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%
110.651844151843871843601840021844401843210.10
210.761867181869881868530.11
单位质量响应值RSD%判断
17307.1417365.520.24数据可信
中间条件6月-供试品溶液-X024017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%
5min199700-9970051.75948.367.6051.7648.367.60
294700-9470049.16349.16
395660-9566049.66149.66
479940-7994041.50041.50
597692-9769250.71650.72
691230-9123047.36147.36
10min1146605-14660576.10975.864.1676.4076.134.17
2152020-15202078.92079.19
3148819-14881977.25877.53
4135749-13574970.47370.70
5150898-15089878.33878.62
6142681-14268174.07274.33
15min1171697-17169789.13588.181.8489.8588.871.87
2171878-17187889.22989.94
3170530-17053088.52989.23
4164456-16445685.37686.00
5172669-17266989.64090.36
6167902-16790287.16587.84
20min1179092-17909292.97492.740.5994.1893.920.56
2179238-17923893.05094.26
3178424-17842492.62793.82
4179809-17980993.34794.44
5176787-17678791.77892.99
6178523-17852392.67993.84
30min1182979-18297994.99295.180.8796.7196.880.83
2183874-18387495.45797.18
3184102-18410295.57597.29
4185395-18539596.24697.86
5180644-18064493.78095.50
6183073-18307395.04196.71
45min1185820-18582096.46794.792.5298.7297.022.44
2174599-17459990.64292.90
3180880-18088093.90396.15
4187744-18774497.46699.62
5182612-18261294.80297.05
6183927-18392795.48497.69
60min1179830-17983093.35794.301.3196.1497.051.26
2178739-17873992.79195.55
3185575-18557596.34099.10
4182421-18242194.70397.39
5181253-18125394.09696.87
6182068-18206894.51997.25
极限1178659-17865992.74994.741.4096.0598.011.34
2184589-18458995.82899.10
3181711-18171194.33497.63
4182787-18278794.89398.11
5181352-18135294.14897.44
6185847-18584796.48199.74
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%
110.954276744275924270824273034278204274940.07
211.054325424327184326300.03
单位质量响应值RSD%判断
39040.5539152.040.21数据可信
中间条件6月-供试品溶液-X024017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%
5min1264285-26428560.53556.777.3960.5356.777.39
2250972-25097257.48557.49
3255358-25535858.49058.49
4213037-21303748.79648.80
5258689-25868959.25359.25
6244749-24474956.06056.06
10min1360687-36068782.61582.224.1782.9582.534.18
2373486-37348685.54785.87
3365553-36555383.73084.05
4333616-33361676.41576.69
5370512-37051284.86685.20
6349838-34983880.13180.44
15min1406209-40620993.04291.921.6793.8492.691.70
2404593-40459392.67293.47
3402940-40294092.29493.08
4389747-38974789.27289.97
5407154-40715493.25994.06
6397189-39718990.97691.73
20min1413844-41384494.79194.280.9396.1095.570.89
2410179-41017993.95295.26
3411787-41178794.32095.62
4415819-41581995.24396.44
5404886-40488692.73994.06
6413273-41327394.66095.92
30min1410005-41000593.91293.991.1095.7595.791.06
2410177-41017793.95195.78
3413320-41332094.67196.50
4416334-41633495.36197.08
5402882-40288292.28094.11
6409274-40927493.74495.53
45min1410410-41041094.00592.512.4896.3794.842.40
2386319-38631988.48690.84
3401262-40126291.90994.26
4415536-41553695.17997.43
5403215-40321592.35794.70
6406570-40657093.12595.43
60min1397542-39754291.05791.641.1993.9494.481.16
2394140-39414090.27893.12
3408457-40845793.55796.42
4400614-40061491.76194.54
5399823-39982391.58094.44
6399968-39996891.61394.44
极限1393994-39399490.24491.941.1793.6395.291.11
2404312-40431292.60895.95
3399654-39965491.54194.92
4402261-40226192.13895.43
5400261-40026191.68095.05
6407788-40778893.40496.74
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%
110.651860261862611861271859811858011860390.10
210.761859401860181859790.03
单位质量响应值RSD%判断
17468.4517284.290.75数据可信
加速6月-供试品溶液-X024017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%
5min190410-9041046.82947.268.2946.8347.268.30
283044-8304443.01343.01
394780-9478049.09249.09
484002-8400243.51043.51
591651-9165147.47147.47
6103610-10361053.66653.67
10min1133677-13367769.23970.373.6769.5070.643.68
2131619-13161968.17368.41
3135789-13578970.33370.61
4132399-13239968.57768.82
5136446-13644670.67370.94
6145288-14528875.25375.55
15min1158913-15891382.31083.581.4882.9684.231.50
2159009-15900982.36082.98
3160271-16027183.01483.68
4161877-16187783.84684.47
5163295-16329584.58085.24
6164762-16476285.34086.06
20min1169079-16907987.57688.261.4288.6889.381.45
2167617-16761786.81987.89
3169701-16970187.89889.02
4169603-16960387.84788.94
5171981-17198189.07990.21
6174402-17440290.33391.52
30min1177469-17746991.92292.191.7693.5193.791.77
2176472-17647291.40592.96
3175918-17591891.11892.73
4174449-17444990.35791.93
5181365-18136593.94095.56
6182219-18221994.38296.07
45min1177659-17765992.02093.791.7094.1295.911.67
2181208-18120893.85895.92
3184137-18413795.37597.49
4183748-18374895.17497.25
5177007-17700791.68293.83
6182688-18268894.62596.84
60min1181445-18144593.98194.621.0696.5997.261.06
2182746-18274694.65597.24
3182991-18299194.78297.43
4179860-17986093.16095.77
5185596-18559696.13198.78
6183390-18339094.98997.73
极限1181498-18149894.00994.270.5697.1497.440.59
2180890-18089093.69496.81
3181308-18130893.91097.09
4181817-18181794.17497.30
5183208-18320894.89498.08
6183286-18328694.93598.20
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%
110.954308904309644311224305774303414307790.08
211.054302464298934300700.06
单位质量响应值RSD%判断
39340.5538920.360.76数据可信
加速6月-供试品溶液-X024017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%
5min1246029-24602956.30557.207.8056.3157.207.80
2230302-23030252.70652.71
3255892-25589258.56358.56
4231124-23112452.89452.89
5253351-25335157.98157.98
6283052-28305264.77864.78
10min1342661-34266178.42079.732.9978.7380.053.01
2340771-34077177.98878.28
3347528-34752879.53479.86
4343027-34302778.50478.80
5347528-34752879.53479.86
6368885-36888584.42284.78
15min1391070-39107089.49990.941.2790.2591.701.27
2393744-39374490.11190.84
3394279-39427990.23391.00
4402570-40257092.13192.86
5399499-39949991.42892.19
6402983-40298392.22593.05
20min1402612-40261292.14092.511.0393.3993.781.05
2400739-40073991.71292.94
3399650-39965091.46292.73
4405913-40591392.89694.14
5405470-40547092.79494.07
6411041-41104194.06995.41
30min1404440-40444092.55992.581.4694.3294.361.47
2402747-40274792.17193.91
3399527-39952791.43493.21
4398027-39802791.09192.85
5408775-40877593.55195.34
6413674-41367494.67296.54
45min1392969-39296989.93491.701.6692.2193.991.64
2400335-40033591.61993.87
3407384-40738493.23295.52
4404140-40414092.49094.75
5392471-39247189.82092.13
6406761-40676193.09095.48
60min1395241-39524190.45391.070.9593.2293.870.95
2399526-39952691.43494.19
3398822-39882291.27394.08
4391716-39171689.64792.42
5401759-40175991.94594.75
6400422-40042291.63994.55
极限1393968-39396890.16290.280.6493.4493.590.66
2392090-39209089.73293.00
3391935-39193589.69793.01
4394127-39412790.19993.47
5396405-39640590.72094.04
6398349-39834991.16594.58
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%
110.651848901848731850591850741851531850100.07
210.761870001869921869960.01
单位质量响应值RSD%判断
17371.8317378.810.03数据可信
长期6月-供试品溶液-X024017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%
5min183923-8392343.47047.1413.3243.4747.1413.32
2105679-10567954.73954.74
3101561-10156152.60652.61
492849-9284948.09448.09
572230-7223037.41337.41
689803-8980346.51646.52
10min1130987-13098767.84874.417.2468.0974.687.25
2157109-15710981.37981.68
3152179-15217978.82579.12
4145475-14547575.35375.62
5132601-13260168.68468.89
6143622-14362274.39374.65
15min1165761-16576185.86088.173.0286.4888.843.06
2175603-17560390.95891.71
3176096-17609691.21491.94
4170488-17048888.30988.99
5163288-16328884.57985.17
6170091-17009188.10388.77
20min1179730-17973093.09692.671.7194.1993.841.71
2175614-17561490.96492.23
3183735-18373595.17096.41
4177997-17799792.19893.37
5175934-17593491.13092.19
6180425-18042593.45694.62
30min1183988-18398895.30195.601.5096.9197.281.53
2184143-18414395.38297.15
3185819-18581996.25098.02
4185480-18548096.07497.76
5179827-17982793.14694.71
6188137-18813797.45099.13
45min1185436-18543696.05195.960.7198.1998.180.75
2184575-18457595.60597.90
3186713-18671396.71399.01
4186867-18686796.79399.02
5183619-18361995.11097.19
6184400-18440095.51597.74
60min1184437-18443795.53496.091.0698.2198.841.03
2182372-18237294.46497.29
3188147-18814797.456100.29
4186403-18640396.55299.31
5186205-18620596.45099.06
6185531-18553196.10198.85
极限1184315-18431595.47195.451.0898.6898.731.03
2186356-18635696.52899.88
3180758-18075893.62897.01
4185991-18599196.33999.64
5184082-18408295.35098.50
6184158-18415895.38998.68
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%
110.954279004276184277684277674282804278670.06
211.054349404342054345720.12
单位质量响应值RSD%判断
39074.6139327.780.46数据可信
长期6月-供试品溶液-X024017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%
5min1219489-21948950.14055.0313.6250.1455.0413.62
2280280-28028064.02764.03
3269168-26916861.48961.49
4248588-24858856.78756.79
5190922-19092243.61443.61
6237045-23704554.15054.15
10min1322639-32263973.70381.246.7873.9881.546.80
2387909-38790988.61488.97
3373112-37311285.23385.58
4359513-35951382.12782.44
5334429-33442976.39776.64
6356120-35612081.35281.65
15min1398173-39817390.95893.792.3491.6594.542.39
2420265-42026596.00596.85
3421149-42114996.20797.02
4411346-41134693.96894.74
5400726-40072691.54292.21
6411715-41171594.05294.80
20min1421186-42118696.21595.941.4197.4197.211.38
2410352-41035293.74195.12
3428490-42849097.88499.23
4417953-41795395.47796.77
5419820-41982095.90397.08
6421972-42197296.39597.67
30min1418299-41829995.55696.091.1297.2897.901.15
2419476-41947695.82597.73
3423878-42387896.83098.72
4420822-42082296.13297.96
5413838-41383894.53796.24
6427447-42744797.64699.46
45min1415337-41533794.87994.330.5797.1496.680.55
2409865-40986593.62996.06
3414442-41444294.67597.11
4415157-41515794.83897.20
5411453-41145393.99296.23
6411386-41138693.97796.33
60min1405600-40560092.65593.601.1695.4496.471.14
2403119-40311992.08895.04
3416270-41627095.09298.05
4410307-41030793.73096.62
5410911-41091193.86896.62
6412339-41233994.19497.07
极限1407199-40719993.02093.021.1496.3296.411.09
2413303-41330394.41597.88
3399334-39933491.22494.71
4409783-40978393.61197.02
5407136-40713693.00696.28
6406435-40643592.84696.24
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