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%
111.181846121846911849441847101851811848280.13
211.181848411860071854240.45
单位质量响应值RSD%判断
16532.0216585.330.23数据可信
供试品溶液-2024011223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%
5min110722-107225.8085.2913.035.815.2913.04
27439-74394.0304.03
310738-107385.8175.82
49733-97335.2735.27
59399-93995.0925.09
610600-106005.7425.74
10min115694-156948.5028.017.458.538.047.47
213363-133637.2397.26
316186-161868.7688.80
413702-137027.4237.45
514701-147017.9647.99
615052-150528.1548.19
15min116155-161558.7528.623.298.838.703.34
215624-156248.4648.53
316699-166999.0469.13
415143-151438.2038.27
515853-158538.5888.66
616013-160138.6758.75
20min116001-160018.6688.493.088.808.613.11
215713-157138.5128.62
316366-163668.8669.00
415253-152538.2638.38
515048-150488.1528.27
615615-156158.4598.58
30min115976-159768.6558.532.538.838.702.56
215933-159338.6318.79
316330-163308.8469.03
415398-153988.3428.50
515292-152928.2848.45
615551-155518.4248.60
45min115883-158838.6048.402.948.838.612.91
215828-158288.5748.78
315735-157358.5248.75
415302-153028.2908.50
514676-146767.9508.16
615584-155848.4428.66
60min115371-153718.3278.261.648.608.521.62
215609-156098.4568.71
315417-154178.3528.63
415049-150498.1528.41
515032-150328.1438.40
615022-150228.1388.40
极限114996-149968.1248.262.748.448.572.71
215561-155618.4308.73
315918-159188.6238.95
414797-147978.0168.32
515013-150138.1338.43
615210-152108.2408.55
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%
110.871560661561411562151561211562621561610.05
210.931563051573011568030.45
单位质量响应值RSD%判断
14366.2414346.110.10数据可信
供试品溶液-2024011223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%
5min173228-7322842.13346.8525.3242.1346.8425.32
245223-4522326.02026.02
3103678-10367859.65259.65
481191-8119146.71446.71
591949-9194952.90452.90
693256-9325653.65653.66
10min1107401-10740161.79566.7823.9662.0367.0423.96
263958-6395836.79936.94
3137165-13716578.92079.25
4121017-12101769.62969.89
5133419-13341976.76477.06
6133481-13348176.80077.10
15min1122761-12276170.63275.5822.0371.2176.2122.03
276357-7635743.93344.28
3139930-13993080.51081.28
4149435-14943585.97986.63
5148746-14874685.58386.30
6150907-15090786.82687.55
20min1137563-13756379.14979.3619.8980.1280.4119.92
284031-8403148.34848.94
3142178-14217881.80483.02
4156291-15629189.92491.05
5153540-15354088.34189.54
6153935-15393588.56889.78
30min1151869-15186987.38085.0615.7288.7986.5615.80
2102831-10283159.16560.03
3145598-14559883.77285.44
4162999-16299993.78495.41
5158075-15807590.95092.64
6165684-16568495.32897.03
45min1162577-16257793.54189.6910.0795.4491.6510.21
2128770-12877074.08975.28
3145738-14573883.85285.99
4165819-16581995.40697.55
5161962-16196293.18795.38
6170421-17042198.054100.28
60min1162571-16257193.53791.497.1895.9593.957.35
2142595-14259582.04483.65
3147134-14713484.65587.26
4166466-16646695.77898.45
5164307-16430794.53697.25
6170993-17099398.383101.16
极限1166937-16693796.04996.821.2198.9899.791.15
2169788-16978897.69099.75
3168959-16895997.213100.29
4165093-16509394.98898.20
5168165-16816596.75699.99
6170727-17072798.230101.55
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%
111.181847821846671846561847571847311847190.03
211.181878581886591882580.31
单位质量响应值RSD%判断
16522.2716838.821.35数据可信
供试品溶液-2024011223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%
5min19932-99325.3425.4012.795.345.4012.82
29323-93235.0145.01
311520-115206.1966.20
410355-103555.5695.57
511127-111275.9845.98
67983-79834.2934.29
10min115475-154758.3238.2310.338.358.2610.34
215072-150728.1068.13
316361-163618.7998.83
414674-146747.8927.92
517431-174319.3759.41
612783-127836.8756.90
15min116612-166128.9348.805.239.018.885.27
215691-156918.4398.51
317007-170079.1479.23
416598-165988.9279.00
517255-172559.2809.37
614992-149928.0638.13
20min116598-165988.9278.783.579.058.903.63
215832-158328.5158.63
316818-168189.0459.18
416303-163038.7688.89
516929-169299.1059.24
615450-154508.3098.42
30min115840-158408.5198.721.758.698.891.80
215991-159918.6008.77
316595-165958.9259.11
416190-161908.7078.88
516459-164598.8529.04
616156-161568.6898.84
45min116051-160518.6338.552.878.858.772.88
216129-161298.6748.89
315958-159588.5838.82
416139-161398.6808.90
516108-161088.6638.90
614976-149768.0548.26
60min115516-155168.3458.554.708.628.824.61
215659-156598.4228.68
315369-153698.2668.55
415849-158498.5248.79
517384-173849.3499.63
615597-155978.3888.63
极限114949-149498.0408.302.408.368.622.33
215125-151258.1358.44
315962-159628.5858.91
415635-156358.4098.73
515351-153518.2568.59
615596-155968.3888.68
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%
110.871560061559201558861559361559941559480.04
210.931581231587321584280.28
单位质量响应值RSD%判断
14346.6414494.780.73数据可信
供试品溶液-2024011223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%
5min161314-6131435.12140.6436.0135.1240.6436.01
273768-7376842.25442.25
3102699-10269958.82658.83
496395-9639555.21555.22
556742-5674232.50232.50
634823-3482319.94719.95
10min1108931-10893162.39665.4312.5662.5965.6612.64
2113659-11365965.10465.34
3131425-13142575.28175.61
4125122-12512271.67071.98
5116109-11610966.50866.69
690097-9009751.60851.72
15min1136923-13692378.43075.934.5278.9776.524.62
2132651-13265175.98376.58
3139302-13930279.79380.54
4135489-13548977.60878.31
5127325-12732572.93273.48
6123708-12370870.86071.26
20min1142242-14224281.47780.793.3282.4581.803.29
2145624-14562483.41484.43
3145212-14521283.17884.37
4135716-13571677.73878.87
5134844-13484477.23978.19
6142665-14266581.71982.51
30min1144522-14452282.78385.224.2784.2186.684.14
2155780-15578089.23190.71
3150154-15015486.00987.66
4140152-14015280.27981.85
5146090-14609083.68185.07
6155919-15591989.31190.56
45min1157527-15752790.23288.654.3292.1290.584.18
2163965-16396593.92095.90
3151073-15107386.53588.66
4144107-14410782.54584.56
5155315-15531588.96590.81
6156559-15655989.67791.42
60min1158910-15891091.02489.714.3193.4292.134.13
2162962-16296293.34595.84
3152067-15206787.10489.71
4145085-14508583.10585.58
5159647-15964791.44693.79
6160984-16098492.21294.45
极限1169585-16958597.13995.892.35100.0498.822.29
2160699-16069992.04995.07
3172489-17248998.802101.90
4167015-16701595.66798.60
5166481-16648195.36198.21
6168172-16817296.32999.08
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%
111.181872101868871864921863911861751866310.23
211.181887041894871890960.30
单位质量响应值RSD%判断
16693.2916913.770.93数据可信
供试品溶液-2024012021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%
5min110989-109895.8675.755.285.875.755.26
211543-115436.1626.16
310672-106725.6975.70
49850-98505.2585.26
511025-110255.8865.89
610561-105615.6385.64
10min114118-141187.5378.053.757.578.083.75
215890-158908.4838.52
315128-151288.0768.11
415119-151198.0718.10
515038-150388.0288.06
615177-151778.1028.13
15min115513-155138.2828.782.888.368.862.85
216481-164818.7988.88
316583-165838.8538.93
416775-167758.9559.03
516744-167448.9399.02
616618-166188.8728.95
20min116131-161318.6128.821.438.738.951.45
216422-164228.7678.90
316639-166398.8839.01
416676-166768.9039.03
516802-168028.9709.10
616497-164978.8078.93
30min116543-165438.8328.741.389.008.921.32
215975-159758.5288.71
316508-165088.8138.99
416544-165448.8329.01
516448-164488.7818.96
616262-162628.6828.86
45min116311-163118.7088.611.098.938.831.06
216110-161108.6008.83
315982-159828.5328.76
416362-163628.7358.96
515967-159678.5248.75
615997-159978.5408.76
60min115701-157018.3828.481.528.658.751.47
215678-156788.3708.64
316220-162208.6598.93
416150-161508.6228.89
515709-157098.3868.66
615869-158698.4728.74
极限115429-154298.2378.411.668.558.731.61
215511-155118.2818.60
315965-159658.5238.84
416116-161168.6048.92
515763-157638.4158.73
615770-157708.4198.74
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%
110.873121123117003111743110533108553113790.17
210.933155553165193160370.22
单位质量响应值RSD%判断
28645.7228914.640.67数据可信
供试品溶液-2024012021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%
5min1158486-15848645.48745.4534.5345.4945.4534.54
2218700-21870062.76962.77
377630-7763022.28122.28
4183158-18315852.56852.57
5110459-11045931.70331.70
6201763-20176357.90857.91
10min1229548-22954865.88265.0318.1266.1465.2818.18
2262159-26215975.24275.59
3154405-15440544.31644.44
4245556-24555670.47770.77
5206771-20677159.34559.52
6260960-26096074.89875.22
15min1257533-25753373.91472.9910.7074.5373.6010.80
2272943-27294378.33779.10
3202999-20299958.26358.63
4258536-25853674.20274.89
5253262-25326272.68973.19
6280608-28060880.53781.27
20min1279387-27938780.18776.538.1781.2277.558.27
2276893-27689379.47180.67
3226872-22687265.11465.81
4260023-26002374.62975.72
5268421-26842177.03977.95
6288353-28835382.76083.95
30min1298836-29883685.76981.115.8587.2482.565.91
2282839-28283981.17782.82
3258250-25825074.12075.18
4267850-26785076.87578.39
5290031-29003183.24284.58
6297859-29785985.48887.13
45min1311384-31138489.37085.915.0891.3287.815.14
2304119-30411987.28589.38
3284076-28407681.53283.00
4278333-27833379.88481.82
5301199-30119986.44788.25
6316911-31691190.95693.08
60min1318947-31894791.54188.634.5893.9991.004.60
2311314-31131489.35091.93
3301426-30142686.51288.43
4285362-28536281.90284.28
5310262-31026289.04891.33
6325557-32555793.43896.06
极限1326048-32604893.57996.281.6696.5499.141.49
2332136-33213695.32698.40
3339175-33917597.34699.75
4340822-34082297.819100.66
5338784-33878497.234100.01
6335700-33570096.34999.49
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%
111.181892251894951896481896741895861895260.10
211.181860091875321867700.58
单位质量响应值RSD%判断
16952.2416705.721.04数据可信
供试品溶液-2024012021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%
5min110229-102295.4535.879.385.455.879.41
212733-127336.7876.79
310168-101685.4205.42
411816-118166.2996.30
510563-105635.6315.63
610569-105695.6345.63
10min113561-135617.2297.886.677.267.926.65
216518-165188.8058.84
315061-150618.0288.06
414697-146977.8347.87
514287-142877.6167.65
614625-146257.7967.83
15min115577-155778.3038.502.698.378.572.75
216661-166618.8818.97
316251-162518.6638.74
415742-157428.3918.47
515816-158168.4318.50
615607-156078.3198.39
20min116502-165028.7968.601.788.918.731.78
216303-163038.6908.83
316235-162358.6548.78
415943-159438.4998.62
516179-161798.6248.74
615689-156898.3638.48
30min116257-162578.6668.531.818.838.701.82
216445-164458.7668.95
315882-158828.4668.64
415895-158958.4738.65
515750-157508.3968.56
615743-157438.3928.56
45min116208-162088.6408.322.568.858.542.52
215916-159168.4848.72
315571-155718.3008.52
415413-154138.2168.44
515062-150628.0298.24
615525-155258.2768.49
60min116100-161008.5828.262.588.848.532.52
215816-158168.4318.71
315300-153008.1568.42
415132-151328.0668.33
515103-151038.0518.31
615547-155478.2878.55
极限116251-162518.6638.193.138.978.513.00
215514-155148.2708.60
314983-149837.9878.30
415037-150378.0168.33
515066-150668.0318.34
615372-153728.1948.50
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%
110.873167023168393180143166823175153171500.19
210.933113403135533124460.51
单位质量响应值RSD%判断
29176.6328586.091.45数据可信
供试品溶液-2024012021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%
5min1145844-14584441.71536.8931.1941.7236.8931.19
2157505-15750545.05145.05
393716-9371626.80526.81
489687-8968725.65325.65
5100083-10008328.62628.63
6187035-18703553.49753.50
10min1231971-23197166.35064.5017.1766.5864.7017.21
2268954-26895476.92877.18
3220760-22076063.14363.29
4176600-17660050.51250.65
5187724-18772453.69453.85
6266983-26698376.36476.66
15min1265790-26579076.02372.3613.5076.6272.9213.56
2286301-28630181.89082.57
3249522-24952271.37071.87
4207305-20730559.29559.72
5219472-21947262.77563.23
6289429-28942982.78583.51
20min1281185-28118580.42777.3711.6781.4578.3411.75
2298603-29860385.40986.54
3266786-26678676.30877.20
4230317-23031765.87766.63
5238215-23821568.13668.94
6307977-30797788.09089.27
30min1294917-29491784.35484.338.6585.8285.728.77
2325632-32563293.14094.75
3281390-28139080.48581.81
4274410-27441078.48979.61
5267113-26711376.40277.59
6325441-32544193.08594.76
45min1310374-31037488.77688.276.9290.7190.137.03
2331750-33175094.89097.01
3301336-30133686.19087.96
4301122-30112286.12987.68
5275435-27543578.78280.39
6331558-33155894.83597.02
60min1321475-32147591.95190.246.3194.3892.596.43
2333118-33311895.28197.93
3306737-30673787.73589.98
4309533-30953388.53590.57
5283860-28386081.19283.24
6338207-33820796.73799.45
极限1343420-34342098.22896.701.10101.1799.551.28
2336113-33611396.13899.32
3339164-33916497.01099.74
4333945-33394595.51798.04
5334882-33488295.78598.28
6340884-34088497.502100.75
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