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%
110.591781001783231781671782341781721781990.05
210.621781221782631781920.06
单位质量响应值RSD%判断
16827.1016778.910.21数据可信
中间条件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%
5min176630-7663040.94243.4117.4640.9443.4117.47
295064-9506450.79150.79
363026-6302633.67433.67
496889-9688951.76651.77
568046-6804636.35636.36
687792-8779246.90646.91
10min1123760-12376066.12368.876.8366.3569.116.87
2137552-13755273.49173.77
3119639-11963963.92164.11
4140056-14005674.82975.12
5120669-12066964.47164.67
6131702-13170270.36670.63
15min1150123-15012380.20881.562.9880.8082.183.03
2157565-15756584.18484.87
3150063-15006380.17680.72
4158445-15844584.65485.36
5146962-14696278.51979.08
6152783-15278381.62982.28
20min1161650-16165086.36687.073.4087.4188.153.40
2168764-16876490.16791.33
3163097-16309787.14088.13
4169046-16904690.31891.49
5161096-16109686.07087.07
6154173-15417382.37283.48
30min1166034-16603488.70990.361.7590.2391.921.78
2169774-16977490.70792.37
3166814-16681489.12590.60
4173535-17353592.71694.39
5171381-17138191.56693.04
6167158-16715889.30990.87
45min1168179-16817989.85592.411.8091.8794.471.83
2174601-17460193.28695.45
3172020-17202091.90793.87
4177485-17748594.82797.02
5173563-17356392.73194.71
6171938-17193891.86393.92
60min1167107-16710789.28292.151.9291.7994.731.93
2175208-17520893.61096.29
3171547-17154791.65494.13
4175424-17542493.72696.44
5174881-17488193.43695.93
6170715-17071591.21093.78
极限1172675-17267592.25792.881.6595.2795.971.61
2172871-17287192.36295.56
3173227-17322792.55295.54
4176258-17625894.17197.41
5178022-17802295.11498.13
6170000-17000090.82893.90
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%
110.413869693864363865893867623865323866580.06
210.443859633867623863620.15
单位质量响应值RSD%判断
37142.9437007.850.26数据可信
中间条件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%
5min1185807-18580744.87947.8616.6244.8847.8616.62
2229385-22938555.40555.40
3155535-15553537.56737.57
4236266-23626657.06757.07
5169511-16951140.94340.94
6212464-21246451.31851.32
10min1286776-28677669.26772.336.0269.5272.606.06
2316320-31632076.40376.71
3279978-27997867.62567.83
4323747-32374778.19678.51
5285813-28581369.03469.26
6304128-30412873.45873.74
15min1339191-33919181.92783.532.5782.5684.202.62
2354094-35409485.52686.26
3341417-34141782.46483.05
4359198-35919886.75987.51
5336831-33683181.35781.97
6344259-34425983.15183.84
20min1357361-35736186.31588.162.4787.4089.302.50
2373269-37326990.15891.37
3363908-36390887.89788.94
4378198-37819891.34892.58
5362113-36211387.46388.53
6355226-35522685.80086.95
30min1361177-36117787.23789.232.3288.8190.862.32
2369404-36940489.22490.93
3363164-36316487.71789.25
4381614-38161492.17393.91
5377969-37796991.29392.84
6363339-36333987.75989.39
45min1360846-36084687.15790.122.2089.2192.242.22
2375238-37523890.63392.84
3369640-36964089.28191.30
4384054-38405492.76395.02
5379236-37923691.59993.66
6369650-36965089.28491.40
60min1356026-35602685.99389.442.5388.5392.062.52
2371093-37109389.63292.34
3367738-36773888.82291.34
4380256-38025691.84594.61
5380745-38074591.96394.53
6365992-36599288.40091.02
极限1367710-36771088.81589.682.3391.8392.802.29
2368002-36800288.88692.09
3369195-36919589.17492.18
4379863-37986391.75095.03
5383224-38322492.56295.64
6359871-35987186.92290.03
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%
110.591799811801351800661798291796761799370.11
210.621800121801151800640.05
单位质量响应值RSD%判断
16991.2216955.180.16数据可信
中间条件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%
5min174041-7404139.16244.5415.4739.1644.5415.47
272833-7283338.52338.52
3105550-10555055.82855.83
477648-7764841.07041.07
594434-9443449.94849.95
680765-8076542.71842.72
10min1125492-12549266.37671.9810.7466.5972.2210.75
2131187-13118769.38869.60
3156721-15672182.89383.20
4117378-11737862.08462.31
5148500-14850078.54578.82
6137206-13720672.57172.81
15min1155877-15587782.44785.325.5083.0385.975.54
2160504-16050484.89485.49
3169625-16962589.71990.49
4146685-14668577.58578.16
5168449-16844989.09789.81
6166723-16672388.18488.82
20min1166492-16649288.06190.092.4989.1191.212.54
2172287-17228791.12792.20
3172718-17271891.35492.62
4164261-16426186.88187.89
5175627-17562792.89394.10
6170558-17055890.21291.34
30min1174992-17499292.55794.011.5994.0995.631.61
2180587-18058795.51797.09
3177319-17731993.78895.56
4175790-17579092.97994.47
5181796-18179696.15697.88
6175905-17590593.04094.67
45min1173874-17387491.96693.921.2494.0196.071.29
2178246-17824694.27896.39
3179588-17958894.98897.29
4177784-17778494.03496.04
5179602-17960294.99697.25
6176348-17634893.27495.42
60min1176998-17699893.61894.171.0596.1896.841.04
2180440-18044095.43998.07
3176631-17663193.42496.25
4178095-17809594.19896.72
5180101-18010195.26098.05
6175977-17597793.07895.74
极限1177692-17769293.98594.710.9197.0697.900.99
2180199-18019995.31198.47
3181291-18129195.88999.23
4177114-17711493.68096.73
5179798-17979895.09998.42
6178239-17823994.27597.46
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%
110.413902153897423908443898033896863900580.13
210.443908543906253907400.05
单位质量响应值RSD%判断
37469.5537427.200.08数据可信
中间条件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%
5min1181269-18126943.34749.4014.9743.3549.4014.97
2179140-17914042.83842.84
3256427-25642761.31961.32
4190043-19004345.44545.44
5231071-23107155.25655.26
6201462-20146248.17548.18
10min1293259-29325970.12775.2110.2870.3775.4810.29
2303599-30359972.59972.84
3359364-35936485.93486.28
4270978-27097864.79965.05
5341540-34154081.67281.98
6318283-31828376.11176.38
15min1354381-35438184.74386.715.3185.3787.405.34
2361061-36106186.34086.98
3380228-38022890.92491.74
4328930-32893078.65779.27
5375566-37556689.80990.57
6375497-37549789.79290.48
20min1372935-37293589.18090.251.6990.2891.421.76
2379874-37987490.83991.96
3380735-38073591.04592.37
4368250-36825088.05989.11
5386379-38637992.39593.65
6376289-37628989.98291.17
30min1383184-38318491.63192.011.1093.2393.691.12
2388016-38801692.78694.41
3384042-38404291.83693.66
4382641-38264191.50193.04
5391313-39131393.57495.35
6379499-37949990.74992.44
45min1374384-37438489.52690.591.0291.6392.771.07
2376922-37692290.13392.27
3384112-38411291.85294.19
4381064-38106491.12493.17
5381180-38118091.15193.44
6375258-37525889.73591.93
60min1377461-37746190.26290.350.7992.8793.050.76
2379395-37939590.72493.37
3375995-37599589.91192.76
4379643-37964390.78493.34
5381412-38141291.20794.01
6373161-37316189.23491.93
极限1376826-37682690.11090.580.6493.2193.770.71
2378505-37850590.51293.66
3383556-38355691.71995.07
4377660-37766090.31093.37
5377824-37782490.34993.65
6378352-37835290.47593.66
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%
110.591798541802051805101805301803741802950.16
210.621792391792321792360.01
单位质量响应值RSD%判断
17025.0216877.210.62数据可信
中间条件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%
5min189252-8925247.27038.5013.5447.2738.5013.54
272820-7282038.56738.57
363711-6371133.74333.74
466230-6623035.07735.08
565488-6548834.68434.68
678625-7862541.64141.64
10min1139911-13991174.10064.388.4474.3664.608.45
2112657-11265759.66659.88
3122206-12220664.72364.91
4114301-11430160.53660.73
5115042-11504260.92961.12
6125271-12527166.34666.58
15min1168140-16814089.05080.565.3889.7281.135.41
2146304-14630477.48678.03
3152044-15204480.52681.07
4148334-14833478.56179.09
5146738-14673877.71678.25
6151126-15112680.04080.64
20min1171458-17145890.80887.922.4091.9888.942.45
2166724-16672488.30189.28
3167204-16720488.55589.55
4164104-16410486.91387.88
5159474-15947484.46185.42
6167052-16705288.47489.52
30min1175994-17599493.21092.411.9094.8893.921.88
2172456-17245691.33692.80
3168685-16868589.33990.83
4176716-17671693.59395.04
5177346-17734693.92695.36
6175684-17568493.04694.58
45min1176158-17615893.29792.931.2195.4994.951.21
2175731-17573193.07195.05
3173247-17324791.75593.74
4178687-17868794.63696.61
5172963-17296391.60593.56
6175957-17595793.19195.24
60min1172333-17233391.27192.791.4493.9895.331.33
2176007-17600793.21795.71
3177200-17720093.84996.34
4177254-17725493.87796.37
5176728-17672893.59996.06
6171690-17169090.93193.50
极限1176324-17632493.38592.941.2596.6095.991.22
2174285-17428592.30595.31
3174834-17483492.59695.61
4179097-17909794.85497.87
5175754-17575493.08396.07
6172598-17259891.41294.49
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%
110.413888163907983905553910223911303904640.25
210.443893543885533889540.15
单位质量响应值RSD%判断
37508.5537256.130.48数据可信
中间条件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%
5min1216019-21601951.74842.2413.0251.7542.2413.02
2175629-17562942.07342.07
3156062-15606237.38537.39
4160047-16004738.34038.34
5161395-16139538.66338.66
6188905-18890545.25345.25
10min1324058-32405877.63067.238.7177.9267.468.71
2256151-25615161.36261.60
3282821-28282167.75167.96
4265180-26518063.52563.74
5266890-26689063.93564.15
6288690-28869069.15769.41
15min1380551-38055191.16382.655.2691.8883.255.29
2331149-33114979.32879.90
3343365-34336582.25582.84
4338616-33861681.11781.68
5333103-33310379.79680.37
6343218-34321882.21982.85
20min1382219-38221991.56288.842.2192.7989.912.26
2372181-37218189.15890.17
3372934-37293489.33890.38
4367748-36774888.09689.11
5357234-35723485.57786.59
6372806-37280689.30790.40
30min1385095-38509592.25191.152.0193.9992.722.01
2375033-37503389.84191.35
3367458-36745888.02689.56
4386826-38682692.66694.17
5385201-38520192.27793.77
6383451-38345191.85793.45
45min1380657-38065791.18890.621.4193.4392.681.42
2378173-37817390.59392.60
3373503-37350389.47491.50
4385910-38591092.44694.47
5371156-37115688.91290.91
6380237-38023791.08793.19
60min1370555-37055588.76890.051.3591.5292.621.24
2376935-37693590.29692.81
3380782-38078291.21893.74
4379862-37986290.99893.53
5378658-37865890.70993.20
6368693-36869388.32290.93
极限1378427-37842790.65489.861.4593.9092.931.42
2371896-37189689.08992.10
3373536-37353689.48292.51
4383731-38373191.92494.96
5374996-37499689.83292.83
6368119-36811988.18591.28
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