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%
110.161769601769141766861770081770431769220.08
210.191767331771791769560.18
单位质量响应值RSD%判断
17413.5817365.650.20数据可信
供试品溶液-25030302批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13743-37431.9322.5715.731.932.5715.71
24819-48192.4882.49
35258-52582.7142.71
46052-60523.1243.12
54635-46352.3932.39
65390-53902.7832.78
10min113378-133786.9067.141.816.927.161.84
214007-140077.2317.25
313774-137747.1117.13
414059-140597.2587.28
513973-139737.2147.23
613841-138417.1467.16
15min114431-144317.4507.762.607.507.812.59
215102-151027.7977.85
315072-150727.7817.84
414957-149577.7227.78
515647-156478.0788.13
614941-149417.7137.77
20min114812-148127.6477.751.577.747.851.55
215252-152527.8747.97
314778-147787.6297.73
414886-148867.6857.79
515337-153377.9188.02
615001-150017.7447.84
30min114341-143417.4047.763.637.547.903.58
214796-147967.6397.78
314842-148427.6627.80
415980-159808.2508.39
515083-150837.7877.93
615161-151617.8277.97
45min114692-146927.5857.691.187.767.871.15
215149-151497.8218.00
314870-148707.6777.86
414733-147337.6067.80
515038-150387.7637.95
614857-148577.6707.85
60min114537-145377.5057.581.477.727.811.44
214912-149127.6987.93
314784-147847.6327.86
414331-143317.3987.63
514745-147457.6127.84
614827-148277.6557.88
极限115070-150707.7807.683.398.047.953.28
215393-153937.9478.22
315278-152787.8878.16
414507-145077.4897.76
514927-149277.7067.98
614065-140657.2617.53
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.143152453166723165383164383162583162300.19
211.123163733170523167120.16
单位质量响应值RSD%判断
28386.8928481.290.24数据可信
供试品溶液-25030302批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158913-5891317.15018.125.1917.1518.125.20
260019-6001917.47217.47
359406-5940617.29417.29
464084-6408418.65518.66
564423-6442318.75418.75
666703-6670319.41819.42
10min1104032-10403230.28532.214.1330.3832.314.13
2111583-11158332.48332.58
3106559-10655931.02031.12
4112295-11229532.69032.79
5112897-11289732.86532.97
6116550-11655033.92934.04
15min1119826-11982634.88237.184.3135.1537.464.30
2127381-12738137.08237.36
3124477-12447736.23636.50
4127100-12710037.00037.29
5132156-13215638.47238.76
6135337-13533739.39839.69
20min1133152-13315238.76240.233.6339.2240.723.64
2139972-13997240.74741.23
3132751-13275138.64539.11
4137831-13783140.12440.61
5139162-13916240.51141.01
6146338-14633842.60043.12
30min1123400-12340035.92338.805.7536.6039.515.70
2133111-13311138.75039.46
3127175-12717537.02237.71
4143359-14335941.73342.45
5131958-13195838.41439.14
6140685-14068540.95541.71
45min1128841-12884137.50738.953.2138.3839.883.23
2136280-13628039.67240.60
3129479-12947937.69338.58
4134474-13447439.14740.09
5133446-13344638.84739.79
6140302-14030240.84341.82
60min1123089-12308935.83237.473.5336.9138.613.53
2130785-13078538.07339.22
3125541-12554136.54637.65
4128490-12849037.40538.57
5128101-12810137.29138.45
6136210-13621039.65240.86
极限1143592-14359241.80142.722.8143.0844.072.74
2154381-15438144.94246.30
3145535-14553542.36743.67
4143888-14388841.88743.26
5148310-14831043.17444.54
6144724-14472442.13143.56
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%
110.161781511779471777621777341776131778410.12
210.191760931775271768100.58
单位质量响应值RSD%判断
17504.0417351.320.62数据可信
供试品溶液-25030302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%
5min112274-122746.3235.5012.366.325.5012.38
210519-105195.4195.42
312057-120576.2116.21
410626-106265.4745.47
59656-96564.9744.97
68897-88974.5834.58
10min115599-155998.0368.132.118.078.162.13
215762-157628.1208.15
316317-163178.4068.44
416018-160188.2518.28
515598-155988.0358.06
615408-154087.9377.96
15min115370-153707.9188.061.228.008.141.19
215776-157768.1278.20
315802-158028.1408.22
415446-154467.9578.03
515792-157928.1358.21
615683-156838.0798.15
20min115581-155818.0267.960.678.158.080.66
215310-153107.8878.01
315435-154357.9518.08
415368-153687.9178.04
515551-155518.0118.13
615457-154577.9628.08
30min115131-151317.7958.145.697.968.315.63
215232-152327.8478.01
317581-175819.0579.23
415712-157128.0948.26
515626-156268.0508.21
615552-155528.0118.17
45min114412-144127.4247.712.337.647.922.26
214732-147327.5897.80
314976-149767.7157.94
415289-152897.8768.09
515333-153337.8998.11
615037-150377.7467.95
60min115063-150637.7607.621.128.017.861.06
214781-147817.6147.86
314579-145797.5107.77
414716-147167.5817.83
514848-148487.6497.90
614711-147117.5787.82
极限115657-156578.0667.652.838.367.952.71
214852-148527.6517.94
314610-146107.5267.83
414584-145847.5137.81
514910-149107.6817.97
614535-145357.4887.78
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.143182803179683177133174383174753177750.12
211.123147233173553160390.59
单位质量响应值RSD%判断
28525.5828420.770.27数据可信
供试品溶液-25030302批-阿托伐他汀钙-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%
5min1155000-15500045.06029.4139.3145.0629.4139.31
267369-6736919.58519.58
3141159-14115941.03641.04
4107872-10787231.35931.36
568217-6821719.83119.83
667454-6745419.61019.61
10min1230406-23040666.98167.006.2967.2367.176.35
2211148-21114861.38361.49
3250087-25008772.70372.93
4244376-24437671.04371.22
5223708-22370865.03465.14
6223167-22316764.87764.99
15min1257268-25726874.79078.863.4675.4179.393.45
2262060-26206076.18376.63
3278411-27841180.93781.57
4280458-28045881.53282.10
5275256-27525680.02080.49
6274067-27406779.67480.14
20min1276791-27679180.46683.632.9881.5084.602.96
2276769-27676980.46081.33
3291155-29115584.64285.72
4294412-29441285.58986.61
5292126-29212684.92485.84
6294774-29477485.69486.61
30min1284811-28481182.79790.456.6584.2891.906.60
2295445-29544585.88987.21
3344547-344547100.163101.72
4319490-31949092.87994.38
5313520-31352091.14392.53
6309098-30909889.85891.25
45min1277338-27733880.62588.855.5382.5790.795.45
2293704-29370485.38387.18
3310412-31041290.24092.35
4318967-31896792.72794.74
5321146-32114693.36095.25
6312284-31228490.78492.67
60min1288394-28839483.83989.173.7586.2391.603.71
2297300-29730086.42888.70
3308264-30826489.61592.22
4315678-31567891.77194.30
5316507-31650792.01294.42
6314246-31424691.35493.75
极限1284021-28402182.56890.255.2185.4393.185.11
2298208-29820886.69289.44
3313755-31375591.21294.32
4321494-32149493.46296.50
5318773-31877392.67095.59
6326367-32636794.87897.78
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%
110.161772011772191774441774971775541773830.10
210.191766051768571767310.11
单位质量响应值RSD%判断
17458.9617343.570.47数据可信
供试品溶液-25030302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%
5min110278-102785.3034.708.965.304.708.91
29276-92764.7864.79
37861-78614.0564.06
49523-95234.9134.91
58663-86634.4694.47
69056-90564.6724.67
10min113854-138547.1487.293.177.187.323.14
213934-139347.1897.22
313906-139067.1747.20
415032-150327.7557.78
514122-141227.2867.31
613967-139677.2067.23
15min113850-138507.1457.251.087.217.311.08
213890-138907.1667.23
314158-141587.3047.37
414131-141317.2907.36
514025-140257.2367.30
614222-142227.3377.40
20min113741-137417.0897.152.377.207.262.31
213579-135797.0067.11
314497-144977.4797.58
413861-138617.1517.26
513867-138677.1547.26
613661-136617.0487.15
30min113394-133946.9106.990.897.067.140.83
213635-136357.0357.18
313569-135697.0007.14
413452-134526.9407.09
513720-137207.0787.22
613518-135186.9747.12
45min113393-133936.9106.921.337.107.111.29
213474-134746.9517.14
313737-137377.0877.27
413343-133436.8847.07
513352-133526.8897.07
613209-132096.8157.00
60min113039-130396.7276.781.286.957.011.25
212892-128926.6516.87
313160-131606.7897.01
413189-131896.8047.03
513374-133746.9007.12
613246-132466.8347.06
极限112897-128976.6547.2210.896.927.4810.47
213468-134686.9487.21
317024-170248.7839.04
413164-131646.7927.06
513854-138547.1487.41
613511-135116.9717.23
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.143160243161193164853166663167603164110.11
211.123161383171843166610.24
单位质量响应值RSD%判断
28403.1428476.710.19数据可信
供试品溶液-25030302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%
5min1173562-17356250.51542.0030.2350.5242.0030.23
2129105-12910537.57637.58
3131038-13103838.13938.14
4200510-20051058.35858.36
574188-7418821.59221.59
6157361-15736145.80045.80
10min1232854-23285467.77267.765.2468.0568.005.29
2226591-22659165.94966.16
3219130-21913063.77863.99
4255473-25547374.35574.68
5231499-23149967.37867.50
6231348-23134867.33467.59
15min1239957-23995769.83969.173.7170.5069.783.69
2234718-23471868.31568.89
3221498-22149864.46765.03
4241267-24126770.22170.96
5246678-24667871.79572.29
6241925-24192570.41271.04
20min1237565-23756569.14368.862.4870.1969.852.45
2231333-23133367.32968.28
3229536-22953666.80667.73
4237928-23792869.24970.38
5246121-24612171.63372.53
6237006-23700668.98070.00
30min1238618-23861869.45068.824.0170.8870.203.95
2239945-23994569.83671.16
3219032-21903263.74965.04
4235613-23561368.57570.09
5247677-24767772.08673.38
6237914-23791469.24570.65
45min1239373-23937369.66969.062.8871.4870.822.85
2236710-23671068.89470.61
3225181-22518165.53967.19
4237633-23763369.16371.06
5246260-24626071.67473.37
6238521-23852169.42171.21
60min1239008-23900869.56368.933.1471.7771.083.11
2235987-23598768.68470.78
3223959-22395965.18367.20
4239858-23985869.81172.09
5246558-24655871.76173.85
6235683-23568368.59570.77
极限1254479-25447974.06675.412.8276.6577.932.77
2252199-25219973.40275.88
3254549-25454974.08676.46
4263597-26359776.72079.38
5271572-27157279.04181.53
6258094-25809475.11877.67
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