XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
117.651101181100531101761102111102001101520.06
217.611096401096161096280.02
单位质量响应值RSD%判断
6240.916225.330.18数据可信
供试品溶液-2024121021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min197855-9785593.63091.301.4893.6391.301.48
294637-9463790.55190.55
396242-9624292.08792.09
494205-9420590.13890.14
595284-9528491.17091.17
694304-9430490.23390.23
5min1105687-105687101.124100.660.64102.16101.670.64
2105718-105718101.154102.16
3105809-105809101.241102.26
4104549-104549100.035101.04
5105180-105180100.639101.65
6104240-10424099.740100.74
10min1105794-105794101.226100.790.64103.39102.920.64
2105921-105921101.348103.48
3105895-105895101.323103.47
4104755-104755100.232102.35
5105319-105319100.772102.90
6104324-10432499.820101.93
15min1104310-10431099.807100.990.71103.10104.240.66
2106249-106249101.662104.92
3105040-105040100.505103.78
4106012-106012101.435104.66
5106030-106030101.452104.70
6105640-105640101.079104.30
30min1104384-10438499.877100.860.62104.27105.230.59
2105469-105469100.916105.30
3104882-104882100.354104.74
4106020-106020101.443105.80
5105970-105970101.395105.77
6105743-105743101.178105.52
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
117.651095421096311097691096211095901096310.08
217.611094541096041095290.10
单位质量响应值RSD%判断
6211.396219.700.10数据可信
供试品溶液-2024121021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min193906-9390690.10690.821.4590.1190.821.45
296419-9641992.51792.52
396329-9632992.43192.43
493202-9320289.43089.43
594033-9403390.22790.23
694030-9403090.22590.22
5min1104350-104350100.127100.610.59101.13101.620.58
2104494-104494100.265101.29
3104255-104255100.036101.06
4105899-105899101.613102.61
5104997-104997100.748101.75
6105097-105097100.844101.85
10min1104369-104369100.145100.720.60102.26102.840.58
2104575-104575100.343102.48
3104401-104401100.176102.31
4105797-105797101.515103.64
5105065-105065100.813102.93
6105593-105593101.320103.44
15min1104155-10415599.940100.610.64103.17103.860.62
2104538-104538100.307103.56
3104345-104345100.122103.37
4105925-105925101.638104.89
5104882-104882100.637103.88
6105307-105307101.045104.29
30min1104307-104307100.086100.680.66104.42105.050.65
2104707-104707100.469104.84
3104215-10421599.997104.36
4105862-105862101.578105.96
5104822-104822100.580104.94
6105662-105662101.386105.76
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
117.651097911098161097611095671096701097210.10
217.611094551093491094020.07
单位质量响应值RSD%判断
6216.496212.490.05数据可信
供试品溶液-2024121021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1105603-105603101.34699.221.16101.3599.221.16
2102805-10280598.66198.66
3103746-10374699.56499.56
4102672-10267298.53498.53
5102274-10227498.15298.15
6103213-10321399.05399.05
5min1105099-105099100.86399.691.19101.99100.791.19
2102098-10209897.98399.08
3105125-105125100.888101.99
4103553-10355399.379100.47
5102912-10291298.76499.85
6104449-104449100.239101.34
10min1103780-10378099.59799.471.11101.84101.681.09
2104546-104546100.332102.52
3105229-105229100.988103.21
4103404-10340499.236101.44
5102085-10208597.970100.16
6102826-10282698.681100.90
15min1103097-10309798.94197.521.97102.29100.831.93
298251-9825194.29197.59
3104022-10402299.829103.18
4102042-10204297.929101.23
5101034-10103496.962100.24
6101229-10122997.149100.46
30min1101932-10193297.82397.401.23102.28101.801.20
299278-9927895.27699.62
3101953-10195397.844102.30
4102890-10289098.743103.13
5101911-10191197.803102.16
6101005-10100596.934101.32
XXYYYY片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
117.651096121096141096961096171095371096150.06
217.611095001096941095970.13
单位质量响应值RSD%判断
6210.486223.570.15数据可信
供试品溶液-2024121021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1101060-10106096.94797.610.9996.9597.610.99
2101216-10121697.09797.10
3102831-10283198.64698.65
4100865-10086596.76096.76
5101331-10133197.20797.21
6103215-10321599.01499.01
5min1103120-10312098.923100.651.41100.00101.741.41
2104411-104411100.162101.24
3107406-107406103.035104.13
4104721-104721100.459101.53
5104155-10415599.916101.00
6105710-105710101.408102.51
10min1103173-10317398.974100.601.13101.15102.811.13
2104504-104504100.251102.44
3106490-106490102.156104.40
4104844-104844100.577102.77
5104330-104330100.084102.27
6105890-105890101.581103.81
15min1103171-10317198.972100.591.20102.25103.911.19
2104429-104429100.179103.48
3106674-106674102.333105.71
4104801-104801100.536103.84
5104188-10418899.948103.25
6105866-105866101.558104.91
30min1103094-10309498.898100.551.14103.27104.981.14
2104432-104432100.182104.60
3106450-106450102.118106.63
4104874-104874100.606105.03
5104222-10422299.980104.39
6105797-105797101.491105.98
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