依折麦布阿托伐他汀钙片项目信息
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对照品来源自制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%
111.331935711939411938991940361938111938520.10
211.381946681948811947740.08
单位质量响应值RSD%判断
17109.6217115.470.03数据可信
长期12月-供试品溶液-2024011221批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160245-6024531.60525.8616.2531.6125.8616.25
257013-5701329.91029.91
342729-4272922.41622.42
440348-4034821.16721.17
545180-4518023.70223.70
650241-5024126.35726.36
10min1134993-13499370.81967.196.4570.9967.346.47
2133360-13336069.96370.13
3123284-12328464.67764.80
4119080-11908062.47162.59
5119938-11993862.92163.05
6137834-13783472.31072.46
15min1157807-15780782.78882.493.6483.3683.013.65
2161086-16108684.50885.06
3160170-16017084.02884.51
4149567-14956778.46578.93
5151081-15108179.25979.74
6163756-16375685.90986.46
20min1165012-16501286.56889.002.7987.6089.982.79
2174180-17418091.37792.40
3174671-17467191.63592.59
4165554-16555486.85287.75
5165538-16553886.84487.77
6172916-17291690.71491.74
30min1169145-16914588.73692.433.1690.2593.903.14
2180323-18032394.60096.13
3180600-18060094.74696.21
4175351-17535191.99293.37
5170024-17002489.19790.60
6181628-18162895.28596.81
45min1177669-17766993.20895.011.3095.2196.991.32
2183193-18319396.10698.16
3183095-18309596.05498.04
4179799-17979994.32596.22
5179770-17977094.31096.21
6183112-18311296.06398.12
60min1177725-17772593.23794.161.5295.7696.681.55
2182522-18252295.75498.35
3181421-18142195.17697.70
4177896-17789693.32795.75
5175755-17575592.20494.63
6181598-18159895.26997.86
极限1179749-17974994.29994.540.7697.3497.570.80
2180450-18045094.66797.79
3182283-18228395.62898.68
4178699-17869993.74896.68
5178952-17895293.88196.82
6181094-18109495.00598.13
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981569331569171572041572491567351570080.14
210.961571621572641572130.05
单位质量响应值RSD%判断
14299.4514344.250.23数据可信
长期12月-供试品溶液-2024011221批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101463-10146358.64168.4813.9258.6468.4813.92
2118382-11838268.42068.42
398375-9837556.85756.86
4132427-13242776.53776.54
5140134-14013480.99280.99
6120090-12009069.40769.41
10min1149993-14999386.69089.865.0787.0290.245.10
2160245-16024592.61592.99
3142216-14221682.19582.51
4163444-16344494.46494.89
5158899-15889991.83792.29
6158094-15809491.37291.76
15min1160286-16028692.63993.981.4793.4594.861.51
2165184-16518495.46996.36
3159782-15978292.34793.12
4165007-16500795.36796.32
5161571-16157193.38194.34
6163863-16386394.70695.60
20min1161922-16192293.58495.581.6094.9196.981.62
2168187-16818797.20598.63
3165159-16515995.45596.74
4168785-16878597.55199.03
5164206-16420694.90496.38
6163965-16396594.76596.18
30min1162088-16208893.68095.461.9195.5297.401.88
2167486-16748696.80098.76
3167078-16707896.56498.38
4167680-16768096.91298.93
5160328-16032892.66394.67
6166386-16638696.16498.11
45min1166873-16687396.44696.590.8798.8199.050.83
2168634-16863497.46399.97
3168629-16862997.46099.81
4167534-16753496.82899.39
5166018-16601895.95198.47
6165012-16501295.37097.85
60min1165943-16594395.90895.591.5198.8198.591.42
2167953-16795397.070100.11
3168245-16824597.239100.13
4164712-16471295.19798.29
5161902-16190293.57396.63
6163608-16360894.55997.57
极限1166180-16618096.04596.261.8099.4899.801.70
2167267-16726796.673100.26
3171679-17167999.223102.66
4164759-16475995.22498.85
5166739-16673996.36899.94
6162734-16273494.05397.59
依折麦布阿托伐他汀钙片项目信息
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对照品来源自制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%
111.331947021947581943601944061939891944430.16
211.381955711959481957600.14
单位质量响应值RSD%判断
17161.7817202.110.17数据可信
长期12月-供试品溶液-2024011222批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177366-7736640.42329.5129.6640.4229.5129.66
247993-4799325.07625.08
329516-2951615.42215.42
457627-5762730.11030.11
569361-6936136.24136.24
657035-5703529.80129.80
10min1149736-14973678.23772.237.1978.4672.407.23
2141174-14117473.76373.90
3121631-12163163.55263.64
4139240-13924072.75272.92
5144950-14495075.73675.94
6132748-13274869.36069.53
15min1166399-16639986.94385.753.4387.6086.323.46
2169009-16900988.30788.86
3158722-15872282.93283.37
4164364-16436485.88086.45
5170067-17006788.85989.48
6156126-15612681.57582.13
20min1176975-17697592.46991.202.9093.6192.242.94
2179233-17923393.64994.69
3168849-16884988.22389.12
4173449-17344990.62791.68
5180140-18014094.12395.24
6168667-16866788.12889.13
30min1178387-17838793.20793.281.5594.8694.831.58
2182626-18262695.42296.98
3176005-17600591.96293.35
4178886-17888693.46795.02
5180194-18019494.15195.79
6175095-17509591.48792.98
45min1173615-17361590.71392.932.3992.8995.002.37
2180303-18030394.20896.30
3175996-17599691.95793.86
4183399-18339995.82597.90
5180798-18079894.46696.63
6173058-17305890.42292.42
60min1176972-17697292.46793.661.3595.1596.241.35
2182269-18226995.23597.85
3178608-17860893.32295.73
4180500-18050094.31196.91
5181015-18101594.58097.27
6176156-17615692.04194.55
极限1175808-17580891.85992.812.2695.0595.912.27
2181972-18197295.08098.22
3174744-17474491.30394.23
4178680-17868093.36096.49
5182182-18218295.19098.40
6172359-17235990.05793.07
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981576671575231570891571601567181572310.24
210.961580671591201585940.47
单位质量响应值RSD%判断
14319.7614470.260.74数据可信
长期12月-供试品溶液-2024011222批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107069-10706961.56864.3524.7761.5764.3524.77
278935-7893545.39045.39
397130-9713055.85355.85
4137259-13725978.92978.93
5152909-15290987.92887.93
698166-9816656.44956.45
10min1142364-14236481.86485.768.5082.2186.118.57
2131402-13140275.56175.81
3149505-14950585.97186.28
4160620-16062092.36292.80
5166204-16620495.57396.06
6144700-14470083.20883.52
15min1147659-14765984.90990.144.3185.7190.984.38
2151866-15186687.32888.00
3157799-15779990.74091.53
4161542-16154292.89293.84
5166480-16648095.73296.75
6155197-15519789.24490.02
20min1155454-15545489.39292.312.7590.6693.642.83
2159080-15908091.47792.63
3157893-15789390.79492.09
4160741-16074192.43293.90
5168347-16834796.80598.36
6161615-16161592.93494.21
30min1153976-15397688.54291.482.2790.3193.332.32
2159807-15980791.89593.56
3155749-15574989.56191.36
4159768-15976891.87293.85
5163535-16353594.03896.13
6161727-16172792.99994.79
45min1149297-14929785.85190.353.0788.1192.703.12
2157669-15766990.66592.84
3154368-15436888.76791.06
4160651-16065192.38094.87
5162968-16296893.71296.32
6157780-15778090.72993.03
60min1152231-15223187.53890.902.4790.2793.752.50
2159770-15977091.87394.55
3155249-15524989.27492.06
4157736-15773690.70493.71
5163125-16312593.80396.93
6160326-16032692.19395.00
极限1153235-15323588.11590.112.8691.3493.482.86
2160041-16004192.02995.22
3152415-15241587.64490.93
4154524-15452488.85792.37
5164026-16402694.32197.97
6156025-15602589.72093.04
依折麦布阿托伐他汀钙片项目信息
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对照品来源自制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%
111.331946011944381945711946641943831945310.07
211.381943601948491946040.18
单位质量响应值RSD%判断
17169.5517100.530.29数据可信
长期12月-供试品溶液-2024011223批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163278-6327833.15327.0829.4333.1527.0829.42
258992-5899230.90830.91
352418-5241827.46327.46
429314-2931415.35815.36
568278-6827835.77335.77
637832-3783219.82119.82
10min1136497-13649771.51570.727.2171.7070.877.25
2139822-13982273.25773.43
3132173-13217369.24969.40
4117365-11736561.49161.58
5145923-14592376.45376.65
6138128-13812872.36972.48
15min1159095-15909583.35483.623.8583.9484.173.89
2161949-16194984.85085.43
3160367-16036784.02184.56
4147862-14786277.46977.90
5165199-16519986.55287.18
6163176-16317685.49386.00
20min1168380-16838088.21987.942.1589.2688.952.19
2167363-16736387.68688.74
3168541-16854188.30389.31
4161437-16143784.58185.44
5168859-16885988.47089.57
6172516-17251690.38691.37
30min1172087-17208790.16190.371.7391.7091.871.69
2167532-16753287.77589.31
3175025-17502591.70193.20
4172318-17231890.28291.61
5171888-17188890.05791.65
6176066-17606692.24693.74
45min1179600-17960094.09892.821.0796.1394.821.02
2174430-17443091.38993.41
3176706-17670692.58194.59
4178251-17825193.39195.22
5175786-17578692.09994.20
6178191-17819193.35995.36
60min1176941-17694192.70492.421.5795.2694.941.48
2171772-17177289.99692.53
3178669-17866993.61096.13
4179153-17915393.86396.21
5174670-17467091.51594.12
6177235-17723592.85895.38
极限1174826-17482691.59691.721.5194.6794.751.48
2170283-17028389.21692.25
3177696-17769693.10096.14
4174614-17461491.48594.35
5175921-17592192.17095.29
6177009-17700992.74095.78
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981573111574461573991576251569411573440.17
210.961571421577281574350.27
单位质量响应值RSD%判断
14330.0514364.510.17数据可信
长期12月-供试品溶液-2024011223批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130036-13003675.02262.6521.1775.0262.6521.18
268952-6895239.78139.78
395947-9594755.35555.35
4109916-10991663.41463.41
5125977-12597772.68072.68
6120740-12074069.65969.66
10min1152472-15247287.96683.986.7088.3884.336.76
2130522-13052275.30275.52
3136872-13687278.96679.27
4147822-14782285.28385.64
5155433-15543389.67490.08
6150290-15029086.70787.09
15min1155290-15529089.59287.963.2390.5088.773.31
2143665-14366582.88583.52
3151896-15189687.63488.38
4151670-15167087.50388.33
5158082-15808291.20392.10
6154148-15414888.93389.80
20min1157019-15701990.58989.401.7591.9990.701.83
2149764-14976486.40487.50
3156897-15689790.51991.75
4154754-15475489.28390.59
5156248-15624890.14591.55
6155090-15509089.47790.84
30min1155511-15551189.71989.901.9191.6391.701.93
2151118-15111887.18588.76
3158470-15847091.42793.16
4159534-15953492.04093.85
5155463-15546389.69291.60
6154885-15488589.35891.22
45min1156756-15675690.43891.041.3392.8493.341.30
2157247-15724790.72192.79
3157939-15793991.12093.36
4161729-16172993.30795.63
5157521-15752190.87993.29
6155601-15560189.77192.13
60min1157632-15763290.94390.891.8193.8593.701.79
2154943-15494389.39291.96
3159531-15953192.03994.79
4161967-16196793.44496.28
5156745-15674590.43193.34
6154446-15444689.10591.96
极限1155675-15567589.81490.211.2393.2393.521.23
2154694-15469489.24892.31
3158830-15883091.63494.90
4156963-15696390.55793.91
5158037-15803791.17794.59
6153955-15395588.82292.17
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