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%
111.331932971929361930231933751931391931540.10
211.381937621934001935810.14
单位质量响应值RSD%判断
17048.0117010.630.16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%
5min150899-5089926.83328.4932.3626.8328.5032.36
277483-7748340.84740.85
352598-5259827.72927.73
463239-6323933.33833.34
524367-2436712.84612.85
655722-5572229.37529.38
10min1136702-13670272.06670.1815.1772.2270.3415.20
2144286-14428676.06576.29
3141953-14195374.83574.99
4148000-14800078.02378.21
593147-9314749.10549.18
6134605-13460570.96171.12
15min1165166-16516687.07285.796.7687.6286.346.83
2168528-16852888.84589.49
3168188-16818888.66589.24
4172139-17213990.74891.37
5141720-14172074.71275.06
6160607-16060784.66985.23
20min1171453-17145390.38790.274.3491.4291.304.44
2174830-17483092.16793.31
3175586-17558692.56593.63
4178993-17899394.36195.48
5157932-15793283.25984.02
6168649-16864988.90889.94
30min1167790-16779088.45593.133.3189.9994.663.36
2181271-18127195.56297.22
3179600-17960094.68196.26
4181519-18151995.69397.34
5170916-17091690.10391.33
6178873-17887394.29895.82
45min1177560-17756093.60694.801.3795.6396.841.48
2179510-17951094.63496.82
3181372-18137295.61697.72
4183679-18367996.83299.01
5177038-17703893.33195.05
6179812-17981294.79396.84
60min1177292-17729293.46594.271.6396.0196.841.74
2182829-18282996.38499.10
3180704-18070495.26397.90
4180330-18033095.06697.78
5175257-17525792.39294.63
6176533-17653393.06595.64
极限1175925-17592592.74493.861.5495.8196.961.64
2182052-18205295.97499.22
3178058-17805893.86997.03
4180584-18058495.20098.44
5175327-17532792.42995.18
6176330-17633092.95896.05
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%
110.981565061565441565681565451565741565470.02
210.961566871566021566440.04
单位质量响应值RSD%判断
14257.4714292.340.18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%
5min1133284-13328477.28664.3325.9677.2964.3425.96
2151310-15131087.73887.74
381753-8175347.40547.41
4116828-11682867.74467.74
5104608-10460860.65860.66
677909-7790945.17645.18
10min1157096-15709691.09391.132.4491.5291.482.50
2164699-16469995.50295.99
3155763-15576390.32090.58
4154838-15483889.78490.16
5154300-15430089.47289.81
6156221-15622190.58690.84
15min1164554-16455495.41895.422.1796.3596.282.20
2168803-16880397.88298.90
3162044-16204493.96394.73
4160483-16048393.05793.93
5168864-16886497.91798.75
6162612-16261294.29295.05
20min1163866-16386695.01994.911.5696.4896.301.60
2166645-16664596.63098.19
3163068-16306894.55695.84
4160289-16028992.94594.34
5166477-16647796.53397.91
6161684-16168493.75495.03
30min1155713-15571390.29194.522.8492.2896.442.79
2167396-16739697.06699.16
3163605-16360594.86896.68
4159273-15927392.35694.26
5167047-16704796.86498.78
6164955-16495595.65197.45
45min1163442-16344294.77395.161.5197.2797.611.48
2163937-16393795.06097.70
3164983-16498395.66798.01
4160538-16053893.08995.51
5168150-16815097.50399.96
6163595-16359594.86297.19
60min1162865-16286594.43994.562.1197.4697.542.11
2167088-16708896.887100.05
3164826-16482695.57698.45
4157873-15787391.54494.48
5165394-16539495.90598.90
6160405-16040593.01295.87
极限1161647-16164793.73295.021.6797.2898.521.65
2165349-16534995.87999.58
3166985-16698596.828100.23
4165169-16516995.77599.22
5164499-16449995.38698.91
6159571-15957192.52995.90
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%
111.331931581932831932531932821931611932270.04
211.381939541940531940040.04
单位质量响应值RSD%判断
17054.4617047.800.03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%
5min161605-6160532.43530.6427.8032.4430.6427.81
251131-5113126.92126.92
376628-7662840.34540.35
455726-5572629.34029.34
531737-3173716.71016.71
672391-7239138.11438.11
10min1138249-13824972.78970.807.5172.9770.967.56
2137251-13725172.26372.41
3141076-14107674.27774.50
4134547-13454770.84071.00
5114494-11449460.28260.37
6141181-14118174.33274.54
15min1160447-16044784.47683.822.8685.0684.382.91
2163357-16335786.00886.56
3161952-16195285.26885.91
4156747-15674782.52883.08
5151135-15113579.57380.00
6161562-16156285.06385.69
20min1168460-16846088.69588.621.1389.7589.651.17
2170503-17050389.77190.80
3169629-16962989.31090.42
4165367-16536787.06788.08
5166895-16689587.87188.74
6169087-16908789.02590.12
30min1174072-17407291.65091.281.7493.2092.801.67
2171214-17121490.14591.67
3174776-17477692.02093.63
4169403-16940389.19190.69
5178072-17807293.75695.11
6172688-17268890.92192.51
45min1177181-17718193.28792.031.1795.3494.061.16
2171208-17120890.14292.17
3175805-17580592.56294.68
4174022-17402291.62393.62
5175445-17544592.37394.25
6175084-17508492.18394.28
60min1178187-17818793.81692.851.5896.3995.391.50
2173293-17329391.24093.77
3175387-17538792.34294.97
4173902-17390291.56094.06
5180666-18066695.12197.51
6176699-17669993.03395.64
极限1177911-17791193.67192.211.5796.7795.271.53
2170233-17023389.62892.66
3175452-17545292.37695.52
4174275-17427591.75794.77
5177347-17734793.37496.29
6175632-17563292.47195.60
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%
110.981565571567141566441567031567131566660.05
210.961570991572221571600.06
单位质量响应值RSD%判断
14268.3114339.420.36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%
5min1131842-13184276.29568.5621.7876.3068.5621.78
277210-7721044.68044.68
3143813-14381383.22383.22
4108755-10875562.93562.94
5106808-10680861.80861.81
6142432-14243282.42482.42
10min1152917-15291788.49184.908.5488.9185.288.58
2121789-12178970.47870.73
3154595-15459589.46289.92
4146390-14639084.71485.06
5152503-15250388.25288.59
6152058-15205887.99488.45
15min1153535-15353588.84987.944.5789.7688.794.64
2138205-13820579.97780.62
3155951-15595190.24791.21
4152214-15221488.08488.90
5156622-15662290.63591.47
6155229-15522989.82990.78
20min1152733-15273388.38588.683.4789.7990.023.56
2142975-14297582.73883.82
3156008-15600890.28091.74
4154002-15400289.11990.43
5157656-15765691.23392.57
6156058-15605890.30991.75
30min1152588-15258888.30188.923.4690.2090.763.53
2144595-14459583.67585.22
3156636-15663690.64392.61
4152855-15285588.45590.26
5160528-16052892.89594.74
6154746-15474689.55091.50
45min1153369-15336988.75388.602.6491.1490.932.74
2145008-14500883.91485.92
3155304-15530489.87292.34
4155325-15532589.88592.18
5154902-15490289.64092.00
6154739-15473989.54591.99
60min1154301-15430189.29289.312.2292.1892.132.31
2148283-14828385.80988.28
3154503-15450389.40992.37
4154361-15436189.32792.12
5158760-15876091.87294.73
6155802-15580290.16193.10
极限1155178-15517889.80089.480.5093.1892.800.38
2155457-15545789.96192.91
3153643-15364388.91192.37
4154599-15459989.46492.76
5155130-15513089.77293.14
6153752-15375288.97492.42
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%
111.331939741942771941711942721937721940930.12
211.381941561945641943600.15
单位质量响应值RSD%判断
17130.8917079.090.22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%
5min172336-7233637.96531.1540.1737.9731.1540.18
248262-4826225.33025.33
361625-6162532.34432.34
434875-3487518.30418.30
598987-9898751.95351.95
639999-3999920.99320.99
10min1141223-14122374.12168.7212.4574.3368.8912.52
2115764-11576460.75960.90
3134145-13414570.40670.59
4116141-11614160.95661.06
5156871-15687182.33382.62
6121433-12143363.73463.85
15min1160585-16058584.28381.374.9884.9181.935.08
2146300-14630076.78577.26
3157672-15767282.75483.32
4147943-14794377.64878.09
5166051-16605187.15287.90
6151672-15167279.60580.08
20min1167159-16715987.73386.732.8088.8287.732.91
2160566-16056684.27385.18
3166392-16639287.33188.36
4159517-15951783.72284.59
5172073-17207390.31291.54
6165724-16572486.98087.89
30min1174795-17479591.74191.511.7393.3293.001.75
2171447-17144789.98491.36
3170227-17022789.34390.86
4174809-17480991.74893.09
5176983-17698392.88994.62
6177911-17791193.37694.77
45min1174317-17431791.49092.131.0393.5894.130.99
2178453-17845393.66195.53
3174629-17462991.65493.67
4173561-17356191.09392.94
5175533-17553392.12894.38
6176738-17673892.76194.68
60min1173099-17309990.85191.090.7093.4593.600.76
2172832-17283290.71193.10
3172226-17222690.39292.91
4173016-17301690.80793.16
5175047-17504791.87394.63
6175078-17507891.88994.32
极限1176876-17687692.83392.271.8095.9395.281.81
2174686-17468691.68494.58
3170184-17018489.32192.34
4176735-17673592.75995.62
5179551-17955194.23797.51
6176740-17674092.76295.70
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%
110.981570211570641571371571611568571570480.08
210.961573221575481574350.11
单位质量响应值RSD%判断
14303.1014364.510.31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%
5min1137338-13733879.31071.9011.9479.3171.8911.94
2122898-12289870.97170.97
3134365-13436577.59377.59
4113603-11360365.60365.60
5137667-13766779.50079.50
6101117-10111758.39358.39
10min1151245-15124587.34187.342.4087.7887.742.40
2145291-14529183.90284.30
3151024-15102487.21387.64
4154824-15482489.40789.77
5155178-15517889.61290.05
6149881-14988186.55386.88
15min1153052-15305288.38489.072.0089.3189.961.98
2150410-15041086.85887.72
3154004-15400488.93489.85
4159526-15952692.12392.98
5155476-15547689.78490.72
6153010-15301088.36089.17
20min1154103-15410388.99189.641.4990.4191.021.50
2153443-15344388.61089.95
3154352-15435289.13590.54
4156877-15687790.59391.97
5159164-15916491.91493.35
6153447-15344788.61289.91
30min1156332-15633290.27890.852.0792.1992.722.04
2155129-15512989.58391.42
3153048-15304888.38290.29
4161088-16108893.02594.90
5161121-16112193.04494.99
6157180-15718090.76892.56
45min1154721-15472189.34890.201.4691.7692.591.45
2159181-15918191.92394.26
3155274-15527489.66792.06
4155893-15589390.02592.42
5158706-15870691.64994.11
6153448-15344888.61390.91
60min1153804-15380488.81888.861.4191.7391.751.42
2152947-15294788.32391.17
3152926-15292688.31191.21
4154710-15471089.34292.23
5157631-15763191.02894.00
6151291-15129187.36790.15
极限1155934-15593490.04889.702.4693.4593.082.43
2153937-15393788.89592.23
3150597-15059786.96690.35
4157507-15750790.95794.35
5161349-16134993.17596.66
6152694-15269488.17791.45
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