依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.851291051291231289441290151287591289890.12
210.881277091275111276100.11
单位质量响应值RSD%判断
11888.3911728.860.96数据可信
供试品溶液-24021802批-匹伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1124655-12465591.49593.422.8791.5093.422.86
2121250-12125088.99689.00
3130372-13037295.69295.69
4130388-13038895.70395.70
5129160-12916094.80294.80
6127808-12780893.81093.81
10min1132369-13236997.15799.851.7197.31100.001.71
2135041-13504199.11999.27
3139055-139055102.065102.22
4137294-137294100.772100.93
5135310-13531099.31699.47
6137143-137143100.661100.82
15min1132039-13203996.91599.951.7897.23100.271.78
2135325-13532599.32799.64
3139100-139100102.098102.43
4137267-137267100.752101.08
5135929-13592999.770100.09
6137398-137398100.849101.17
20min1131830-13183096.76299.551.7797.24100.041.77
2134385-13438598.63799.12
3138897-138897101.949102.45
4136871-136871100.462100.96
5135538-13553899.48399.97
6136256-136256100.010100.50
30min1131683-13168396.65499.581.7697.29100.231.76
2134971-13497199.06799.71
3138925-138925101.969102.64
4136664-136664100.310100.97
5135518-13551899.469100.12
6136245-136245100.002100.66
45min1131457-13145796.48899.391.7497.29100.221.74
2134168-13416898.47899.29
3138016-138016101.302102.14
4136704-136704100.339101.17
5135329-13532999.330100.15
6136826-136826100.429101.25
60min1130645-13064595.89299.051.8996.85100.041.89
2133940-13394098.31099.28
3138093-138093101.359102.37
4136389-136389100.108101.11
5134746-13474698.90299.89
6135859-13585999.719100.71
极限1130634-13063495.88498.651.6697.0099.801.66
2133406-13340697.91899.06
3136845-136845100.443101.62
4135575-13557599.511100.67
5134100-13410098.42899.58
6135815-13581599.687100.85
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113805993813513806923814793809763810190.11
210.933785523782443783980.06
单位质量响应值RSD%判断
34638.0934620.130.04数据可信
供试品溶液-24021802批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min123570-235706.1265.5210.066.135.5210.08
217351-173514.5094.51
321512-215125.5915.59
421851-218515.6795.68
522422-224225.8275.83
620631-206315.3625.36
10min135680-356809.2739.202.889.289.202.87
233317-333178.6598.67
335866-358669.3219.33
435879-358799.3259.33
535921-359219.3369.35
635638-356389.2629.27
15min138568-3856810.0249.941.0010.059.971.00
238473-384739.99910.02
337538-375389.7569.78
438427-384279.98710.01
538411-384119.98310.01
638159-381599.9179.94
20min138797-3879710.0839.734.3010.139.774.28
238019-380199.8819.92
337453-374539.7349.78
438165-381659.9199.96
534274-342748.9088.95
637864-378649.8419.88
30min137029-370299.6249.701.919.689.761.90
236029-360299.3649.42
337838-378389.8349.89
437964-379649.8679.92
537504-375049.7479.80
637590-375909.7709.83
45min138711-3871110.0619.466.2510.149.536.21
235363-353639.1919.26
333066-330668.5948.67
434952-349529.0849.16
537812-378129.8279.90
638463-384639.99610.07
60min138270-382709.9469.762.4910.049.852.49
235764-357649.2959.38
338331-383319.96210.05
437579-375799.7679.86
537685-376859.7949.88
637624-376249.7789.87
极限138251-382519.9419.562.4910.059.672.49
237106-371069.6449.75
336722-367229.5449.65
435995-359959.3559.46
535664-356649.2699.37
637032-370329.6259.73
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.851294151297641292901297831293001295100.19
210.881297361293321295340.23
单位质量响应值RSD%判断
11936.4111905.700.19数据可信
供试品溶液-24021802批-匹伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1127117-12711792.41891.744.6592.4291.744.65
2126984-12698492.32292.32
3130620-13062094.96594.97
4131262-13126295.43295.43
5126081-12608191.66591.67
6115007-11500783.61483.61
10min1135453-13545398.47999.411.6298.6399.561.62
2134575-13457597.84197.99
3138609-138609100.774100.93
4139593-139593101.489101.65
5134430-13443097.73597.89
6137729-137729100.134100.27
15min1135247-13524798.32999.901.6998.65100.221.69
2135388-13538898.43298.75
3139051-139051101.095101.42
4140571-140571102.200102.53
5135488-13548898.50498.82
6138724-138724100.857101.16
20min1135268-13526898.34499.601.6398.83100.081.63
2134867-13486798.05398.53
3138609-138609100.774101.27
4139873-139873101.692102.19
5134901-13490198.07898.56
6138432-138432100.645101.12
30min1134993-13499398.14599.491.7098.79100.141.70
2134814-13481498.01498.66
3138757-138757100.881101.54
4139826-139826101.658102.33
5134576-13457697.84198.48
6138088-138088100.395101.04
45min1134445-13444597.74699.211.6898.56100.031.68
2134642-13464297.88998.70
3137924-137924100.275101.11
4139984-139984101.773102.61
5134569-13456997.83698.64
6137206-13720699.753100.56
60min1133973-13397397.40398.881.7198.3899.861.71
2133816-13381697.28998.26
3137333-13733399.846100.84
4139324-139324101.293102.30
5134164-13416497.54298.51
6137400-13740099.895100.87
极限1133716-13371697.21698.701.6398.3599.851.62
2133720-13372097.21998.35
3137356-13735699.863101.03
4138626-138626100.786101.96
5133975-13397597.40498.54
6137148-13714899.711100.85
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113794223806413799013806833801303801550.14
210.933809963804653807300.10
单位质量响应值RSD%判断
34559.5534833.490.56数据可信
供试品溶液-24021802批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min123020-230205.9715.248.995.975.249.01
219859-198595.1515.15
321475-214755.5715.57
419512-195125.0615.06
519524-195245.0645.06
617787-177874.6144.61
10min135943-359439.3239.243.149.339.253.14
236285-362859.4129.42
337292-372929.6739.68
435041-350419.0899.10
535007-350079.0819.09
634145-341458.8578.86
15min136726-367269.5279.693.599.559.723.58
237996-379969.8569.88
339484-3948410.24210.27
437768-377689.7979.82
535719-357199.2659.29
636480-364809.4639.49
20min136535-365359.4779.398.849.529.438.84
237689-376899.7769.82
337539-375399.7379.78
437781-377819.8009.84
537885-378859.8279.87
629745-297457.7167.75
30min136982-369829.5939.603.529.659.663.52
237253-372539.6639.72
339058-3905810.13110.19
437345-373459.6879.74
535107-351079.1079.16
636317-363179.4209.47
45min130787-307877.9869.228.718.069.298.63
232722-327228.4888.56
338502-385029.98710.06
437514-375149.7319.80
537629-376299.7619.83
636146-361469.3769.44
60min135937-359379.3229.551.879.419.631.86
236131-361319.3729.46
337352-373529.6899.78
437724-377249.7859.87
536930-369309.5799.67
636749-367499.5339.61
极限137155-371559.6389.680.539.749.790.56
237503-375039.7289.83
337469-374699.7199.83
437454-374549.7159.82
537376-373769.6959.80
637026-370269.6049.70
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