沙库巴曲缬沙坦钠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%
114.033540773554273557333559933548013552060.22
214.013475743478033476880.05
单位质量响应值RSD%判断
25317.6124817.131.42数据可信
供试品溶液-24FA489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%
5min174898-7489821.45021.5821.2821.4521.5821.27
299510-9951028.49928.50
376946-7694622.03722.04
463883-6388318.29618.30
553102-5310215.20815.21
683823-8382324.00624.01
10min1158927-15892745.51645.589.3245.5545.619.33
2173966-17396649.82349.87
3166697-16669747.74147.78
4132967-13296738.08138.11
5153094-15309443.84543.87
6169159-16915948.44648.49
15min1198621-19862156.88456.856.5957.0056.966.60
2209807-20980760.08760.22
3204401-20440158.53958.66
4173944-17394449.81649.91
5196442-19644256.26056.36
6207736-20773659.49459.61
20min1223139-22313963.90564.434.9664.1164.634.97
2232805-23280566.67466.90
3229890-22989065.83966.05
4204509-20450958.57058.75
5223852-22385264.11064.30
6235543-23554367.45867.68
30min1253526-25352672.60873.742.0872.9274.062.10
2262343-26234375.13375.47
3260634-26063474.64474.97
4249383-24938371.42271.70
5256392-25639273.42973.73
6262651-26265175.22175.55
45min1278789-27878979.84381.901.3480.2882.341.34
2289397-28939782.88183.35
3285752-28575281.83782.29
4287158-28715882.24082.63
5285930-28593081.88882.31
6288883-28888382.73483.19
60min1294340-29434084.29786.701.6684.8687.271.64
2304292-30429287.14787.75
3300745-30074586.13186.72
4308758-30875888.42688.96
5302072-30207286.51187.07
6306083-30608387.66088.26
极限1305900-30590087.60890.562.0688.3291.282.04
2319197-31919791.41692.17
3310892-31089289.03789.77
4321023-32102391.93992.62
5322808-32280892.45093.15
6317416-31741690.90691.65
沙库巴曲缬沙坦钠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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.566061366070316079826078156058996069730.16
222.455928145934955931540.09
单位质量响应值RSD%判断
26904.8326421.111.29数据可信
供试品溶液-24FA489批-沙库巴曲-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%
5min1143028-14302810.84812.828.8810.8512.828.89
2188223-18822314.27514.28
3167060-16706012.67012.67
4171808-17180813.03013.03
5166959-16695912.66212.66
6177203-17720313.43913.44
10min1352371-35237126.72428.003.0626.7428.023.06
2381052-38105228.90028.92
3379966-37996628.81728.84
4367364-36736427.86227.88
5360763-36076327.36127.38
6373673-37367328.34028.36
15min1493265-49326537.41038.322.3537.4738.392.35
2512765-51276538.88938.96
3520959-52095939.51039.58
4491180-49118037.25237.32
5501664-50166438.04738.11
6511815-51181538.81738.89
20min1592807-59280744.96045.802.3645.0845.942.35
2602827-60282745.72045.86
3620614-62061447.06947.20
4583942-58394244.28744.42
5605161-60516145.89746.03
6618226-61822646.88747.02
30min1656162-65616249.76550.472.0949.9650.682.08
2674529-67452951.15851.37
3657389-65738949.85850.07
4675082-67508251.19951.40
5682478-68247851.76051.97
6646921-64692149.06449.28
45min1656363-65636349.78050.512.3350.0650.802.32
2676590-67659051.31451.61
3657228-65722849.84550.14
4678062-67806251.42551.71
5683431-68343151.83352.13
6644359-64435948.86949.16
60min1655990-65599049.75250.542.2550.1250.922.24
2676561-67656151.31251.70
3658080-65808049.91050.29
4681685-68168551.70052.08
5679815-67981551.55851.94
6645896-64589648.98649.36
极限1656211-65621149.76850.352.3350.2250.822.32
2674529-67452951.15851.63
3655870-65587049.74250.21
4676095-67609551.27651.74
5680231-68023151.59052.06
6640669-64066948.59049.05
沙库巴曲缬沙坦钠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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.561094578109727410980741099500109483810968530.20
222.451087227108679710870120.03
单位质量响应值RSD%判断
48619.3748419.240.30数据可信
供试品溶液-24FA489批-缬沙坦钠-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%
5min1256874-25687410.12212.039.1310.1212.039.12
2340644-34064413.42213.42
3302087-30208711.90311.90
4309871-30987112.21012.21
5301889-30188911.89511.90
6320895-32089512.64412.64
10min1635533-63553325.04226.413.2825.0626.423.28
2694339-69433927.35927.38
3688080-68808027.11227.13
4666793-66679326.27426.29
5656317-65631725.86125.88
6679936-67993626.79126.81
15min1899074-89907435.42636.282.4035.4836.342.41
2934578-93457836.82536.89
3949727-94972737.42237.49
4893358-89335835.20135.26
5914780-91478036.04536.11
6933077-93307736.76636.83
20min11082569-108256942.65643.432.3442.7743.552.34
21098755-109875543.29443.42
31133221-113322144.65244.78
41066088-106608842.00742.13
51104665-110466543.52743.65
61127522-112752244.42844.55
30min11197995-119799547.20447.892.0447.3948.092.03
21230347-123034748.47948.68
31201606-120160647.34747.55
41233723-123372348.61248.80
51246199-124619949.10449.30
61182894-118289446.60946.81
45min11198659-119865947.23147.992.3447.5048.272.33
21237415-123741548.75849.04
31202477-120247747.38147.66
41240768-124076848.89049.16
51249638-124963849.23949.52
61178637-117863746.44246.72
60min11200058-120005847.28648.002.1747.6348.352.16
21237653-123765348.76749.13
31203549-120354947.42347.78
41242132-124213248.94349.30
51243542-124354248.99949.36
61181585-118158546.55846.91
极限11194728-119472847.07647.812.3947.5048.252.37
21233464-123346448.60249.05
31198865-119886547.23947.68
41236590-123659048.72549.16
51244817-124481749.04949.49
61172328-117232846.19346.63
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