依折麦布瑞舒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RSF-703-230318-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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.951702211696401701821684571695501696100.43
211.031708031716941712480.37
单位质量响应值RSD%判断
15489.5015525.660.17数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1134543-13454374.29075.2310.3974.2975.2310.39
2132483-13248373.15373.15
3148807-14880782.16682.17
4110709-11070961.13061.13
5144008-14400879.51679.52
6146904-14690481.11681.12
10min1129346-12934671.42188.8010.3971.8389.2210.36
2170356-17035694.06594.47
3166101-16610191.71692.17
4155043-15504385.61085.95
5171760-17176094.84095.28
6172353-17235395.16895.62
15min1156725-15672586.53891.633.5087.3592.543.49
2167995-16799592.76193.69
3172569-17256995.28796.25
4170406-17040694.09394.91
5162105-16210589.50990.48
6165899-16589991.60492.58
20min1175071-17507196.66897.162.6297.9698.582.62
2177796-17779698.17399.62
3172071-17207195.01296.51
4170571-17057194.18495.52
5183510-183510101.328102.79
6176802-17680297.62499.11
30min1172803-17280395.41696.292.3697.2498.252.37
2175203-17520396.74198.73
3171905-17190594.92096.94
4169936-16993693.83395.69
5181811-181811100.390102.42
6174672-17467296.44898.48
45min1172783-17278395.40596.071.7897.7698.561.81
2172317-17231795.14897.67
3174660-17466096.44298.99
4170387-17038794.08296.46
5179470-17947099.097101.68
6174343-17434396.26698.83
60min1169838-16983893.77996.192.4296.6799.222.45
2173498-17349895.80098.86
3175853-17585397.100100.19
4169530-16953093.60996.51
5180658-18065899.753102.89
6175880-17588097.115100.22
极限1168170-16817092.85895.192.5996.2798.762.61
2173645-17364595.88199.47
3171569-17156994.73598.36
4167264-16726492.35895.78
5179431-17943199.076102.77
6174298-17429896.24299.88
依折麦布瑞舒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%
111.061833081840161833051832381837471835230.19
211.131852231851581851900.03
单位质量响应值RSD%判断
16593.4016638.810.20数据可信
供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100029-10002954.18053.237.4054.1853.247.40
2102652-10265255.60155.60
3105301-10530157.03657.04
489061-8906148.23948.24
589242-8924248.33748.34
6103400-10340056.00656.01
10min1115351-11535162.47980.2211.1962.7880.5211.15
2160824-16082487.10987.42
3153919-15391983.36983.69
4152343-15234382.51682.78
5148916-14891680.65980.93
6157326-15732685.21585.53
15min1150132-15013281.31887.405.1981.9788.145.18
2165267-16526789.51690.31
3166966-16696690.43691.22
4171564-17156492.92793.65
5152843-15284382.78783.50
6161420-16142087.43288.22
20min1173104-17310493.76194.811.3594.8696.041.35
2177486-17748696.13497.42
3171977-17197793.15094.43
4174093-17409394.29695.54
5177723-17772396.26397.44
6175870-17587095.25996.53
30min1174327-17432794.42395.081.8796.0496.831.82
2175073-17507394.82796.65
3171158-17115892.70794.51
4174187-17418794.34796.11
5180552-18055297.79599.51
6177889-17788996.35398.15
45min1176424-17642495.55995.550.9097.7097.830.86
2176331-17633195.50997.86
3175557-17555795.08997.40
4175008-17500894.79297.08
5179468-17946897.20899.46
6175674-17567495.15397.49
60min1172385-17238593.37195.661.6996.0598.471.69
2176097-17609795.38298.26
3178349-17834996.60299.44
4173939-17393994.21397.03
5179803-17980397.389100.18
6179044-17904496.97899.84
极限1170718-17071892.46894.881.8195.6698.221.81
2176121-17612195.39598.81
3173164-17316493.79397.17
4173889-17388994.18697.53
5179179-17917997.051100.39
6177959-17795996.39099.79
依折麦布瑞舒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RSF-703-230318-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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.951695831707771697581700431697661699850.28
211.031707691713571710630.25
单位质量响应值RSD%判断
15523.7415508.880.07数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123457-12345768.13057.4730.4068.1357.4730.40
261029-6102933.67933.68
3141700-14170078.19878.20
4108415-10841559.82959.83
570774-7077439.05739.06
6119472-11947265.93165.93
10min1157730-15773087.04479.9621.5787.4280.2821.60
297456-9745653.78253.97
3166580-16658091.92892.36
4161968-16196889.38389.72
5113680-11368062.73562.95
6171951-17195194.89295.26
15min1163282-16328290.10886.1816.9890.9786.9417.04
2114977-11497763.45163.94
3175381-17538196.78597.73
4171314-17131494.54195.37
5131856-13185672.76573.33
6180192-18019299.440100.33
20min1165747-16574791.46888.4613.1192.8389.7013.23
2126588-12658869.85870.70
3174821-17482196.47697.96
4168414-16841492.94094.29
5143744-14374479.32680.30
6182457-182457100.690102.14
30min1163151-16315190.03690.039.4191.9191.769.58
2137679-13767975.97977.21
3173322-17332295.64997.67
4169079-16907993.30795.18
5154609-15460985.32286.73
6180970-18097099.869101.87
45min1166882-16688292.09591.039.2894.4793.279.45
2139445-13944576.95378.60
3179645-17964599.138101.69
4167532-16753292.45394.84
5156456-15645686.34188.23
6179801-17980199.224101.78
60min1164614-16461490.84392.177.2893.7394.917.49
2147543-14754381.42283.50
3177858-17785898.152101.25
4170551-17055194.12097.02
5160911-16091188.80091.16
6180645-18064599.690102.80
极限1173411-17341195.69897.652.2199.09100.902.19
2176182-17618297.22799.76
3174064-17406496.05899.70
4174915-17491596.52899.95
5179660-17966099.146102.00
6183502-183502101.267104.93
依折麦布瑞舒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%
111.061832691839801843541835621838081837950.23
211.131823811840681832240.66
单位质量响应值RSD%判断
16617.9916462.170.67数据可信
供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162179-6217933.83438.4423.4633.8338.4423.46
280701-8070143.91343.91
392223-9222350.18350.18
451166-5116627.84227.84
581958-8195844.59744.60
655606-5560630.25830.26
10min1127709-12770969.49276.056.7369.6876.276.75
2148250-14825080.66980.91
3142269-14226977.41577.69
4128591-12859169.97270.13
5148911-14891181.02981.28
6142889-14288977.75277.92
15min1150822-15082282.06987.914.7982.6488.554.80
2167044-16704490.89691.59
3163393-16339388.90989.62
4153745-15374583.66084.20
5163599-16359989.02289.72
6170757-17075792.91793.52
20min1162644-16264488.50292.393.9289.5393.513.93
2175703-17570395.60896.80
3167869-16786991.34592.55
4162707-16270788.53689.54
5171139-17113993.12494.32
6178670-17867097.22298.34
30min1164377-16437789.44594.563.8790.9796.203.87
2179639-17963997.75099.48
3170445-17044592.74794.46
4170003-17000392.50694.01
5175875-17587595.70197.41
6182333-18233399.216100.87
45min1171126-17112693.11795.212.3695.1497.372.37
2175778-17577895.64997.92
3177597-17759796.63898.86
4172044-17204493.61795.63
5171711-17171193.43695.68
6181561-18156198.795101.00
60min1168579-16857991.73195.272.5694.2797.962.56
2176858-17685896.23699.04
3174349-17434994.87197.63
4174368-17436894.88197.42
5174020-17402094.69297.45
6182297-18229799.196101.95
极限1181302-18130298.65598.930.67101.70102.160.66
2180469-18046998.201101.54
3181102-18110298.546101.84
4182210-18221099.149102.21
5181848-18184898.952102.24
6183954-183954100.098103.41
依折麦布瑞舒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RSF-703-230318-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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.951717251736901725831730181740261730080.53
211.031731871732141732000.02
单位质量响应值RSD%判断
15799.8215702.630.44数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108991-10899159.25158.086.2659.2558.086.26
297861-9786153.20053.20
3105310-10531057.25057.25
4105208-10520857.19457.19
5118283-11828364.30264.30
6105374-10537457.28557.28
10min1142156-14215677.28077.144.5877.6177.474.55
2149985-14998581.53681.83
3143766-14376678.15678.47
4143276-14327677.88978.21
5142186-14218677.29777.65
6130070-13007070.71071.03
15min1144101-14410178.33880.055.6979.1080.805.65
2157232-15723285.47686.22
3149833-14983381.45482.21
4152532-15253282.92183.67
5146915-14691579.86780.65
6132895-13289572.24672.96
20min1146269-14626979.51680.505.5680.7181.705.53
2157917-15791785.84887.07
3150964-15096482.06983.27
4152910-15291083.12784.34
5146686-14668679.74380.97
6133753-13375372.71273.82
30min1144429-14442978.51679.495.7480.1581.135.70
2156355-15635584.99986.70
3149214-14921481.11782.78
4151338-15133882.27283.94
5144141-14414178.35980.03
6131841-13184171.67373.19
45min1144350-14435078.47380.216.1980.5482.296.14
2157518-15751885.63287.80
3151595-15159582.41284.52
4152924-15292483.13485.26
5147512-14751280.19282.30
6131393-13139371.42973.34
60min1146957-14695779.89080.765.0982.4083.295.08
2157270-15727085.49788.15
3151515-15151582.36884.94
4152868-15286883.10485.70
5147521-14752180.19782.75
6135207-13520773.50375.81
极限1164728-16472889.55190.941.3392.5093.921.40
2167544-16754491.08294.21
3168722-16872291.72294.75
4169594-16959492.19695.25
5168751-16875191.73894.74
6164369-16436989.35692.08
依折麦布瑞舒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%
111.061865671868611867121868281872291868390.14
211.131867881869671868780.07
单位质量响应值RSD%判断
16893.2216790.480.44数据可信
供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166477-6647735.52536.418.2835.5236.418.29
269492-6949237.13637.14
366043-6604335.29335.29
459476-5947631.78331.78
576327-7632740.78840.79
670973-7097337.92737.93
10min1144999-14499977.48677.432.4177.6877.642.42
2144167-14416777.04177.25
3146277-14627778.16978.36
4139334-13933474.45874.64
5150103-15010380.21380.44
6144521-14452177.23077.44
15min1159564-15956485.26986.501.3485.9087.131.35
2160625-16062585.83686.47
3163981-16398187.63088.26
4160140-16014085.57786.17
5164888-16488888.11488.79
6161970-16197086.55587.19
20min1166899-16689989.18989.311.0390.2990.431.04
2166068-16606888.74589.86
3169433-16943390.54391.66
4164617-16461787.96989.04
5168427-16842790.00591.17
6167364-16736489.43790.56
30min1168253-16825389.91290.550.6691.5192.160.67
2169559-16955990.61092.21
3170827-17082791.28892.91
4168626-16862690.11291.67
5170702-17070291.22192.88
6168678-16867890.14091.76
45min1169883-16988390.78391.640.9292.8893.750.91
2171415-17141591.60293.71
3172929-17292992.41194.54
4172269-17226992.05994.11
5173040-17304092.47194.64
6169346-16934690.49692.61
60min1170533-17053391.13191.840.6593.7394.460.64
2170875-17087591.31493.93
3172623-17262392.24894.89
4172165-17216592.00394.57
5171514-17151491.65594.34
6173490-17349092.71195.33
极限1168474-16847490.03191.631.0093.1494.760.99
2173285-17328592.60195.73
3171714-17171491.76294.92
4170691-17069191.21594.29
5172475-17247592.16995.36
6172167-17216792.00495.14
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