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%
110.161756241751881762451756801758301757130.22
210.191758671774791766730.65
单位质量响应值RSD%判断
17294.5917337.880.18数据可信
供试品溶液-25030301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%
5min15712-57122.9612.3819.012.962.3819.06
24597-45972.3832.38
34970-49702.5772.58
43114-31141.6141.61
54241-42412.1992.20
64904-49042.5422.54
10min114036-140367.2776.923.797.296.943.80
213688-136887.0967.11
313587-135877.0447.06
412821-128216.6476.66
512770-127706.6216.63
613196-131966.8416.86
15min114903-149037.7267.741.367.787.791.41
215229-152297.8957.95
315089-150897.8237.88
414690-146907.6167.66
514866-148667.7077.76
614759-147597.6527.70
20min115309-153097.9377.871.588.047.971.57
215276-152767.9208.02
315420-154207.9948.09
415281-152817.9228.01
515051-150517.8037.89
614762-147627.6537.75
30min114550-145507.5437.731.627.697.871.54
215034-150347.7947.93
315101-151017.8297.97
414935-149357.7437.88
515139-151397.8497.98
614679-146797.6107.75
45min115240-152407.9017.771.508.097.951.52
215012-150127.7837.97
315164-151647.8628.05
415023-150237.7897.96
514842-148427.6957.87
614623-146237.5817.76
60min114787-147877.6667.913.157.908.143.00
214891-148917.7207.95
315001-150017.7778.01
415161-151617.8608.08
515725-157258.1538.37
615965-159658.2778.50
极限115318-153187.9427.761.938.218.021.91
215094-150947.8258.10
315121-151217.8398.11
414868-148687.7087.97
514898-148987.7247.99
614479-144797.5077.77
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%
111.143149043144753160353149773154553151690.19
211.123162433173463167940.25
单位质量响应值RSD%判断
28291.6528488.670.50数据可信
供试品溶液-25030301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%
5min161763-6176318.00817.643.9618.0117.643.96
256228-5622816.39416.39
360512-6051217.64317.64
461538-6153817.94217.94
559835-5983517.44617.45
663192-6319218.42418.42
10min1109531-10953131.93533.844.5332.0433.934.52
2109206-10920631.84031.93
3119665-11966534.89034.99
4118368-11836834.51234.61
5118644-11864434.59234.69
6120874-12087435.24235.34
15min1127846-12784637.27539.624.7937.5539.904.78
2127986-12798637.31637.58
3136652-13665239.84340.13
4139201-13920140.58640.88
5142995-14299541.69241.98
6140605-14060540.99541.29
20min1145913-14591342.54343.844.1543.0344.354.14
2140051-14005140.83441.31
3151388-15138844.13944.65
4155723-15572345.40345.92
5155738-15573845.40745.93
6153370-15337044.71745.24
30min1135033-13503339.37141.085.4440.0941.835.42
2128434-12843437.44738.15
3141754-14175441.33042.09
4145728-14572842.48943.26
5146940-14694042.84243.62
6147422-14742242.98343.76
45min1140781-14078141.04641.633.9541.9942.613.95
2132510-13251038.63539.55
3143298-14329841.78042.77
4146929-14692942.83943.84
5145533-14553342.43243.44
6147700-14770043.06444.08
60min1133644-13364438.96641.397.4240.1342.607.32
2127694-12769437.23138.36
3138828-13882840.47741.70
4145080-14508042.30043.54
5151218-15121844.09045.34
6155208-15520845.25346.51
极限1156066-15606645.50344.862.8946.8946.302.90
2144852-14485242.23343.57
3155693-15569345.39446.84
4155905-15590545.45646.93
5155708-15570845.39946.89
6154998-15499845.19246.70
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%
110.161778171771171774221772201770581773270.18
210.191753431761481757460.33
单位质量响应值RSD%判断
17453.4417246.910.85数据可信
供试品溶液-25030301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%
5min19447-94474.8885.327.564.895.327.56
29858-98585.1015.10
310238-102385.2985.30
411327-113275.8615.86
511125-111255.7575.76
69706-97065.0225.02
10min116096-160968.3298.341.328.368.371.31
216389-163898.4808.51
316092-160928.3278.36
416326-163268.4488.48
515974-159748.2668.30
615823-158238.1888.22
15min116163-161638.3648.351.638.448.421.58
216501-165018.5388.61
316226-162268.3968.47
416127-161278.3458.42
515687-156878.1178.20
616098-160988.3308.40
20min115962-159628.2608.172.398.388.292.36
216379-163798.4758.60
315956-159568.2568.38
415592-155928.0688.19
515388-153887.9628.09
615469-154698.0048.12
30min115038-150387.7818.215.197.958.385.12
216485-164858.5308.70
317196-171968.8989.07
415793-157938.1728.34
515388-153887.9628.13
615306-153067.9208.08
45min115211-152117.8718.177.498.088.387.31
218161-181619.3979.61
315690-156908.1198.34
415066-150667.7968.01
515236-152367.8848.10
615354-153547.9458.15
60min115148-151487.8388.5321.708.098.7821.12
223755-2375512.29212.56
315446-154467.9938.26
414997-149977.7608.02
514728-147287.6217.88
614789-147897.6537.90
极限115110-151107.8198.8427.768.119.1427.00
226748-2674813.84114.18
315196-151967.8638.17
415200-152007.8658.17
514883-148837.7018.00
615326-153267.9308.23
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%
111.143166483170633171623173353174043171220.10
211.123155373159993157680.11
单位质量响应值RSD%判断
28466.9728396.400.18数据可信
供试品溶液-25030301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%
5min1110238-11023832.09431.2833.5632.0931.2833.57
238927-3892711.33311.33
3113924-11392433.16733.17
4107663-10766331.34431.34
5134191-13419139.06839.07
6139703-13970340.67240.67
10min1240188-24018869.92767.717.9170.1167.897.97
2195704-19570456.97657.04
3241770-24177070.38770.57
4239195-23919569.63869.81
5234188-23418868.18068.40
6244441-24444171.16571.39
15min1274735-27473579.98579.632.8280.5580.182.87
2262419-26241976.39976.78
3281052-28105281.82482.40
4276950-27695080.62981.19
5265818-26581877.38977.98
6280083-28008381.54282.16
20min1290366-29036684.53583.572.5385.5584.572.52
2284327-28432782.77783.58
3296803-29680386.40987.44
4288530-28853084.00185.01
5274935-27493580.04381.07
6287422-28742283.67884.75
30min1293088-29308885.32888.326.1386.8189.786.06
2296110-29611086.20887.47
3338366-33836698.510100.02
4307503-30750389.52491.00
5285808-28580883.20884.68
6299402-29940287.16688.71
45min1302311-30231188.01388.792.3489.9790.732.33
2305502-30550288.94290.68
3313190-31319091.18093.24
4307643-30764389.56591.54
5292443-29244385.14087.07
6308715-30871589.87791.90
60min1308801-30880189.90288.903.0892.3591.343.03
2308100-30810089.69891.94
3314348-31434891.51794.08
4309650-30965090.15092.62
5287472-28747283.69386.10
6303718-30371888.42390.95
极限1309197-30919790.01889.572.6092.9692.502.56
2309855-30985590.20992.94
3310408-31040890.37093.44
4311320-31132090.63693.61
5291655-29165584.91187.78
6313523-31352391.27794.29
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%
110.161770871775061779631783041783381778400.31
210.191752751758401755580.23
单位质量响应值RSD%判断
17503.9417228.461.13数据可信
供试品溶液-25030301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%
5min19507-95074.9154.697.194.914.697.17
28511-85114.4004.40
39179-91794.7454.75
410099-100995.2215.22
58727-87274.5124.51
68410-84104.3484.35
10min114221-142217.3527.342.647.387.362.65
213919-139197.1967.22
314875-148757.6907.72
414291-142917.3887.42
513896-138967.1847.21
613951-139517.2127.24
15min114146-141467.3137.291.487.387.351.46
214416-144167.4537.52
314032-140327.2547.32
413830-138307.1507.22
514216-142167.3497.41
613946-139467.2107.27
20min114486-144867.4897.272.977.607.382.92
214186-141867.3347.44
314534-145347.5147.62
413482-134826.9707.08
513921-139217.1977.30
613757-137577.1127.22
30min113363-133636.9087.031.707.067.181.66
213766-137667.1177.26
313949-139497.2117.36
413468-134686.9637.11
513640-136407.0527.20
613400-134006.9287.07
45min113328-133286.8907.012.307.087.202.22
214117-141177.2987.48
313645-136457.0547.25
413604-136047.0337.22
513332-133326.8927.08
613314-133146.8837.07
60min113027-130276.7357.027.786.967.247.58
215592-155928.0618.29
313574-135747.0187.25
412738-127386.5856.81
513666-136667.0657.29
612868-128686.6536.87
极限113208-132086.8287.1411.057.097.4010.72
216839-168398.7068.98
313386-133866.9207.19
412924-129246.6826.94
512757-127576.5956.86
613713-137137.0897.35
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%
111.143174803181703190483183593189433184000.20
211.123144523151263147890.16
单位质量响应值RSD%判断
28581.6928308.360.68数据可信
供试品溶液-25030301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%
5min1218551-21855163.59950.6522.0063.6050.6522.00
2180103-18010352.41152.41
3103339-10333930.07230.07
4170064-17006449.48949.49
5186620-18662054.30754.31
6185661-18566154.02854.03
10min1262733-26273376.45672.508.8576.8172.788.83
2248374-24837472.27872.57
3254718-25471874.12474.29
4205608-20560859.83360.11
5261415-26141576.07376.37
6261956-26195676.23076.53
15min1268335-26833578.08673.999.1478.8674.679.13
2257796-25779675.02075.71
3252403-25240373.45074.03
4209706-20970661.02561.63
5275192-27519280.08280.81
6262054-26205476.25976.98
20min1271528-27152879.01675.288.9480.2376.388.91
2259396-25939675.48576.59
3265408-26540877.23578.22
4212954-21295461.97062.92
5275998-27599880.31681.49
6266944-26694477.68278.83
30min1263122-26312276.56974.768.0278.2276.278.01
2255887-25588774.46475.99
3260944-26094475.93677.35
4217373-21737363.25664.55
5276655-27665580.50882.12
6267397-26739777.81379.39
45min1267405-26740577.81675.847.4979.8977.777.50
2258840-25884075.32377.27
3257745-25774575.00576.84
4224897-22489765.44667.09
5278513-27851381.04883.11
6276325-27632580.41282.42
60min1265191-26519177.17175.858.1279.6878.208.11
2258881-25888175.33577.70
3258871-25887175.33277.59
4221945-22194564.58766.59
5278501-27850181.04583.56
6280487-28048781.62384.08
极限1312907-31290791.05790.342.7693.9993.112.85
2308777-30877789.85592.63
3316110-31611091.98994.66
4296170-29617086.18688.55
5307652-30765289.52892.49
6321058-32105893.42996.34
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