依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院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500
标示量(mg)10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%
110.393386903384983392703401993388773391070.20
210.413400043397893398960.05
单位质量响应值RSD%判断
32637.8232650.910.03数据可信
影响因素30天-裸放高温-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1146584-14658444.90348.5320.1744.9048.5420.17
2143460-14346043.94643.95
3156799-15679948.03248.03
4133396-13339640.86340.86
5148615-14861545.52545.53
6221782-22178267.93967.94
10min1279036-27903685.47883.219.2485.6183.359.25
2237612-23761272.78872.92
3283778-28377886.93087.07
4256490-25649078.57178.69
5262708-26270880.47680.61
6310081-31008194.98895.19
15min1310482-31048295.11092.515.0095.5092.905.02
2275889-27588984.51484.86
3311718-31171895.48995.89
4293416-29341689.88390.24
5303941-30394193.10793.48
6316562-31656296.97397.46
20min1314921-31492196.47094.993.1997.1595.663.21
2296649-29664990.87391.48
3318101-31810197.44498.14
4298191-29819191.34591.97
5316352-31635296.90997.57
6316233-31623396.87297.65
30min1320312-32031298.12296.582.1999.0997.542.20
2315176-31517696.54897.42
3320376-32037698.14199.12
4301913-30191392.48593.39
5318006-31800697.41598.36
6315962-31596296.78997.86
45min1322509-32250998.79597.262.57100.0598.502.55
2324211-32421199.316100.48
3322242-32224298.71399.99
4302175-30217592.56693.75
5318292-31829297.50398.74
6315505-31550596.64998.01
60min1322983-32298398.94097.302.67100.5098.842.64
2326043-32604399.877101.34
3321078-32107898.35699.93
4302126-30212692.55194.01
5318277-31827797.49899.03
6315200-31520096.55698.21
极限1327134-327134100.211100.131.23102.06101.961.19
2331903-331903101.672103.44
3327268-327268100.253102.12
4328834-328834100.732102.47
5319773-31977397.95799.78
6326292-32629299.954101.89
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院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500
标示量(mg)10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%
110.393394273397543390073394093401163395430.13
210.413400243389213394720.23
单位质量响应值RSD%判断
32679.7932610.180.16数据可信
影响因素30天-裸放高湿-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1179872-17987255.09953.4210.0355.1053.4210.03
2157543-15754348.26048.26
3167060-16706051.17551.17
4168391-16839151.58351.58
5166540-16654051.01651.02
6207002-20700263.41063.41
10min1277366-27736684.96484.516.7485.1384.676.74
2254034-25403477.81777.96
3286393-28639387.73087.88
4264080-26408080.89581.05
5267161-26716181.83881.99
6306212-30621293.80193.99
15min1309907-30990794.93394.463.9495.3594.873.95
2296997-29699790.97891.36
3321948-32194898.62199.04
4293101-29310189.78490.18
5306250-30625093.81294.21
6321931-32193198.61699.09
20min1318647-31864797.61097.273.2498.3197.973.24
2311146-31114695.31295.96
3330510-330510101.244101.96
4301094-30109492.23392.90
5320016-32001698.02998.71
6323842-32384299.20199.97
30min1325385-32538599.67499.312.94100.67100.302.94
2326222-32622299.930100.87
3335171-335171102.672103.69
4306337-30633793.83994.78
5327084-327084100.194101.17
6324920-32492099.531100.60
45min1327183-327183100.22599.883.00101.52101.172.98
2330700-330700101.302102.54
3337551-337551103.401104.73
4308210-30821094.41395.64
5327296-327296100.259101.53
6325412-32541299.682101.05
60min1326540-326540100.028100.162.82101.63101.742.81
2330324-330324101.187102.73
3337371-337371103.346104.98
4309771-30977194.89196.40
5328705-328705100.691102.27
6329067-329067100.802102.46
极限1332018-332018101.706101.931.46103.60103.821.49
2333500-333500102.160104.00
3339679-339679104.053106.00
4326458-326458100.003101.80
5328643-328643100.672102.55
6336237-336237102.998104.96
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院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500
标示量(mg)10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%
110.393418883410163415143396973417003411630.26
210.413409643412983411310.07
单位质量响应值RSD%判断
32835.7132769.550.15数据可信
影响因素30天-裸放光照-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1151929-15192946.31651.4418.0846.3251.4418.07
2123149-12314937.54237.54
3179030-17903054.57854.58
4180606-18060655.05855.06
5213651-21365165.13265.13
6163966-16396649.98649.99
10min1271100-27110082.64685.417.2682.7885.567.28
2244035-24403574.39574.51
3300840-30084091.71291.88
4283934-28393486.55886.72
5293853-29385389.58289.78
6287230-28723087.56387.71
15min1304170-30417092.72794.352.3293.1194.762.33
2301109-30110991.79492.13
3314864-31486495.98896.43
4308808-30880894.14194.57
5307392-30739293.71094.17
6320600-32060097.73698.15
20min1315633-31563396.22296.651.5796.8997.341.53
2322240-32224098.23698.85
3317300-31730096.73097.46
4313611-31361195.60696.31
5310318-31031894.60295.35
6323126-32312698.50699.21
30min1323791-32379198.70998.242.1799.6699.222.12
2330195-330195100.661101.57
3322157-32215798.21199.23
4316240-31624096.40797.40
5312323-31232395.21396.24
6328834-328834100.246101.25
45min1325803-32580399.32298.532.83100.5799.812.77
2333593-333593101.697102.91
3325129-32512999.117100.43
4314802-31480295.96997.25
5309813-30981394.44895.76
6330092-330092100.630101.93
60min1323496-32349698.61998.342.76100.1799.912.71
2333146-333146101.561103.07
3326468-32646899.525101.13
4313900-31390095.69497.26
5309997-30999794.50496.10
6328455-328455100.131101.73
极限1328135-328135100.033101.140.91101.88103.010.89
2335193-335193102.185104.00
3330840-330840100.858102.77
4335081-335081102.151104.01
5328901-328901100.267102.15
6332466-332466101.354103.26
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