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DSMF-387-240606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(%)99.75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%
110.591791351791681794351790651789921791590.10
210.621791841792821792330.04
单位质量响应值RSD%判断
16917.7516876.930.18数据可信
长期24月-供试品溶液-2024030121批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165509-6550934.80543.9113.8534.8043.9013.86
2100030-10003053.14653.15
377749-7774941.30841.31
482336-8233643.74543.74
581730-8173043.42343.42
688483-8848347.01147.01
10min1117172-11717262.25373.269.0662.4573.509.06
2151822-15182280.66380.96
3148572-14857278.93679.17
4141356-14135675.10275.35
5133043-13304370.68570.93
6135330-13533071.90072.16
15min1152382-15238280.96086.173.5681.5086.823.60
2165275-16527587.81088.55
3169128-16912889.85790.53
4163842-16384287.04987.71
5159257-15925784.61385.25
6163259-16325986.73987.40
20min1161442-16144285.77489.852.3986.7690.982.44
2171343-17134391.03492.27
3170510-17051090.59291.76
4172028-17202891.39892.54
5167886-16788689.19790.30
6171428-17142891.07992.22
30min1165581-16558187.97391.172.3889.4492.802.40
2173474-17347492.16693.90
3172002-17200291.38493.05
4175299-17529993.13694.79
5175492-17549293.23894.84
6167800-16780089.15290.80
45min1173272-17327292.05992.841.3694.0194.981.36
2173992-17399292.44194.69
3177836-17783694.48496.66
4176820-17682093.94496.11
5175177-17517793.07195.19
6171413-17141391.07193.22
60min1170631-17063190.65693.021.7593.1295.671.75
2173904-17390492.39595.16
3174299-17429992.60595.31
4176860-17686093.96596.66
5179756-17975695.50498.14
6175030-17503092.99395.64
极限1171213-17121390.96592.861.5893.9396.021.60
2173251-17325192.04895.32
3177518-17751894.31597.53
4178560-17856094.86898.08
5174267-17426792.58895.75
6173813-17381392.34695.51
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500
标示量(mg)20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%
110.413947553940983949483942943942473944680.10
210.443940733946233943480.10
单位质量响应值RSD%判断
37893.1837772.800.23数据可信
长期24月-供试品溶液-2024030121批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1165846-16584639.25649.2113.3339.2649.2213.32
2249958-24995859.16559.16
3198525-19852546.99146.99
4206078-20607848.77848.78
5205060-20506048.53748.54
6222051-22205152.55952.56
10min1278476-27847665.91577.048.9166.1377.318.92
2355842-35584284.22784.56
3352821-35282183.51283.77
4335093-33509379.31679.59
5311653-31165373.76874.04
6318967-31896775.49975.79
15min1353681-35368183.71688.163.2184.3088.863.24
2379147-37914789.74490.54
3386087-38608791.38692.11
4377484-37748489.35090.06
5362849-36284985.88686.57
6375583-37558388.90089.61
20min1368702-36870287.27190.712.2188.3291.902.26
2386180-38618091.40892.70
3386050-38605091.37892.61
4391110-39111092.57593.78
5377836-37783689.43390.59
6389485-38948592.19193.40
30min1368423-36842387.20590.412.2988.7492.112.32
2387168-38716891.64293.45
3381945-38194590.40692.15
4391843-39184392.74994.47
5387275-38727591.66893.32
6375174-37517488.80390.52
45min1384151-38415190.92891.261.4192.9593.451.41
2384816-38481691.08593.40
3392340-39234092.86695.11
4391508-39150892.66994.91
5381758-38175890.36292.52
6378629-37862989.62191.83
60min1376292-37629289.06890.871.2591.5993.571.27
2382220-38222090.47193.29
3382616-38261690.56593.32
4389600-38960092.21894.97
5388288-38828891.90794.57
6384382-38438290.98393.69
极限1374342-37434288.60690.192.0591.6293.402.04
2377680-37768089.39692.72
3387709-38770991.77095.03
4393105-39310593.04796.31
5373564-37356488.42291.60
6379856-37985689.91193.13
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DSMF-387-240606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(%)99.75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%
110.591794061794991792821804791798971797130.28
210.621829051828511828780.03
单位质量响应值RSD%判断
16970.0717220.151.04数据可信
长期24月-供试品溶液-2024030221批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168336-6833635.88938.3312.5235.8938.3312.52
273284-7328438.48738.49
366941-6694135.15635.16
465483-6548334.39034.39
590368-9036847.45947.46
673469-7346938.58438.58
10min1128026-12802667.23667.297.3467.4467.517.35
2120670-12067063.37363.59
3122424-12242464.29464.49
4121040-12104063.56863.76
5145225-14522576.26976.53
6131407-13140769.01269.23
15min1158337-15833783.15583.594.0283.7384.174.05
2152320-15232079.99580.56
3156751-15675182.32282.87
4154893-15489381.34681.89
5170177-17017789.37390.06
6162459-16245985.32085.92
20min1171465-17146590.05090.380.8391.0891.430.83
2171502-17150290.06991.08
3170170-17017089.37090.38
4174302-17430291.54092.54
5172162-17216290.41691.60
6172984-17298490.84791.92
30min1170925-17092589.76693.242.2291.3094.792.18
2180139-18013994.60596.12
3176347-17634792.61494.12
4182552-18255295.87297.38
5178067-17806793.51795.20
6177192-17719293.05794.63
45min1173875-17387591.31593.321.7593.3595.391.70
2179346-17934694.18996.22
3176734-17673492.81794.84
4182944-18294496.07898.12
5176494-17649492.69194.90
6176751-17675192.82694.92
60min1173363-17336391.04692.851.0893.5995.441.05
2178046-17804693.50696.07
3177804-17780493.37995.92
4178232-17823293.60496.17
5175755-17575592.30395.02
6177625-17762593.28595.89
极限1175515-17551592.17793.542.2295.2296.652.11
2183090-18309096.15599.23
3178903-17890393.95697.01
4182361-18236195.77298.86
5174236-17423691.50594.74
6174605-17460591.69994.83
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500
标示量(mg)20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%
110.413942693950153941803968963960203952760.30
210.444018824014944016880.07
单位质量响应值RSD%判断
37970.8038475.860.94数据可信
长期24月-供试品溶液-2024030221批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172178-17217840.34043.4712.0340.3443.4712.03
2184369-18436943.19643.20
3171999-17199940.29840.30
4168214-16821439.41139.41
5228158-22815853.45553.46
6188311-18831144.12044.12
10min1304374-30437471.31271.157.0071.5471.397.02
2284225-28422566.59166.83
3292379-29237968.50268.73
4287385-28738567.33267.55
5341222-34122279.94580.24
6312506-31250673.21773.46
15min1365733-36573385.68885.883.5886.3186.523.61
2350060-35006082.01682.63
3365083-36508385.53686.14
4357652-35765283.79584.39
5388240-38824090.96191.70
6372470-37247087.26687.92
20min1388050-38805090.91791.290.8392.0192.400.78
2389362-38936291.22492.29
3388189-38818990.94992.03
4395919-39591992.76093.82
5386860-38686090.63891.88
6389431-38943191.24092.38
30min1378544-37854488.69091.902.1790.2993.522.12
2397065-39706593.02994.60
3391313-39131391.68193.27
4403966-40396694.64696.22
5393345-39334592.15793.91
6389226-38922691.19292.84
45min1379978-37997889.02690.951.6891.1293.081.63
2389258-38925891.20093.29
3390013-39001391.37793.47
4399294-39929493.55195.65
5385098-38509890.22592.49
6385478-38547890.31492.46
60min1376828-37682888.28790.061.1790.8892.701.12
2387217-38721790.72293.32
3388642-38864291.05593.66
4386770-38677090.61793.24
5381272-38127289.32992.09
6385571-38557190.33692.99
极限1377940-37794088.54890.192.2991.6393.322.18
2395680-39568092.70495.80
3387099-38709990.69493.80
4394703-39470392.47595.60
5376848-37684888.29291.55
6377372-37737288.41591.57
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DSMF-387-240606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(%)99.75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%
110.591814271815531816121816051815741815540.05
210.621814401814471814440.01
单位质量响应值RSD%判断
17143.9117085.120.25数据可信
长期24月-供试品溶液-2024030321批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170542-7054237.00340.4016.6637.0040.4016.66
293344-9334448.96448.96
382390-8239043.21843.22
468435-6843535.89835.90
587615-8761545.95945.96
659725-5972531.32931.33
10min1116315-11631561.01467.1510.5461.2267.3810.55
2149006-14900678.16278.43
3138758-13875872.78673.03
4120424-12042463.16963.37
5128201-12820167.24967.50
6115409-11540960.53960.71
15min1148667-14866777.98481.174.9778.5381.765.00
2162680-16268085.33586.04
3164930-16493086.51587.16
4155259-15525981.44281.99
5150843-15084379.12679.75
6146039-14603976.60677.12
20min1157223-15722382.47286.283.2883.4587.333.31
2170831-17083189.61090.79
3167962-16796288.10689.23
4168621-16862188.45189.45
5160545-16054584.21585.28
6161719-16171984.83185.77
30min1177915-17791593.32691.231.3394.7692.761.29
2172576-17257690.52692.20
3175224-17522491.91593.53
4173625-17362591.07692.57
5171569-17156989.99891.53
6172632-17263290.55591.96
45min1177652-17765293.18892.011.9095.1494.041.84
2174677-17467791.62893.81
3176004-17600492.32494.45
4179365-17936594.08796.09
5169635-16963588.98391.02
6175069-17506991.83493.74
60min1181646-18164695.28493.201.8597.7695.751.77
2176419-17641992.54295.23
3176930-17693092.81095.45
4181213-18121395.05697.58
5172920-17292090.70693.24
6176921-17692192.80595.23
极限1184242-18424296.64593.052.6399.6596.122.54
2175709-17570992.16995.37
3176438-17643892.55295.71
4181837-18183795.38498.43
5172825-17282590.65693.69
6173297-17329790.90493.84
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500
标示量(mg)20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%
110.413995053996163996823989543988733993260.10
210.443989703990903990300.03
单位质量响应值RSD%判断
38359.8538221.260.26数据可信
长期24月-供试品溶液-2024030321批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176488-17648841.27544.9716.7441.2844.9816.74
2233501-23350154.60954.61
3207983-20798348.64148.64
4169692-16969239.68639.69
5217022-21702250.75550.76
6149143-14914334.88034.88
10min1273104-27310463.87170.1610.0964.1070.4110.10
2348047-34804781.39881.70
3322810-32281075.49675.77
4282427-28242766.05166.27
5300319-30031970.23670.52
6273302-27330263.91764.11
15min1341558-34155879.88082.824.4380.4683.464.48
2370621-37062186.67787.43
3373716-37371687.40188.09
4356428-35642883.35883.95
5347454-34745481.25981.93
6334990-33499078.34478.89
20min1355737-35573783.19686.632.7884.2287.732.82
2382397-38239789.43190.67
3374363-37436387.55288.73
4380111-38011188.89789.95
5365176-36517685.40486.53
6364765-36476585.30886.29
30min1394224-39422492.19789.851.4293.6991.431.36
2379886-37988688.84490.58
3384526-38452689.92991.59
4383374-38337489.66091.20
5384014-38401489.81091.41
6378986-37898688.63490.09
45min1390005-39000591.21189.991.5793.2192.071.50
2381375-38137589.19291.42
3382920-38292089.55491.71
4394044-39404492.15594.20
5377767-37776788.34990.45
6382534-38253489.46391.41
60min1397097-39709792.86990.851.7795.3893.431.69
2384974-38497490.03492.76
3384965-38496590.03292.69
4397220-39722092.89895.45
5381822-38182289.29791.88
6384624-38462489.95292.40
极限1401734-40173493.95490.402.6496.9893.492.54
2381953-38195389.32892.55
3382147-38214789.37392.53
4396430-39643092.71395.78
5381649-38164989.25692.34
6375399-37539987.79590.74
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DSMF-387-240606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(%)99.75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%
110.591827511828271827111827051825201827030.07
210.621835531832981834260.10
单位质量响应值RSD%判断
17252.4117271.750.08数据可信
长期24月-供试品溶液-X024017批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184504-8450443.94846.0910.3843.9546.0910.38
2102559-10255953.33853.34
397611-9761150.76550.76
479699-7969941.44941.45
584744-8474444.07344.07
682645-8264542.98142.98
10min1136095-13609570.77971.494.7871.0271.754.80
2146024-14602475.94376.24
3144923-14492375.37075.65
4129865-12986567.53967.77
5132862-13286269.09869.34
6135038-13503870.22970.47
15min1159278-15927882.83683.411.6283.4784.061.64
2163108-16310884.82885.55
3162143-16214384.32685.03
4157697-15769782.01482.62
5157358-15735881.83782.47
6162697-16269784.61485.24
20min1167890-16789087.31587.791.2088.4188.911.21
2169073-16907387.93089.12
3169909-16990988.36589.53
4166012-16601286.33887.40
5168019-16801987.38288.47
6171937-17193789.41990.52
30min1171268-17126889.07190.182.9890.6591.782.97
2177764-17776492.45094.13
3174840-17484090.92992.59
4167052-16705286.87988.42
5169122-16912287.95589.52
6180373-18037393.80795.40
45min1175736-17573691.39591.672.2693.4793.782.23
2175643-17564391.34793.54
3176719-17671991.90694.07
4172686-17268689.80991.83
5173129-17312990.03992.10
6183699-18369995.53697.65
60min1177710-17771092.42291.441.6295.0194.061.62
2177363-17736392.24194.94
3174926-17492690.97493.65
4173116-17311690.03392.55
5172299-17229989.60892.17
6179520-17952093.36396.01
极限1171004-17100488.93490.521.4392.0393.641.44
2177928-17792892.53595.75
3173239-17323990.09793.28
4172062-17206289.48492.51
5175113-17511391.07194.13
6174980-17498091.00294.17
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500
标示量(mg)20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%
110.414006774010484015194010784002844009210.12
210.444023974029574026770.10
单位质量响应值RSD%判断
38513.0638570.590.11数据可信
长期24月-供试品溶液-X024017批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1221471-22147151.45854.229.9451.4654.229.94
2268710-26871062.43362.43
3256058-25605859.49459.49
4211069-21106949.04149.04
5222220-22222051.63251.63
6220707-22070751.28051.28
10min1335687-33568777.99578.544.3078.2878.844.32
2356308-35630882.78683.13
3354782-35478282.43282.76
4320179-32017974.39274.66
5328928-32892876.42576.71
6332199-33219977.18577.47
15min1377868-37786887.79688.601.2588.5189.341.26
2385166-38516689.49190.30
3382141-38214188.78989.58
4378971-37897188.05288.74
5375685-37568587.28988.00
6388243-38824390.20690.92
20min1386816-38681689.87590.451.0491.0891.681.04
2389086-38908690.40291.71
3390030-39003090.62291.90
4384438-38443889.32290.50
5389006-38900690.38491.58
6396472-39647292.11893.33
30min1382657-38265788.90890.112.8890.6191.842.86
2396572-39657292.14293.95
3390795-39079590.79992.58
4374850-37485087.09588.77
5378345-37834587.90789.61
6403628-40362893.78195.51
45min1385292-38529289.52189.991.9891.7292.221.96
2386731-38673189.85592.17
3388254-38825490.20992.50
4380701-38070188.45490.61
5381166-38116688.56290.75
6401662-40166293.32495.57
60min1388215-38821590.20089.351.5892.9092.091.58
2387047-38704789.92892.75
3383436-38343689.08991.88
4378895-37889588.03490.68
5376879-37687987.56690.24
6392956-39295691.30194.07
极限1373407-37340786.75988.031.3689.9691.261.35
2387611-38761190.06093.38
3378039-37803987.83691.12
4375914-37591487.34290.48
5382004-38200488.75791.92
6376317-37631787.43590.71
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