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%
19.911714401714121711631714081709941712830.12
210.011715251721361718300.26
单位质量响应值RSD%判断
17283.8517165.830.49数据可信
供试品溶液-24121902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%
5min16470-64703.3723.269.583.373.269.59
26461-64613.3673.37
36415-64153.3443.34
45048-50482.6312.63
56675-66753.4793.48
66474-64743.3743.37
10min113604-136047.0907.043.847.117.063.86
213367-133676.9676.99
313504-135047.0387.06
412578-125786.5566.57
514041-140417.3187.34
613916-139167.2537.27
15min115339-153397.9957.981.918.058.041.92
215218-152187.9327.99
315683-156838.1748.23
415079-150797.8597.91
514934-149347.7847.84
615597-155978.1298.19
20min115055-150557.8477.842.517.957.942.46
215143-151437.8937.99
315500-155008.0798.18
415017-150177.8277.92
514358-143587.4837.59
615192-151927.9188.02
30min115435-154358.0457.991.198.198.131.21
215168-151687.9068.05
315187-151877.9158.06
415150-151507.8968.03
515435-154358.0458.19
615581-155818.1218.27
45min114588-145887.6037.832.337.798.022.26
214594-145947.6067.80
315131-151317.8868.08
415273-152737.9608.14
515236-152367.9418.13
615368-153688.0108.20
60min115322-153227.9867.903.118.228.143.05
214480-144807.5477.78
315813-158138.2428.48
415055-150557.8478.07
514854-148547.7427.98
615463-154638.0598.30
极限114804-148047.7167.962.787.998.242.69
214710-147107.6677.94
315598-155988.1308.41
415717-157178.1928.46
515517-155178.0878.36
615307-153077.9788.26
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%
111.033120113119313117923120003117463118960.04
211.053127673134683131180.16
单位质量响应值RSD%判断
28277.0628336.470.15数据可信
供试品溶液-24121902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%
5min144189-4418912.89412.185.4112.8912.185.40
242688-4268812.45712.46
339686-3968611.58111.58
438268-3826811.16711.17
542895-4289512.51712.52
642702-4270212.46112.46
10min187015-8701525.39126.286.3925.4626.356.37
294241-9424127.50027.57
394421-9442127.55227.62
481755-8175523.85623.92
586621-8662125.27625.35
696264-9626428.09028.16
15min1113643-11364333.16133.694.0633.3733.904.07
2117421-11742134.26434.49
3119732-11973234.93835.16
4108701-10870131.71931.91
5112352-11235232.78532.99
6120808-12080835.25235.48
20min1117035-11703534.15134.683.1234.5535.083.13
2121163-12116335.35635.77
3123374-12337436.00136.41
4114970-11497033.54933.92
5114828-11482833.50733.90
6121748-12174835.52635.95
30min1127369-12736937.16737.112.3437.7537.702.33
2129089-12908937.66938.28
3126514-12651436.91737.53
4121727-12172735.52036.08
5130229-13022938.00138.58
6128094-12809437.37838.00
45min1119042-11904234.73736.143.0335.5336.942.99
2121686-12168635.50836.33
3124545-12454536.34337.16
4121538-12153835.46536.22
5128613-12861337.53038.32
6127580-12758037.22838.05
60min1126863-12686337.01937.202.5338.0138.202.49
2123758-12375836.11337.13
3129936-12993637.91638.93
4123960-12396036.17237.12
5131691-13169138.42839.43
6128590-12859037.52338.56
极限1136284-13628439.76841.753.2240.9642.963.13
2139742-13974240.77741.99
3145303-14530342.40043.63
4146220-14622042.66743.82
5148824-14882443.42744.64
6142120-14212041.47142.71
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%
19.911710811706471710071709131711561709610.12
210.011714681723261718970.36
单位质量响应值RSD%判断
17251.3617172.530.33数据可信
供试品溶液-24121902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%
5min17047-70473.6763.7711.183.683.7711.12
26864-68643.5803.58
36288-62883.2803.28
48597-85974.4844.48
57714-77144.0244.02
66897-68973.5973.60
10min115300-153007.9808.413.498.008.433.48
216043-160438.3688.39
316739-167398.7318.75
416525-165258.6198.64
515645-156458.1608.18
616478-164788.5958.61
15min115897-158978.2928.634.178.368.704.13
216810-168108.7688.83
317389-173899.0709.14
416639-166398.6798.75
515550-155508.1118.18
616957-169578.8458.91
20min115415-154158.0408.534.088.158.654.06
216938-169388.8358.95
317254-172548.9999.12
416410-164108.5598.68
515967-159678.3288.44
616170-161708.4348.55
30min115097-150977.8748.273.448.038.443.42
215931-159318.3098.47
316703-167038.7128.88
415941-159418.3158.48
515469-154698.0688.23
616017-160178.3548.52
45min114495-144957.5608.184.907.768.394.82
215812-158128.2478.46
316810-168108.7688.98
415507-155078.0888.30
515406-154068.0368.24
616049-160498.3718.58
60min114066-140667.3377.765.537.588.025.41
214914-149147.7798.04
316391-163918.5498.81
414681-146817.6577.92
514261-142617.4387.69
614987-149877.8178.07
极限114195-141957.4047.702.237.698.002.16
214982-149827.8148.11
314548-145487.5887.90
414814-148147.7278.03
514977-149777.8128.10
615036-150367.8438.14
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%
111.033102953112993110733108293103583107710.15
211.053121053140073130560.43
单位质量响应值RSD%判断
28175.0728330.860.39数据可信
供试品溶液-24121902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%
5min179906-7990623.36124.2325.2023.3624.2325.19
263577-6357718.58718.59
355371-5537116.18816.19
4103412-10341230.23430.23
587680-8768025.63425.63
6107312-10731231.37431.37
10min1184014-18401453.79956.764.5453.9356.894.57
2191315-19131555.93356.04
3189373-18937355.36555.46
4208229-20822960.87861.05
5190938-19093855.82355.97
6200887-20088758.73258.91
15min1221890-22189064.87267.494.2265.3067.944.22
2232597-23259768.00268.42
3230673-23067367.44067.84
4247760-24776072.43572.94
5220684-22068464.51964.97
6231446-23144667.66668.17
20min1232808-23280868.06472.575.0468.8573.405.02
2253953-25395374.24675.04
3246401-24640172.03872.81
4268917-26891778.62179.53
5248001-24800172.50673.32
6239308-23930869.96470.84
30min1247665-24766572.40876.796.1573.5778.026.12
2262463-26246376.73477.94
3260608-26060876.19277.36
4292971-29297185.65387.00
5262014-26201476.60377.82
6250304-25030473.17974.44
45min1258094-25809475.45780.647.0977.0382.297.04
2278634-27863481.46283.09
3273787-27378780.04581.64
4311892-31189291.18593.01
5273275-27327579.89581.53
6259178-25917875.77477.45
60min1259853-25985375.97180.147.4277.9682.247.35
2279008-27900881.57183.65
3279902-27990281.83283.87
4309394-30939490.45592.78
5263854-26385477.14179.22
6252737-25273773.89075.98
极限1281665-28166582.34884.516.8484.7687.066.76
2299429-29942987.54190.08
3267547-26754778.22080.72
4317507-31750792.82795.66
5299328-29932887.51290.02
6268804-26880478.58881.09
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%
19.911718031721601718211721681720771720060.11
210.011738021747491742760.39
单位质量响应值RSD%判断
17356.8117410.190.22数据可信
供试品溶液-24121902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%
5min16669-66693.4442.6320.783.442.6320.73
25316-53162.7452.75
33641-36411.8801.88
45168-51682.6692.67
54218-42182.1782.18
65495-54952.8382.84
10min114323-143237.3977.293.427.427.303.43
214785-147857.6367.65
313479-134796.9616.97
414341-143417.4067.42
513657-136577.0537.07
614108-141087.2867.30
15min114790-147907.6387.583.487.707.643.51
215336-153367.9207.98
314238-142387.3537.40
414157-141577.3117.37
514334-143347.4037.45
615201-152017.8507.91
20min114480-144807.4787.415.057.587.515.04
215289-152897.8968.00
313403-134036.9227.01
413881-138817.1697.27
514007-140077.2347.33
615049-150497.7727.87
30min114100-141007.2827.313.747.437.453.74
214961-149617.7267.87
314187-141877.3277.46
413648-136487.0487.18
513558-135587.0027.13
614523-145237.5007.64
45min113377-133776.9086.944.727.097.124.66
214356-143567.4147.60
313496-134966.9707.14
412562-125626.4886.66
512981-129816.7046.88
613862-138627.1597.34
60min113903-139037.1807.073.827.407.293.84
214364-143647.4187.65
313598-135987.0237.23
412940-129406.6836.89
513283-132836.8607.07
614049-140497.2557.48
极限113670-136707.0606.963.497.327.223.52
213883-138837.1707.44
313497-134976.9707.22
412828-128286.6256.87
513000-130006.7146.96
613981-139817.2207.49
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%
111.033122143123133125663125563125083124310.06
211.053162143183023172580.47
单位质量响应值RSD%判断
28325.5728711.130.96数据可信
供试品溶液-24121902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%
5min1163759-16375947.43342.848.6947.4342.848.69
2147739-14773942.79342.79
3127330-12733036.88136.88
4142909-14290941.39441.39
5159066-15906646.07446.07
6146700-14670042.49242.49
10min1210418-21041860.94860.976.8061.2161.216.79
2209364-20936460.64360.88
3202946-20294658.78458.99
4209621-20962160.71760.95
5236704-23670468.56268.82
6193877-19387756.15756.39
15min1220683-22068363.92164.218.0964.5264.788.07
2214765-21476562.20762.78
3216942-21694262.83863.37
4213936-21393661.96762.53
5257053-25705374.45675.09
6206668-20666859.86260.41
20min1228678-22867866.23764.969.6667.1965.899.62
2217821-21782163.09264.01
3202480-20248058.64959.53
4216018-21601862.57063.48
5265072-26507276.77877.83
6215538-21553862.43163.31
30min1239453-23945369.35868.4110.3270.6869.7010.26
2225349-22534965.27366.54
3229422-22942266.45267.66
4222161-22216164.34965.61
5283500-28350082.11683.59
6217187-21718762.90964.14
45min1251362-25136272.80768.8710.6874.5270.5410.61
2228858-22885866.28967.92
3234672-23467267.97369.55
4215949-21594962.55064.17
5281531-28153181.54683.48
6214160-21416062.03263.61
60min1274216-27421679.42773.1911.4081.5475.2511.32
2241844-24184470.05072.05
3241260-24126069.88171.83
4231836-23183667.15269.12
5300679-30067987.09289.48
6226263-22626365.53767.46
极限1317823-31782392.05891.613.7694.6194.083.87
2311628-31162890.26392.65
3317658-31765892.01094.35
4313866-31386690.91293.25
5336616-33661697.501100.37
6300138-30013886.93589.22
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