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%
1 12.224714674725064715334726274705524717370.19
2 12.204708504717004712750.13
单位质量响应值RSD%判断
38603.6838629.100.05数据可信
中间条件18月-供试品溶液-2024082321批-氢氯噻嗪-含0.35%吐温20的磷酸盐缓冲液(pH6.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1535360-53536099.51899.680.6599.5299.680.64
2532553-53255398.99699.00
3537222-53722299.86499.86
4535295-53529599.50699.51
5534394-53439499.33999.34
6542530-542530100.851100.85
10min1543960-543960101.117101.781.23101.28101.951.22
2538653-538653100.130100.30
3555879-555879103.332103.50
4544804-544804101.274101.44
5554917-554917103.154103.32
6547058-547058101.693101.86
15min1537929-53792999.996100.641.21100.33100.981.21
2530528-53052898.62098.95
3548855-548855102.027102.37
4545328-545328101.371101.71
5544744-544744101.262101.60
6540923-540923100.552100.89
20min1-0.0000.00-0.500.501.09
2-0.0000.50
3-0.0000.51
4-0.0000.50
5-0.0000.51
6-0.0000.51
30min1-0.0000.00-0.500.501.09
2-0.0000.50
3-0.0000.51
4-0.0000.50
5-0.0000.51
6-0.0000.51
45min1-0.0000.00-0.500.501.09
2-0.0000.50
3-0.0000.51
4-0.0000.50
5-0.0000.51
6-0.0000.51
60min1-0.0000.00-0.500.501.09
2-0.0000.50
3-0.0000.51
4-0.0000.50
5-0.0000.51
6-0.0000.51
极限1-0.0000.00-0.500.501.09
2-0.0000.50
3-0.0000.51
4-0.0000.50
5-0.0000.51
6-0.0000.51
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%
116.451544341547251544501548621544901545920.13
216.381544611549571547090.23
单位质量响应值RSD%判断
9397.699444.990.36数据可信
中间条件18月-供试品溶液-2024082321批-坎地沙坦酯-含0.35%吐温20的磷酸盐缓冲液(pH6.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152108-15210890.63590.791.1190.6390.791.11
2149977-14997789.36589.37
3152756-15275691.02191.02
4153201-15320191.28691.29
5151302-15130290.15590.15
6154882-15488292.28892.29
10min1153485-15348591.45592.691.3791.6192.841.36
2153773-15377391.62791.78
3158469-15846994.42594.58
4154453-15445392.03292.18
5157831-15783194.04594.20
6155334-15533492.55792.71
15min1152555-15255590.90191.400.9891.2091.710.98
2150835-15083589.87690.18
3154289-15428991.93492.24
4154614-15461492.12892.43
5154661-15466192.15692.46
6153445-15344591.43191.74
20min1-0.0000.00-0.450.461.14
2-0.0000.45
3-0.0000.46
4-0.0000.46
5-0.0000.46
6-0.0000.46
30min1-0.0000.00-0.450.461.14
2-0.0000.45
3-0.0000.46
4-0.0000.46
5-0.0000.46
6-0.0000.46
45min1-0.0000.00-0.450.461.14
2-0.0000.45
3-0.0000.46
4-0.0000.46
5-0.0000.46
6-0.0000.46
60min1-0.0000.00-0.450.461.14
2-0.0000.45
3-0.0000.46
4-0.0000.46
5-0.0000.46
6-0.0000.46
极限1-0.0000.00-0.450.461.14
2-0.0000.45
3-0.0000.46
4-0.0000.46
5-0.0000.46
6-0.0000.46
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%
1 12.224707894708194705904709904700184706410.08
2 12.204687644697704692670.16
单位质量响应值RSD%判断
38513.9938464.510.10数据可信
中间条件18月-供试品溶液-2024082521批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1373674-37367469.69270.808.4569.6970.808.45
2409751-40975176.42076.42
3342371-34237163.85463.85
4366813-36681368.41268.41
5426493-42649379.54379.54
6358539-35853966.86966.87
10min1468182-46818287.31886.783.5987.4386.893.60
2476197-47619788.81388.94
3444792-44479282.95683.06
4452295-45229584.35584.47
5490693-49069391.51691.65
6459525-45952585.70385.81
15min1482674-48267490.02189.871.7790.2890.131.78
2482357-48235789.96290.24
3474064-47406488.41588.66
4474141-47414188.42988.68
5497310-49731092.75093.04
6480590-48059089.63289.89
20min1485765-48576590.59791.161.3291.0191.581.33
2487276-48727690.87991.30
3487635-48763590.94691.34
4481856-48185689.86890.27
5500883-50088393.41793.86
6489445-48944591.28391.69
30min1492329-49232991.82192.701.5292.3893.261.51
2490128-49012891.41191.99
3504694-50469494.12794.67
4490074-49007491.40191.95
5507247-50724794.60495.20
6497780-49778092.83893.39
45min1495201-49520192.35794.041.7693.0794.761.74
2492790-49279091.90792.64
3514643-51464395.98396.68
4504364-50436494.06694.77
5512420-51242095.56896.32
6506047-50604794.38095.09
60min1495607-49560792.43394.212.0093.3095.081.99
2493288-49328892.00092.88
3518404-51840496.68497.54
4501869-50186993.60194.46
5514395-51439595.93796.85
6507233-50723394.60195.47
极限1530313-53031398.90699.170.7699.93100.200.75
2525788-52578898.06299.10
3536172-53617299.998101.02
4529045-52904598.66999.69
5534685-53468599.721100.79
6534374-53437499.663100.69
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%
116.451546001544341544881544591546791545320.07
216.381542371545151543760.13
单位质量响应值RSD%判断
9394.049424.660.24数据可信
中间条件18月-供试品溶液-2024082521批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162743-6274337.43337.078.5737.4337.068.56
267304-6730440.15540.15
355120-5512032.88532.89
463243-6324337.73237.73
567829-6782940.46840.47
656525-5652533.72433.72
10min1105925-10592563.19662.694.6963.2662.764.69
2108982-10898265.02065.09
398605-9860558.82958.88
4102971-10297161.43461.50
5112075-11207566.86666.93
6101936-10193660.81760.87
15min1123387-12338773.61574.162.7573.7874.332.76
2125917-12591775.12475.30
3120514-12051471.90172.05
4123235-12323573.52473.69
5130301-13030177.74077.92
6122459-12245973.06173.22
20min1135311-13531180.72980.532.0081.0280.822.01
2134284-13428480.11680.42
3132923-13292379.30479.58
4132874-13287479.27579.56
5140138-14013883.60883.92
6134355-13435580.15880.44
30min1143585-14358585.66586.401.4286.0986.821.43
2143680-14368085.72286.16
3144466-14446686.19186.60
4144111-14411185.97986.40
5148959-14895988.87189.32
6144089-14408985.96686.38
45min1149987-14998789.48589.940.9290.0590.510.92
2149072-14907288.93989.52
3151514-15151490.39690.94
4150334-15033489.69290.25
5153059-15305991.31791.91
6150583-15058389.84090.40
60min1150817-15081789.98090.770.9890.7091.490.98
2150417-15041789.74190.47
3152740-15274091.12791.83
4152011-15201190.69291.40
5154555-15455592.21092.96
6152324-15232490.87991.58
极限1156187-15618793.18493.360.8394.0594.230.82
2154927-15492792.43293.31
3158284-15828494.43595.29
4155187-15518792.58793.45
5157163-15716393.76694.67
6157154-15715493.76094.62
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%
1 12.224689144694094684484691784679244687750.13
2 12.204674044686834680440.20
单位质量响应值RSD%判断
38361.2938364.260.01数据可信
中间条件18月-供试品溶液-2024082721批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1305798-30579857.22158.4215.3457.2258.4215.34
2304937-30493757.05957.06
3382187-38218771.51471.51
4352755-35275566.00766.01
5271912-27191250.88050.88
6255671-25567147.84147.84
10min1438894-43889482.12581.746.8882.2281.836.89
2442639-44263982.82682.92
3472548-47254888.42388.54
4461683-46168386.39086.50
5413144-41314477.30777.39
6391955-39195573.34273.42
15min1467424-46742487.46487.443.1687.7087.683.18
2474987-47498788.87989.11
3485940-48594090.92991.20
4473920-47392088.67988.93
5457617-45761785.62985.84
6444022-44402283.08583.29
20min1476496-47649689.16189.621.8489.5490.001.86
2485151-48515190.78191.16
3491288-49128891.92992.35
4481214-48121490.04490.45
5472684-47268488.44888.80
6466955-46695587.37687.72
30min1485331-48533190.81592.371.5491.3492.901.53
2504079-50407994.32394.86
3495987-49598792.80993.38
4484681-48468190.69391.24
5498360-49836093.25393.76
6493302-49330292.30692.79
45min1489763-48976391.64493.852.2092.3294.532.17
2512483-51248395.89596.59
3497860-49786093.15993.89
4488339-48833991.37792.08
5510937-51093795.60696.27
6509855-50985595.40396.04
60min1492046-49204692.07194.372.6092.9095.212.56
2515725-51572596.50297.35
3499252-49925293.41994.30
4487438-48743891.20992.06
5516615-51661596.66897.49
6514943-51494396.35697.15
极限1520915-52091597.47399.501.1998.46100.501.19
2538105-538105100.690101.70
3536567-536567100.402101.44
4529613-52961399.101100.11
5535072-535072100.122101.10
6530165-53016599.204100.16
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%
116.451543741542211540681546041539661542470.17
216.381539771539841539800.01
单位质量响应值RSD%判断
9376.729400.490.18数据可信
中间条件18月-供试品溶液-2024082721批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147408-4740828.34729.2412.6428.3529.2412.64
247708-4770828.52628.53
358489-5848934.97334.97
453743-5374332.13532.13
544141-4414126.39326.39
641885-4188525.04425.04
10min192156-9215655.10354.637.8155.1554.687.82
290394-9039454.05054.10
3100788-10078860.26560.32
497596-9759658.35658.41
585219-8521950.95551.00
682012-8201249.03849.08
15min1115236-11523668.90367.573.9169.0467.703.92
2112057-11205767.00367.14
3118654-11865470.94771.11
4115655-11565569.15469.30
5109936-10993665.73465.86
6106454-10645463.65263.78
20min1127290-12729076.11175.341.7976.3675.591.80
2126409-12640975.58475.83
3128439-12843976.79877.07
4127116-12711676.00776.27
5124553-12455374.47474.71
6122242-12224273.09373.32
30min1140426-14042683.96583.520.9884.3583.900.97
2140455-14045583.98384.36
3139641-13964183.49683.90
4137823-13782382.40982.80
5141365-14136584.52784.89
6138363-13836382.73283.08
45min1146774-14677487.76188.191.2788.2888.701.24
2148092-14809288.54989.06
3146047-14604787.32687.87
4145115-14511586.76987.30
5150165-15016589.78990.29
6148749-14874988.94289.43
60min1149340-14934089.29590.031.6889.9690.691.65
2150720-15072090.12190.78
3148843-14884388.99889.69
4147599-14759988.25488.93
5154418-15441892.33292.98
6152487-15248791.17791.81
极限1153944-15394492.04893.591.1092.8694.401.08
2157871-15787194.39695.21
3157011-15701193.88294.72
4155005-15500592.68393.50
5156929-15692993.83394.64
6158368-15836894.69495.48
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%
1 12.224675964665874668244678174671954672040.11
2 12.204664514656484660500.13
单位质量响应值RSD%判断
38232.7338200.820.06数据可信
中间条件18月-供试品溶液批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1392422-39242273.71070.108.0573.7170.108.05
2405125-40512576.09676.10
3380680-38068071.50571.50
4338955-33895563.66763.67
5389319-38931973.12773.13
6332829-33282962.51762.52
10min1466693-46669387.66185.654.2487.7885.774.24
2478706-47870689.91790.04
3473178-47317888.87989.00
4446330-44633083.83683.94
5438181-43818182.30582.43
6432979-43297981.32881.43
15min1482424-48242490.61688.793.6290.8889.053.62
2489674-48967491.97792.25
3490913-49091392.21092.48
4464238-46423887.20087.45
5456624-45662485.76986.03
6452272-45227284.95285.19
20min1488011-48801191.66590.013.3192.0890.413.32
2493615-49361592.71893.15
3496463-49646393.25393.67
4472557-47255788.76289.15
5467251-46725187.76688.17
6457154-45715485.86986.25
30min1495998-49599893.16591.462.9193.7492.022.92
2496705-49670593.29893.88
3504270-50427094.71995.30
4479037-47903789.97990.52
5477845-47784589.75590.30
6467553-46755387.82288.35
45min1500591-50059194.02892.482.1794.7693.202.18
2498050-49805093.55194.29
3506278-50627895.09695.83
4484399-48439990.98691.68
5485325-48532591.16091.86
6479609-47960990.08790.76
60min1501138-50113894.13192.492.1295.0293.352.14
2497599-49759993.46694.36
3505386-50538694.92995.82
4484123-48412390.93591.78
5486873-48687391.45192.30
6479262-47926290.02290.84
极限1517706-51770697.24397.720.6898.2898.740.69
2522256-52225698.09799.15
3523495-52349598.33099.38
4523392-52339298.31199.30
5514642-51464296.66797.67
6520062-52006297.68598.66
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%
116.451538941536201538921540651537871538520.11
216.381536731534281535500.12
单位质量响应值RSD%判断
9352.719374.240.17数据可信
中间条件18月-供试品溶液批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161408-6140836.81636.166.7736.8236.166.77
264681-6468138.77938.78
362906-6290637.71537.71
455494-5549433.27133.27
562454-6245437.44437.44
654973-5497332.95832.96
10min1101462-10146260.83060.282.9660.8960.342.96
2104937-10493762.91462.98
3102172-10217261.25661.32
498542-9854259.08059.14
599649-9964959.74359.81
696490-9649057.84957.90
15min1120323-12032372.13871.382.3272.3071.542.32
2121725-12172572.97973.15
3121204-12120472.66672.83
4119867-11986771.86572.02
5116015-11601569.55569.72
6115230-11523069.08569.24
20min1129393-12939377.57677.462.0677.8677.742.06
2131250-13125078.68978.98
3131550-13155078.86979.16
4131134-13113478.62078.89
5126420-12642075.79476.07
6125460-12546075.21875.48
30min1140439-14043984.19983.601.9884.6184.011.98
2141164-14116484.63385.06
3141731-14173184.97385.39
4141418-14141884.78585.19
5135522-13552281.25181.65
6136368-13636881.75882.15
45min1148198-14819888.85087.711.8689.4088.261.85
2147095-14709588.18988.75
3147542-14754288.45789.02
4148575-14857589.07689.62
5141396-14139684.77285.31
6144993-14499386.92987.46
60min1148276-14827688.89788.681.8289.6089.381.82
2149338-14933889.53490.24
3150121-15012190.00390.71
4150446-15044690.19890.89
5143770-14377086.19686.88
6145573-14557387.27787.95
极限1153285-15328591.90091.671.1792.7592.511.17
2153325-15332591.92492.78
3153579-15357992.07692.93
4154126-15412692.40493.25
5149310-14931089.51790.34
6153785-15378592.20093.02
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