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对照品来源自制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%
111.051845731845961845631847031843491845570.07
211.121842601857951850280.59
单位质量响应值RSD%判断
16701.9916639.210.27数据可信
供试品溶液-2024011621批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19660-96605.1985.0610.355.205.0610.31
27889-78894.2454.25
38704-87044.6844.68
49730-97305.2365.24
510674-106745.7445.74
69813-98135.2805.28
10min115231-152318.1968.394.768.228.424.75
215078-150788.1138.14
314887-148878.0118.04
416933-169339.1129.14
515829-158298.5178.55
615585-155858.3868.42
15min117822-178229.5909.283.619.669.353.55
218105-181059.7429.81
316474-164748.8658.94
416863-168639.0749.15
517264-172649.2909.37
616893-168939.0909.17
20min118081-180819.7299.583.869.869.703.82
218884-1888410.16110.28
316883-168839.0859.20
417301-173019.3109.44
517904-179049.6349.76
617729-177299.5409.67
30min117240-172409.2779.292.019.469.471.97
217724-177249.5379.72
317254-172549.2849.45
417104-171049.2049.39
517561-175619.4499.63
616738-167389.0079.19
45min117220-172209.2669.252.879.509.482.82
218041-180419.7089.94
316866-168669.0759.30
416870-168709.0789.31
517437-174379.3839.62
616718-167188.9969.23
60min116702-167028.9879.162.479.279.442.42
217649-176499.4979.78
316873-168739.0799.35
417010-170109.1539.44
517381-173819.3539.64
616540-165408.9009.18
极限116825-168259.0539.192.699.399.522.63
217761-177619.5579.90
317183-171839.2469.57
416911-169119.1009.43
517355-173559.3399.68
616443-164438.8489.18
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%
111.043125153127443128933130413128123128010.07
211.023130773151543141160.47
单位质量响应值RSD%判断
28333.4228504.170.43数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148201-4820114.01013.5926.3214.0113.6026.32
227379-273797.9587.96
349837-4983714.48514.49
438147-3814711.08811.09
561641-6164117.91617.92
655390-5539016.09916.10
10min1140917-14091740.95835.7221.2941.0435.7921.30
286434-8643425.12325.17
3119062-11906234.60634.69
4100531-10053129.22029.28
5156586-15658645.51345.61
6133731-13373138.87038.96
15min1193520-19352056.24850.0317.0456.5550.3017.07
2129840-12984037.73937.92
3167169-16716948.58948.86
4146928-14692842.70542.93
5204328-20432859.38959.74
6190983-19098355.51055.82
20min1220775-22077564.16958.3613.7164.7958.9213.76
2156888-15688845.60045.99
3200543-20054358.28958.83
4181937-18193752.88153.34
5231668-23166867.33668.02
6213000-21300061.91062.52
30min1239891-23989169.72667.6210.8570.7068.4910.89
2182264-18226452.97653.62
3237481-23748169.02569.89
4243593-24359370.80271.56
5252363-25236373.35174.41
6240227-24022769.82370.78
45min1265226-26522677.08973.078.2878.4574.338.38
2215086-21508662.51663.46
3256911-25691174.67375.92
4240826-24082669.99771.15
5273234-27323479.41780.88
6257199-25719974.75676.10
60min1265193-26519377.08075.357.0778.8777.017.19
2225068-22506865.41766.71
3267388-26738877.71879.38
4254822-25482274.06575.60
5278177-27817780.85482.76
6264828-26482876.97478.73
极限1277153-27715380.55680.821.7082.7782.891.90
2271242-27124278.83880.49
3280105-28010581.41483.51
4278537-27853780.95882.91
5285453-28545382.96885.32
6275833-27583380.17282.36
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对照品来源自制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%
111.051835791833211835861836021836081835390.07
211.121835811836961836380.05
单位质量响应值RSD%判断
16609.8616514.210.41数据可信
供试品溶液-2024011621批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17579-75794.1054.168.254.104.168.24
26865-68653.7183.72
37428-74284.0234.02
47897-78974.2774.28
58774-87744.7524.75
67529-75294.0784.08
10min115431-154318.3588.126.148.388.146.10
213418-134187.2677.29
315986-159868.6588.68
414841-148418.0388.06
514642-146427.9307.96
615642-156428.4728.49
15min117567-175679.5159.273.049.589.343.03
216665-166659.0269.09
317278-172789.3589.43
416881-168819.1439.21
516502-165028.9389.01
617813-178139.6489.72
20min117801-178019.6419.461.899.769.581.87
217238-172389.3369.45
317939-179399.7169.84
417126-171269.2769.40
517291-172919.3659.49
617381-173819.4149.54
30min117706-177069.5909.342.749.779.522.66
217660-176609.5659.73
317283-172839.3619.54
417294-172949.3679.54
517182-171829.3069.48
616396-163968.8809.06
45min117046-170469.2339.252.929.469.482.82
217883-178839.6869.90
316789-167899.0939.32
417243-172439.3399.56
517157-171579.2939.52
616392-163928.8789.10
60min116877-168779.1419.172.449.429.452.37
217628-176289.5489.82
317018-170189.2179.50
416970-169709.1919.47
516787-167879.0929.37
616355-163558.8589.13
极限116677-166779.0339.042.509.369.362.44
217010-170109.2139.54
316638-166389.0129.34
417087-170879.2559.58
516760-167609.0789.40
615915-159158.6208.94
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%
111.043100323101193106893103013103593103000.09
211.023105723105203105460.02
单位质量响应值RSD%判断
28106.8828180.220.19数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164918-6491819.05312.7132.5119.0512.7032.52
230604-306048.9828.98
340626-4062611.92411.92
449843-4984314.62914.63
547567-4756713.96113.96
626174-261747.6827.68
10min1153827-15382745.14835.1223.0945.2535.1923.11
2111841-11184132.82532.87
3117574-11757434.50734.57
4142234-14223441.74541.83
5118414-11841434.75434.83
674130-7413021.75721.80
15min1197410-19741057.93949.3117.9158.3049.5817.95
2166942-16694248.99749.23
3168989-16898949.59849.86
4192283-19228356.43456.75
5169748-16974849.82050.09
6112641-11264133.06033.22
20min1225426-22542666.16258.6414.9366.8459.1814.98
2202597-20259759.46159.97
3203618-20361859.76160.29
4221706-22170665.07065.70
5202930-20293059.55960.11
6142571-14257141.84442.19
30min1255550-25555075.00368.4110.1076.0569.2810.21
2236004-23600469.26670.10
3234572-23457268.84669.71
4247566-24756672.66073.65
5236871-23687169.52170.40
6188027-18802755.18555.76
45min1271945-27194579.81576.415.5881.2877.665.74
2263811-26381177.42778.65
3259087-25908776.04177.29
4269565-26956579.11680.51
5265481-26548177.91879.18
6232166-23216668.14069.03
60min1279660-27966082.07979.363.7083.9981.033.89
2270732-27073279.45981.11
3273856-27385680.37682.05
4274361-27436180.52482.36
5272864-27286480.08481.78
6250932-25093273.64774.91
极限1285821-28582183.88782.961.2586.2585.071.47
2279704-27970482.09284.18
3282356-28235682.87084.99
4286982-28698284.22886.51
5283379-28337983.17185.31
6277778-27777881.52783.20
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对照品来源自制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%
111.051840431841861843791845191845681843390.13
211.121846291858671852480.48
单位质量响应值RSD%判断
16682.2616658.990.10数据可信
供试品溶液-2024011821批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111325-113256.0946.326.896.096.326.87
211949-119496.4306.43
311243-112436.0506.05
411571-115716.2266.23
513273-132737.1427.14
611086-110865.9655.97
10min115703-157038.4508.876.008.488.906.00
216975-169759.1349.17
317130-171309.2179.25
415346-153468.2588.29
517869-178699.6159.65
615850-158508.5298.56
15min118971-1897110.2089.693.8510.299.773.82
217762-177629.5589.64
317835-178359.5979.68
417048-170489.1739.25
517755-177559.5549.65
618633-1863310.02610.11
20min117886-178869.6249.422.669.769.562.66
217625-176259.4849.62
317682-176829.5159.65
417264-172649.2909.42
517897-178979.6309.78
616681-166818.9769.11
30min117535-175359.4359.351.299.639.541.32
217597-175979.4699.66
317247-172479.2809.47
417332-173329.3269.51
517538-175389.4379.64
617013-170139.1559.34
45min117333-173339.3279.231.259.579.471.26
217186-171869.2489.49
317172-171729.2409.48
417056-170569.1789.41
517375-173759.3499.60
616783-167839.0319.27
60min117033-170339.1659.062.109.469.362.06
217365-173659.3449.64
316764-167649.0219.31
416877-168779.0819.37
516725-167259.0009.30
616301-163018.7719.06
极限116801-168019.0408.852.699.399.192.57
215647-156478.4208.77
316559-165598.9109.25
416861-168619.0739.41
516478-164788.8679.22
616285-162858.7639.10
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%
111.043108013108003111993114093114663111350.11
211.023126803144693135740.41
单位质量响应值RSD%判断
28182.5228454.990.69数据可信
供试品溶液-2024011821批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132582-325829.50416.4651.179.5016.4651.15
289629-8962926.14426.14
395595-9559527.88427.88
439927-3992711.64611.65
530946-309469.0279.03
649940-4994014.56714.57
10min180495-8049523.47936.4625.4723.5336.5525.52
2161736-16173647.17647.32
3158634-15863446.27146.43
4101721-10172129.67129.74
5118311-11831134.51034.56
6129008-12900837.63037.71
15min1122406-12240635.70448.8517.9235.8949.1418.00
2202727-20272759.13359.54
3195900-19590057.14157.55
4149004-14900443.46243.69
5161080-16108046.98547.23
6173694-17369450.66450.95
20min1153543-15354344.78656.3213.3545.1756.8813.46
2223069-22306965.06665.80
3216605-21660563.18163.91
4177680-17768051.82752.30
5188072-18807254.85855.36
6199433-19943358.17258.74
30min1191404-19140455.83065.288.8156.4666.168.97
2247044-24704472.05973.16
3238650-23865069.61170.69
4216319-21631963.09763.86
5218536-21853663.74464.55
6230789-23078967.31868.21
45min1229464-22946466.93272.654.9567.8773.885.16
2263423-26342376.83778.33
3260048-26004875.85277.32
4242976-24297670.87371.98
5246864-24686472.00773.17
6251548-25154873.37374.64
60min1252072-25207273.52676.503.3174.8478.153.51
2277002-27700280.79882.72
3267067-26706777.90079.79
4260411-26041175.95877.46
5258182-25818275.30876.87
6258950-25895075.53277.21
极限1275972-27597280.49780.041.3082.2282.101.20
2271165-27116579.09581.47
3275505-27550580.36182.68
4279635-27963581.56683.49
5269719-26971978.67380.65
6274338-27433880.02182.12
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对照品来源自制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%
111.051838011848301852371853821858181850140.42
211.121867201874371870780.28
单位质量响应值RSD%判断
16743.3516823.560.34数据可信
供试品溶液-2024011821批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111065-110655.9145.7515.945.915.7515.96
211736-117366.2736.27
37453-74533.9833.98
410608-106085.6705.67
511488-114886.1406.14
612231-122316.5376.54
10min114389-143897.6918.575.867.728.605.87
216852-168529.0079.04
315955-159558.5288.55
415730-157308.4078.44
516332-163328.7298.76
616954-169549.0629.10
15min116267-162678.6949.293.738.779.373.75
217720-177209.4719.56
317256-172569.2239.29
417884-178849.5599.64
517132-171329.1579.24
618017-180179.6309.72
20min116903-169039.0349.202.219.169.332.22
217781-177819.5049.64
316876-168769.0209.14
417557-175579.3849.52
517230-172309.2099.34
616955-169559.0629.20
30min116788-167888.9739.031.189.159.211.21
216980-169809.0759.27
316627-166278.8879.06
417162-171629.1739.36
517020-170209.0979.28
616750-167508.9529.14
45min117023-170239.0988.921.839.329.151.77
216820-168208.9909.23
316307-163078.7168.94
417000-170009.0869.32
516470-164708.8039.04
616481-164818.8099.05
60min116480-164808.8088.743.079.089.023.07
216754-167548.9559.25
315389-153898.2258.49
416729-167298.9419.23
516420-164208.7769.06
616320-163208.7239.01
极限116591-165918.8678.564.409.198.894.28
216560-165608.8519.19
314764-147647.8918.21
416484-164848.8109.14
515931-159318.5158.85
615773-157738.4308.77
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100590-202005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%
111.043116083126723131403138143141033130670.32
211.023152393164133158260.27
单位质量响应值RSD%判断
28357.5228659.350.75数据可信
供试品溶液-2024011821批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133990-339909.84913.4745.149.8513.4645.14
248894-4889414.16714.17
387566-8756625.37225.37
439454-3945411.43211.43
531974-319749.2649.26
636967-3696710.71110.71
10min1101446-10144629.39432.6121.4229.4532.6921.47
2120877-12087735.02435.10
3155634-15563445.09445.24
496992-9699228.10328.17
5112633-11263332.63532.69
687780-8778025.43425.49
15min1154041-15404144.63346.949.7444.8547.209.83
2166603-16660348.27348.55
3188982-18898254.75755.15
4145578-14557842.18142.40
5166674-16667448.29348.53
6150149-15014943.50543.71
20min1188754-18875454.69155.217.3855.1655.737.45
2195827-19582756.74057.28
3208252-20825260.34061.04
4169438-16943849.09449.55
5200460-20046058.08358.58
6180600-18060052.32852.77
30min1219377-21937763.56463.655.5764.3364.475.64
2216931-21693162.85563.71
3233940-23394067.78368.81
4200785-20078558.17758.90
5232191-23219167.27768.10
6214783-21478362.23362.97
45min1244086-24408670.72370.443.3771.8571.623.45
2240826-24082669.77970.98
3251562-25156272.88974.30
4229104-22910466.38267.43
5250923-25092372.70473.90
6242251-24225170.19171.27
60min1252710-25271073.22273.202.5674.7474.772.58
2250411-25041172.55674.15
3253103-25310373.33675.15
4242508-24250870.26671.68
5262407-26240776.03277.63
6254712-25471273.80275.27
极限1263101-26310176.23377.392.5578.1679.372.64
2264672-26467276.68878.68
3280728-28072881.34083.56
4262943-26294376.18778.00
5264709-26470976.69978.72
6266491-26649177.21579.09
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DJ333-221017对照品来源自制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%
111.051838361836331836161831421835881835630.14
211.121857341852041854690.21
单位质量响应值RSD%判断
16612.0416678.870.29数据可信
供试品溶液-2024012021批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113299-132997.1676.934.337.176.934.33
213151-131517.0877.09
312732-127326.8616.86
412657-126576.8216.82
513417-134177.2317.23
611911-119116.4196.42
10min116872-168729.0928.793.249.138.833.22
216780-167809.0439.08
316090-160908.6718.71
416001-160018.6238.66
516585-165858.9388.98
615512-155128.3608.40
15min117997-179979.6999.463.539.799.553.53
217454-174549.4069.50
317885-178859.6389.72
417126-171269.2299.32
518252-182529.8369.93
616591-165918.9419.02
20min117858-178589.6249.542.039.779.682.05
217724-177249.5529.69
318009-180099.7059.84
417730-177309.5559.69
517882-178829.6379.78
617001-170019.1629.29
30min117556-175569.4619.462.159.669.652.17
217543-175439.4549.65
317750-177509.5669.76
417403-174039.3799.57
518080-180809.7439.94
616943-169439.1319.31
45min117551-175519.4589.292.219.719.542.22
217522-175229.4439.69
317114-171149.2239.47
417292-172929.3199.56
517457-174579.4089.66
616549-165498.9189.15
60min117117-171179.2249.323.069.539.622.93
216974-169749.1479.45
316797-167979.0529.35
416992-169929.1579.45
517671-176719.5239.83
618176-181769.79510.08
极限118557-1855710.0009.185.2310.359.535.07
217158-171589.2479.60
316060-160608.6559.00
417159-171599.2479.59
517052-170529.1899.55
616219-162198.7419.08
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%
111.043102263101823102733098883101663101470.05
211.023137273129993133630.17
单位质量响应值RSD%判断
28093.0328435.840.86数据可信
供试品溶液-2024012021批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198144-9814428.68317.5237.5128.6817.5237.51
276529-7652922.36622.37
344624-4462413.04113.04
448088-4808814.05414.05
541972-4197212.26612.27
650247-5024714.68514.68
10min1155698-15569845.50338.9014.2145.6639.0014.25
2146401-14640142.78642.91
3136006-13600639.74839.82
4127199-12719937.17437.25
5100593-10059329.39829.47
6132700-13270038.78238.86
15min1197868-19786857.82752.249.6758.2452.569.72
2186538-18653854.51654.88
3188687-18868755.14455.44
4173383-17338350.67150.96
5148103-14810343.28343.51
6177966-17796652.01152.31
20min1217927-21792763.68960.437.6764.4261.047.72
2217138-21713863.45964.12
3215375-21537562.94463.54
4207318-20731860.58961.15
5175949-17594951.42151.89
6207030-20703060.50561.09
30min1238778-23877869.78368.674.8070.8769.614.87
2243105-24310571.04872.07
3245039-24503971.61372.56
4234141-23414168.42869.33
5213729-21372962.46263.22
6234961-23496168.66869.59
45min1263265-26326576.93974.973.3578.4176.293.45
2263153-26315376.90778.32
3262664-26266476.76478.11
4256180-25618074.86976.15
5241587-24158770.60471.71
6252290-25229073.73275.04
60min1268639-26863978.51077.671.3980.4179.401.49
2266027-26602777.74779.59
3270475-27047579.04780.82
4266360-26636077.84479.54
5261186-26118676.33277.83
6261824-26182476.51878.23
极限1272211-27221179.55479.540.8581.8981.700.89
2276142-27614280.70382.97
3270070-27007078.92881.14
4272885-27288579.75181.88
5271739-27173979.41681.34
6269875-26987578.87181.01
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对照品来源自制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%
111.051850081843511843411844101839811844180.21
211.121850781849091849940.07
单位质量响应值RSD%判断
16689.4116636.150.23数据可信
供试品溶液-2024012021批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111254-112546.0596.0514.916.066.0514.89
213178-131787.0947.09
38625-86254.6434.64
49966-99665.3655.37
512170-121706.5526.55
612206-122066.5716.57
10min115149-151498.1558.586.708.198.616.67
217263-172639.2939.33
315238-152388.2038.23
417194-171949.2569.29
514824-148247.9808.02
615942-159428.5828.62
15min116959-169599.1309.122.909.219.202.93
217647-176479.5009.59
316418-164188.8398.91
417169-171699.2439.32
516344-163448.7998.88
617102-171029.2079.29
20min117280-172809.3039.261.509.439.391.53
217475-174759.4089.55
316783-167839.0359.16
417146-171469.2309.36
517068-170689.1889.32
617427-174279.3829.52
30min117214-172149.2679.222.379.459.412.40
217367-173679.3499.55
316409-164098.8349.00
417041-170419.1749.36
517610-176109.4809.66
617159-171599.2379.42
45min116783-167839.0358.982.369.279.222.37
217118-171189.2159.46
315949-159498.5868.81
416875-168759.0859.32
516674-166748.9769.21
616684-166848.9829.22
60min116693-166938.9878.813.639.279.093.60
216767-167679.0269.33
315286-152868.2298.50
416029-160298.6298.91
516695-166958.9889.27
616685-166858.9829.27
极限116677-166778.9788.823.179.319.153.14
216602-166028.9389.29
315428-154288.3068.62
416225-162258.7359.07
516907-169079.1029.43
616430-164308.8459.18
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%
111.043105803109313118253118223104943111300.22
211.023131803127453129620.10
单位质量响应值RSD%判断
28182.0728399.460.55数据可信
供试品溶液-2024012021批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150906-5090614.86316.9541.7814.8616.9541.78
217609-176095.1415.14
387299-8729925.48925.49
477625-7762522.66422.66
560082-6008217.54217.54
654778-5477815.99415.99
10min1122465-12246535.75636.1328.4835.8436.2228.51
256049-5604916.36516.39
3147690-14769043.12143.26
4154231-15423145.03145.16
5128358-12835837.47737.57
6133609-13360939.01039.10
15min1174025-17402550.81149.7714.7451.0950.0614.84
2119944-11994435.02035.14
3183435-18343553.55853.94
4186721-18672154.51754.89
5178450-17845052.10252.41
6180196-18019652.61252.92
20min1203574-20357459.43859.029.1960.0059.599.32
2164932-16493248.15648.47
3213946-21394662.46663.15
4209705-20970561.22861.91
5212309-21230961.98862.58
6208363-20836360.83661.43
30min1235215-23521568.67668.935.5069.5769.835.65
2211656-21165661.79862.38
3247050-24705072.13273.16
4237558-23755869.36070.38
5246945-24694572.10173.04
6238126-23812669.52670.46
45min1254827-25482774.40274.712.9975.6876.003.13
2245339-24533971.63272.56
3269014-26901478.54579.97
4253599-25359974.04475.45
5255482-25548274.59475.93
6257104-25710475.06776.39
60min1265379-26537977.48378.042.5279.1779.742.58
2261856-26185676.45577.78
3277103-27710380.90682.77
4258586-25858675.50077.32
5269857-26985778.79180.55
6270949-27094979.11080.85
极限1276956-27695680.86481.041.5482.9883.171.67
2272250-27225079.49081.24
3283209-28320982.68985.00
4273501-27350179.85582.09
5281161-28116182.09184.28
6278228-27822881.23583.41
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