奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062399752383332397132373192380642386810.48
215.102392052392662392360.02
单位质量响应值RSD%判断
15848.6715843.440.03数据可信
长期36月-供试品溶液-20210216批-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%
5min199919-9991942.22243.098.8942.2243.098.89
2105196-10519644.45244.45
386335-8633536.48236.48
499479-9947942.03642.04
5111392-11139247.07047.07
6109488-10948846.26646.27
10min1143362-14336260.58061.672.7460.8161.912.76
2147838-14783862.47162.72
3141684-14168459.87160.07
4142446-14244660.19360.43
5148994-14899462.96063.22
6151378-15137863.96764.22
15min1165891-16589170.10071.752.2970.6772.332.30
2172245-17224572.78573.38
3168703-16870371.28871.82
4165084-16508469.75970.33
5174901-17490173.90774.52
6171907-17190772.64273.25
20min1182612-18261277.16677.682.1578.1378.662.15
2187551-18755179.25380.25
3182170-18217076.97977.91
4177421-17742174.97275.93
5187821-18782179.36780.39
6185385-18538578.33779.35
30min1191630-19163080.97683.952.4682.3785.372.44
2196389-19638982.98784.43
3202853-20285385.71987.08
4196113-19611382.87184.24
5204811-20481186.54688.01
6200243-20024384.61686.07
45min1213146-21314690.06889.331.8691.9191.211.82
2212241-21224189.68691.59
3216107-21610791.31993.15
4204515-20451586.42188.25
5212439-21243989.77091.71
6209944-20994488.71590.64
60min1214533-21453390.65491.512.3192.9993.892.28
2217989-21798992.11594.51
3222204-22220493.89696.24
4207674-20767487.75690.07
5218368-21836892.27594.72
6218618-21861892.38194.79
极限1218160-21816092.18792.872.1695.0395.752.12
2220015-22001592.97195.88
3226983-22698395.91598.78
4212829-21282989.93492.73
5222418-22241893.98696.94
6218279-21827992.23795.16
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062418442414892411342407412415302413480.18
215.102420362420172420260.01
单位质量响应值RSD%判断
16025.7616028.210.02数据可信
长期36月-供试品溶液-20210217批-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%
5min1103353-10335343.18043.192.8643.1843.192.86
2106914-10691444.66844.67
399940-9994041.75541.75
4105559-10555944.10244.10
5104701-10470143.74443.74
699812-9981241.70141.70
10min1144681-14468160.44760.413.4260.6960.653.40
2140703-14070358.78559.03
3140588-14058858.73758.97
4147320-14732061.55061.79
5141230-14123059.00559.25
6153071-15307163.95264.18
15min1166597-16659769.60471.003.0170.1871.583.00
2169297-16929770.73271.31
3162792-16279268.01468.57
4169813-16981370.94771.53
5174176-17417672.77073.34
6177008-17700873.95374.54
20min1176422-17642273.70876.032.8774.6777.002.85
2175865-17586573.47674.44
3183108-18310876.50277.44
4181290-18129075.74276.72
5186446-18644677.89678.87
6188762-18876278.86479.86
30min1195466-19546681.66583.071.9083.0484.461.90
2199977-19997783.55084.93
3194975-19497581.46082.82
4198357-19835782.87384.27
5198748-19874883.03684.44
6205409-20540985.81987.25
45min1195580-19558081.71284.452.7383.5486.312.71
2198534-19853482.94784.79
3201538-20153884.20286.02
4201054-20105483.99985.86
5204611-20461185.48687.35
6211543-21154388.38290.29
60min1205770-20577085.97085.990.6588.2588.310.67
2203631-20363185.07687.38
3205678-20567885.93188.21
4206426-20642686.24488.57
5205666-20566685.92688.27
6207750-20775086.79789.20
极限1211526-21152688.37587.552.1891.1390.352.15
2207297-20729786.60889.38
3206746-20674686.37889.14
4203902-20390285.18988.00
5210994-21099488.15290.97
6216864-21686490.60593.49
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062384972397282388522387502389362389530.20
215.102409862412012410940.07
单位质量响应值RSD%判断
15866.7315966.490.45数据可信
长期36月-供试品溶液-20210218批-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%
5min1112070-11207047.14844.643.2047.1544.643.20
2102767-10276743.23443.23
3106465-10646544.79044.79
4102965-10296543.31743.32
5105624-10562444.43644.44
6106830-10683044.94344.94
10min1151632-15163263.79165.601.3964.0565.851.38
2157158-15715866.11666.36
3156119-15611965.67965.93
4157528-15752866.27266.51
5156723-15672365.93366.18
6156411-15641165.80266.05
15min1176245-17624574.14675.551.4174.7676.161.39
2182234-18223476.66577.27
3178336-17833675.02575.64
4180175-18017575.79976.41
5177949-17794974.86375.48
6182587-18258776.81477.43
20min1191938-19193880.74881.773.0181.7882.812.97
2198887-19888783.67184.70
3190920-19092080.31981.35
4186894-18689478.62679.66
5194515-19451581.83282.86
6203105-20310585.44686.49
30min1199870-19987084.08586.462.1585.5687.952.12
2203709-20370985.70087.20
3205231-20523186.34087.82
4203849-20384985.75987.23
5207496-20749687.29388.78
6212926-21292689.57791.09
45min1212498-21249889.39790.581.7691.3492.541.75
2216325-21632591.00792.98
3210591-21059188.59590.55
4213945-21394590.00691.95
5217315-21731591.42493.39
6221160-22116093.04195.06
60min1214319-21431990.16391.931.8592.6094.401.83
2225015-22501594.66397.14
3216697-21669791.16493.61
4215623-21562390.71293.16
5217811-21781191.63294.11
6221593-22159393.22495.75
极限1216974-21697491.28092.152.0894.2295.142.05
2218554-21855491.94594.95
3213149-21314989.67192.63
4218692-21869292.00394.95
5219992-21999292.55095.54
6226954-22695495.47998.53
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062406682400882430982427312421002417370.55
215.102439382432752436060.20
单位质量响应值RSD%判断
16051.5916132.850.36数据可信
长期36月-供试品溶液-SX026YA批-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%
5min1111307-11130746.31542.676.5046.3242.676.50
2108721-10872145.23945.24
396385-9638540.10640.11
4102742-10274242.75142.75
5101784-10178442.35342.35
694294-9429439.23639.24
10min1158284-15828465.86365.382.2966.1265.622.30
2162695-16269567.69867.95
3153660-15366063.93964.16
4158236-15823665.84366.08
5152795-15279563.57963.81
6157076-15707665.36065.58
15min1181265-18126575.42574.801.5376.0575.401.53
2179605-17960574.73475.36
3181606-18160675.56776.15
4181012-18101275.32075.92
5180746-18074675.20975.80
6174363-17436372.55373.13
20min1193983-19398380.71780.340.9181.7681.360.89
2189535-18953578.86679.91
3193394-19339480.47281.47
4193979-19397980.71681.74
5193606-19360680.56081.57
6193921-19392180.69181.68
30min1196071-19607181.58683.361.4383.0884.821.40
2199955-19995583.20284.68
3200685-20068583.50684.95
4203562-20356284.70386.17
5203278-20327884.58586.04
6198494-19849482.59484.03
45min1201677-20167783.91986.411.9085.8688.331.85
2210806-21080687.71789.66
3208457-20845786.74088.65
4203977-20397784.87686.82
5209616-20961687.22289.15
6211413-21141387.97089.86
60min1209673-20967387.24687.390.9389.6689.800.91
2210847-21084787.73490.16
3209053-20905386.98889.38
4213332-21333288.76891.18
5207557-20755786.36588.77
6209725-20972587.26889.65
极限1208281-20828186.66787.801.2789.5690.691.23
2208377-20837786.70789.62
3214205-21420589.13292.01
4213568-21356888.86791.77
5212272-21227288.32791.22
6209301-20930187.09189.96
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