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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.561799771825761827091828341829711822130.70
210.481820611820491820550.01
单位质量响应值RSD%判断
17255.0217371.660.48数据可信
供试品溶液-2024012021批-依折麦布-pH6.8(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%
5min136313-3631318.81519.3521.2718.8119.3521.27
250814-5081426.32826.33
337382-3738219.36819.37
425892-2589213.41513.42
537681-3768119.52319.52
636029-3602918.66718.67
10min1106219-10621955.03449.1115.8455.1449.2115.82
296354-9635449.92350.07
3117958-11795861.11661.22
479305-7930541.09041.16
585367-8536744.23044.34
683476-8347643.25143.35
15min1144006-14400674.61366.9310.3875.0267.3110.39
2135152-13515270.02570.45
3141665-14166573.40073.85
4126478-12647865.53165.83
5116363-11636360.29060.64
6111419-11141957.72958.07
20min1158409-15840982.07576.769.5582.9077.529.53
2162942-16294284.42485.24
3150582-15058278.02078.87
4154143-15414379.86580.53
5137524-13752471.25471.94
6125340-12534064.94165.61
30min1172451-17245189.35087.086.9590.6388.256.92
2179803-17980393.16094.44
3161901-16190183.88485.17
4177939-17793992.19493.30
5167917-16791787.00188.09
6148356-14835676.86677.89
45min1179183-17918392.83893.484.2794.6295.154.22
2188993-18899397.92199.72
3169789-16978987.97189.73
4187997-18799797.40599.03
5182887-18288794.75896.33
6173725-17372590.01191.46
60min1181397-18139793.98694.582.6396.2896.762.61
2188448-18844897.63999.98
3176695-17669591.54993.79
4188167-18816797.49399.66
5179209-17920992.85294.95
6181350-18135093.96195.91
极限1186456-18645696.60796.681.4399.4299.381.39
2189543-18954398.206101.09
3181834-18183494.21296.96
4187086-18708696.93399.64
5186152-18615296.44999.06
6188473-18847397.652100.13
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.943106663104253106573109193110933107520.09
211.053088703095943092320.17
单位质量响应值RSD%判断
28405.1227984.801.06数据可信
供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(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%
5min1227200-22720066.56445.8844.8766.5645.8844.88
271676-7167620.99921.00
3231217-23121767.74167.74
4108522-10852231.79431.79
5102891-10289130.14530.14
6198163-19816358.05758.06
10min1267484-26748478.36762.0626.6478.7462.3226.71
2147693-14769343.27143.39
3274597-27459780.45080.83
4183876-18387653.87154.05
5156056-15605645.72145.89
6241327-24132770.70371.03
15min1282560-28256082.78369.7418.6483.5970.3418.77
2199471-19947158.44058.80
3285671-28567183.69584.52
4208108-20810860.97161.45
5188009-18800955.08255.50
6264507-26450777.49478.21
20min1286207-28620783.85274.0214.1585.1275.0114.31
2233274-23327468.34469.03
3293703-29370386.04887.34
4222582-22258265.21166.03
5208673-20867361.13661.86
6271554-27155479.55980.70
30min1294988-29498886.42582.766.2688.1684.166.49
2281838-28183882.57283.63
3305414-30541489.47991.25
4271961-27196179.67880.86
5254963-25496374.69875.77
6285624-28562483.68185.27
45min1307126-30712689.98190.853.5092.1992.713.56
2316421-31642192.70494.22
3313653-31365391.89394.16
4316914-31691492.84894.47
5289374-28937484.78086.26
6317126-31712692.91094.96
60min1313352-31335291.80595.262.3394.5297.632.20
2325495-32549595.36297.40
3324801-32480195.15997.93
4321350-32135094.14896.28
5330843-33084396.92998.88
6335126-33512698.184100.75
极限1333685-33368597.76298.540.94100.98101.430.88
2338649-33864999.216101.78
3332653-33265397.460100.76
4336247-33624798.512101.17
5335592-33559298.321100.81
6341181-34118199.958103.07
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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.561802471827021826971829531827371822670.63
210.481837781838451838120.03
单位质量响应值RSD%判断
17260.1317539.311.14数据可信
供试品溶液-2024012021批-依折麦布-pH6.8(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%
5min161496-6149631.70626.9034.6431.7126.9034.64
233684-3368417.36717.37
334875-3487517.98117.98
443074-4307422.20822.21
560271-6027131.07431.07
679693-7969341.08841.09
10min1155023-15502379.92677.0211.1380.1077.1711.17
2127187-12718765.57565.67
3135294-13529469.75469.85
4144953-14495374.73474.86
5163732-16373284.41684.59
6170156-17015687.72887.96
15min1176315-17631590.90491.415.3491.5291.995.41
2166025-16602585.59886.06
3171315-17131588.32688.81
4174158-17415889.79290.33
5183245-18324594.47795.12
6192747-19274799.376100.09
20min1181748-18174893.70594.154.6794.8395.244.73
2168318-16831886.78187.72
3181692-18169293.67694.65
4181326-18132693.48794.52
5189927-18992797.92299.09
6192709-19270999.356100.62
30min1184612-18461295.18197.423.5296.8399.033.58
2178905-17890592.23993.66
3190008-19000897.96499.46
4189001-18900197.44499.00
5193286-19328699.654101.36
6197949-197949102.058103.88
45min1185174-18517495.47197.782.6197.6599.932.67
2182105-18210593.88995.82
3190496-19049698.215100.26
4192193-19219399.090101.19
5194397-194397100.226102.49
6193531-19353199.780102.17
60min1190971-19097198.46097.152.86101.1799.852.93
2178387-17838791.97294.42
3186242-18624296.02298.61
4191769-19176998.871101.52
5190778-19077898.361101.18
6192476-19247699.236102.18
极限1184850-18485095.30496.441.3298.5699.681.35
2184168-18416894.95397.92
3189263-18926397.579100.70
4189303-18930397.600100.80
5185490-18549095.63499.00
6189269-18926997.583101.07
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
110.943110083118493103973108293106323109430.18
211.053115643127223121430.27
单位质量响应值RSD%判断
28422.5828248.240.44数据可信
供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(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%
5min1225987-22598765.87852.4020.3565.8852.4020.35
2131129-13112938.22638.23
3145431-14543142.39542.39
4203702-20370259.38159.38
5199481-19948158.15158.15
6172834-17283450.38350.38
10min1265644-26564477.43879.463.8777.8079.753.89
2260295-26029575.87976.09
3270909-27090978.97379.21
4291315-29131584.92185.25
5273773-27377379.80880.13
6273619-27361979.76380.04
15min1273019-27301979.58881.562.9580.3882.292.97
2272342-27234279.39180.02
3278250-27825081.11381.79
4294540-29454085.86286.66
5283297-28329782.58483.35
6277201-27720180.80781.53
20min1271947-27194779.27680.833.7880.5182.023.80
2262732-26273276.58977.66
3279888-27988881.59082.72
4291753-29175385.04986.33
5285333-28533383.17884.40
6272059-27205979.30880.48
30min1270292-27029278.79381.533.1280.4783.163.12
2271795-27179579.23180.73
3282553-28255382.36783.95
4293441-29344185.54187.29
5283913-28391382.76484.45
6276120-27612080.49282.10
45min1270081-27008178.73280.632.0880.8582.722.08
2274888-27488880.13382.07
3279940-27994081.60683.64
4281295-28129582.00184.23
5283273-28327382.57784.72
6270134-27013478.74780.81
60min1282443-28244382.33582.462.8284.8984.992.78
2287292-28729283.74986.13
3282950-28295082.48384.97
4293860-29386085.66388.35
5280887-28088781.88284.49
6269716-26971678.62581.12
极限1327666-32766695.51898.951.9498.53101.951.89
2339907-33990799.087101.94
3342572-34257299.863102.81
4345486-345486100.713103.87
5336788-33678898.177101.24
6344280-344280100.361103.30
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