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(%)99.70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%
112.184819194816224811944810524808174813210.10
212.204789004791544790270.04
单位质量响应值RSD%判断
39517.3239264.510.46数据可信
供试品溶液-24072901-1批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1360452-36045265.68857.018.8165.6957.018.81
2307129-30712955.97055.97
3315552-31555257.50557.51
4303120-30312055.24055.24
5275640-27564050.23250.23
6315130-31513057.42857.43
10min1468862-46886285.44479.953.7785.5580.053.78
2430220-43022078.40278.50
3438087-43808779.83679.93
4430040-43004078.36978.46
5421755-42175576.85976.94
6443450-44345080.81380.91
15min1493631-49363189.95886.761.9890.2186.981.99
2472454-47245486.09886.32
3465629-46562984.85585.08
4475216-47521686.60286.82
5472659-47265986.13686.35
6476747-47674786.88187.11
20min1501973-50197391.47889.241.7791.8889.611.77
2489944-48994489.28689.65
3475311-47531186.61986.99
4491458-49145889.56289.93
5492058-49205889.67190.03
6487399-48739988.82289.20
30min1515493-51549393.94292.151.8494.5092.681.84
2507343-50734392.45792.97
3489212-48921289.15289.67
4509938-50993892.92993.45
5510722-51072293.07293.58
6501357-50135791.36691.89
45min1531561-53156196.87095.062.0297.5895.732.01
2525117-52511795.69696.37
3503912-50391291.83192.49
4526696-52669695.98396.65
5528273-52827396.27196.93
6514178-51417893.70294.38
60min1542284-54228498.82497.212.0599.7098.052.04
2537796-53779698.00698.84
3514377-51437793.73894.55
4539183-53918398.25999.09
5540578-54057898.51399.33
6526510-52651095.94996.78
极限1555847-555847101.29699.942.40102.33100.942.39
2554585-554585101.066102.06
3526598-52659895.96696.94
4560231-560231102.095103.09
5555167-555167101.172102.16
6538028-53802898.04899.04
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(%)99.80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%
116.513164603161553162953162103161153162470.05
216.173112433116563114500.10
单位质量响应值RSD%判断
19154.8819260.980.40数据可信
供试品溶液-24072901-1批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129665-12966537.89633.927.0137.9033.937.02
2113478-11347833.16633.17
3117582-11758234.36534.37
4112265-11226532.81132.81
5105219-10521930.75230.75
6118237-11823734.55634.56
10min1221398-22139864.70761.123.9164.7761.173.92
2202476-20247659.17759.23
3211207-21120761.72861.79
4206519-20651960.35860.41
5198968-19896858.15158.20
6214089-21408962.57162.63
15min1265490-26549077.59375.441.9377.7675.601.93
2252309-25230973.74173.89
3254039-25403974.24774.41
4259873-25987375.95276.11
5255725-25572574.73974.89
6261236-26123676.35076.51
20min1289615-28961584.64483.151.6384.9483.441.62
2281526-28152682.28082.56
3276745-27674580.88381.17
4286914-28691483.85584.14
5286233-28623383.65683.93
6286009-28600983.59083.88
30min1313470-31347091.61690.571.8592.0691.001.85
2309384-30938490.42290.84
3299107-29910787.41887.84
4313912-31391291.74592.17
5314151-31415191.81592.23
6309345-30934590.41190.84
45min1325695-32569595.18994.282.0095.7894.861.99
2325677-32567795.18495.75
3311424-31142491.01891.58
4327804-32780495.80596.38
5326710-32671095.48696.05
6318254-31825493.01493.59
60min1329135-32913596.19495.192.1396.9595.922.12
2329372-32937296.26496.99
3313422-31342291.60292.32
4331269-33126996.81897.55
5329529-32952996.31097.03
6321399-32139993.93394.67
极限1330806-33080696.68395.652.2497.6096.542.23
2331726-33172696.95297.84
3314876-31487692.02792.90
4333452-33345297.45698.35
5330882-33088296.70597.59
6321841-32184194.06394.95
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(%)99.70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%
112.184787634785234782254779404782404783380.07
212.204786544787114786820.01
单位质量响应值RSD%判断
39272.4139236.230.07数据可信
供试品溶液-24072901-2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%
5min1330069-33006960.35959.6614.2460.3659.6614.24
2292609-29260953.50953.51
3337536-33753661.72561.72
4333948-33394861.06961.07
5400213-40021373.18773.19
6263181-26318148.12848.13
10min1452473-45247382.74381.004.3782.8481.104.38
2423643-42364377.47177.56
3443587-44358781.11881.22
4444724-44472481.32681.43
5472792-47279286.45986.58
6420384-42038476.87576.96
15min1475570-47557086.96785.712.5287.2185.942.54
2462024-46202484.49084.71
3477393-47739387.30087.54
4462600-46260084.59584.83
5482875-48287588.30388.57
6451634-45163482.59082.80
20min1483295-48329588.38087.771.6288.7688.141.62
2481182-48118287.99388.35
3487603-48760389.16889.55
4468160-46816085.61285.99
5486377-48637788.94389.36
6473051-47305186.50686.85
30min1494771-49477190.47890.031.8191.0190.551.80
2498139-49813991.09491.60
3501904-50190491.78392.31
4476143-47614387.07287.59
5490569-49056989.71090.27
6492341-49234190.03490.52
45min1511597-51159793.55592.162.5594.2492.842.52
2512302-51230293.68494.34
3515442-51544294.25894.94
4483635-48363588.44289.11
5492613-49261390.08490.79
6508335-50833592.95993.60
60min1522796-52279695.60393.813.4996.4494.643.45
2524876-52487695.98496.80
3526105-52610596.20897.05
4486654-48665488.99489.81
5493608-49360890.26691.13
6523770-52377095.78196.58
极限1548046-548046100.22198.491.50101.2299.471.48
2539675-53967598.69099.66
3539544-53954498.66699.67
4530484-53048497.00997.97
5527883-52788396.53397.55
6545763-54576399.803100.76
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(%)99.80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%
116.513162813159263156643156663157123158500.09
216.173120773120083120420.02
单位质量响应值RSD%判断
19130.8319297.590.62数据可信
供试品溶液-24072901-2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%
5min1123730-12373036.15036.0112.7936.1536.0112.79
2110804-11080432.37432.37
3127569-12756937.27237.27
4128681-12868137.59737.60
5147147-14714742.99242.99
6101642-10164229.69729.70
10min1222704-22270465.06863.664.7265.1363.724.72
2204909-20490959.86959.92
3219439-21943964.11464.18
4221200-22120064.62864.69
5232079-23207967.80767.88
6206922-20692260.45760.51
15min1264137-26413777.17376.022.6377.3476.192.64
2251989-25198973.62473.78
3264648-26464877.32377.49
4258598-25859875.55575.73
5268913-26891378.56978.75
6252955-25295573.90674.06
20min1286670-28667083.75782.991.3784.0583.281.37
2281474-28147482.23982.52
3287368-28736883.96184.26
4278111-27811181.25681.55
5287733-28773384.06884.38
6282871-28287182.64782.92
30min1309412-30941290.40289.531.7190.8489.961.70
2306968-30696889.68790.10
3310551-31055190.73491.17
4296901-29690186.74687.18
5304403-30440388.93889.39
6310370-31037090.68191.09
45min1322405-32240594.19892.682.4094.7993.262.38
2320785-32078593.72494.29
3321331-32133193.88494.47
4304692-30469289.02389.60
5310872-31087290.82891.43
6323148-32314894.41594.98
60min1327319-32731995.63393.402.7696.3894.142.73
2322891-32289194.34095.06
3323000-32300094.37295.12
4306741-30674189.62190.35
5310744-31074490.79191.55
6327438-32743895.66896.39
极限1330072-33007296.43894.801.5197.3495.691.49
2324659-32465994.85695.73
3324165-32416594.71295.61
4318595-31859593.08593.96
5319551-31955193.36494.27
6329825-32982596.36697.24
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