依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.651831751833531832001834821833201833060.07
210.761858161861781859970.14
单位质量响应值RSD%判断
17211.8317285.970.31数据可信
中间条件6月-供试品溶液-2024030121批-依折麦布-pH7.0(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%
5min173872-7387238.54543.7217.9038.5443.7117.90
283679-8367943.66243.66
3103604-10360454.05854.06
469595-6959536.31336.31
5100489-10048952.43352.43
671454-7145437.28337.28
10min1135688-13568870.79974.736.1971.0174.976.23
2141617-14161773.89274.13
3154649-15464980.69280.99
4135114-13511470.49970.70
5153885-15388580.29380.58
6138370-13837072.19872.41
15min1167019-16701987.14689.412.6387.7590.072.68
2173084-17308490.31190.96
3177127-17712792.42093.17
4172243-17224389.87290.47
5173663-17366390.61391.35
6165007-16500786.09786.70
20min1180915-18091594.39796.091.3195.4997.241.37
2184631-18463196.33697.49
3187212-18721297.68398.94
4181797-18179794.85795.95
5185988-18598897.04498.28
6184442-18444296.23797.32
30min1187449-18744997.80698.080.7199.4299.770.76
2188734-18873498.477100.17
3189434-18943498.842100.65
4185669-18566996.87798.50
5188631-18863198.423100.20
6187925-18792598.05599.68
45min1190083-19008399.18198.291.39101.34100.531.37
2191277-19127799.804102.04
3190709-19070999.507101.86
4186656-18665697.39299.55
5185168-18516896.61698.94
6186403-18640397.26099.43
60min1184184-18418496.10397.742.2498.81100.522.24
2193145-193145100.778103.57
3188223-18822398.210101.12
4185633-18563396.85999.56
5190718-19071899.512102.38
6181980-18198094.95397.66
极限1186740-18674097.43698.061.42100.68101.391.44
2188554-18855498.383101.73
3187916-18791698.050101.50
4186381-18638197.249100.49
5192810-192810100.603104.02
6185255-18525596.66199.90
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数2500
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%
110.954268684266394271434265104265744267470.07
211.054311584330024320800.31
单位质量响应值RSD%判断
38972.3339102.260.24数据可信
中间条件6月-供试品溶液-2024030121批-辛伐他汀-pH7.0(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%
5min1196844-19684445.15549.9116.8145.1649.9116.80
2215673-21567349.47549.47
3267577-26757761.38161.38
4182765-18276541.92641.93
5256690-25669058.88458.88
6185851-18585142.63442.63
10min1327338-32733875.09078.985.4275.3479.265.46
2341712-34171278.38878.66
3368317-36831784.49184.83
4327811-32781175.19975.43
5366503-36650384.07584.40
6334119-33411976.64676.88
15min1391551-39155189.82091.892.1490.4992.612.16
2408398-40839893.68594.40
3407635-40763593.51094.32
4405233-40523392.95993.61
5402224-40222492.26993.06
6388383-38838389.09489.76
20min1417912-41791295.86897.020.8897.0398.240.91
2425384-42538497.58298.81
3425748-42574897.66599.00
4418485-41848595.99997.17
5424345-42434597.34398.65
6425612-42561297.63498.79
30min1422713-42271396.96996.900.8898.6798.670.86
2427141-42714197.98599.76
3421587-42158796.71198.58
4416950-41695095.64797.35
5420357-42035796.42898.28
6425720-42572097.65999.36
45min1423462-42346297.14196.071.6699.3898.371.61
2428571-42857198.313100.63
3420609-42060996.48698.90
4413246-41324694.79797.03
5409540-40954093.94796.33
6417277-41727795.72297.96
60min1408174-40817493.63495.102.2396.4197.942.21
2429815-42981598.598101.46
3414204-41420495.01797.96
4412871-41287194.71197.47
5419122-41912296.14599.05
6403267-40326792.50895.28
极限1412446-41244694.61494.851.2497.9198.221.23
2417151-41715195.69399.10
3407864-40786493.56397.04
4411382-41138294.37097.65
5421841-42184196.769100.21
6410276-41027694.11697.40
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.651846601849511854191854001855591851980.21
210.761838631837841838240.04
单位质量响应值RSD%判断
17389.4817084.011.26数据可信
中间条件6月-供试品溶液-2024030221批-依折麦布-pH7.0(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%
5min183890-8389043.80638.4310.2443.8138.4310.25
281729-8172942.67742.68
364544-6454433.70433.70
470909-7090937.02737.03
570393-7039336.75836.76
670090-7009036.60036.60
10min1141013-14101373.63472.275.5973.8872.485.60
2149920-14992078.28578.52
3134975-13497570.48170.67
4131977-13197768.91669.12
5143236-14323674.79575.00
6129287-12928767.51167.71
15min1177905-17790592.89991.503.6493.5592.123.65
2184704-18470496.44997.12
3170185-17018588.86789.45
4172713-17271390.18790.78
5178581-17858193.25293.87
6167313-16731387.36887.95
20min1187087-18708797.69397.441.9898.8698.561.99
2191069-19106999.773100.98
3186391-18639197.33098.40
4189594-18959499.002100.09
5184810-18481096.50497.64
6180644-18064494.32995.39
30min1193359-193359100.968100.750.82102.68102.420.85
2194761-194761101.701103.46
3194176-194176101.395103.01
4191361-19136199.925101.56
5193239-193239100.906102.58
6190763-19076399.613101.20
45min1187456-18745697.88699.921.65100.16102.141.64
2196201-196201102.452104.78
3192070-192070100.295102.47
4193282-193282100.928103.12
5189593-18959399.002101.24
6189463-18946398.934101.08
60min1188756-18875698.56599.661.79101.38102.441.79
2197476-197476103.118106.01
3191129-19112999.804102.54
4190202-19020299.320102.08
5188058-18805898.200100.98
6189519-18951998.963101.65
极限1184739-18473996.46798.801.8199.83102.141.80
2195072-195072101.863105.33
3189277-18927798.837102.13
4189546-18954698.977102.28
5189384-18938498.893102.22
6187246-18724697.776101.02
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数2500
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%
110.954293974301334311714311234313244306300.20
211.054274344273484273910.02
单位质量响应值RSD%判断
39326.9438677.921.18数据可信
中间条件6月-供试品溶液-2024030221批-辛伐他汀-pH7.0(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%
5min1220907-22090750.72444.699.8950.7244.699.89
2215403-21540349.46049.46
3171433-17143339.36439.36
4186396-18639642.80042.80
5187746-18774643.11043.11
6185867-18586742.67842.68
10min1342807-34280778.71476.715.4179.0076.965.41
2359521-35952182.55282.83
3325652-32565274.77574.99
4317248-31724872.84673.08
5345556-34555679.34679.59
6313604-31360472.00972.25
15min1416051-41605195.53293.813.5496.2594.483.56
2431431-43143199.06499.80
3397043-39704391.16891.80
4400964-40096492.06892.71
5413217-41321794.88295.56
6392616-39261690.15190.79
20min1427093-42709398.06897.561.9799.3298.761.98
2434647-43464799.802101.09
3423142-42314297.16198.30
4432952-43295299.413100.57
5418403-41840396.07297.28
6413130-41313094.86296.00
30min1434654-43465499.80498.870.95101.60100.610.97
2434770-43477099.831101.67
3433120-43312099.452101.13
4426142-42614297.84999.56
5426345-42634597.89699.64
6428455-42845598.381100.05
45min1414822-41482295.25096.661.4497.6098.951.43
2430799-43079998.919101.31
3420393-42039396.52998.76
4424832-42483297.54999.80
5415261-41526195.35197.64
6419786-41978696.39098.60
60min1415046-41504695.30296.011.8298.1898.841.81
2432407-43240799.288102.23
3417660-41766095.90298.67
4416057-41605795.53498.33
5409750-40975094.08696.90
6417980-41798095.97598.72
极限1405263-40526393.05594.671.4796.4698.031.47
2423402-42340297.220100.71
3411257-41125794.43297.73
4412932-41293294.81698.14
5409524-40952494.03497.37
6411456-41145694.47797.76
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 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(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10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%
110.651865001869361871441869491872531869560.16
210.761879641880761880200.05
单位质量响应值RSD%判断
17554.5517473.980.33数据可信
中间条件6月-供试品溶液-2024030321批-依折麦布-pH7.0(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%
5min188769-8876945.61640.7513.0545.6240.7513.04
276090-7609039.10039.10
365435-6543533.62533.63
470170-7017036.05836.06
584520-8452043.43243.43
690789-9078946.65446.65
10min1142913-14291373.43970.956.4273.6971.186.44
2134403-13440369.06669.28
3127049-12704965.28765.47
4129787-12978766.69466.89
5146980-14698075.52975.77
6147340-14734075.71475.97
15min1165397-16539784.99285.923.7885.6586.543.81
2166308-16630885.46186.06
3159587-15958782.00782.56
4162586-16258683.54884.12
5173012-17301288.90689.57
6176267-17626790.57891.26
20min1178101-17810191.52192.431.2892.6593.531.33
2180315-18031592.65893.73
3176963-17696390.93691.94
4179219-17921992.09593.13
5183394-18339494.24195.40
6181238-18123893.13394.32
30min1178691-17869191.82493.181.8193.4794.791.71
2180746-18074692.88094.47
3186910-18691096.04797.56
4183468-18346894.27995.83
5178534-17853491.74393.42
6179593-17959392.28793.99
45min1180984-18098493.00294.461.5395.1596.581.46
2184174-18417494.64196.75
3183600-18360094.34696.39
4188591-18859196.91198.98
5184549-18454994.83497.02
6180994-18099493.00795.22
60min1180873-18087392.94595.032.0495.6197.681.93
2185547-18554795.34797.98
3190470-19047097.877100.44
4187326-18732696.26198.87
5184545-18454594.83297.55
6180763-18076392.88995.62
极限1183688-18368894.39294.680.5997.5897.870.54
2183326-18332694.20697.37
3186174-18617495.66998.78
4184299-18429994.70697.85
5183388-18338894.23897.48
6184668-18466894.89598.14
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数2500
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%
110.954337264343484343424355484359624347850.22
211.054357924368724363320.18
单位质量响应值RSD%判断
39706.3939487.060.40数据可信
中间条件6月-供试品溶液-2024030321批-辛伐他汀-pH7.0(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%
5min1221245-22124550.03645.4412.8050.0445.4412.80
2191995-19199543.42143.42
3166446-16644637.64337.64
4178982-17898240.47840.48
5215468-21546848.73048.73
6231431-23143152.34052.34
10min1338910-33891076.64774.326.3676.9274.576.39
2320258-32025872.42972.67
3303014-30301468.52968.74
4308585-30858569.78970.01
5350488-35048879.26579.54
6350355-35035579.23579.53
15min1384011-38401186.84787.893.7987.5588.563.82
2387073-38707387.53988.18
3370331-37033183.75384.34
4378863-37886385.68286.30
5401110-40111090.71491.42
6410396-41039692.81493.54
20min1407795-40779592.22692.550.8193.4193.700.86
2412860-41286093.37194.50
3405011-40501191.59692.65
4406850-40685092.01293.10
5409532-40953292.61893.83
6413211-41321193.45094.70
30min1401934-40193490.90092.121.8292.6093.791.72
2407119-40711992.07393.72
3419967-41996794.97896.54
4411132-41113292.98094.58
5399378-39937890.32292.05
6404531-40453191.48793.25
45min1403055-40305591.15492.551.1993.3694.731.12
2412409-41240993.26995.43
3409731-40973192.66394.76
4416093-41609394.10296.22
5409651-40965192.64594.88
6404474-40447491.47593.75
60min1403193-40319391.18592.811.8093.8995.511.69
2412237-41223793.23095.91
3421645-42164595.35897.96
4414489-41448993.74096.38
5408810-40881092.45595.20
6402015-40201590.91893.70
极限1405984-40598491.81692.140.6795.0395.350.61
2406245-40624591.87595.07
3412002-41200293.17796.31
4407716-40771692.20895.37
5404176-40417691.40794.67
6408479-40847992.38095.67
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