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(%)100.00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%
111.411898921901651903371901911895601900290.17
211.381920231922741921480.10
单位质量响应值RSD%判断
16654.6016884.710.98数据可信
影响因素30天-供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113260-11326060.78861.504.9960.7961.504.99
2115293-11529361.87961.88
3122799-12279965.90765.91
4114842-11484261.63761.64
5116277-11627762.40762.41
6105058-10505856.38656.39
10min1155833-15583383.63784.803.1683.9785.143.16
2155330-15533083.36783.71
3162767-16276787.35887.72
4161662-16166286.76587.11
5162121-16212187.01287.36
6150319-15031980.67880.99
15min1180361-18036196.80193.982.4997.6094.792.49
2170794-17079491.66792.47
3176309-17630994.62795.48
4176619-17661994.79395.62
5177619-17761995.33096.16
6168899-16889990.65091.41
20min1184713-18471399.13797.362.06100.4898.702.06
2177807-17780795.43196.75
3186741-186741100.226101.60
4181875-18187597.61498.97
5179672-17967296.43297.79
6177642-17764295.34296.61
30min1187895-187895100.84599.441.25102.74101.321.22
2183912-18391298.707100.55
3183408-18340898.437100.37
4187271-187271100.510102.40
5182420-18242097.90699.80
6186796-186796100.255102.05
45min1184452-18445298.99798.560.79101.45100.980.81
2183704-18370498.596100.99
3185386-18538699.498101.98
4182287-18228797.835100.29
5184388-18438898.963101.40
6181575-18157597.45399.80
60min1190600-190600102.29799.951.56105.30102.931.51
2183590-18359098.534101.48
3182940-18294098.186101.22
4185298-18529899.451102.45
5188195-188195101.006104.00
6186771-186771100.242103.13
极限1185043-18504399.31499.190.56102.88102.720.54
2183834-18383498.665102.16
3184992-18499299.287102.87
4186018-18601899.838103.39
5183370-18337098.416101.97
6185594-18559499.610103.06
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100590-202005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2500
标示量(mg)20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%
110.924160954183224179504173824176834174860.21
211.024217924221714219820.07
单位质量响应值RSD%判断
38231.3238292.380.12数据可信
影响因素30天-供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1284960-28496066.69467.944.7966.6967.934.79
2290219-29021967.92467.92
3310714-31071472.72172.72
4292736-29273668.51368.51
5294907-29490769.02269.02
6268076-26807662.74262.74
10min12108-21080.49315.08236.310.8615.45230.53
2375118-37511887.79588.17
32083-20830.4880.89
42119-21190.4960.88
52579-25790.6040.99
62472-24720.5790.93
15min12383-23830.5580.609.540.931.0620.63
22711-27110.6341.50
32340-23400.5480.95
42899-28990.6781.06
52358-23580.5520.94
62782-27820.6511.00
20min12473-24730.5790.6310.040.961.1016.37
22439-24390.5711.44
32906-29060.6801.09
42411-24110.5640.95
52938-29380.6881.08
62948-29480.6901.05
30min12624-26240.6140.6310.640.991.1015.17
22376-23760.5561.43
32492-24920.5831.00
42628-26280.6151.01
53023-30230.7081.10
63087-30870.7221.08
45min12429-24290.5680.6410.410.951.1122.15
23086-30860.7221.60
32475-24750.5791.00
42626-26260.6151.01
53056-30560.7151.11
62681-26810.6270.99
60min13251-32510.7610.698.091.151.1717.82
22982-29820.6981.58
32645-26450.6191.04
42831-28310.6631.06
53225-32250.7551.16
62837-28370.6641.03
极限13266-32660.7640.738.681.151.2112.37
22671-26710.6251.51
33219-32190.7531.18
42928-29280.6851.09
53318-33180.7771.18
63362-33620.7871.16
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(%)100.00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%
111.411927231931871933941935121933081932250.16
211.381919611922291920950.10
单位质量响应值RSD%判断
16934.7116880.050.23数据可信
影响因素30天-供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183814-8381444.61549.0910.1844.6249.0910.17
287695-8769546.68146.68
382591-8259143.96443.96
4103816-10381655.26355.26
5103238-10323854.95554.95
692139-9213949.04749.05
10min1132794-13279470.68876.915.6470.9477.195.65
2139873-13987374.45674.72
3140040-14004074.54574.79
4150348-15034880.03280.34
5154017-15401781.98582.29
6149854-14985479.76980.04
15min1185415-18541598.69992.013.5899.3492.713.52
2170105-17010590.54991.22
3169958-16995890.47191.13
4169936-16993690.45991.21
5170182-17018290.59091.35
6171531-17153191.30892.02
20min1178698-17869895.12395.110.8896.3196.320.89
2178418-17841894.97496.15
3176848-17684894.13995.30
4181566-18156696.65097.90
5178029-17802994.76796.03
6178484-17848495.00996.23
30min1181331-18133196.52596.871.2498.2498.601.21
2184211-18421198.05899.76
3183098-18309897.46699.15
4183006-18300697.41799.21
5182377-18237797.08298.87
6177810-17781094.65196.40
45min1183234-18323497.53897.390.9399.7999.670.90
2183624-18362497.74699.99
3184139-18413998.020100.25
4184936-18493698.444100.78
5180942-18094296.31898.65
6180851-18085196.26998.55
60min1182269-18226997.02497.531.5999.82100.351.55
2185721-18572198.862101.65
3183667-18366797.768100.54
4186994-18699499.539102.42
5181742-18174296.74499.61
6178941-17894195.25398.06
极限1179827-17982795.72496.991.3299.06100.351.28
2185322-18532298.649101.99
3180659-18065996.16799.48
4183991-18399197.941101.37
5179845-17984595.73499.14
6183620-18362097.743101.08
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100590-202005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2500
标示量(mg)20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%
110.924231404244724248934246974244514243310.17
211.024213224224004218610.19
单位质量响应值RSD%判断
38858.1538281.401.06数据可信
影响因素30天-供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204533-20453347.49051.679.5747.4951.679.57
2212941-21294149.44349.44
3198735-19873546.14446.14
4249578-24957857.94957.95
5246006-24600657.12057.12
6223337-22333751.85751.86
10min1307948-30794871.50276.794.3871.7777.084.39
2326516-32651675.81476.09
3321916-32191674.74675.00
4342357-34235779.49279.81
5344206-34420679.92180.24
6341417-34141779.27379.56
15min1374737-37473787.01044.02108.3287.6744.74106.55
22067-20670.4801.18
3381602-38160288.60489.28
4374782-37478287.02087.78
52260-22600.5251.29
62115-21150.4911.22
20min12034-20340.47230.33152.431.6231.29147.23
22235-22350.5191.22
32045-20450.4751.64
42120-21200.4921.74
5385801-38580189.57990.34
6389516-38951690.44291.17
30min12052-20520.47615.67237.051.6216.80221.51
22073-20730.4811.18
32128-21280.4941.66
4394079-39407991.50192.75
52555-25550.5931.86
62083-20830.4841.72
45min12240-22400.52015.33236.891.6716.54219.58
22173-21730.5051.21
32165-21650.5031.67
42151-21510.4992.26
52139-21390.4971.76
6385246-38524689.45090.69
60min12293-22930.5320.544.951.691.8421.43
22305-23050.5351.24
32333-23330.5421.71
42183-21830.5072.27
52538-25380.5891.86
62341-23410.5442.28
极限12291-22910.5320.5812.571.691.8820.46
22868-28680.6661.38
32577-25770.5981.77
42236-22360.5192.28
52162-21620.5021.77
62853-28530.6622.40
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