托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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2000
标示量(mg)7.5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%
116.482033912037972035912036942035742036090.08
216.552030372027372028870.11
单位质量响应值RSD%判断
12354.9212259.030.56数据可信
供试品溶液-2025050921批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186285-18628590.73091.061.2190.7391.061.21
2186882-18688291.02191.02
3188931-18893192.01992.02
4187177-18717791.16491.16
5183112-18311289.18489.18
6189403-18940392.24892.25
10min1199689-19968997.25897.230.7497.4197.380.74
2199015-19901596.93097.08
3198294-19829496.57996.73
4200517-20051797.66197.81
5198243-19824396.55496.70
6202065-20206598.41598.57
15min1199563-19956397.19797.300.6997.5197.610.69
2198701-19870196.77797.09
3198851-19885196.85097.16
4200965-20096597.88098.19
5198642-19864296.74897.06
6201939-20193998.35498.67
20min1199623-19962397.22697.160.7097.7097.640.70
2198449-19844996.65497.13
3198712-19871296.78297.26
4200416-20041697.61298.09
5198044-19804496.45796.93
6201720-20172098.24798.73
30min1198930-19893096.88997.190.7597.5397.830.75
2198646-19864696.75097.39
3199287-19928797.06297.70
4200280-20028097.54698.19
5198005-19800596.43897.07
6202174-20217498.46999.11
45min1198666-19866696.76097.090.8597.5697.890.85
2198180-19818096.52397.32
3198898-19889896.87397.67
4200598-20059897.70198.50
5197629-19762996.25597.05
6202086-20208698.42699.24
60min1200393-20039397.60196.950.8298.5697.920.82
2197862-19786296.36897.33
3198437-19843796.64897.61
4199802-19980297.31398.28
5196827-19682795.86496.82
6201051-20105197.92298.90
极限1198021-19802196.44697.151.1597.5798.271.14
2198106-19810696.48797.61
3202783-20278398.76599.89
4199151-19915196.99698.12
5196988-19698895.94397.06
6201705-20170598.24099.38
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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2000
标示量(mg)7.5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%
116.482013432015652013892012902015162014210.06
216.552034552035802035180.05
单位质量响应值RSD%判断
12222.1512297.160.44数据可信
供试品溶液-2025050921批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1188533-18853392.17989.964.1292.1889.964.12
2178782-17878287.41187.41
3192658-19265894.19594.20
4187347-18734791.59991.60
5184893-18489390.39990.40
6171703-17170383.95083.95
10min1198325-19832596.96698.071.7797.1298.221.76
2199231-19923197.40997.55
3206338-206338100.884101.04
4200352-20035297.95798.11
5196408-19640896.02996.18
6202785-20278599.14799.29
15min1197880-19788096.74998.171.8097.0698.481.80
2199396-19939697.49097.80
3206410-206410100.919101.24
4201199-20119998.37198.69
5196635-19663596.14096.45
6203204-20320499.35299.66
20min1198131-19813196.87198.191.8997.3598.661.88
2199209-19920997.39897.87
3205988-205988100.713101.21
4201697-20169798.61599.09
5195913-19591395.78796.26
6203994-20399499.738100.21
30min1197680-19768096.65197.971.8097.2998.611.80
2199408-19940897.49698.13
3205667-205667100.556101.22
4199975-19997597.77398.42
5196048-19604895.85396.48
6203441-20344199.467100.10
45min1197742-19774296.68197.861.7597.4898.661.74
2199409-19940997.49698.29
3205254-205254100.354101.18
4199340-19934097.46298.27
5195902-19590295.78196.57
6203243-20324399.371100.17
60min1197340-19734096.48597.661.8497.4498.631.84
2198798-19879897.19798.16
3204961-204961100.211101.21
4198703-19870397.15198.12
5195353-19535395.51396.46
6203354-20335499.425100.39
极限1196511-19651196.07997.731.8697.2098.861.85
2201468-20146898.50399.62
3204284-20428499.880101.04
4198653-19865397.12698.26
5195168-19516895.42396.53
6203286-20328699.392100.53
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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2000
标示量(mg)7.5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%
116.482031902035182035222035842038812035390.13
216.552038972039232039100.01
单位质量响应值RSD%判断
12350.6712320.850.18数据可信
供试品溶液-2025051021批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176214-17621485.62386.994.0185.6286.994.01
2173547-17354784.32784.33
3191734-19173493.16593.16
4176807-17680785.91185.91
5172921-17292184.02384.02
6182914-18291488.87988.88
10min1194393-19439394.45796.171.4694.6096.321.46
2196825-19682595.63895.78
3202792-20279298.53898.69
4199361-19936196.87197.01
5197511-19751195.97296.11
6196664-19666495.56095.71
15min1195189-19518994.84396.621.5095.1496.921.50
2197309-19730995.87396.17
3203459-20345998.86299.18
4200469-20046997.40997.71
5199701-19970197.03697.34
6196959-19695995.70396.01
20min1195018-19501894.76096.601.6595.2297.061.65
2197422-19742295.92896.39
3203964-20396499.10799.59
4200679-20067997.51197.98
5199515-19951596.94597.41
6196190-19619095.33095.80
30min1195307-19530794.90196.471.5295.5297.101.52
2197142-19714295.79296.41
3203789-20378999.02299.67
4199222-19922296.80397.43
5199257-19925796.82097.44
6196525-19652595.49396.12
45min1195337-19533794.91596.671.5595.6997.461.55
2198099-19809996.25797.04
3204030-20403099.13999.95
4200282-20028297.31898.11
5199391-19939196.88597.67
6196541-19654195.50096.29
60min1196428-19642895.44597.011.5496.3897.961.53
2203229-20322998.75099.69
3203246-20324698.75899.74
4199604-19960496.98997.94
5198904-19890496.64897.59
6196487-19648795.47496.42
极限1194841-19484194.67496.451.3695.7797.561.36
2196766-19676695.61096.71
3202872-20287298.57799.72
4198748-19874896.57397.69
5198322-19832296.36697.47
6199372-19937296.87697.98
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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2000
标示量(mg)7.5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%
116.482046142046642049132046062046572046910.07
216.552048742054012051380.19
单位质量响应值RSD%判断
12420.5712395.050.15数据可信
供试品溶液-2025051021批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184867-18486789.30687.913.2789.3187.913.27
2172959-17295983.55483.55
3183850-18385088.81588.81
4176556-17655685.29185.29
5184892-18489289.31889.32
6188712-18871291.16491.16
10min1197891-19789195.59897.651.9895.7597.791.98
2204389-20438998.73798.88
3198511-19851195.89796.05
4199462-19946296.35796.50
5207386-207386100.185100.33
6205139-20513999.09999.25
15min1198021-19802195.66197.651.8295.9797.961.82
2205006-20500699.03599.34
3198949-19894996.10996.42
4199544-19954496.39696.70
5205858-20585899.44799.76
6205512-20551299.27999.60
20min1197486-19748695.40297.401.8195.8797.871.81
2204908-20490898.98899.46
3198358-19835895.82396.29
4199155-19915596.20896.67
5205050-20505099.05699.54
6204793-20479398.93299.41
30min1196535-19653594.94397.522.2195.5798.162.21
2204278-20427898.68399.32
3197953-19795395.62896.26
4199781-19978196.51197.13
5204714-20471498.89499.54
6207961-207961100.463101.11
45min1196798-19679895.07098.915.2195.8599.715.18
2204019-20401998.55899.36
3198095-19809595.69696.48
4198939-19893996.10496.89
5225368-225368108.872109.68
6205319-20531999.186100.00
60min1196805-19680595.07397.141.9596.0298.101.95
2203642-20364298.37699.34
3197611-19761195.46396.41
4198452-19845295.86996.81
5206058-20605899.543100.54
6203925-20392598.51399.49
极限1196988-19698895.16296.871.6996.2698.001.70
2203154-20315498.14099.27
3196709-19670995.02796.13
4198900-19890096.08597.19
5203819-20381998.46299.62
6203631-20363198.37199.52
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