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对照品来源中检院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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159271892546924479261592592925840.11
211.239247092414924420.05
单位质量响应值RSD%判断
8303.508231.700.62数据可信
供试品溶液-JT1707批-瑞舒伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min158396-5839660.35672.619.6660.3672.619.66
278118-7811880.74080.74
373467-7346775.93375.93
469156-6915671.47771.48
568509-6850970.80970.81
673856-7385676.33576.34
10min177040-7704079.62685.383.9579.9685.783.97
285549-8554988.42188.87
384561-8456187.39987.82
480332-8033283.02983.43
583881-8388186.69787.09
684274-8427487.10387.53
15min186144-8614489.03689.252.8689.8190.122.86
288185-8818591.14592.08
386713-8671389.62490.53
481616-8161684.35685.21
588326-8832691.29192.17
687117-8711790.04190.95
20min188048-8804891.00490.202.4292.2891.582.42
288197-8819791.15892.60
387359-8735990.29191.70
483047-8304785.83587.16
588399-8839991.36692.75
688582-8858291.55592.96
30min189039-8903992.02891.652.2493.8193.522.23
289416-8941692.41794.37
389291-8929192.28894.20
484719-8471987.56389.37
590274-9027493.30495.19
689287-8928792.28494.20
45min189435-8943592.43793.471.9094.7395.851.91
290335-9033593.36795.83
390862-9086293.91296.33
487665-8766590.60892.90
592306-9230695.40497.81
691980-9198095.06897.50
60min192172-9217295.26695.102.0798.0798.002.07
293859-9385997.01099.99
391958-9195895.04597.99
488416-8841691.38494.18
593205-9320596.33499.27
692437-9243795.54098.50
极限191091-9109194.14994.632.5497.4898.062.53
292751-9275195.86499.39
392321-9232195.42098.89
487072-8707289.99593.30
593255-9325596.38599.86
692831-9283195.94799.44
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DSMF-387-240606对照品来源中检院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%
111.388954189357893808950489589894740.12
211.448956589577895710.01
单位质量响应值RSD%判断
7862.397829.630.30数据可信
供试品溶液-JT1707批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11476-14761.6893.0932.081.693.0932.01
23857-38574.4134.41
33481-34813.9833.98
42578-25782.9502.95
52671-26713.0563.06
62155-21552.4662.47
10min14889-48895.5947.1712.725.607.1912.76
26633-66337.5907.61
37270-72708.3188.34
46084-60846.9616.98
56564-65647.5117.53
66155-61557.0437.06
15min16763-67637.7388.083.557.788.133.61
27232-72328.2758.34
37434-74348.5068.57
46896-68967.8917.95
57118-71188.1458.20
66903-69037.8997.95
20min16807-68077.7897.993.097.878.093.17
27296-72968.3488.46
37169-71698.2038.32
46994-69948.0038.10
56880-68807.8727.98
66743-67437.7157.81
30min16837-68377.8238.053.037.958.203.12
27134-71348.1638.32
37371-73718.4348.60
46816-68167.7997.94
56943-69437.9448.09
67130-71308.1588.30
45min16629-66297.5857.902.137.768.102.21
26996-69968.0058.21
37036-70368.0518.26
46938-69387.9398.13
56879-68797.8718.06
66967-69677.9728.16
60min16798-67987.7787.891.847.998.121.92
26899-68997.8948.14
37066-70668.0858.34
46746-67467.7197.95
56841-68417.8288.06
67024-70248.0378.27
极限16648-66487.6077.801.757.868.081.87
26952-69527.9558.25
36931-69317.9318.23
46742-67427.7147.99
56765-67657.7418.02
66866-68667.8568.13
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对照品来源中检院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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159251992435924559235692337924200.09
211.239087092443916561.22
单位质量响应值RSD%判断
8288.798161.711.10数据可信
供试品溶液-JT1707批-瑞舒伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min175202-7520278.13075.955.0578.1375.945.05
272603-7260375.43075.43
369670-6967072.38272.38
468166-6816670.82070.82
574979-7497977.89877.90
677975-7797581.01181.01
10min184315-8431587.59885.692.0688.0386.112.07
282737-8273785.95886.38
381006-8100684.16084.56
480404-8040483.53483.93
581883-8188385.07185.50
684511-8451187.80188.25
15min187182-8718290.57688.991.4991.5089.891.49
285202-8520288.51989.42
386275-8627589.63490.50
485272-8527288.59289.45
583561-8356186.81487.72
686466-8646689.83290.77
20min187532-8753290.94090.121.8192.3691.501.80
287305-8730590.70492.09
388250-8825091.68693.05
484794-8479488.09589.44
584737-8473788.03689.42
687818-8781891.23792.67
30min191693-9169395.26392.241.8197.1994.131.79
289276-8927692.75294.64
388656-8865692.10893.98
487661-8766191.07492.91
587200-8720090.59592.47
688208-8820891.64293.59
45min192306-9230695.90093.561.6698.3695.961.65
290561-9056194.08796.49
390904-9090494.44396.83
488768-8876892.22494.57
588286-8828691.72394.10
689504-8950492.98995.44
60min192323-9232395.91793.962.3098.9196.892.26
289827-8982793.32496.25
393543-9354397.185100.10
488667-8866792.11994.98
588261-8826191.69794.59
690035-9003593.54096.51
极限193085-9308596.70994.361.82100.2397.811.80
291109-9110994.65698.10
391930-9193095.50998.96
489716-8971693.20996.58
588382-8838291.82395.22
690747-9074794.28097.77
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DSMF-387-240606对照品来源中检院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%
111.388939189480893998932989543894280.10
211.448927889400893390.10
单位质量响应值RSD%判断
7858.357809.350.45数据可信
供试品溶液-JT1707批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12993-29933.4302.8226.063.432.8226.10
23033-30333.4763.48
31712-17121.9621.96
41598-15981.8311.83
52648-26483.0353.03
62785-27853.1923.19
10min16358-63587.2866.889.627.316.899.67
26431-64317.3707.39
35267-52676.0366.05
45264-52646.0336.04
56194-61947.0987.12
66485-64857.4327.45
15min17332-73328.4028.212.518.468.262.53
27074-70748.1078.17
36904-69047.9127.96
47103-71038.1408.18
57172-71728.2198.28
67394-73948.4748.53
20min17026-70268.0528.041.758.168.141.79
27114-71148.1538.26
36856-68567.8577.95
46951-69517.9668.05
56943-69437.9578.06
67189-71898.2398.34
30min17077-70778.1107.961.588.268.101.67
27010-70108.0338.18
36826-68267.8237.95
46797-67977.7897.92
56978-69787.9978.14
66976-69767.9948.15
45min16777-67777.7667.862.997.968.052.97
27171-71718.2188.41
36813-68137.8087.98
46800-68007.7937.97
56582-65827.5437.73
67011-70118.0358.23
60min16750-67507.7357.891.417.978.121.30
26917-69177.9278.17
36953-69537.9688.19
47011-70118.0358.25
56802-68027.7958.03
66883-68837.8888.13
极限16823-68237.8197.742.178.108.022.14
27011-70118.0358.32
36625-66257.5927.86
46730-67307.7137.98
56691-66917.6687.94
66633-66337.6017.89
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