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%
111.081274991275891273031272111275131274230.13
211.101292021293401292710.08
单位质量响应值RSD%判断
11500.2711646.040.90数据可信
供试品溶液-24021801批-匹伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116518-11651887.26288.204.2087.2688.204.20
2114178-11417885.51085.51
3118801-11880188.97288.97
4115513-11551386.51086.51
5114348-11434885.63785.64
6127250-12725095.30095.30
10min1117364-11736487.89689.363.8188.0489.503.81
2114814-11481485.98686.13
3119454-11945489.46189.61
4115848-11584886.76186.90
5121111-12111190.70290.84
6127290-12729095.33095.49
15min1116330-11633087.12288.983.8087.4189.283.80
2114666-11466685.87586.16
3119010-11901089.12989.43
4115192-11519286.26986.56
5121179-12117990.75391.05
6126524-12652494.75695.07
20min1116540-11654087.27988.743.8587.7289.193.85
2114049-11404985.41385.84
3118401-11840188.67389.12
4114933-11493386.07586.51
5120609-12060990.32690.77
6126441-12644194.69495.17
30min1115697-11569786.64888.503.7487.2389.093.74
2113937-11393785.32985.90
3118480-11848088.73289.33
4114881-11488186.03686.61
5120264-12026490.06890.66
6125774-12577494.19494.83
45min1115565-11556586.54988.223.6487.2888.963.64
2113934-11393485.32786.04
3117578-11757888.05688.80
4114496-11449685.74886.47
5119874-11987489.77690.52
6125308-12530893.84594.64
60min1115306-11530686.35588.013.6287.2388.903.62
2113752-11375285.19186.05
3117670-11767088.12589.01
4113867-11386785.27786.14
5119671-11967189.62490.52
6124821-12482193.48194.43
极限1115017-11501786.13887.713.7087.1588.743.70
2113358-11335884.89685.89
3116940-11694087.57888.61
4113477-11347784.98585.99
5119137-11913789.22490.27
6124727-12472793.41094.51
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.413820603804653806033801143808083808100.20
211.423838503830823834660.15
单位质量响应值RSD%判断
33375.1133578.460.43数据可信
供试品溶液-24021801批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.96244.950.000.96244.95
2-0.0000.00
3-0.0000.00
421431-214315.7435.74
5-0.0000.00
6-0.0000.00
10min127430-274307.3507.353.697.357.353.72
227578-275787.3907.39
328651-286517.6777.68
427604-276047.3977.41
525572-255726.8526.85
627762-277627.4397.44
15min129001-290017.7717.752.027.787.762.06
228665-286657.6817.69
328997-289977.7707.78
429940-299408.0238.04
528636-286367.6737.68
628215-282157.5607.57
20min129101-291017.7987.652.097.827.672.06
227907-279077.4787.50
328466-284667.6287.65
427759-277597.4387.47
529085-290857.7947.82
628911-289117.7477.77
30min128683-286837.6867.762.157.727.802.19
228325-283257.5907.63
329583-295837.9277.97
429867-298678.0038.05
528613-286137.6677.70
628625-286257.6707.71
45min125761-257616.9037.544.596.957.604.60
228437-284377.6207.67
329476-294767.8987.95
429014-290147.7757.84
528261-282617.5737.62
627977-279777.4977.55
60min127487-274877.3657.623.787.437.683.77
229009-290097.7737.84
326826-268267.1887.25
429706-297067.9608.03
528993-289937.7697.83
628555-285557.6527.71
极限127370-273707.3347.485.517.417.565.45
229340-293407.8627.94
330241-302418.1038.18
427501-275017.3697.46
526725-267257.1617.24
626331-263317.0567.13
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%
111.081297961297791296651296911293861296630.13
211.101295501295961295730.03
单位质量响应值RSD%判断
11702.4411673.240.18数据可信
供试品溶液-24021801批-匹伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132550-13255098.29193.993.3598.2993.993.35
2121616-12161690.18390.18
3124118-12411892.03992.04
4127199-12719994.32394.32
5124222-12422292.11692.12
6130771-13077196.97296.97
10min1134892-134892100.02897.043.37100.1997.203.36
2124266-12426692.14892.30
3127334-12733494.42394.58
4131314-13131497.37597.53
5131674-13167497.64297.80
6135726-135726100.646100.81
15min1134877-134877100.01796.913.44100.3597.223.44
2123607-12360791.66091.96
3127395-12739594.46994.78
4131090-13109097.20997.53
5131868-13186897.78698.10
6135247-135247100.291100.62
20min1135218-135218100.27096.633.27100.7797.113.26
2124559-12455992.36692.82
3126612-12661293.88894.36
4129925-12992596.34596.83
5130859-13085997.03797.52
6134663-13466399.858100.35
30min1134189-13418999.50796.553.49100.1797.193.49
2123565-12356591.62992.24
3126726-12672693.97394.60
4130014-13001496.41197.05
5131017-13101797.15497.80
6135696-135696100.624101.29
45min1133339-13333998.87696.193.2399.7197.003.23
2123745-12374591.76292.53
3126074-12607493.48994.27
4129958-12995896.36997.17
5130488-13048896.76297.57
6134713-13471399.895100.73
60min1133930-13393099.31596.093.46100.3197.053.46
2123059-12305991.25392.17
3126151-12615193.54694.48
4129748-12974896.21397.18
5129825-12982596.27197.23
6134781-13478199.946100.94
极限1132913-13291398.56095.423.4199.7296.543.41
2122120-12212090.55791.63
3125443-12544393.02194.11
4128364-12836495.18796.31
5129660-12966096.14897.27
6133545-13354599.029100.19
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.413881273881453877813883683875143879870.09
211.423854823852023853420.06
单位质量响应值RSD%判断
34004.1233742.730.55数据可信
供试品溶液-24021801批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120488-204885.4265.505.875.435.505.89
219686-196865.2135.21
322770-227706.0306.03
421687-216875.7435.74
519763-197635.2345.23
620207-202075.3515.35
10min130161-301617.9877.803.288.007.813.27
228922-289227.6597.67
328405-284057.5227.53
431010-310108.2128.22
529364-293647.7767.78
628879-288797.6487.66
15min131584-315848.3648.213.118.398.233.10
229633-296337.8477.87
330306-303068.0268.05
432174-321748.5208.54
531672-316728.3878.41
630663-306638.1208.14
20min131024-310248.2168.282.428.258.312.39
232055-320558.4898.52
331572-315728.3618.40
429957-299577.9337.97
531828-318288.4298.46
631074-310748.2298.26
30min131569-315698.3608.153.588.418.203.55
231597-315978.3688.42
330343-303438.0358.09
430854-308548.1718.22
528770-287707.6197.67
631496-314968.3418.39
45min130145-301457.9838.142.928.058.202.88
231130-311308.2448.31
331197-311978.2628.32
430484-304848.0738.14
531947-319478.4608.52
629409-294097.7887.85
60min129701-297017.8657.913.077.947.983.06
230205-302057.9998.08
328601-286017.5747.65
431196-311968.2618.34
529177-291777.7277.80
630310-303108.0278.10
极限130399-303998.0507.911.638.148.001.61
229640-296407.8497.94
330079-300797.9668.06
429001-290017.6807.77
530016-300167.9498.04
630035-300357.9548.04
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%
111.081308191309131306911307171302941306870.19
211.101324311324121324220.02
单位质量响应值RSD%判断
11794.8611929.910.81数据可信
供试品溶液-24021801批-匹伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121583-12158388.83592.468.0588.8392.468.05
2135395-13539598.92798.93
3118808-11880886.80786.81
4142422-142422104.061104.06
5124478-12447890.95090.95
6116587-11658785.18585.18
10min1123853-12385390.49495.426.8090.6495.586.80
2137197-137197100.243100.41
3120763-12076388.23688.38
4144456-144456105.547105.72
5130718-13071895.50995.66
6126619-12661992.51592.66
15min1124034-12403490.62695.786.6390.9296.106.63
2136842-13684299.984100.32
3120967-12096788.38588.68
4144401-144401105.507105.86
5132657-13265796.92697.24
6127651-12765193.26993.56
20min1123961-12396190.57295.656.5991.0296.126.59
2136299-13629999.587100.09
3120656-12065688.15888.60
4144021-144021105.229105.75
5133120-13312097.26497.74
6127405-12740593.08993.54
30min1123362-12336290.13595.276.5790.7495.906.57
2135621-13562199.09299.76
3120391-12039187.96488.55
4143503-143503104.851105.55
5132562-13256296.85797.49
6126870-12687092.69893.30
45min1122785-12278589.71395.056.5590.4695.846.56
2135211-13521198.79299.62
3120530-12053088.06688.80
4143385-143385104.765105.64
5131951-13195196.41097.21
6126681-12668192.56093.32
60min1122262-12226289.33194.666.6290.2395.616.62
2134870-13487098.54399.54
3120187-12018787.81588.69
4142839-142839104.366105.42
5131728-13172896.24797.20
6125467-12546791.67392.59
极限1122452-12245289.47094.626.4690.5295.736.46
2133963-13396397.88099.04
3119988-11998887.67088.70
4142683-142683104.252105.48
5131667-13166796.20397.32
6126249-12624992.24493.31
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.413868723883293873103881383869413875180.18
211.423899883900413900140.01
单位质量响应值RSD%判断
33963.0134151.840.40数据可信
供试品溶液-24021801批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122047-220475.8074.3850.335.814.3850.33
220651-206515.4395.44
321662-216625.7065.71
4-0.0000.00
517112-171124.5074.51
618368-183684.8384.84
10min126725-267257.0397.012.737.057.012.73
226920-269207.0907.10
327643-276437.2817.29
426772-267727.0517.05
525751-257516.7836.79
625774-257746.7896.80
15min127926-279267.3557.173.917.387.193.93
227252-272527.1787.20
328607-286077.5357.56
427580-275807.2647.28
525794-257946.7946.81
626185-261856.8976.92
20min127236-272367.1746.894.537.216.924.58
227357-273577.2067.24
326992-269927.1097.14
424711-247116.5096.53
525754-257546.7836.81
624954-249546.5736.60
30min127031-270317.1207.103.787.177.143.77
227395-273957.2167.26
327690-276907.2937.34
427991-279917.3737.41
526388-263886.9506.99
625213-252136.6416.68
45min125605-256056.7447.002.096.807.062.04
226906-269067.0877.14
326543-265436.9917.05
427242-272427.1757.22
526742-267427.0447.10
626442-264426.9657.02
60min125718-257186.7746.984.046.847.044.00
226912-269127.0887.16
327597-275977.2697.34
427632-276327.2787.34
526085-260856.8716.94
624995-249956.5836.65
极限126657-266577.0217.032.877.107.102.83
227308-273087.1937.27
327324-273247.1977.28
426904-269047.0867.16
526628-266287.0147.09
625248-252486.6506.73
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%
111.081310961311321311211310431309281310640.07
211.101331281330841331060.03
单位质量响应值RSD%判断
11828.8811991.530.97数据可信
供试品溶液-24021801批-匹伐他汀钙-pH4.5(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126783-12678392.26493.165.3492.2693.165.34
2125414-12541491.26791.27
3120945-12094588.01588.02
4138107-138107100.504100.50
5122385-12238589.06389.06
6134469-13446997.85797.86
10min1132124-13212496.15096.384.5596.3096.544.55
2132886-13288696.70596.86
3123980-12398090.22490.37
4139869-139869101.787101.95
5127732-12773292.95493.10
6138066-138066100.475100.64
15min1132013-13201396.07096.414.4796.3896.734.47
2132637-13263796.52496.84
3124528-12452890.62390.92
4140231-140231102.050102.39
5127684-12768492.91993.22
6137795-137795100.277100.61
20min1131514-13151495.70796.084.3896.1896.554.39
2132691-13269196.56397.04
3124038-12403890.26690.71
4139812-139812101.745102.25
5127454-12745492.75293.21
6136615-13661599.41999.92
30min1131132-13113295.42996.124.4196.0696.754.41
2134030-13403097.53898.17
3123898-12389890.16490.76
4139608-139608101.597102.27
5127388-12738892.70493.32
6136408-13640899.26899.93
45min1131051-13105195.37095.484.3696.1696.284.36
2131355-13135595.59196.39
3123270-12327089.70790.46
4138482-138482100.777101.62
5126672-12667292.18392.95
6136391-13639199.256100.08
60min1130149-13014994.71395.214.4495.6696.164.44
2131084-13108495.39496.35
3122788-12278889.35690.25
4138286-138286100.635101.65
5126504-12650492.06192.98
6136171-13617199.096100.09
极限1130455-13045594.93695.134.6896.0596.244.68
2130517-13051794.98196.10
3122203-12220388.93189.98
4138843-138843101.040102.22
5126245-12624591.87292.95
6136043-13604399.002100.16
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.413875983879693878683878183875393877580.05
211.423909013916463912740.14
单位质量响应值RSD%判断
33984.0534262.170.58数据可信
供试品溶液-24021801批-依折麦布-pH4.5(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1171357-17135745.04747.2412.3845.0547.2412.38
2147754-14775438.84238.84
3187701-18770149.34449.34
4212275-21227555.80455.80
5168226-16822644.22444.22
6190918-19091850.18950.19
10min1292879-29287976.99379.314.1777.0779.394.17
2290438-29043876.35276.42
3304595-30459580.07380.16
4324460-32446085.29685.39
5294329-29432977.37577.45
6303362-30336279.74979.83
15min1333834-33383487.76089.572.3887.9689.782.39
2334277-33427787.87688.07
3342176-34217689.95390.17
4355835-35583593.54493.78
5338244-33824488.91989.12
6339940-33994089.36589.58
20min1354700-35470093.24594.421.4693.5994.781.47
2356199-35619993.63993.98
3358761-35876194.31394.68
4369401-36940197.11097.50
5358281-35828194.18794.54
6357616-35761694.01294.38
30min1370125-37012597.30098.350.9897.8198.870.99
2375146-37514698.62099.11
3373627-37362798.22198.74
4380684-380684100.076100.63
5373548-37354898.20098.71
6371675-37167597.70898.23
45min1378868-37886899.599100.040.67100.27100.720.68
2382071-382071100.441101.10
3379713-37971399.821100.51
4384612-384612101.109101.83
5380565-380565100.045100.72
6377396-37739699.21299.90
60min1378576-37857699.522100.440.73100.36101.280.72
2385989-385989101.471102.30
3380669-380669100.072100.92
4384637-384637101.115102.00
5381643-381643100.328101.17
6380800-380800100.107100.96
极限1379887-37988799.867100.270.79100.87101.280.79
2383291-383291100.761101.76
3378302-37830299.450100.47
4386440-386440101.589102.65
5380945-380945100.145101.15
6379571-37957199.783100.80
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