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DJ333-221017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(%)99.67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%
19.851658471665161668011671001669261666380.30
29.911644831653121648980.36
单位质量响应值RSD%判断
16917.5616639.561.18数据可信
供试品溶液-2022091401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%
5min19406-94065.0295.026.285.035.026.24
210406-104065.5645.56
39171-91714.9034.90
49561-95615.1125.11
59228-92284.9344.93
68614-86144.6064.61
10min114607-146077.8107.841.487.847.871.50
214662-146627.8397.87
314905-149057.9698.00
414890-148907.9617.99
514316-143167.6547.68
614620-146207.8177.84
15min115203-152038.1298.040.818.208.120.79
215120-151208.0848.16
314974-149748.0068.08
415013-150138.0278.10
514860-148607.9458.02
615097-150978.0728.14
20min115095-150958.0717.962.698.198.082.68
215076-150768.0618.18
314969-149698.0038.12
415122-151228.0858.20
514084-140847.5307.64
614995-149958.0178.13
30min114520-145207.7637.750.997.927.911.01
214572-145727.7917.96
314220-142207.6037.76
414633-146337.8247.99
514525-145257.7667.92
614507-145077.7567.91
45min113832-138327.3957.454.067.607.663.98
214375-143757.6867.89
313872-138727.4177.62
414649-146497.8328.04
512996-129966.9497.15
613900-139007.4327.63
60min113960-139607.4647.531.497.717.771.49
214077-140777.5267.78
314141-141417.5617.80
414389-143897.6937.94
513760-137607.3577.59
614137-141377.5597.80
极限113959-139597.4637.492.977.757.782.90
213994-139947.4827.77
314501-145017.7538.04
414423-144237.7118.00
513352-133527.1397.42
613872-138727.4177.70
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%
111.001585901591231593111594221593341591560.22
211.051574411580771577590.29
单位质量响应值RSD%判断
14468.7314276.830.95数据可信
供试品溶液-2022091401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%
5min187670-8767050.38647.168.8450.3947.168.85
276564-7656444.00344.00
370390-7039040.45540.45
488412-8841250.81250.81
582272-8227247.28447.28
687010-8701050.00750.01
10min1112472-11247264.64063.025.0264.9263.285.01
2100614-10061457.82558.07
3112221-11222164.49664.72
4109365-10936562.85563.14
5106782-10678261.37061.63
6116461-11646166.93367.21
15min1119551-11955168.70967.033.7269.3567.643.72
2112990-11299064.93865.50
3117048-11704867.27067.85
4113160-11316065.03665.67
5113381-11338165.16365.77
6123659-12365971.07071.72
20min1122318-12231870.29968.604.6071.3269.594.58
2115433-11543366.34267.27
3118528-11852868.12169.08
4115094-11509466.14767.14
5115761-11576166.53167.50
6129066-12906674.17775.22
30min1124518-12451871.56370.656.0672.9772.026.02
2116025-11602566.68267.98
3121080-12108069.58770.92
4119766-11976668.83270.19
5119172-11917268.49169.83
6137042-13704278.76180.22
45min1125489-12548972.12173.237.0473.9374.986.97
2121378-12137869.75971.42
3130087-13008774.76476.49
4122384-12238470.33772.08
5120812-12081269.43371.15
6144323-14432382.94684.84
60min1139167-13916779.98277.218.0682.1979.377.96
2121705-12170569.94772.00
3138045-13804579.33881.47
4124718-12471871.67873.81
5131149-13114975.37477.48
6151250-15125086.92789.28
极限1157120-15712090.30089.362.4292.9591.962.39
2159453-15945391.64194.08
3156333-15633389.84892.43
4149089-14908985.68588.22
5153145-15314588.01690.54
6157759-15775990.66893.51
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DJ333-221017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(%)99.67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%
19.851663871666961666241665741662651665090.11
29.911673771686731680250.55
单位质量响应值RSD%判断
16904.4716955.100.22数据可信
供试品溶液-2022091401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%
5min18918-89184.7255.005.064.735.005.05
29468-94685.0175.02
310211-102115.4105.41
49010-90104.7744.77
59285-92854.9204.92
69682-96825.1305.13
10min114496-144967.6817.831.907.717.861.88
214967-149677.9307.96
314414-144147.6377.67
415140-151408.0228.05
514782-147827.8327.86
614885-148857.8877.92
15min114894-148947.8927.962.387.968.032.36
215163-151638.0348.11
314474-144747.6697.74
415538-155388.2338.30
515156-151568.0308.10
614889-148897.8897.96
20min114664-146647.7707.933.047.888.052.99
215451-154518.1878.30
314610-146107.7417.86
415576-155768.2538.37
515008-150087.9528.07
614516-145167.6917.81
30min114547-145477.7087.852.277.868.012.27
215183-151838.0458.21
314479-144797.6727.83
414972-149727.9338.10
515166-151668.0368.20
614507-145077.6877.85
45min113775-137757.2997.673.557.507.873.49
214761-147617.8218.03
314105-141057.4747.67
414577-145777.7247.93
515240-152408.0758.28
614370-143707.6147.82
60min114228-142287.5397.731.917.787.971.89
214758-147587.8208.07
314419-144197.6407.88
415006-150067.9518.20
514644-146447.7598.01
614442-144427.6527.90
极限113917-139177.3747.672.527.667.962.49
214932-149327.9128.21
314237-142377.5447.83
414662-146627.7698.06
514674-146747.7758.07
614378-143787.6187.90
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%
111.001590941594881593641592081588031591910.17
211.051606091614141610120.36
单位质量响应值RSD%判断
14471.9114571.220.49数据可信
供试品溶液-2022091401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%
5min193881-9388153.40145.6517.8253.4045.6517.82
258152-5815233.07833.08
391685-9168552.15252.15
476447-7644743.48443.48
570616-7061640.16840.17
690749-9074951.61951.62
10min1113660-11366064.65258.159.1564.9558.419.17
298150-9815055.82956.01
3107867-10786761.35661.65
492685-9268552.72152.96
591549-9154952.07552.30
6109505-10950562.28862.57
15min1118988-11898867.68261.458.3868.3462.038.41
2104093-10409359.21059.70
3112028-11202863.72364.35
496683-9668354.99555.53
5100173-10017356.98057.49
6116239-11623966.11966.75
20min1119700-11970068.08762.707.5169.1263.627.53
2107159-10715960.95461.78
3113703-11370364.67665.66
497059-9705955.20956.05
5106761-10676160.72761.56
6116971-11697166.53567.54
30min1122310-12231069.57265.027.6170.9866.297.61
2111369-11136963.34864.51
3116366-11636666.19167.53
498928-9892856.27257.42
5114543-11454365.15466.32
6122342-12234269.59070.96
45min1121823-12182369.29567.498.3371.0969.118.29
2113386-11338664.49666.01
3122922-12292269.92071.63
4101201-10120157.56559.02
5123871-12387170.46071.99
6128649-12864973.17874.93
60min1131882-13188275.01770.509.2877.2072.509.23
2119888-11988868.19470.07
3125544-12554471.41173.51
4104303-10430359.32961.11
5124189-12418970.64172.56
6137838-13783878.40480.57
极限1158100-15810089.93086.263.1092.5388.653.23
2150630-15063085.68187.93
3152153-15215386.54789.04
4144168-14416882.00584.11
5150149-15014985.40787.72
6154640-15464087.96290.56
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DJ333-221017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(%)99.67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%
19.851650961650061649071648841649791649740.06
29.911685491687141686320.07
单位质量响应值RSD%判断
16748.6317016.351.13数据可信
供试品溶液-2022091402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%
5min111690-116906.2126.026.006.216.025.97
210954-109545.8215.82
311390-113906.0526.05
410175-101755.4075.41
512088-120886.4236.42
611687-116876.2106.21
10min115262-152628.1108.022.528.148.062.51
215096-150968.0228.05
315543-155438.2598.29
414976-149767.9587.99
514433-144337.6697.70
615290-152908.1258.16
15min114872-148727.9038.073.247.988.153.20
215091-150918.0198.10
315946-159468.4738.55
415171-151718.0618.14
514549-145497.7317.81
615526-155268.2508.33
20min114911-149117.9237.943.898.058.063.85
215207-152078.0818.20
315564-155648.2708.40
415109-151098.0288.15
513851-138517.3607.48
615010-150107.9768.10
30min114316-143167.6077.711.917.777.871.94
214312-143127.6057.77
314893-148937.9148.09
414606-146067.7617.92
514175-141757.5327.69
614702-147027.8127.98
45min114052-140527.4677.633.377.687.843.31
214361-143617.6317.84
315020-150207.9818.20
414825-148257.8788.08
513774-137747.3197.52
614082-140827.4837.70
60min113650-136507.2537.393.757.507.643.69
214065-140657.4747.72
314787-147877.8578.12
413733-137337.2977.55
513232-132327.0317.28
614004-140047.4417.70
极限113916-139167.3957.563.387.697.853.33
214144-141447.5167.81
314985-149857.9638.27
414512-145127.7118.00
513602-136027.2287.51
614201-142017.5467.84
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%
111.001575341576071576701575141575851575820.04
211.051611381612161611770.04
单位质量响应值RSD%判断
14325.6414586.151.28数据可信
供试品溶液-2022091402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%
5min196822-9682255.32856.664.8055.3356.664.80
2106856-10685661.06261.06
3100225-10022557.27357.27
492834-9283453.04953.05
5101012-10101257.72257.72
697169-9716955.52655.53
10min1113021-11302164.58567.203.3464.8967.513.34
2124465-12446571.12471.46
3118867-11886767.92568.24
4116379-11637966.50466.80
5115170-11517065.81366.13
6117641-11764167.22567.53
15min1115260-11526065.86469.413.4466.5370.103.44
2127333-12733372.76373.50
3123988-12398870.85271.55
4121672-12167269.52870.19
5118690-11869067.82468.51
6121814-12181469.60970.29
20min1118124-11812467.50170.203.0068.5371.273.00
2128184-12818473.24974.39
3125662-12566271.80872.90
4122324-12232469.90170.95
5119926-11992668.53069.59
6122851-12285170.20271.27
30min1117428-11742867.10370.802.7468.5172.272.74
2126686-12668672.39373.94
3125260-12526071.57973.07
4125136-12513671.50872.95
5123057-12305770.32071.76
6125865-12586571.92473.38
45min1119399-11939968.22972.083.5170.0173.943.48
2130606-13060674.63376.58
3129699-12969974.11576.00
4129231-12923173.84875.68
5123630-12363070.64772.48
6124254-12425471.00472.86
60min1120385-12038568.79372.603.6170.9574.863.58
2130679-13067974.67577.04
3132126-13212675.50277.80
4127300-12730072.74474.99
5122844-12284470.19872.42
6128944-12894473.68475.94
极限1152305-15230587.03390.702.5489.5793.362.55
2161713-16171392.40995.19
3163157-16315793.23495.95
4160182-16018291.53494.18
5155718-15571888.98391.60
6159280-15928091.01993.68
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DJ333-221017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(%)99.67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%
19.851665911669651679331685011683951676770.52
29.911693251706591699920.56
单位质量响应值RSD%判断
17023.0517153.580.55数据可信
供试品溶液-2022091402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%
5min112143-121436.3746.146.386.376.146.36
211279-112795.9215.92
311282-112825.9225.92
412674-126746.6536.65
510648-106485.5905.59
612123-121236.3646.36
10min115064-150647.9087.991.507.948.031.51
215169-151697.9638.00
315137-151377.9467.98
415562-155628.1698.21
515444-154448.1078.14
614981-149817.8647.90
15min115284-152848.0237.981.348.108.061.34
215060-150607.9067.98
314859-148597.8007.88
415286-152868.0248.11
515344-153448.0558.13
615388-153888.0788.16
20min115194-151947.9767.991.158.108.111.12
215063-150637.9078.03
315456-154568.1148.23
415345-153458.0558.18
515253-152538.0078.13
614988-149887.8687.99
30min114892-148927.8177.701.117.997.861.10
214559-145597.6437.81
314424-144247.5727.74
414724-147247.7297.90
514734-147347.7357.90
614620-146207.6757.84
45min114638-146387.6847.641.357.907.851.35
214396-143967.5577.76
314300-143007.5077.71
414536-145367.6317.85
514577-145777.6527.86
614861-148617.8018.01
60min115003-150037.8767.603.898.137.853.82
214057-140577.3797.63
313554-135547.1157.36
414874-148747.8088.07
514804-148047.7718.02
614594-145947.6617.91
极限114896-148967.8207.721.938.128.011.89
214360-143607.5387.83
314344-143447.5307.82
414742-147427.7398.04
515027-150277.8888.18
614811-148117.7758.07
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%
111.001587761596641602671606841607131600210.51
211.051623971630281627120.28
单位质量响应值RSD%判断
14547.3614725.070.86数据可信
供试品溶液-2022091402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%
5min195040-9504053.63854.824.7253.6454.824.73
294441-9444153.30053.30
398632-9863255.66555.67
4100240-10024056.57356.57
590830-9083051.26251.26
6103594-10359458.46658.47
10min1110722-11072262.48965.273.3762.7965.573.37
2116933-11693365.99466.29
3117159-11715966.12266.43
4112715-11271563.61363.93
5114526-11452664.63664.92
6121800-12180068.74169.07
15min1116060-11606065.50167.494.2766.1568.164.26
2118359-11835966.79967.46
3120642-12064268.08768.76
4115222-11522265.02865.70
5117970-11797066.57967.22
6129240-12924072.94073.65
20min1116412-11641265.70068.865.0366.7169.905.01
2120962-12096268.26869.30
3125378-12537870.76071.81
4117907-11790766.54467.57
5118634-11863466.95467.97
6132793-13279374.94576.06
30min1115844-11584465.37968.354.4966.7569.784.48
2120288-12028867.88769.30
3121907-12190768.80170.25
4117089-11708966.08267.48
5120328-12032867.91069.30
6131206-13120674.04975.58
45min1123925-12392569.94070.635.5671.6872.435.52
2122773-12277369.29071.08
3123354-12335469.61871.45
4119689-11968967.54969.32
5122084-12208468.90170.66
6139013-13901378.45580.40
60min1125937-12593771.07671.966.0473.2074.155.96
2124017-12401769.99272.17
3119150-11915067.24569.46
4126650-12665071.47873.62
5127217-12721771.79873.94
6142032-14203280.15982.53
极限1154080-15408086.95989.422.1489.4892.022.19
2157612-15761288.95291.52
3156826-15682688.50991.10
4158132-15813289.24691.78
5159803-15980390.18992.73
6164194-16419492.66795.49
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