依折麦布阿托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对照品来源工作对照品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%
110.001746171749461743271748611743821746270.16
210.011743441747421745430.17
单位质量响应值RSD%判断
17462.7017436.860.11数据可信
供试品溶液-2023120821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%
5min111033-110335.6765.2311.825.685.2311.81
210778-107785.5455.55
311083-110835.7025.70
48798-87984.5264.53
510822-108225.5685.57
68451-84514.3484.35
10min116170-161708.3197.6910.898.357.7210.91
215552-155528.0018.03
315929-159298.1958.23
414630-146307.5277.55
515560-155608.0058.04
611799-117996.0706.09
15min116430-164308.4538.212.638.538.282.64
216051-160518.2588.33
316274-162748.3738.45
415237-152377.8397.91
515797-157978.1278.20
615935-159358.1988.26
20min116121-161218.2948.123.208.428.243.24
216454-164548.4658.59
316088-160888.2778.40
415213-152137.8277.94
515415-154157.9318.05
615386-153867.9168.02
30min116187-161878.3288.022.738.508.182.77
215553-155538.0028.17
315733-157338.0948.26
415245-152457.8438.00
515793-157938.1258.29
614989-149897.7117.86
45min115592-155928.0227.862.608.248.072.63
215067-150677.7527.96
315922-159228.1918.41
415057-150577.7467.94
514872-148727.6517.86
615165-151657.8027.99
60min115802-158028.1307.942.858.398.202.88
215471-154717.9598.22
316108-161088.2878.55
415165-151657.8028.04
515037-150377.7367.99
615053-150537.7447.98
极限115472-154727.9607.821.568.278.121.63
215131-151317.7858.08
315398-153987.9228.23
415290-152907.8668.15
515126-151267.7828.08
614814-148147.6217.90
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211599481608271598891598281605421602070.29
211.241601601604451603020.13
单位质量响应值RSD%判断
14291.4414261.740.15数据可信
供试品溶液-2023120821批-阿托伐他汀钙-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%
5min194678-9467854.77841.3933.8454.7841.3833.84
296227-9622755.67455.67
355913-5591332.35032.35
488198-8819851.02951.03
541328-4132823.91123.91
652838-5283830.57030.57
10min1124822-12482272.21866.4810.0172.5266.7110.06
2124342-12434271.94172.25
3116688-11668867.51267.69
4117716-11771668.10768.39
5112283-11228364.96465.10
693555-9355554.12854.30
15min1136668-13666879.07278.243.3479.7878.843.25
2134447-13444777.78778.50
3132227-13222776.50377.06
4129956-12995675.18975.85
5135001-13500178.10878.60
6143099-14309982.79383.26
20min1139370-13937080.63581.032.0781.7882.061.95
2138670-13867080.23081.37
3139312-13931280.60281.58
4136242-13624278.82679.91
5142223-14222382.28683.21
6144469-14446983.58584.52
30min1153375-15337588.73886.402.6990.3387.882.64
2144932-14493283.85385.44
3149728-14972886.62888.06
4149373-14937386.42387.94
5154003-15400389.10290.49
6144568-14456883.64385.04
45min1161054-16105493.18190.483.1095.2792.453.04
2149041-14904186.23188.28
3160815-16081593.04394.95
4156752-15675290.69292.69
5158482-15848291.69393.57
6152207-15220788.06289.92
60min1168254-16825497.34793.404.3099.9595.864.23
2156391-15639190.48393.01
3168833-16883397.682100.11
4161263-16126393.30295.80
5162928-16292894.26596.65
6150885-15088587.29889.65
极限1174359-174359100.87999.540.83104.02102.530.89
2171273-17127399.093102.13
3170884-17088498.868101.84
4173232-173232100.227103.25
5171545-17154599.251102.16
6170991-17099198.930101.76
依折麦布阿托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对照品来源工作对照品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%
110.001745661745581741911743431743841744080.10
210.011759411761601760500.09
单位质量响应值RSD%判断
17440.8017587.410.60数据可信
供试品溶液-2023120821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%
5min112514-125146.4156.057.596.416.057.58
211012-110125.6455.64
311749-117496.0226.02
410496-104965.3805.38
512300-123006.3056.30
612763-127636.5426.54
10min116030-160308.2178.152.928.258.182.87
215894-158948.1478.18
315784-157848.0918.12
416726-167268.5748.60
515521-155217.9567.99
615431-154317.9107.95
15min116497-164978.4568.063.548.548.143.54
216072-160728.2388.32
316029-160298.2168.29
415348-153487.8677.94
515009-150097.6947.77
615429-154297.9097.99
20min116280-162808.3458.073.008.478.202.95
216095-160958.2508.37
315984-159848.1938.32
415579-155797.9868.11
515582-155827.9878.11
614974-149747.6767.80
30min115510-155107.9507.822.078.127.992.04
215646-156468.0208.19
315472-154727.9318.10
414930-149307.6537.82
515008-150087.6937.86
614999-149997.6887.86
45min115456-154567.9237.852.568.148.062.53
215528-155287.9608.17
315922-159228.1628.38
415112-151127.7467.95
514842-148427.6087.82
615063-150637.7217.93
60min115281-152817.8337.883.608.108.133.54
216042-160428.2238.48
316051-160518.2288.49
415114-151147.7478.00
514929-149297.6537.90
614786-147867.5797.83
极限115650-156508.0227.812.718.338.112.70
215640-156408.0178.32
315541-155417.9668.27
415013-150137.6967.99
514803-148037.5887.88
614805-148057.5897.88
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211602171598161597491601021598811599530.13
211.241619721616801618260.13
单位质量响应值RSD%判断
14268.7814397.330.64数据可信
供试品溶液-2023120821批-阿托伐他汀钙-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%
5min1110279-11027963.55457.2611.8563.5557.2611.85
2110351-11035163.59563.60
3101431-10143158.45558.45
4101126-10112658.27958.28
578925-7892545.48545.48
694077-9407754.21754.22
10min1141439-14143981.51282.845.2381.8683.165.25
2152928-15292888.13388.49
3140586-14058681.02081.34
4152181-15218187.70288.03
5133328-13332876.83777.09
6142003-14200381.83782.14
15min1149227-14922786.00086.003.4886.8186.783.51
2156620-15662090.26091.10
3146423-14642384.38485.16
4153243-15324388.31489.13
5141845-14184581.74682.43
6148018-14801885.30386.06
20min1151685-15168587.41687.412.7588.7088.672.78
2159052-15905291.66293.01
3149166-14916685.96587.21
4153495-15349588.45989.76
5148120-14812085.36286.50
6148517-14851785.59186.82
30min1153093-15309388.22888.972.0290.0090.711.97
2157542-15754290.79292.65
3153789-15378988.62990.35
4152575-15257587.92989.72
5158672-15867291.44393.05
6150573-15057386.77688.48
45min1157715-15771590.89191.703.2793.1593.943.17
2160571-16057192.53794.90
3161847-16184793.27395.49
4155399-15539989.55791.84
5166976-16697696.22998.34
6152181-15218187.70289.89
60min1159894-15989492.14793.184.5294.9195.924.39
2164301-16430194.68797.56
3168184-16818496.92599.66
4155758-15575889.76492.54
5170411-17041198.208100.86
6151551-15155187.33990.01
极限1170344-17034498.17097.640.85101.45100.910.76
2166566-16656695.99299.39
3170251-17025198.116101.39
4169604-16960497.743101.02
5169705-16970597.801101.00
6170097-17009798.027101.19
依折麦布阿托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对照品来源工作对照品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%
110.001747891746541749251753141748691749100.15
210.011770531776811773670.26
单位质量响应值RSD%判断
17491.0017718.980.92数据可信
供试品溶液-2023120822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%
5min113092-130926.6766.424.466.686.424.47
212850-128506.5536.55
313104-131046.6836.68
412734-127346.4946.49
511852-118526.0446.04
611936-119366.0876.09
10min116190-161908.2568.143.068.298.183.04
216436-164368.3828.42
315881-158818.0998.14
416343-163438.3348.37
515104-151047.7027.74
615814-158148.0658.10
15min115986-159868.1528.231.038.248.310.99
216338-163388.3328.41
316011-160118.1658.25
416336-163368.3318.41
516001-160018.1608.24
616140-161408.2318.31
20min116258-162588.2918.093.628.428.213.61
216537-165378.4338.56
315567-155677.9398.07
416251-162518.2878.42
515064-150647.6827.80
615462-154627.8858.01
30min115929-159298.1238.062.918.308.242.89
216611-166118.4718.65
315346-153467.8268.00
415631-156317.9718.15
515430-154307.8698.03
615897-158978.1078.28
45min115086-150867.6937.772.737.917.982.70
215821-158218.0688.29
314834-148347.5657.78
415649-156497.9808.20
515156-151567.7297.94
614841-148417.5687.78
60min115028-150287.6647.782.767.938.042.76
215800-158008.0578.33
314935-149357.6167.87
415811-158118.0638.33
515003-150037.6517.90
615005-150057.6527.91
极限115104-151047.7027.762.418.018.062.41
215678-156787.9958.31
314698-146987.4957.79
415596-155967.9538.26
515082-150827.6917.98
615107-151077.7048.00
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211604701599131597991607201597261601260.28
211.241628251633251630750.22
单位质量响应值RSD%判断
14284.2114508.451.11数据可信
供试品溶液-2023120822批-阿托伐他汀钙-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%
5min169108-6910839.65447.7622.4939.6547.7622.50
282741-8274147.47647.48
380001-8000145.90445.90
498916-9891656.75756.76
558879-5887933.78433.78
6109726-10972662.96062.96
10min195637-9563754.87665.5610.0655.1065.8310.09
2110551-11055163.43363.70
3121146-12114669.51369.77
4118776-11877668.15368.47
5110440-11044063.37063.56
6129008-12900874.02474.37
15min199087-9908756.85567.879.2157.3868.509.23
2115270-11527066.14166.76
3125748-12574872.15372.79
4120783-12078369.30470.00
5118135-11813567.78568.32
6130651-13065174.96775.73
20min1102923-10292359.05668.978.3859.9069.978.41
2116618-11661866.91467.90
3126844-12684472.78273.82
4122127-12212770.07671.15
5120305-12030569.03069.95
6132347-13234775.94077.12
30min1107973-10797361.95470.446.9563.1271.837.01
2120744-12074469.28270.64
3128605-12860573.79375.24
4123111-12311170.64072.11
5123051-12305170.60671.91
6133073-13307376.35677.96
45min1108044-10804461.99571.216.9763.5173.007.02
2122575-12257570.33372.07
3130649-13064974.96576.82
4125862-12586272.21974.08
5125300-12530071.89673.59
6132244-13224475.88177.90
60min1110390-11039063.34172.167.1365.2074.337.19
2123741-12374171.00273.13
3133589-13358976.65278.93
4126615-12661572.65174.91
5124527-12452771.45373.54
6135661-13566177.84180.29
极限1171275-17127598.27697.811.72100.49100.391.70
2170309-17030997.722100.25
3164931-16493194.63697.33
4171862-17186298.613101.28
5170899-17089998.061100.55
6173520-17352099.564102.44
依折麦布阿托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对照品来源工作对照品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%
110.001760021764671769541769281774311767560.31
210.011754051757691755870.15
单位质量响应值RSD%判断
17675.6017541.160.54数据可信
供试品溶液-2023120822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%
5min112477-124776.3615.977.046.365.977.04
211790-117906.0116.01
312783-127836.5176.52
411402-114025.8135.81
510549-105495.3785.38
611255-112555.7385.74
10min115520-155207.9137.831.757.957.871.78
215506-155067.9067.94
315700-157008.0058.04
415123-151237.7107.74
514985-149857.6407.67
615350-153507.8267.86
15min115684-156847.9967.951.128.088.021.15
215828-158288.0708.15
315695-156958.0028.08
415430-154307.8677.94
515409-154097.8567.93
615459-154597.8827.96
20min115819-158198.0658.052.548.198.172.49
215743-157438.0278.15
316416-164168.3708.49
415157-151577.7287.85
515822-158228.0678.18
615723-157238.0168.14
30min115716-157168.0137.932.018.188.102.01
216070-160708.1938.36
315569-155697.9388.11
415162-151627.7307.89
515381-153817.8428.00
615447-154477.8768.04
45min115346-153467.8247.902.238.048.112.18
215258-152587.7797.99
315610-156107.9598.17
415356-153567.8298.03
515250-152507.7757.98
616146-161468.2328.44
60min115607-156077.9577.741.618.217.991.57
215248-152487.7748.03
315041-150417.6697.93
415203-152037.7518.00
515057-150577.6777.92
614903-149037.5987.85
极限115156-151567.7277.650.748.037.950.69
214910-149107.6027.90
314899-148997.5967.90
415107-151077.7027.99
514942-149427.6187.91
615061-150617.6797.97
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211603151605141610021608991611961607850.23
211.241600801603271602040.11
单位质量响应值RSD%判断
14343.0014253.020.45数据可信
供试品溶液-2023120822批-阿托伐他汀钙-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%
5min1105184-10518460.76643.3430.9160.7743.3430.91
247919-4791927.68327.68
3101071-10107158.39058.39
466717-6671738.54338.54
558382-5838233.72833.73
670808-7080840.90640.91
10min1124711-12471172.04771.229.7572.3871.469.76
2119779-11977969.19769.35
3131066-13106675.71876.04
4103854-10385459.99760.21
5120743-12074369.75469.94
6139505-13950580.59380.82
15min1128455-12845574.21075.509.1374.9576.149.10
2138631-13863180.08880.63
3134161-13416177.50678.25
4110821-11082164.02264.57
5126591-12659173.13373.71
6145497-14549784.05584.73
20min1132112-13211276.32276.969.8677.4778.029.82
2142728-14272882.45583.44
3136279-13627978.73079.91
4110523-11052363.85064.75
5129304-12930474.70075.68
6148389-14838985.72686.87
30min1132669-13266976.64478.169.5278.2279.649.48
2146427-14642784.59286.03
3138058-13805879.75781.37
4113321-11332165.46766.72
5131945-13194576.22677.62
6149300-14930086.25287.87
45min1131912-13191276.20779.3710.2578.2181.2910.16
2155524-15552489.84891.76
3139080-13908080.34882.40
4116637-11663767.38269.00
5131175-13117575.78177.60
6149997-14999786.65588.75
60min1134972-13497277.97479.8510.6280.4082.2110.51
2160213-16021392.55694.97
3136450-13645078.82881.33
4116905-11690567.53769.53
5132771-13277176.70378.94
6147992-14799285.49688.08
极限1170582-17058298.54799.111.37101.40101.911.40
2170921-17092198.743101.67
3168777-16877797.504100.44
4171143-17114398.871101.24
5172185-17218599.473102.14
6175765-175765101.541104.59
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