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%
111.539596696095961689606796063960720.08
211.639613596039960870.08
单位质量响应值RSD%判断
8332.358261.990.60数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-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%
5min180704-8070483.28974.356.3383.2974.346.33
271067-7106773.34373.34
368021-6802170.20070.20
472447-7244774.76774.77
571209-7120973.49073.49
668780-6878070.98370.98
10min191607-9160794.54192.812.8795.0093.232.86
291255-9125594.17894.59
391681-9168194.61795.01
491788-9178894.72895.14
587028-8702889.81590.22
686243-8624389.00589.40
15min194850-9485097.88895.923.2298.8896.853.21
293448-9344896.44197.37
396902-96902100.006100.92
493170-9317096.15497.10
590890-9089093.80194.71
688377-8837791.20892.10
20min196946-96946100.05196.923.35101.5898.383.34
295721-9572198.787100.25
397114-97114100.224101.70
492986-9298695.96497.44
590851-9085193.76195.19
689856-8985692.73494.13
30min195459-9545998.51698.231.34100.60100.231.30
293202-9320296.18798.20
395881-9588198.952100.98
495173-9517398.221100.23
594459-9445997.48499.43
696932-96932100.037101.95
45min194040-9404097.05295.042.5499.6997.592.53
293531-9353196.52799.08
393879-9387996.88699.46
492770-9277095.74198.30
588637-8863791.47693.97
689695-8969592.56895.03
60min190510-9051093.40994.721.9296.5897.801.89
294037-9403797.049100.13
393680-9368096.68099.80
491848-9184894.79097.88
590984-9098493.89896.90
689653-8965392.52495.51
极限194976-9497698.01896.072.36101.7199.672.34
293923-9392396.931100.56
395866-9586698.936102.59
491438-9143894.36797.98
590154-9015493.04196.56
692183-9218395.13598.63
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%
111.108739287361874588739787393874000.05
211.078774887685877160.06
单位质量响应值RSD%判断
7873.877923.760.45数据可信
供试品溶液-2023122321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%
5min15931-59316.7586.118.906.766.118.87
25079-50795.7875.79
34606-46065.2485.25
45630-56306.4156.41
55656-56566.4456.44
65292-52926.0306.03
10min17261-72618.2738.273.318.318.313.32
27032-70328.0128.04
37037-70378.0188.05
47667-76678.7368.77
57381-73818.4108.45
67184-71848.1868.22
15min17620-76208.6828.461.548.778.541.59
27344-73448.3688.44
37352-73528.3778.45
47509-75098.5568.64
57347-73478.3718.45
67378-73788.4078.49
20min18188-81889.3308.524.949.468.654.90
27376-73768.4048.53
37250-72508.2618.38
47553-75538.6068.74
57172-71728.1728.30
67351-73518.3768.50
30min17517-75178.5658.421.168.758.591.17
27440-74408.4778.65
37323-73238.3448.51
47276-72768.2908.47
57389-73898.4198.59
67375-73758.4038.58
45min17510-75108.5578.402.348.798.622.33
27530-75308.5808.80
37199-71998.2038.42
47514-75148.5628.79
57143-71438.1398.36
67333-73338.3558.57
60min17140-71408.1358.291.448.418.561.37
27449-74498.4888.75
37208-72088.2138.47
47269-72698.2828.56
57305-73058.3238.59
67295-72958.3128.58
极限17402-74028.4348.291.498.768.601.47
27162-71628.1618.47
37319-73198.3398.64
47356-73568.3828.70
57129-71298.1238.44
67286-72868.3028.61
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%
111.539602595731955259551095582956750.23
211.639501494934949740.06
单位质量响应值RSD%判断
8297.928166.291.14数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-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%
5min180175-8017583.40175.469.2783.4075.469.27
273730-7373076.69676.70
360208-6020862.63062.63
471127-7112773.98973.99
575071-7507178.09178.09
674928-7492877.94377.94
10min194824-9482498.63996.083.4999.1096.503.50
290319-9031993.95394.38
388459-8845992.01892.37
490410-9041094.04794.46
597041-97041100.945101.38
693154-9315496.90297.33
15min196031-9603199.89599.421.97100.91100.382.00
294310-9431098.10499.05
393259-9325997.01197.87
494882-9488298.69999.63
598647-98647102.616103.61
696334-96334100.210101.18
20min195413-9541399.25299.262.89100.82100.772.89
293492-9349297.25398.75
392670-9267096.39897.80
494145-9414597.93399.41
5100295-100295104.330105.89
696515-96515100.398101.93
30min195428-9542899.26799.031.83101.39101.091.86
295471-9547199.312101.35
392903-9290396.64198.57
493520-9352097.28399.31
597570-97570101.496103.64
696328-96328100.204102.29
45min194794-9479498.60897.902.41101.28100.512.42
290948-9094894.60797.19
392329-9232996.04498.51
493981-9398197.762100.33
597381-97381101.299104.01
695273-9527399.106101.75
60min193483-9348397.24497.331.05100.46100.481.10
292464-9246496.18499.29
392848-9284896.58499.59
493317-9331797.071100.18
595245-9524599.077102.35
694013-9401397.795100.99
极限193865-9386597.64198.211.39101.40101.901.42
293803-9380397.577101.22
392909-9290996.647100.19
493964-9396497.744101.39
596471-96471100.352104.17
695486-9548699.328103.06
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%
111.108787087352875188737387393875010.25
211.078690686906869060.00
单位质量响应值RSD%判断
7882.977850.590.30数据可信
供试品溶液-2023122321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%
5min15211-52115.9625.926.195.965.926.20
25606-56066.4146.41
35019-50195.7425.74
45077-50775.8085.81
54706-47065.3845.38
65442-54426.2266.23
10min17456-74568.5308.411.178.568.451.19
27421-74218.4908.53
37390-73908.4558.49
47350-73508.4098.44
57239-72398.2828.31
67270-72708.3178.35
15min17702-77028.8128.622.058.898.702.03
27726-77268.8398.92
37488-74888.5678.65
47519-75198.6028.68
57325-73258.3808.46
67447-74478.5208.60
20min17649-76498.7518.700.448.888.830.48
27593-75938.6878.82
37559-75598.6488.77
47607-76078.7038.83
57589-75898.6828.80
67639-76398.7398.87
30min17421-74218.4908.541.698.678.721.69
27659-76598.7628.94
37476-74768.5538.73
47464-74648.5398.71
57272-72728.3208.49
67518-75188.6018.78
45min17167-71678.1998.330.958.428.560.96
27316-73168.3708.60
37312-73128.3658.59
47371-73718.4338.66
57262-72628.3088.53
67271-72718.3188.54
60min17258-72588.3048.411.998.578.681.94
27382-73828.4458.72
37509-75098.5918.86
47456-74568.5308.80
57108-71088.1328.40
67388-73888.4528.72
极限17320-73208.3748.561.768.698.881.75
27712-77128.8239.15
37508-75088.5908.91
47485-74858.5638.88
57420-74208.4898.80
67433-74338.5048.82
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