58434-84342.5432.55
67949-79492.3962.40
45min19298-92982.8032.771.842.822.781.80
29247-92472.7882.80
39097-90972.7422.76
49432-94322.8432.85
58954-89542.6992.71
69124-91242.7512.76
60min19176-91762.7662.885.262.782.895.22
210140-101403.0573.07
39835-98352.9652.98
49897-98972.9843.00
59426-94262.8422.86
68806-88062.6552.67
极限110341-103413.1172.974.853.142.994.86
210138-101383.0563.08
39260-92602.7922.81
49305-93052.8052.83
510265-102653.0953.12
69816-98162.9592.98
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%
112.694685514686054686294686794684314685790.03
212.714679934675154677540.08
单位质量响应值RSD%判断
36925.0636802.050.24数据可信
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%
5min1316965-31696561.72256.756.0161.7256.756.01
2288747-28874756.22856.23
3307517-30751759.88359.88
4286790-28679055.84655.85
5273508-27350853.26053.26
6274957-27495753.54253.54
10min1428984-42898483.53682.252.8183.6482.342.81
2434046-43404684.52284.62
3433097-43309784.33784.44
4421417-42141782.06282.16
5410739-41073979.98380.07
6405961-40596179.05379.14
15min1472954-47295492.09892.341.8992.3492.581.89
2486150-48615094.66894.90
3482092-48209293.87894.12
4470636-47063691.64791.88
5472505-47250592.01192.23
6460961-46096189.76389.98
20min1483534-48353494.15895.331.6194.5595.721.61
2503383-50338398.02498.42
3493714-49371496.14196.54
4488065-48806595.04195.42
5486303-48630394.69895.07
6482394-48239493.93694.31
30min1491203-49120395.65297.301.5696.2097.841.56
2513659-513659100.025100.58
3502317-50231797.81698.37
4498021-49802196.97997.52
5494910-49491096.37496.91
6497797-49779796.93697.46
45min1499900-49990097.34599.091.4898.0699.801.47
2522369-522369101.721102.44
3510384-51038499.387100.11
4507128-50712898.75399.46
5505262-50526298.38999.08
6508182-50818298.95899.65
60min1502040-50204097.76299.491.4498.64100.361.44
2524112-524112102.060102.95
3511487-51148799.602100.49
4509665-50966599.247100.11
5507127-50712798.75399.61
6510973-51097399.502100.36
极限1500958-50095897.55199.591.4998.59100.631.48
2524466-524466102.129103.19
3511103-51110399.527100.58
4510192-51019299.349100.38
5509305-50930599.177100.20
6512634-51263499.825100.84
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%
116.343042493042013041923041573041553041910.02
216.283040003038363039180.04
单位质量响应值RSD%判断
18616.3418668.180.20数据可信
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
10min13929-39291.1831.1612.081.181.1611.97
23946-39461.1881.19
33106-31060.9350.94
44330-43301.3041.30
53497-34971.0531.05
64236-42361.2761.28
15min15175-51751.5581.757.091.561.757.12
25699-56991.7161.72
36166-61661.8571.86
46258-62581.8841.89
55532-55321.6661.67
65968-59681.7971.80
20min16227-62271.8752.066.261.882.066.27
26476-64761.9501.95
37433-74332.2382.24
46979-69792.1022.11
57012-70122.1122.12
66920-69202.0842.09
30min17248-72482.1832.285.672.192.295.66
27057-70572.1252.13
37497-74972.2582.27
47637-76372.3002.31
57767-77672.3392.35
68282-82822.4942.50
45min18384-83842.5252.684.462.542.694.42
29020-90202.7162.73
39358-93582.8182.83
49116-91162.7452.76
59065-90652.7302.74
68429-84292.5382.55
60min18626-86262.5982.876.142.612.886.15
29479-94792.8542.87
310265-102653.0913.11
410054-100543.0283.04
59267-92672.7912.81
69456-94562.8472.86
极限19524-95242.8682.913.802.892.933.77
210143-101433.0543.08
39082-90822.7352.76
49850-98502.9662.99
59806-98062.9532.97
69487-94872.8572.88
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%
112.694678734677904680134676704678484678390.03
212.714675404672164673780.05
单位质量响应值RSD%判断
36866.7536772.460.19数据可信
供试品溶液-516246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%
5min1194517-19451737.92343.0111.3437.9243.0111.34
2225311-22531143.92743.93
3216045-21604542.12042.12
4257390-25739050.18150.18
5192922-19292237.61237.61
6237489-23748946.30146.30
10min1371460-37146072.42077.096.9372.4877.166.93
2379648-37964874.01774.09
3398935-39893577.77777.85
4415690-41569081.04481.13
5368965-36896571.93472.00
6437839-43783985.36285.44
15min1440272-44027285.83688.155.1186.0288.355.12
2433916-43391684.59784.79
3442882-44288286.34586.54
4461531-46153189.98190.20
5439088-43908885.60585.79
6495126-49512696.53196.75
20min1467072-46707291.06192.533.7091.3992.873.70
2459297-45929789.54589.88
3463823-46382390.42890.77
4485834-48583494.71995.09
5466348-46634890.92091.25
6505148-50514898.48598.86
30min1489616-48961695.45696.582.0295.9497.082.03
2491252-49125295.77596.26
3485538-48553894.66195.16
4507245-50724598.89399.42
5489801-48980195.49295.97
6508741-50874199.18599.73
45min1501882-50188297.84898.880.7198.4999.540.73
2509660-50966099.364100.01
3505953-50595398.64199.29
4509057-50905799.24799.94
5504932-50493298.44299.08
6511648-51164899.752100.46
60min1505065-50506598.46899.230.4999.27100.060.51
2510591-51059199.546100.36
3506859-50685998.81899.63
4510318-51031899.492100.35
5509525-50952599.338100.14
6511483-51148399.720100.60
极限1505257-50525798.50699.410.6999.47100.400.71
2510604-51060499.548100.53
3507326-50732698.90999.89
4511269-51126999.678100.70
5509433-50943399.320100.29
6515356-515356100.475101.52
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%
116.343044033044643044353043903044063044200.01
216.283043213043613043410.01
单位质量响应值RSD%判断
18630.3518694.160.25数据可信
供试品溶液-516246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
10min13047-30470.9170.889.140.920.889.09
23123-31230.9390.94
32415-24150.7260.73
42873-28730.8640.86
52888-28880.8690.87
63112-31120.9360.94
15min14058-40581.2211.328.941.221.329.04
24718-47181.4191.42
34525-45251.3611.36
44586-45861.3801.38
53762-37621.1321.13
64713-47131.4181.42
20min15286-52861.5901.665.501.591.665.48
25605-56051.6861.69
35772-57721.7361.74
45944-59441.7881.79
55168-51681.5551.56
65341-53411.6071.61
30min16342-63421.9081.939.721.911.939.72
26993-69932.1042.11
36909-69092.0782.08
46000-60001.8051.81
56823-68232.0522.06
65407-54071.6261.63
45min17598-75982.2862.307.222.292.317.12
28081-80812.4312.44
37716-77162.3212.33
47886-78862.3722.38
56603-66031.9862.00
68079-80792.4302.44
60min18876-88762.6702.613.502.682.623.49
28772-87722.6392.65
38957-89572.6942.71
48905-89052.6792.69
58277-82772.4902.50
68328-83282.5052.52
极限17156-71562.1532.6610.012.172.689.96
29673-96732.9102.93
38897-88972.6762.69
48839-88392.6592.68
59416-94162.8322.85
69064-90642.7272.74
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