依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.314727584734944736634740534741994736330.12
211.344746374743314744840.05
单位质量响应值RSD%判断
41877.3741841.620.07数据可信
长期3月-供试品溶液-2024030821批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338603-33860369.12185.5513.5569.1285.5513.55
2401937-40193782.04982.05
3478773-47877397.73497.73
4372316-37231676.00276.00
5461940-46194094.29894.30
6461078-46107894.12294.12
10min1491842-491842100.402100.621.72100.52100.761.73
2486998-48699899.41399.55
3504227-504227102.930103.09
4482458-48245898.48698.61
5490368-490368100.101100.26
6501644-501644102.403102.56
15min1494836-494836101.013101.321.25101.30101.641.26
2492737-492737100.585100.89
3505309-505309103.151103.49
4490305-490305100.088100.38
5492186-492186100.472100.80
6502779-502779102.634102.96
20min1494678-494678100.981101.271.18101.43101.751.19
2492496-492496100.535101.01
3504908-504908103.069103.58
4490803-490803100.190100.65
5491809-491809100.395100.89
6501752-501752102.425102.92
30min1494653-494653100.976101.411.21101.59102.061.22
2493234-493234100.686101.32
3505847-505847103.261103.94
4491734-491734100.380101.00
5492406-492406100.517101.18
6502778-502778102.634103.30
45min1495060-495060101.059101.211.20101.85102.031.21
2492329-492329100.501101.31
3504778-504778103.043103.89
4490576-490576100.143100.94
5490742-490742100.177101.00
6501336-501336102.340103.18
60min1492992-492992100.637100.871.16101.59101.851.17
2490837-490837100.197101.17
3502759-502759102.630103.65
4489060-48906099.834100.79
5489542-48954299.932100.93
6499562-499562101.978102.99
极限1492015-492015100.437100.771.20101.56101.921.21
2489623-48962399.949101.09
3502765-502765102.632103.82
4489220-48922099.867100.99
5489082-48908299.838101.00
6499241-499241101.912103.09
依折麦布瑞舒伐他汀钙片项目信息
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1000
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%
110.694109714112244113394114394113054112560.05
210.734108834106334107580.05
单位质量响应值RSD%判断
38471.0938281.270.35数据可信
长期3月-供试品溶液-2024030821批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1147595-14759534.61451.9822.6234.6151.9822.62
2221675-22167551.98851.99
3282927-28292766.35366.35
4179384-17938442.06942.07
5245859-24585957.65957.66
6252505-25250559.21859.22
10min1383408-38340889.91894.083.5089.9894.163.51
2391472-39147291.80991.90
3410161-41016196.19296.30
4392947-39294792.15592.22
5408450-40845095.79095.89
6420389-42038998.59098.69
15min1414305-41430597.16499.301.6097.3799.541.61
2424792-42479299.62399.86
3424056-42405699.45099.72
4419659-41965998.41998.64
5422898-42289899.17999.43
6434698-434698101.946102.21
20min1420098-42009898.52299.901.2898.89100.311.29
2430387-430387100.935101.34
3424519-42451999.559100.00
4422334-42233499.04799.43
5423965-42396599.42999.85
6434633-434633101.931102.36
30min1423445-42344599.307100.331.1599.84100.911.16
2432093-432093101.335101.91
3425631-42563199.820100.42
4425014-42501499.675100.23
5424992-42499299.670100.26
6435753-435753102.194102.80
45min1426599-426599100.047100.351.11100.75101.101.11
2431792-431792101.265102.01
3424844-42484499.635100.40
4424383-42438399.527100.25
5424227-42422799.491100.24
6435577-435577102.152102.93
60min1425726-42572699.842100.111.04100.71101.021.05
2431150-431150101.114102.03
3424303-42430399.508100.44
4423382-42338299.292100.18
5423127-42312799.233100.15
6433619-433619101.693102.64
极限1425223-42522399.72499.981.09100.76101.061.09
2430346-430346100.926102.01
3423139-42313999.235100.34
4423143-42314399.236100.29
5422286-42228699.035100.12
6433638-433638101.698102.81
依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.314746644746154743394742894741854744180.05
211.344744994736944740960.13
单位质量响应值RSD%判断
41946.7741807.410.24数据可信
长期3月-供试品溶液-2024030921批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1406372-40637282.92089.069.6282.9289.069.62
2462755-46275594.42594.42
3472661-47266196.44696.45
4382007-38200777.94877.95
5410749-41074983.81383.81
6484173-48417398.79598.80
10min1501614-501614102.354100.903.72102.49101.043.73
2488612-48861299.70199.86
3495382-495382101.082101.24
4462288-46228894.32994.46
5501719-501719102.375102.52
6517210-517210105.536105.70
15min1512607-512607104.597102.372.72104.91102.692.73
2489678-48967899.918100.24
3496154-496154101.240101.57
4484400-48440098.84199.13
5508728-508728103.806104.12
6518638-518638105.828106.17
20min1512609-512609104.597102.432.45105.08102.922.45
2488781-48878199.735100.23
3496266-496266101.263101.76
4489124-48912499.805100.26
5508052-508052103.668104.15
6517217-517217105.538106.05
30min1512871-512871104.651102.422.57105.31103.082.57
2488274-48827499.632100.29
3495229-495229101.051101.72
4488768-48876899.733100.35
5508220-508220103.702104.36
6518287-518287105.756106.45
45min1512536-512536104.583102.252.57105.41103.082.57
2487864-48786499.548100.37
3494144-494144100.830101.66
4487613-48761399.497100.28
5507479-507479103.551104.38
6516942-516942105.482106.35
60min1511138-511138104.297101.952.57105.30102.952.57
2486639-48663999.298100.29
3493411-493411100.680101.68
4485592-48559299.085100.03
5505824-505824103.213104.21
6515335-515335105.154106.20
极限1509793-509793104.023101.692.52105.20102.852.52
2485166-48516698.998100.15
3492054-492054100.403101.57
4485147-48514798.994100.11
5504275-504275102.897104.07
6513581-513581104.796106.02
依折麦布瑞舒伐他汀钙片项目信息
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1000
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%
110.694107564106514105854104874105734106100.03
210.734110884108044109460.05
单位质量响应值RSD%判断
38410.6638298.790.21数据可信
长期3月-供试品溶液-2024030921批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186984-18698443.87656.7723.5843.8856.7723.58
2247380-24738058.04858.05
3329732-32973277.37277.37
4202258-20225847.46047.46
5198300-19830046.53246.53
6286998-28699867.34567.34
10min1412381-41238196.76696.312.6896.8496.412.70
2414181-41418197.18897.29
3422771-42277199.20499.33
4404756-40475694.97795.06
5391504-39150491.86791.94
6417061-41706197.86497.98
15min1432172-432172101.410100.461.31101.64100.711.33
2428473-428473100.542100.80
3431205-431205101.183101.48
4419740-41974098.49398.73
5423045-42304599.26899.50
6434041-434041101.849102.12
20min1431711-431711101.302100.780.90101.71101.200.92
2428486-428486100.545100.97
3431281-431281101.201101.66
4422416-42241699.12199.52
5429487-429487100.780101.18
6433421-433421101.703102.15
30min1431636-431636101.284100.800.97101.86101.390.98
2427818-427818100.388100.98
3430847-430847101.099101.73
4422361-42236199.10899.67
5430226-430226100.953101.52
6434517-434517101.960102.57
45min1431576-431576101.270100.650.99102.01101.401.00
2427796-427796100.383101.14
3430009-430009100.903101.70
4421163-42116398.82799.56
5429663-429663100.821101.55
6433351-433351101.687102.47
60min1430388-430388100.991100.421.00101.90101.341.00
2426998-426998100.196101.12
3429242-429242100.723101.69
4420100-42010098.57799.47
5428690-428690100.593101.49
6432317-432317101.444102.40
极限1429453-429453100.772100.150.95101.85101.250.96
2425609-42560999.870100.97
3427945-427945100.418101.55
4419335-41933598.39899.46
5427827-427827100.391101.46
6430755-430755101.078102.20
依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.314746084742544743794742424741984743360.04
211.344749134749564749340.01
单位质量响应值RSD%判断
41939.5241881.310.10数据可信
长期3月-供试品溶液-2024031021批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1363502-36350274.11385.6610.0074.1185.6610.00
2453542-45354292.47192.47
3405381-40538182.65282.65
4447432-44743291.22591.23
5383830-38383078.25878.26
6467156-46715695.24795.25
10min1500478-500478102.041101.701.90102.16101.841.90
2513175-513175104.629104.78
3484597-48459798.80398.94
4502259-502259102.404102.56
5498457-498457101.629101.76
6493739-493739100.667100.83
15min1512219-512219104.434103.332.05104.73103.642.04
2520090-520090106.039106.37
3493056-493056100.527100.83
4506233-506233103.214103.54
5512641-512641104.521104.82
6496494-496494101.228101.55
20min1514619-514619104.924103.651.95105.39104.141.94
2520365-520365106.095106.60
3497473-497473101.428101.90
4506385-506385103.245103.74
5514933-514933104.988105.46
6496505-496505101.231101.73
30min1514831-514831104.967103.671.85105.61104.331.84
2519493-519493105.918106.60
3500913-500913102.129102.77
4505838-505838103.133103.80
5514626-514626104.925105.57
6495169-495169100.958101.62
45min1513775-513775104.752103.391.86105.57104.221.85
2518278-518278105.670106.53
3500277-500277102.000102.81
4505124-505124102.988103.83
5512087-512087104.408105.23
6493100-493100100.536101.37
60min1513478-513478104.691103.271.87105.68104.271.86
2517847-517847105.582106.62
3499713-499713101.885102.86
4503937-503937102.746103.76
5511348-511348104.257105.25
6492634-492634100.441101.44
极限1512501-512501104.492102.941.85105.66104.121.84
2515715-515715105.147106.36
3498469-498469101.631102.78
4500610-500610102.068103.25
5510338-510338104.051105.22
6491828-491828100.277101.44
依折麦布瑞舒伐他汀钙片项目信息
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1000
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%
110.694110584109964110174110024110084110160.01
210.734114404114084114240.01
单位质量响应值RSD%判断
38448.6438343.340.20数据可信
长期3月-供试品溶液-2024031021批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1188202-18820244.11546.0414.6144.1146.0414.61
2161172-16117237.77937.78
3207613-20761348.66448.66
4190777-19077744.71844.72
5184254-18425443.18943.19
6246427-24642757.76257.76
10min1399874-39987493.73092.582.3593.8092.652.35
2394960-39496092.57992.64
3402545-40254594.35794.44
4378451-37845188.70988.78
5391249-39124991.70991.78
6402682-40268294.38994.48
15min1426679-426679100.014100.151.06100.24100.381.06
2429664-429664100.713100.93
3426344-42634499.935100.17
4420003-42000398.44998.67
5427203-427203100.136100.36
6433694-433694101.658101.91
20min1435141-435141101.997101.670.61102.39102.060.61
2437073-437073102.450102.83
3432147-432147101.295101.70
4429741-429741100.731101.12
5433007-433007101.497101.89
6435331-435331102.042102.46
30min1436990-436990102.430101.990.47103.00102.550.47
2437188-437188102.477103.03
3434757-434757101.907102.48
4431652-431652101.179101.73
5435499-435499102.081102.64
6434497-434497101.846102.44
45min1436899-436899102.409101.840.48103.15102.580.48
2436448-436448102.303103.03
3434681-434681101.889102.63
4431283-431283101.093101.82
5434171-434171101.770102.50
6433245-433245101.553102.32
60min1436705-436705102.364101.740.53103.27102.650.52
2436053-436053102.211103.11
3434808-434808101.919102.83
4430659-430659100.946101.84
5433545-433545101.623102.52
6432524-432524101.384102.32
极限1436233-436233102.253101.550.63103.33102.630.63
2435534-435534102.089103.16
3434031-434031101.737102.82
4428647-428647100.475101.53
5432620-432620101.406102.48
6432416-432416101.358102.46
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