替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.901290391290831291131289571290011290390.05
2 13.881290421289801290110.04
单位质量响应值RSD%判断
9283.389294.740.09数据可信
供试品溶液-24102401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%
5min1110436-11043685.60087.393.3585.6087.393.35
2114835-11483589.00989.01
3118018-11801891.47691.48
4111566-11156686.47586.48
5107296-10729683.16683.17
6114304-11430488.59888.60
10min1134995-134995104.63596.295.13105.1196.775.10
2128188-12818899.35999.85
3118521-11852191.86692.37
4119975-11997592.99393.47
5119700-11970092.78093.24
6123979-12397996.09796.59
15min1127990-12799099.20698.782.21100.2699.802.21
2131019-131019101.554102.60
3126466-12646698.02499.04
4124240-12424096.29997.30
5124718-12471896.67097.65
6130223-130223100.937101.96
20min1140721-140721109.074101.475.30110.68103.045.26
2136762-136762106.005107.62
3129205-129205100.148101.71
4125838-12583897.53899.07
5121889-12188994.47795.99
6131021-131021101.555103.14
30min1129116-129116100.079100.161.91102.29102.291.89
2131028-131028101.561103.76
3126021-12602197.68099.80
4126456-12645698.017100.09
5131008-131008101.545103.58
6131660-131660102.050104.20
45min1127582-12758298.890100.002.22101.66102.692.20
2131520-131520101.942104.71
3127712-12771298.990101.65
4126407-12640797.979100.60
5127262-12726298.641101.25
6133580-133580103.539106.26
极限1129409-129409100.306102.304.24103.62105.544.13
2132992-132992103.083106.41
3126565-12656598.101101.31
4126242-12624297.851101.01
5136668-136668105.932109.08
6140008-140008108.521111.81
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数110系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.994298624301714303274300454299894300790.05
2 11.014305824307454306640.03
单位质量响应值RSD%判断
39133.6739115.710.04数据可信
供试品溶液-24102401批-替米沙坦-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%
5min199610-99610252.050280.848.04252.05280.848.04
2115268-115268291.671291.67
3102937-102937260.469260.47
4124499-124499315.029315.03
5112446-112446284.530284.53
6111170-111170281.301281.30
10min1217029-217029549.164529.058.56550.56530.618.55
2220372-220372557.623559.24
3173693-173693439.508440.95
4221164-221164559.627561.38
5212412-212412537.481539.06
6209817-209817530.915532.48
15min1267078-267078675.807712.038.33680.26716.538.32
2293432-293432742.492747.21
3239909-239909607.059610.95
4299916-299916758.899763.76
5296091-296091749.220753.79
6291929-291929738.689743.20
20min1358583-358583907.348874.997.93915.55883.447.92
2363503-363503919.798928.64
3291913-291913738.648745.91
4364688-364688922.796931.87
5346185-346185875.977884.71
6349894-349894885.362893.98
30min1404685-4046851024.0031047.619.071037.251060.929.04
2411243-4112431040.5981054.55
3346998-346998878.034889.40
4439248-4392481111.4611125.66
5454444-4544441149.9121163.51
6427464-4274641081.6431095.18
45min1423116-4231161070.6411114.045.071089.581133.175.08
2431191-4311911091.0731110.81
3409418-4094181035.9801052.22
4454454-4544541149.9381170.31
5457606-4576061157.9131177.90
6465811-4658111178.6751198.22
极限1429207-4292071086.0531143.746.521110.941169.076.47
2434422-4344221099.2491125.04
3421514-4215141066.5871088.59
4451188-4511881141.6731168.44
5488424-4884241235.8941262.31
6487280-4872801232.9991259.09
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号H220301-1对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.901289561289831289441289151288081289210.06
2 13.881288021287971288000.01
单位质量响应值RSD%判断
9274.899279.540.04数据可信
供试品溶液-24103001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%
5min1102427-10242779.49383.015.2279.4983.015.22
2112602-11260287.39087.39
3100378-10037877.90377.90
4110868-11086886.04486.04
5112394-11239487.22887.23
6103087-10308780.00580.01
10min1117571-11757191.24692.223.1791.6992.683.17
2125097-12509797.08797.57
3116824-11682490.66791.10
4119475-11947592.72493.20
5120020-12002093.14793.63
6113942-11394288.43088.87
15min1126878-12687898.46995.562.9599.4296.532.94
2123405-12340595.77496.80
3118807-11880792.20693.14
4126113-12611397.87698.87
5124960-12496096.98197.98
6118598-11859892.04392.98
20min1126678-12667898.31496.332.7099.8197.832.69
2124559-12455996.67098.23
3122359-12235994.96296.41
4128027-12802799.361100.90
5124496-12449696.62198.16
6118583-11858392.03293.48
30min1131462-131462102.02798.262.34104.07100.302.32
2125857-12585797.67799.77
3126019-12601997.80399.78
4127911-12791199.271101.36
5125949-12594997.74899.83
6122478-12247895.05597.01
45min1122087-12208794.75196.083.1497.3698.673.11
2123483-12348395.83598.47
3121859-12185994.57497.09
4126168-12616897.918100.56
5130172-130172101.026103.65
6119052-11905292.39694.88
极限1130443-130443101.23696.822.73104.3799.942.69
2124774-12477496.836100.01
3124161-12416196.36199.41
4125720-12572097.571100.76
5123359-12335995.73898.92
6120034-12003493.15896.16
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100320240115对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数110系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.994304104300674300394299514300054300940.05
2 11.014297224291304294260.10
单位质量响应值RSD%判断
39135.0339003.270.24数据可信
供试品溶液-24103001批-替米沙坦-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%
5min1107818-107818273.208282.9313.31273.21282.9313.31
2130452-130452330.562330.56
387533-87533221.807221.81
4113317-113317287.143287.14
5123239-123239312.285312.28
6107570-107570272.580272.58
10min1211827-211827536.764541.906.47538.28543.476.49
2237612-237612602.103603.94
3198848-198848503.876505.11
4207725-207725526.370527.97
5221466-221466561.189562.92
6205638-205638521.082522.60
15min1284340-284340720.511738.814.98725.01743.394.99
2309967-309967785.449790.63
3277412-277412702.955706.99
4286816-286816726.785731.30
5309673-309673784.704789.56
6281150-281150712.427716.84
20min1344188-344188872.164889.573.92880.67898.263.93
2374419-374419948.769958.31
3347325-347325880.113888.05
4344073-344073871.873880.43
5359785-359785911.686920.90
6336546-336546852.799861.17
30min1414317-4143171049.8691051.382.801063.221065.002.78
2430489-4304891090.8491105.66
3424442-4244421075.5261088.35
4397217-3972171006.5381019.94
5411621-4116211043.0381057.31
6411384-4113841042.4371055.54
45min1410936-4109361041.3021081.052.251060.481100.522.21
2424228-4242281074.9831095.86
3434597-4345971101.2581120.06
4425551-4255511078.3361097.33
5438447-4384471111.0141131.09
6425978-4259781079.4181098.31
极限1439517-4395171113.7251096.131.521138.691121.601.44
2427391-4273911082.9981109.85
3442193-4421931120.5061145.43
4428063-4280631084.7011109.68
5427944-4279441084.4001110.64
6430325-4303251090.4331115.33
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