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
211.2310459241446730138.26
单位质量响应值RSD%判断
8303.504161.1847.00数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min158396-5839690.005108.289.6690.01108.289.66
278118-78118120.402120.40
373467-73467113.234113.23
469156-69156106.589106.59
568509-68509105.592105.59
673856-73856113.833113.83
10min177040-77040118.741127.323.95119.24127.923.97
285549-85549131.856132.52
384561-84561130.333130.96
480332-80332123.815124.41
583881-83881129.285129.87
684274-84274129.891130.52
15min186144-86144132.773133.092.86133.93134.402.86
288185-88185135.918137.32
386713-86713133.650135.00
481616-81616125.794127.07
588326-88326136.136137.44
687117-87117134.272135.63
20min188048-88048135.707134.512.43137.60136.562.41
288197-88197135.937138.09
387359-87359134.645136.74
483047-83047127.999129.98
588399-88399136.248138.31
688582-88582136.530138.63
30min189039-89039137.235136.672.24139.89139.472.24
289416-89416137.816140.73
389291-89291137.623140.47
484719-84719130.576133.27
590274-90274139.138141.96
689287-89287137.617140.48
45min189435-89435137.845139.381.90141.26142.931.92
290335-90335139.232142.91
390862-90862140.045143.65
487665-87665135.117138.53
592306-92306142.270145.86
691980-91980141.768145.39
60min192172-92172142.064141.812.07146.24146.142.07
293859-93859144.664149.11
391958-91958141.734146.12
488416-88416136.275140.44
593205-93205143.656148.04
692437-92437142.472146.88
极限191091-91091140.397141.112.54145.37146.232.53
292751-92751142.956148.21
392321-92321142.293147.47
487072-87072134.203139.13
593255-93255143.733148.91
692831-92831143.079148.28
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
211.449247089577910242.25
单位质量响应值RSD%判断
7862.397956.640.85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%
5min11476-14761.6753.0732.091.683.0732.01
23857-38574.3784.38
33481-34813.9513.95
42578-25782.9262.93
52671-26713.0323.03
62155-21552.4462.45
10min14889-48895.5497.1112.725.567.1312.74
26633-66337.5297.55
37270-72708.2528.27
46084-60846.9066.92
56564-65647.4517.47
66155-61556.9867.00
15min16763-67637.6768.013.557.728.073.64
27232-72328.2098.27
37434-74348.4388.51
46896-68967.8277.88
57118-71188.0798.14
66903-69037.8357.89
20min16807-68077.7267.923.097.818.023.15
27296-72968.2818.39
37169-71698.1378.25
46994-69947.9398.04
56880-68807.8097.91
66743-67437.6547.75
30min16837-68377.7607.993.047.898.143.10
27134-71348.0988.26
37371-73718.3678.53
46816-68167.7377.88
56943-69437.8818.03
67130-71308.0938.23
45min16629-66297.5247.842.137.698.032.22
26996-69967.9418.14
37036-70367.9868.19
46938-69387.8758.06
56879-68797.8088.00
66967-69677.9088.09
60min16798-67987.7167.831.847.938.061.87
26899-68997.8318.08
37066-70668.0208.27
46746-67467.6577.89
56841-68417.7658.00
67024-70247.9738.20
极限16648-66487.5467.741.747.808.011.84
26952-69527.8918.18
36931-69317.8678.16
46742-67427.6537.92
56765-67657.6797.96
66866-68667.7938.06
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
45min16777-67777.7666.9634.077.967.1433.18
27171-71718.2188.41
36813-68137.8087.98
46800-68007.7937.97
51861-18612.1332.32
67011-70118.0358.23
60min16750-67507.7357.891.417.978.121.37
26917-69177.9278.17
36953-69537.9688.19
47011-70118.0358.25
56802-68027.7958.00
66883-68837.8888.13
极限16823-68237.8197.742.178.108.012.18
27011-70118.0358.32
36625-66257.5927.86
46730-67307.7137.98
56691-66917.6687.91
66633-66337.6017.89
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