阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802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)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.142936832933042932182939112938512935930.11
211.182941472943962942720.06
单位质量响应值RSD%判断
26354.8526321.290.10数据可信
长期36月-供试品溶液-468193批-阿齐沙坦-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%
5min153449-5344918.20915.8836.4018.2115.8836.39
253176-5317618.11618.12
361379-6137920.91120.91
438120-3812012.98712.99
557531-5753119.60019.60
615967-159675.4405.44
10min1170438-17043858.06654.6922.5058.1754.7822.53
2179920-17992061.29661.40
3186790-18679063.63763.75
4143201-14320148.78748.86
5187929-18792964.02564.13
694909-9490932.33432.36
15min1249350-24935084.95081.239.2185.3781.629.28
2248538-24853884.67385.11
3254436-25443686.68387.15
4234717-23471779.96580.31
5247846-24784684.43884.90
6195700-19570066.67266.88
20min1275827-27582793.97092.563.7394.8793.413.84
2281919-28191996.04696.96
3279411-27941195.19196.14
4261303-26130389.02289.81
5274664-27466493.57494.51
6257025-25702587.56588.15
30min1281190-28119095.79796.444.1997.2297.804.26
2288008-28800898.12099.57
3301680-301680102.778104.26
4270505-27050592.15793.44
5286603-28660397.64299.10
6270538-27053892.16893.24
45min1282941-28294196.39495.892.9198.3497.783.02
2288375-28837598.245100.24
3290572-29057298.994101.04
4275069-27506993.71295.51
5282919-28291996.38698.38
6268915-26891591.61693.19
60min1282353-28235396.19496.192.1398.6898.622.26
2285632-28563297.31199.85
3290804-29080499.073101.67
4276617-27661794.23996.55
5284149-28414996.80699.34
6274480-27448093.51195.60
极限1289735-28973598.70998.441.67101.73101.401.78
2289191-28919198.523101.60
3297334-297334101.297104.45
4288403-28840398.255101.09
5286239-28623997.518100.59
6282832-28283296.35798.96
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.727484674844749107454874775747850.19
215.727425374126741900.13
单位质量响应值RSD%判断
4757.324719.470.57数据可信
长期36月-供试品溶液-468193批-氨氯地平-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%
5min158838-5883880.50879.2314.7280.5179.2314.72
261321-6132183.90583.91
363276-6327686.58086.58
458931-5893180.63580.63
563989-6398987.55687.56
641071-4107156.19756.20
10min171387-7138797.67895.242.8498.1395.682.89
270378-7037896.29896.76
370187-7018796.03696.52
468745-6874594.06394.51
570917-7091797.03597.52
666016-6601690.32990.64
15min172835-7283599.66097.081.35100.6598.051.34
270618-7061896.62697.63
370569-7056996.55997.57
470146-7014695.98096.95
570642-7064296.65997.68
670895-7089597.00597.82
20min173452-73452100.50498.671.04102.05100.181.05
272205-7220598.798100.34
372250-7225098.859100.41
471283-7128397.53699.04
571632-7163298.01499.58
671860-7186098.32699.68
30min170536-7053696.51498.341.5198.62100.401.47
271085-7108597.26599.35
373614-73614100.726102.83
471528-7152897.87199.92
572242-7224298.848100.96
672219-7221998.817100.72
45min172725-7272599.50997.701.39102.15100.301.37
272482-7248299.177101.80
370858-7085896.95599.61
471190-7119097.409100.00
570223-7022396.08698.74
670926-7092697.04899.50
60min171815-7181598.26496.721.28101.4699.871.20
270586-7058696.58299.76
370226-7022696.09099.29
470302-7030296.19499.32
569500-6950095.09698.29
671698-7169898.104101.09
极限172688-7268899.45998.030.78103.20101.720.76
271459-7145997.777101.49
371524-7152497.866101.60
471179-7117997.394101.06
571250-7125097.491101.21
671767-7176798.198101.73
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802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)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.142947612950022949202948102952202949430.07
211.182940272931872936070.21
单位质量响应值RSD%判断
26476.0326261.810.58数据可信
长期36月-供试品溶液-468193批-阿齐沙坦-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%
5min145033-4503315.32411.0854.7915.3211.0854.81
211317-113173.8513.85
329114-291149.9079.91
454968-5496818.70518.71
512998-129984.4234.42
641862-4186214.24514.25
10min1170201-17020157.91844.5937.9558.0044.6537.97
270782-7078224.08724.11
3115555-11555539.32339.38
4183464-18346462.43162.54
577928-7792826.51826.54
6168247-16824757.25357.33
15min1245980-24598083.70575.6717.3484.1175.9817.42
2157109-15710953.46353.62
3224769-22476976.48776.76
4258041-25804187.80988.26
5198389-19838967.51067.68
6249883-24988385.03385.43
20min1276871-27687194.21789.559.0695.0990.289.19
2220905-22090575.17275.62
3265312-26531290.28490.98
4276826-27682694.20295.14
5252330-25233085.86686.41
6286710-28671097.56598.43
30min1281610-28161095.83094.795.7397.2396.025.88
2253660-25366086.31987.19
3276562-27656294.11295.31
4286514-28651497.49998.96
5271533-27153392.40193.42
6301505-301505102.600104.01
45min1287045-28704597.67995.532.1799.6197.292.38
2272477-27247792.72294.07
3279437-27943795.09096.81
4281426-28142695.76797.77
5276053-27605393.93995.48
6288023-28802398.01299.99
60min1290339-29033998.80096.062.38101.2798.352.59
2273135-27313592.94694.81
3277153-27715394.31396.56
4286308-28630897.42899.96
5279447-27944795.09497.15
6287408-28740897.803100.33
极限1281795-28179595.89398.642.1398.91101.462.09
2289871-28987198.641101.02
3290048-29004898.701101.48
4286144-28614497.373100.45
5291026-29102699.034101.62
6300349-300349102.207105.28
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.727593475933759067585975962759190.06
215.727568975901757950.20
单位质量响应值RSD%判断
4829.454821.560.12数据可信
长期36月-供试品溶液-468193批-氨氯地平-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%
5min161510-6151082.64371.0622.5282.6471.0622.52
232831-3283144.11144.11
347773-4777364.18664.19
462613-6261384.12584.13
549669-4966966.73466.73
662946-6294684.57284.57
10min170964-7096495.34589.797.5795.8090.187.62
258920-5892079.16379.41
367005-6700590.02690.38
468960-6896092.65393.12
562953-6295384.58284.95
672160-7216096.95297.42
15min172622-7262297.57396.171.6798.5697.071.73
270718-7071895.01595.70
372441-7244197.33098.19
471152-7115295.59896.58
569835-6983593.82894.67
672716-7271697.69998.71
20min171407-7140795.94096.631.1597.4798.061.10
272424-7242497.30798.52
372847-7284797.87599.27
470905-7090595.26696.78
571278-7127895.76797.13
672673-7267397.64199.19
30min170013-7001394.06796.333.1296.1398.303.10
271546-7154696.12797.88
369371-6937193.20595.15
472337-7233797.19099.23
571234-7123495.70897.60
675699-75699101.707103.80
45min171613-7161396.21796.121.2998.8098.621.20
272955-7295598.020100.31
371640-7164096.25398.71
470210-7021094.33296.91
570971-7097195.35597.78
671873-7187396.56699.23
60min170504-7050494.72795.261.1697.8598.301.09
271959-7195996.68299.51
370107-7010794.19497.19
470013-7001394.06797.17
571160-7116095.60998.56
671680-7168096.30799.50
极限170064-7006494.13696.972.0097.78100.531.93
272523-7252397.440100.81
372504-7250497.414100.93
471011-7101195.40899.04
572764-7276497.764101.25
674166-7416699.647103.38
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