贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.982966642968152965092966312963592965960.06
29.982961542961872961700.01
单位质量响应值RSD%判断
29719.0429676.350.11数据可信
加速6月-供试品溶液-2024090421批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188440-8844029.69731.9021.1829.7031.9021.18
291141-9114130.60430.60
3135219-13521945.40445.40
487552-8755229.39929.40
588463-8846329.70429.70
679196-7919626.59326.59
10min1221166-22116674.26474.460.8274.3174.520.83
2222596-22259674.74474.80
3224463-22446375.37175.45
4222007-22200774.54674.60
5221273-22127374.30074.35
6219002-21900273.53773.58
15min1252348-25234884.73485.460.7684.9185.640.76
2255593-25559385.82486.00
3254014-25401485.29485.50
4254155-25415585.34185.51
5257745-25774586.54786.72
6253220-25322085.02785.19
20min1266782-26678289.58189.610.3889.9089.930.37
2268427-26842790.13390.45
3266663-26666389.54189.88
4266611-26661189.52489.84
5265414-26541489.12289.44
6267350-26735089.77290.08
30min1278778-27877893.60993.940.6894.0794.400.67
2280344-28034494.13594.60
3278356-27835693.46793.96
4277488-27748893.17693.64
5282580-28258094.88695.35
6281003-28100394.35694.81
45min1285910-28591096.00495.860.7296.6296.480.71
2287511-28751196.54297.17
3282257-28225794.77795.43
4284067-28406795.38596.01
5285511-28551195.87096.49
6287547-28754796.55497.17
60min1290507-29050797.54896.980.8998.3397.770.87
2290328-29032897.48798.27
3284600-28460095.56496.37
4287421-28742196.51197.29
5288525-28852596.88297.67
6291610-29161097.91898.69
极限1295179-29517999.11699.710.47100.06100.660.47
2297278-29727899.821100.77
3298568-298568100.254101.22
4295582-29558299.252100.19
5296839-29683999.674100.62
6298236-298236100.143101.08
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.982967372965252966632965282967152966340.04
29.982965952966772966360.02
单位质量响应值RSD%判断
29722.8529723.050.01数据可信
长期6月-供试品溶液-2024090421批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1136122-13612245.66942.883.7345.6742.883.73
2123448-12344841.41741.42
3126662-12666242.49542.49
4130633-13063343.82743.83
5124759-12475941.85641.86
6125261-12526142.02542.02
10min1223432-22343274.96175.711.1575.0475.781.15
2223867-22386775.10775.18
3226022-22602275.83075.90
4230589-23058977.36277.44
5224971-22497175.47775.55
6225030-22503075.49775.57
15min1252518-25251884.71986.241.0284.9286.441.02
2256688-25668886.11886.31
3257222-25722286.29886.49
4260609-26060987.43487.64
5257659-25765986.44486.64
6257638-25763886.43786.63
20min1266879-26687989.53791.010.8489.8891.350.83
2272494-27249491.42191.76
3272467-27246791.41291.75
4272507-27250791.42691.77
5270767-27076790.84291.18
6272433-27243391.40191.74
30min1278021-27802193.27694.610.7693.7795.100.76
2283764-28376495.20295.69
3282718-28271894.85195.34
4282910-28291094.91695.42
5281204-28120494.34394.83
6283344-28334495.06195.55
45min1283522-28352295.12196.210.7395.7796.860.73
2288380-28838096.75197.40
3286945-28694596.27096.92
4287960-28796096.61097.27
5284998-28499895.61696.26
6288747-28874796.87497.52
60min1285931-28593195.92996.880.7496.7397.690.74
2290568-29056897.48598.30
3288263-28826396.71297.52
4290477-29047797.45598.27
5286647-28664796.17096.98
6290658-29065897.51598.33
极限1291355-29135597.74998.910.8598.7199.880.85
2297379-29737999.770100.74
3295668-29566899.196100.17
4293777-29377798.56299.54
5293076-29307698.32799.29
6297628-29762899.854100.83
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.982994632993362997192992342996592994820.07
29.982967322969292968300.05
单位质量响应值RSD%判断
30008.2229742.480.63数据可信
中间条件6月-供试品溶液-2024090421批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114064-11406438.07437.5510.2438.0737.5510.24
2113560-11356037.90637.91
399206-9920633.11433.11
499563-9956333.23333.23
5120021-12002140.06240.06
6128565-12856542.91442.91
10min1222952-22295274.42074.150.9774.4874.210.98
2225446-22544675.25275.32
3218846-21884673.04973.10
4222058-22205874.12274.18
5221396-22139673.90173.97
6222110-22211074.13974.21
15min1257922-25792286.09385.621.2086.2885.801.20
2256397-25639785.58485.77
3252147-25214784.16584.34
4261279-26127987.21387.39
5254691-25469185.01485.20
6256605-25660585.65385.85
20min1272541-27254190.97290.661.4091.3090.991.40
2272405-27240590.92791.26
3265898-26589888.75589.07
4277302-27730292.56292.89
5269293-26929389.88890.22
6272216-27221690.86491.20
30min1284747-28474795.04794.721.4095.5395.201.39
2281723-28172394.03794.52
3278239-27823992.87493.34
4290042-29004296.81497.29
5282681-28268194.35794.84
6285095-28509595.16395.65
45min1291656-29165697.35396.871.4797.9997.501.47
2289255-28925596.55197.19
3285172-28517295.18995.81
4296994-29699499.13599.77
5286446-28644695.61496.25
6291721-29172197.37598.02
60min1293893-29389398.10097.821.3298.9098.621.32
2292319-29231997.57498.37
3288704-28870496.36897.15
4299714-299714100.043100.85
5290015-29001596.80597.60
6293741-29374198.04998.86
极限1295513-29551398.64099.111.2199.61100.071.20
2296056-29605698.82299.78
3295288-29528898.56599.50
4303659-303659101.359102.33
5293402-29340297.93698.90
6297535-29753599.315100.29
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.982970562970352971352970822969752970570.02
29.982964772968752966760.10
单位质量响应值RSD%判断
29765.2329727.050.10数据可信
加速6月-供试品溶液-2010685批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157516-5751619.28120.6111.4919.2820.6111.49
272552-7255224.32224.32
366841-6684122.40822.41
459460-5946019.93319.93
559692-5969220.01120.01
652829-5282917.71017.71
10min1185829-18582962.29762.067.2062.3362.097.19
2204756-20475668.64268.68
3191790-19179064.29564.33
4178257-17825759.75859.79
5185180-18518062.07962.11
6164916-16491655.28655.32
15min1250256-25025683.89584.551.6384.0384.681.64
2253974-25397485.14185.30
3253502-25350284.98385.13
4253042-25304284.82984.96
5257274-25727486.24886.38
6245179-24517982.19382.31
20min1270952-27095290.83391.841.6491.1192.121.64
2271397-27139790.98291.28
3272628-27262891.39591.68
4278027-27802793.20593.48
5280953-28095394.18694.47
6269787-26978790.44390.70
30min1282251-28225194.62195.551.6095.0595.981.59
2279264-27926493.62094.07
3285098-28509895.57596.01
4288961-28896196.87097.30
5291559-29155997.74198.18
6283027-28302794.88195.29
45min1286495-28649596.04496.641.6096.6397.231.59
2281341-28134194.31694.92
3287434-28743496.35896.96
4292064-29206497.91198.50
5294525-29452598.73699.34
6287764-28776496.46997.04
60min1286501-28650196.04696.761.6796.7997.521.66
2283072-28307294.89695.66
3287673-28767396.43997.20
4292274-29227497.98198.74
5296312-29631299.335100.10
6285969-28596995.86796.60
极限1286213-28621395.94996.741.6996.8597.651.68
2281733-28173394.44795.37
3288108-28810896.58497.50
4291268-29126897.64498.56
5296167-29616799.286100.22
6287892-28789296.51297.40
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