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%
111.311933451933791933291931971934741933450.06
211.371943421942521942970.04
单位质量响应值RSD%判断
17095.0517088.570.03数据可信
中间条件12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%
5min1119523-11952362.78056.1216.2862.7856.1216.28
2120853-12085363.47863.48
3111250-11125058.43458.43
4119682-11968262.86362.86
583634-8363443.92943.93
686073-8607345.21045.21
10min1154929-15492981.37778.844.6381.7379.154.67
2154919-15491981.37181.72
3153885-15388580.82881.15
4154060-15406080.92081.27
5143870-14387075.56875.81
6138898-13889872.95673.21
15min1168267-16826788.38387.851.8589.1888.591.87
2170445-17044589.52790.33
3165563-16556386.96287.74
4167720-16772088.09588.89
5169519-16951989.04089.70
6161953-16195385.06685.72
20min1171630-17163090.14990.570.9291.4491.810.87
2172378-17237890.54291.84
3170436-17043689.52290.78
4172496-17249690.60491.89
5175231-17523192.04093.20
6172405-17240590.55691.69
30min1171741-17174190.20791.471.3192.0093.211.23
2173804-17380491.29193.10
3174228-17422891.51493.27
4172549-17254990.63292.42
5174210-17421091.50493.17
6178320-17832093.66395.30
45min1170619-17061989.61892.561.9291.9194.811.83
2176775-17677592.85195.16
3175925-17592592.40594.67
4175225-17522592.03794.33
5180785-18078594.95897.14
6178050-17805093.52195.67
60min1174125-17412591.45992.331.0794.2595.091.03
2177478-17747893.22196.05
3175313-17531392.08394.86
4175066-17506691.95494.76
5174063-17406391.42794.13
6178645-17864593.83496.51
极限1175561-17556192.21493.561.4895.5196.841.44
2182615-18261595.91999.26
3175512-17551292.18895.48
4177959-17795993.47396.79
5179033-17903394.03797.25
6178052-17805293.52296.72
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%
110.834202294200014201204202724200014201250.03
210.884220004222514221260.05
单位质量响应值RSD%判断
38792.7138798.350.02数据可信
中间条件12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%
5min1297636-29763668.70262.1515.5168.7062.1515.52
2304243-30424370.22770.23
3280383-28038364.72064.72
4300422-30042269.34569.35
5214679-21467949.55349.55
6218141-21814150.35350.35
10min1365607-36560784.39182.913.9984.7783.264.03
2368637-36863785.09185.48
3369900-36990085.38285.74
4367281-36728184.77885.16
5349435-34943580.65980.93
6334314-33431477.16877.45
15min1387152-38715289.36589.961.5890.2290.761.59
2396252-39625291.46592.33
3387143-38714389.36390.20
4391180-39118090.29491.15
5396270-39627091.46992.19
6380330-38033087.79088.50
20min1388880-38888089.76390.910.8991.1192.210.86
2394976-39497691.17192.54
3390161-39016190.05991.39
4397195-39719591.68393.04
5396781-39678191.58792.82
6395054-39505491.18992.38
30min1380807-38080787.90090.361.7089.7592.171.61
2390811-39081190.20992.09
3393981-39398190.94192.77
4388976-38897689.78691.65
5393296-39329690.78392.52
6400983-40098392.55794.26
45min1379759-37975987.65890.771.9189.9993.081.83
2393558-39355890.84393.22
3394126-39412690.97493.31
4393194-39319490.75993.13
5402712-40271292.95695.20
6396001-39600191.40793.62
60min1385365-38536588.95290.071.1591.7792.891.11
2393739-39373990.88593.77
3391342-39134290.33293.17
4389007-38900789.79392.66
5385434-38543488.96891.73
6396416-39641691.50394.23
极限1384716-38471688.80290.691.3892.1294.001.34
2400634-40063492.47795.86
3389547-38954789.91793.26
4394263-39426391.00694.38
5395175-39517591.21794.47
6392922-39292290.69693.93
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%
111.311940221940061940061941551940051940390.04
211.371952831954691953760.07
单位质量响应值RSD%判断
17156.4117183.470.12数据可信
中间条件12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%
5min197349-9734950.90042.6125.1550.9042.6225.15
276027-7602739.75239.75
376291-7629139.89039.89
4114234-11423459.72959.73
563671-6367133.29133.29
661445-6144532.12732.13
10min1140471-14047173.44769.8310.2873.7370.0610.33
2133695-13369569.90470.12
3137448-13744871.86672.09
4153484-15348480.25180.58
5119320-11932062.38862.57
6116861-11686161.10261.28
15min1162061-16206184.73684.542.7185.4385.162.80
2163820-16382085.65586.26
3163711-16371185.59886.22
4167466-16746687.56288.34
5156736-15673681.95182.48
6156277-15627781.71182.23
20min1174138-17413891.05090.151.6692.2191.241.68
2167531-16753187.59688.68
3171331-17133189.58290.68
4175487-17548791.75593.02
5171847-17184789.85290.84
6174124-17412491.04392.01
30min1173741-17374190.84392.211.1392.5193.801.14
2176729-17672992.40593.98
3174656-17465691.32192.92
4179222-17922293.70895.48
5177566-17756692.84294.33
6176179-17617992.11793.59
45min1174161-17416191.06292.251.9693.2394.351.84
2179837-17983794.03096.11
3171790-17179089.82291.92
4174497-17449791.23893.53
5177990-17799093.06495.07
6180283-18028394.26396.25
60min1176864-17686492.47591.611.1295.1594.231.14
2173402-17340290.66593.27
3174098-17409891.02993.63
4176717-17671792.39995.20
5177256-17725692.68095.20
6172908-17290890.40792.92
极限1177535-17753592.82692.520.6096.0295.650.58
2177296-17729692.70195.81
3177939-17793993.03896.14
4175901-17590191.97295.29
5177655-17765592.88995.92
6175376-17537691.69794.71
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%
110.834220724220664220124223174222394221410.04
210.884243284248454245860.09
单位质量响应值RSD%判断
38978.8639024.450.09数据可信
中间条件12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%
5min1247803-24780356.89747.9824.5356.9047.9824.53
2195953-19595344.99244.99
3196737-19673745.17245.17
4290935-29093566.80066.80
5163100-16310037.44937.45
6159156-15915636.54336.54
10min1336097-33609777.17073.669.5677.4973.939.61
2322532-32253274.05574.31
3328440-32844075.41275.66
4365482-36548283.91784.29
5288580-28858066.26066.47
6283790-28379065.16065.36
15min1381262-38126287.54086.972.1888.2887.652.27
2383814-38381488.12688.79
3381334-38133487.55688.23
4388788-38878889.26890.11
5369243-36924384.78085.36
6368262-36826284.55585.12
20min1397800-39780091.33790.471.5492.5791.631.55
2385192-38519288.44289.59
3388335-38833589.16490.32
4399571-39957191.74493.08
5394041-39404190.47491.52
6399252-39925291.67192.71
30min1388891-38889189.29290.381.2491.0392.041.23
2396842-39684291.11792.76
3386782-38678288.80790.46
4398520-39852091.50293.35
5397336-39733691.23192.78
6393329-39332990.31191.85
45min1384284-38428488.23489.052.5590.4791.222.44
2397878-39787891.35593.50
3372119-37211985.44187.59
4384137-38413788.20090.55
5390663-39066389.69891.76
6398027-39802791.38993.44
60min1388054-38805489.09988.211.1791.8290.861.17
2380770-38077087.42790.08
3377200-37720086.60789.23
4387213-38721388.90691.75
5388008-38800889.08991.64
6383755-38375588.11290.67
极限1388120-38812089.11588.730.7092.3391.880.67
2389374-38937489.40392.54
3387033-38703388.86591.97
4383665-38366588.09291.43
5387927-38792789.07092.12
6382630-38263087.85490.90
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%
111.311944771946921948551949951949771947990.12
211.371959931965531962730.21
单位质量响应值RSD%判断
17223.6117262.360.16数据可信
中间条件12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%
5min190466-9046647.10143.0215.1747.1043.0215.17
283998-8399843.73343.73
361440-6144031.98931.99
474669-7466938.87638.88
594927-9492749.42349.42
690251-9025146.98946.99
10min1147528-14752876.81070.0011.5377.0770.2411.54
2127681-12768166.47766.72
3114249-11424959.48359.66
4123086-12308664.08464.30
5155078-15507880.74181.02
6139019-13901972.38072.64
15min1162959-16295984.84481.496.3185.5382.126.35
2161337-16133784.00084.61
3141085-14108573.45673.96
4148867-14886777.50778.08
5167710-16771087.31888.04
6157151-15715181.82082.48
20min1167720-16772087.32386.712.9488.4887.793.02
2169907-16990788.46289.54
3158163-15816382.34783.26
4163314-16331485.02986.03
5170913-17091388.98590.19
6169264-16926488.12789.24
30min1170663-17066388.85589.892.4790.5091.462.51
2175975-17597591.62193.19
3164863-16486385.83587.21
4174411-17441190.80792.28
5175566-17556691.40893.11
6174465-17446590.83592.44
45min1178670-17867093.02490.582.5795.1692.642.59
2172468-17246889.79591.87
3166424-16642486.64888.50
4177530-17753092.43194.41
5172776-17277689.95592.17
6176028-17602891.64893.76
60min1174281-17428190.73990.222.3293.3992.792.36
2177071-17707192.19294.77
3166158-16615886.51088.84
4172759-17275989.94692.44
5172512-17251289.81892.53
6176954-17695492.13194.75
极限1173011-17301190.07890.901.6093.2493.971.58
2177085-17708592.19995.29
3173069-17306990.10892.92
4173658-17365890.41593.41
5171765-17176589.42992.64
6178960-17896093.17596.31
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%
110.834228294233804237374239864239264235720.12
210.884251434264684258060.23
单位质量响应值RSD%判断
39110.9939136.580.05数据可信
中间条件12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%
5min1229992-22999252.64348.1914.5152.6448.1914.51
2213264-21326448.81448.81
3158841-15884136.35736.36
4192109-19210943.97243.97
5242106-24210655.41555.42
6226894-22689451.93451.93
10min1350495-35049580.22473.2911.4280.5273.5611.42
2302999-30299969.35369.62
3274240-27424062.77062.97
4292510-29251066.95267.20
5369802-36980284.64484.95
6331251-33125175.82076.11
15min1375625-37562585.97683.265.9786.7183.936.01
2375967-37596786.05586.71
3330646-33064675.68176.23
4346115-34611579.22279.84
5389346-38934689.11789.90
6364769-36476983.49284.20
20min1379864-37986486.94787.202.6988.1688.342.77
2389439-38943989.13890.27
3365459-36545983.65084.62
4372563-37256385.27686.33
5390364-39036489.35090.62
6388237-38823788.86390.04
30min1382139-38213987.46788.842.3489.1790.462.39
2394518-39451890.30191.93
3372618-37261885.28886.72
4390505-39050589.38290.91
5396077-39607790.65892.43
6392947-39294789.94191.61
45min1395871-39587190.61088.492.5192.8090.612.54
2382314-38231487.50789.64
3369858-36985884.65686.57
4392120-39212089.75291.78
5385608-38560888.26190.53
6393958-39395890.17392.34
60min1384828-38482888.08387.932.3790.7790.542.41
2391013-39101389.49992.12
3368704-36870484.39286.77
4382091-38209187.45689.98
5383165-38316587.70290.47
6395190-39519090.45593.12
极限1379580-37958086.88288.151.8690.0691.241.83
2389708-38970889.20092.31
3382451-38245187.53990.39
4381177-38117787.24790.26
5380110-38011087.00390.25
6397642-39764291.01694.19
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%
111.311914441915141914641914091915951914850.04
211.371962701968371965540.21
单位质量响应值RSD%判断
16930.5917287.071.48数据可信
中间条件12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%
5min1101251-10125153.13552.107.4153.1452.107.42
286307-8630745.29345.29
3105581-10558155.40755.41
4101392-10139253.20953.21
5105631-10563155.43455.43
695552-9555250.14450.14
10min1144033-14403375.58673.553.0175.8873.843.02
2133215-13321569.90970.16
3141857-14185774.44574.75
4141572-14157274.29574.59
5143293-14329375.19875.51
6136906-13690671.84672.12
15min1155718-15571881.71983.661.4682.4384.361.45
2159832-15983283.87884.52
3159152-15915283.52184.24
4160338-16033884.14384.85
5162817-16281785.44486.17
6158624-15862483.24483.92
20min1164442-16444286.29786.981.1087.4788.141.10
2166697-16669787.48088.59
3165885-16588587.05488.24
4166603-16660387.43188.61
5167926-16792688.12589.33
6162855-16285585.46486.60
30min1162668-16266885.36688.712.0687.0190.352.01
2172946-17294690.76092.35
3169632-16963289.02090.69
4170001-17000189.21490.88
5170615-17061589.53691.23
6168347-16834788.34689.96
45min1167226-16722687.75890.791.7389.8892.931.70
2175337-17533792.01494.11
3174653-17465391.65593.82
4173861-17386191.24093.40
5174478-17447891.56493.75
6172498-17249890.52592.63
60min1167413-16741387.85689.872.3990.4792.512.32
2176763-17676392.76395.37
3168419-16841988.38491.06
4175927-17592792.32494.99
5170510-17051089.48192.18
6168435-16843588.39291.00
极限1169607-16960789.00791.692.2792.1194.832.22
2179665-17966594.28697.41
3175609-17560992.15795.32
4176479-17647992.61495.79
5176661-17666192.70995.90
6170243-17024389.34192.44
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%
110.834161734160394160564158524163094160860.05
210.884204644216884210760.21
单位质量响应值RSD%判断
38419.7638701.840.52数据可信
中间条件12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%
5min1268944-26894462.45861.247.5562.4661.247.56
2227830-22783052.91052.91
3279707-27970764.95764.96
4272353-27235363.25063.25
5279349-27934964.87464.87
6254114-25411459.01459.01
10min1357083-35708382.92780.522.7983.2780.862.80
2330901-33090176.84677.14
3350661-35066181.43581.80
4350267-35026781.34481.70
5351858-35185881.71382.07
6339474-33947478.83779.17
15min1371440-37144086.26188.491.4787.0789.281.45
2384131-38413189.20889.93
3378466-37846687.89388.71
4383050-38305088.95789.76
5387691-38769190.03590.85
6381359-38135988.56489.33
20min1381725-38172588.64989.661.0889.9490.941.06
2390401-39040190.66491.88
3386456-38645689.74891.05
4387933-38793390.09191.39
5389635-38963590.48691.80
6380395-38039588.34189.60
30min1366006-36600684.99988.322.1386.7890.102.07
2390167-39016790.61092.33
3378351-37835187.86689.67
4383006-38300688.94790.74
5383943-38394389.16590.98
6380430-38043088.34990.10
45min1371075-37107586.17688.851.5488.4391.111.51
2386848-38684889.83992.06
3385569-38556989.54291.83
4383747-38374789.11991.41
5386032-38603289.65091.96
6382136-38213688.74590.98
60min1368676-36867685.61987.452.1688.3590.212.09
2388024-38802490.11292.83
3369886-36988685.90088.69
4385192-38519289.45592.24
5374221-37422186.90789.72
6373308-37330886.69589.43
极限1372973-37297386.61789.081.9689.8292.331.91
2393083-39308391.28794.51
3385394-38539489.50292.76
4386738-38673889.81493.10
5387067-38706789.89093.18
6376330-37633087.39790.61
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