依折麦布匹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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.141330621331341329661329601328091329860.10
211.171341111348431344770.39
单位质量响应值RSD%判断
11937.7012039.120.60数据可信
供试品溶液-24020201批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1125837-12583790.97589.796.0390.9889.796.03
2122661-12266188.67988.68
3132884-13288496.07096.07
4130979-13097994.69394.69
5112386-11238681.25181.25
6120458-12045887.08687.09
10min1140689-140689101.71398.072.86101.8698.212.86
2133778-13377896.71696.86
3138612-138612100.211100.37
4137361-13736199.30799.46
5130415-13041594.28594.42
6133014-13301496.16496.31
15min1140414-140414101.51498.452.84101.8398.762.84
2133709-13370996.66696.98
3139262-139262100.681101.01
4138442-138442100.088100.41
5130352-13035294.23994.53
6134841-13484197.48597.79
20min1139666-139666100.97398.242.73101.4698.722.73
2134226-13422697.04097.51
3138827-138827100.367100.86
4138394-138394100.053100.54
5130092-13009294.05194.50
6134150-13415096.98597.45
30min1140360-140360101.47598.033.01102.1398.673.01
2133552-13355296.55397.18
3138432-138432100.081100.74
4138243-13824399.944100.60
5129604-12960493.69994.31
6133369-13336996.42197.05
45min1140213-140213101.36998.073.06102.2098.883.06
2133186-13318696.28897.08
3138893-138893100.414101.24
4138045-13804599.801100.62
5129223-12922393.42394.19
6134361-13436197.13897.93
60min1138917-138917100.43297.562.93101.4398.532.94
2133190-13319096.29197.24
3138085-13808599.830100.83
4137609-13760999.486100.48
5128705-12870593.04993.97
6133147-13314796.26097.21
极限1139084-139084100.55297.892.67101.7299.022.68
2132939-13293996.11097.22
3137481-13748199.393100.56
4138056-13805699.809100.96
5129541-12954193.65394.73
6135317-13531797.82998.94
依折麦布匹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(%)100.0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%
111.373828003830893829573838933833033832080.12
211.353833293825853829570.14
单位质量响应值RSD%判断
33703.4333740.700.08数据可信
供试品溶液-24020201批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148840-14884039.72432.2029.4639.7232.2029.46
2118701-11870131.68031.68
3118213-11821331.55031.55
460643-6064316.18516.18
5163774-16377443.70943.71
6113726-11372630.35230.35
10min1289400-28940077.23769.8013.9877.3069.8613.99
2263213-26321370.24870.30
3262169-26216969.97070.02
4199241-19924153.17553.20
5304997-30499781.40081.47
6250260-25026066.79166.84
15min1339800-33980090.68887.374.9990.8887.545.02
2325723-32572386.93187.10
3328247-32824787.60587.77
4302076-30207680.62080.74
5349051-34905193.15793.37
6319389-31938985.24185.40
20min1360697-36069796.26694.262.2296.6194.582.26
2351937-35193793.92894.24
3353905-35390594.45394.77
4340533-34053390.88491.13
5362037-36203796.62396.99
6349994-34999493.40993.71
30min1377934-377934100.86699.560.90101.37100.030.94
2372677-37267799.46399.93
3373914-37391499.793100.27
4368714-36871498.40598.81
5374931-374931100.064100.59
6370005-37000598.75099.21
45min1382958-382958102.207101.940.54102.88102.580.55
2378770-378770101.089101.73
3384819-384819102.703103.34
4381011-381011101.687102.25
5382579-382579102.106102.80
6381715-381715101.875102.50
60min1384388-384388102.588102.540.38103.43103.340.37
2381458-381458101.806102.61
3384429-384429102.599103.41
4385683-385683102.934103.67
5384644-384644102.657103.52
6384575-384575102.638103.43
极限1385549-385549102.898103.060.98103.91104.040.95
2381550-381550101.831102.81
3385598-385598102.911103.89
4388366-388366103.650104.56
5383531-383531102.360103.39
6392234-392234104.682105.65
依折麦布匹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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.141330531331701333151337801334071333450.21
211.171353311352281352800.06
单位质量响应值RSD%判断
11969.9312111.010.83数据可信
供试品溶液-24021801批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114287-11428782.26983.706.7782.2783.706.77
2124752-12475289.80289.80
3107643-10764377.48777.49
4108173-10817377.86877.87
5125944-12594490.66090.66
6116836-11683684.10484.10
10min1135664-13566497.65797.981.4397.7998.121.42
2132671-13267195.50395.65
3137940-13794099.29699.42
4137928-13792899.28799.42
5136506-13650698.26398.41
6135999-13599997.89898.04
15min1136953-13695398.58598.850.9998.8999.160.99
2134807-13480797.04097.35
3138115-13811599.42299.72
4137384-13738498.89599.19
5138396-13839699.62499.94
6138277-13827799.53899.84
20min1136839-13683998.50398.790.8298.9799.260.81
2135164-13516497.29797.77
3138300-13830099.555100.02
4137650-13765099.08799.55
5137750-13775099.15999.64
6137699-13769999.12299.59
30min1136726-13672698.42298.820.7899.0599.450.78
2135409-13540997.47498.11
3138433-13843399.651100.28
4137736-13773699.14999.77
5137847-13784799.22999.87
6137503-13750398.98199.62
45min1137132-13713298.71498.860.9199.5199.660.91
2134938-13493897.13597.93
3138424-13842499.644100.44
4137773-13777399.17599.97
5137741-13774199.15299.96
6138015-13801599.350100.15
60min1136371-13637198.16698.510.9799.1299.470.96
2134498-13449896.81897.78
3138281-13828199.541100.50
4137624-13762499.068100.02
5136956-13695698.58799.56
6137344-13734498.86799.83
极限1136631-13663198.35398.440.9399.4799.570.92
2134344-13434496.70797.83
3137824-13782499.212100.34
4136833-13683398.49999.62
5137607-13760799.056100.20
6137311-13731198.84399.97
依折麦布匹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(%)100.0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%
111.373832383838903847333832623829683836180.19
211.353852683852893852780.01
单位质量响应值RSD%判断
33739.4933945.200.43数据可信
供试品溶液-24021801批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149301-14930139.70533.5929.7039.7133.5929.70
266664-6666417.72917.73
3161952-16195243.07043.07
4155584-15558441.37641.38
597642-9764225.96725.97
6126672-12667233.68733.69
10min1291212-29121277.44572.1514.4077.5172.2014.41
2207794-20779455.26155.29
3308220-30822081.96882.04
4304608-30460881.00881.08
5244457-24445765.01165.05
6271409-27140972.17972.24
15min1342005-34200590.95389.254.9691.1589.424.99
2306760-30676081.58081.70
3347964-34796492.53892.75
4351641-35164193.51693.72
5326105-32610586.72586.88
6339083-33908390.17690.35
20min1361536-36153696.14795.562.9296.4995.892.95
2341445-34144590.80491.06
3364389-36438996.90697.27
4371912-37191298.90799.27
5353987-35398794.14094.44
6362779-36277996.47896.80
30min1378420-378420100.638100.491.65101.14100.971.68
2368391-36839197.97098.38
3378805-378805100.740101.26
4386951-386951102.906103.43
5374231-37423199.52499.98
6380310-380310101.140101.63
45min1384653-384653102.295102.541.09102.97103.201.12
2380004-380004101.059101.63
3384915-384915102.365103.06
4392339-392339104.339105.04
5383643-383643102.027102.65
6387906-387906103.160103.82
60min1386273-386273102.726103.211.04103.57104.031.06
2384481-384481102.249102.99
3387155-387155102.961103.82
4395413-395413105.157106.03
5385433-385433102.503103.29
6389694-389694103.636104.46
极限1386071-386071102.672103.240.93103.69104.240.95
2385296-385296102.466103.38
3386939-386939102.903103.94
4394782-394782104.989106.03
5386264-386264102.724103.68
6389915-389915103.695104.70
依折麦布匹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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.141331091323981331671330191330981329580.24
211.171342741346531344640.20
单位质量响应值RSD%判断
11935.1912037.960.61数据可信
供试品溶液-24021802批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124276-12427689.86185.675.3789.8685.675.37
2106906-10690677.30177.30
3115675-11567583.64183.64
4120517-12051787.14387.14
5122529-12252988.59788.60
6120981-12098187.47887.48
10min1135915-13591598.27696.741.8398.4396.881.83
2132856-13285696.06496.19
3137479-13747999.40799.55
4130928-13092894.67094.82
5133290-13329096.37896.53
6132266-13226695.63895.78
15min1136010-13601098.34598.011.9098.6698.311.90
2135156-13515697.72898.02
3140336-140336101.473101.78
4132914-13291496.10696.41
5134781-13478197.45697.76
6134057-13405796.93397.24
20min1135898-13589898.26497.802.1298.7498.272.11
2135367-13536797.88098.33
3140337-140337101.474101.95
4132127-13212795.53796.00
5134661-13466197.37097.84
6133150-13315096.27796.74
30min1135655-13565598.08897.681.9298.7398.321.91
2135067-13506797.66398.28
3139879-139879101.143101.79
4132694-13269495.94796.57
5133951-13395196.85697.49
6133324-13332496.40397.03
45min1136206-13620698.48797.532.1699.2998.322.15
2134750-13475097.43498.21
3139978-139978101.214102.03
4131938-13193895.40196.18
5133568-13356896.57997.37
6132887-13288796.08796.87
60min1135650-13565098.08597.312.1899.0598.262.17
2134649-13464997.36198.30
3139678-139678100.997101.98
4131386-13138695.00295.94
5133620-13362096.61797.57
6132460-13246095.77896.73
极限1134848-13484897.50597.032.3298.6498.152.31
2134423-13442397.19898.30
3139740-139740101.042102.19
4130797-13079794.57695.68
5133380-13338096.44397.56
6131982-13198295.43396.54
依折麦布匹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(%)100.0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%
111.373835953832973826483814803813593824760.27
211.353823333822583822960.02
单位质量响应值RSD%判断
33639.0533682.470.10数据可信
供试品溶液-24021802批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1134845-13484536.05435.2724.7036.0535.2724.70
2160202-16020242.83442.83
3147031-14703139.31239.31
475337-7533720.14320.14
5159561-15956142.66242.66
6114489-11448930.61130.61
10min1294943-29494378.86072.6511.3378.9272.7111.34
2307723-30772382.27782.35
3246868-24686866.00666.07
4229634-22963461.39861.43
5291092-29109277.83077.90
6260069-26006969.53669.59
15min1347087-34708792.80290.003.2992.9990.183.31
2348852-34885293.27493.48
3332556-33255688.91789.09
4320083-32008385.58285.72
5341015-34101591.17891.38
6330157-33015788.27588.44
20min1365044-36504497.60395.971.8397.9596.301.85
2364582-36458297.48097.84
3359734-35973496.18396.51
4348507-34850793.18293.46
5361913-36191396.76697.12
6353827-35382794.60494.92
30min1380496-380496101.735100.460.94102.24100.950.96
2377455-377455100.922101.45
3375492-375492100.397100.88
4371019-37101999.20199.63
5377448-377448100.920101.43
6372525-37252599.603100.08
45min1388941-388941103.993102.440.96104.67103.100.97
2384256-384256102.740103.43
3384636-384636102.842103.49
4378530-378530101.209101.81
5381713-381713102.060102.74
6380715-380715101.793102.43
60min1389360-389360104.105102.850.71104.96103.680.72
2383927-383927102.652103.52
3386339-386339103.297104.12
4382572-382572102.290103.06
5383620-383620102.570103.42
6382186-382186102.187102.99
极限1388698-388698103.928102.910.65104.95103.900.66
2385478-385478103.067104.10
3386423-386423103.319104.31
4381909-381909102.112103.05
5383397-383397102.510103.53
6383413-383413102.515103.49
依折麦布匹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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.141350981351191352921355381356811353460.20
211.171375151365131370140.52
单位质量响应值RSD%判断
12149.5512266.250.68数据可信
供试品溶液-2024061321批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126616-12661689.89385.4510.3689.8985.4510.36
2127308-12730890.38490.38
395070-9507067.49667.50
4123680-12368087.80987.81
5125167-12516788.86488.86
6124328-12432888.26988.27
10min1133005-13300594.42994.601.5594.5894.741.55
2133932-13393295.08795.24
3133018-13301894.43894.55
4134237-13423795.30495.45
5135691-13569196.33696.48
6129556-12955691.98092.13
15min1133054-13305494.46495.372.1394.7795.672.12
2134653-13465395.59995.91
3135025-13502595.86396.13
4136775-13677597.10697.41
5137102-13710297.33897.65
6129342-12934291.82892.13
20min1133603-13360394.85495.492.1995.3295.952.19
2134311-13431195.35695.82
3135641-13564196.30196.73
4137269-13726997.45697.92
5136918-13691897.20797.68
6129239-12923991.75592.21
30min1133227-13322794.58795.472.0495.2196.082.03
2134111-13411195.21495.84
3135895-13589596.48197.07
4137200-13720097.40798.04
5136567-13656796.95897.59
6129800-12980092.15492.76
45min1133124-13312494.51495.322.1295.2996.102.11
2133824-13382495.01195.80
3135830-13583096.43597.19
4137252-13725297.44498.24
5136161-13616196.67097.46
6129373-12937391.85092.61
60min1132691-13269194.20695.082.1895.1496.022.17
2133927-13392795.08496.03
3135141-13514195.94696.86
4136333-13633396.79297.75
5136620-13662096.99697.95
6128801-12880191.44492.36
极限1133268-13326894.61695.032.2195.7196.132.20
2134175-13417595.26096.36
3134963-13496395.81996.89
4136451-13645196.87697.99
5135959-13595996.52697.64
6128321-12832191.10492.17
依折麦布匹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(%)100.0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%
111.373855123862523873923871053861803864880.20
211.353828103839773833940.22
单位质量响应值RSD%判断
33991.9133779.210.45数据可信
供试品溶液-2024061321批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198414-9841426.13925.4919.8726.1425.4919.87
299188-9918826.34526.34
364693-6469317.18317.18
486117-8611722.87322.87
5106899-10689928.39328.39
6120595-12059532.03032.03
10min1245939-24593965.32265.167.7865.3765.207.78
2258321-25832168.61168.65
3236568-23656862.83362.86
4212134-21213456.34356.38
5253525-25352567.33767.38
6265430-26543070.49970.55
15min1312297-31229782.94784.323.3883.1084.473.39
2325509-32550986.45686.61
3319524-31952484.86685.00
4299321-29932179.50079.63
5318426-31842684.57584.73
6329650-32965087.55687.73
20min1343749-34374991.30192.101.7191.5992.391.73
2349225-34922592.75593.06
3350056-35005692.97693.25
4336402-33640289.34989.61
5347879-34787992.39892.70
6353167-35316793.80294.12
30min1366147-36614797.25098.061.0497.6998.501.05
2368931-36893197.98998.45
3373021-37302199.07599.51
4363519-36351996.55296.96
5370402-37040298.38098.83
6373103-37310399.09799.57
45min1375857-37585799.829100.570.91100.43101.180.91
2376246-37624699.932100.55
3383844-383844101.950102.54
4375211-37521199.657100.23
5379994-379994100.927101.55
6380848-380848101.154101.79
60min1378572-378572100.550101.260.91101.32102.040.92
2379165-379165100.707101.49
3386414-386414102.633103.40
4377308-377308100.214100.95
5383104-383104101.753102.54
6382916-382916101.703102.51
极限1378189-378189100.448101.430.89101.39102.380.89
2380680-380680101.110102.06
3387219-387219102.846103.78
4378884-378884100.633101.54
5384031-384031102.000102.96
6382310-382310101.542102.52
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