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%
111.181849601849981852331852901851041851170.08
211.181845371846721846040.06
单位质量响应值RSD%判断
16557.8716511.990.20数据可信
供试品溶液-2024011621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%
5min18766-87664.7565.3312.404.765.3312.40
28237-82374.4694.47
310558-105585.7285.73
49286-92865.0385.04
510981-109815.9575.96
611093-110936.0186.02
10min113739-137397.4548.276.747.488.306.76
214476-144767.8537.88
315361-153618.3338.37
415844-158448.5958.62
516667-166679.0429.08
615378-153788.3438.38
15min115751-157518.5458.854.648.618.924.64
216098-160988.7338.80
315604-156048.4658.54
416761-167619.0939.17
517621-176219.5609.64
616032-160328.6978.78
20min116300-163008.8438.952.458.969.082.47
216596-165969.0039.12
316055-160558.7108.84
416480-164808.9419.07
517235-172359.3509.49
616341-163418.8658.99
30min115269-152698.2848.582.958.458.762.86
216260-162608.8218.99
316273-162738.8289.00
415910-159108.6318.81
515226-152268.2608.45
615967-159678.6628.84
45min116015-160158.6888.571.368.908.801.24
215901-159018.6268.84
315698-156988.5168.74
415968-159688.6638.89
515434-154348.3738.61
615797-157978.5708.80
60min115696-156968.5158.500.638.778.780.62
215601-156018.4648.73
315665-156658.4988.77
415608-156088.4678.74
515628-156288.4788.76
615862-158628.6058.88
极限115573-155738.4488.421.528.758.741.44
215402-154028.3568.67
315575-155758.4508.77
415883-158838.6178.94
515169-151698.2298.56
615488-154888.4028.72
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%
110.873129503136773137443137993132953134930.12
210.933120593129913125250.22
单位质量响应值RSD%判断
28840.2028593.320.61数据可信
供试品溶液-2024011621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%
5min1154738-15473844.50946.2919.6544.5146.2919.66
2106604-10660430.66430.66
3177649-17764951.09951.10
4198322-19832257.04657.05
5176524-17652450.77650.78
6151656-15165643.62343.62
10min1264679-26467976.13369.3211.5476.3869.5811.55
2197623-19762356.84557.02
3259854-25985474.74575.03
4246422-24642270.88171.20
5261334-26133475.17175.45
6216032-21603262.14062.38
15min1289583-28958383.29675.707.9483.9776.347.97
2235089-23508967.62268.11
3279471-27947180.38881.09
4260905-26090575.04775.76
5270184-27018477.71678.42
6243795-24379570.12670.71
20min1301116-30111686.61478.706.8187.7579.766.83
2253028-25302872.78273.64
3288994-28899483.12784.27
4264280-26428076.01877.15
5275583-27558379.26980.40
6258549-25854974.37075.35
30min1257641-25764174.10882.196.0375.7283.695.91
2276133-27613379.42880.69
3282411-28241181.23382.84
4295895-29589585.11286.66
5298927-29892785.98487.56
6303460-30346087.28888.68
45min1267578-26757876.96784.116.2678.9986.066.14
2281740-28174081.04082.75
3280155-28015580.58482.64
4304434-30443487.56889.59
5312907-31290790.00592.05
6307560-30756088.46790.34
60min1266845-26684576.75684.676.9379.2187.106.77
2287319-28731982.64584.80
3278901-27890180.22482.73
4300531-30053186.44588.95
5320333-32033392.14194.69
6312322-31232289.83792.20
极限1335987-33598796.64496.930.9999.5299.820.98
2336591-33659196.81899.43
3331841-33184195.45198.40
4341420-34142098.207101.20
5336411-33641196.76699.83
6339660-33966097.701100.57
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%
111.181864381871971880111880831877381874930.37
211.181862091866921864500.19
单位质量响应值RSD%判断
16770.3916677.100.40数据可信
供试品溶液-2024011621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%
5min19808-98085.2615.526.095.265.526.08
211525-115256.1826.18
310227-102275.4865.49
410234-102345.4895.49
59991-99915.3595.36
69964-99645.3455.34
10min114751-147517.9128.107.637.948.137.62
216634-166348.9228.96
316186-161868.6828.71
413800-138007.4027.43
513974-139747.4957.53
615236-152368.1728.20
15min115943-159438.5528.685.128.628.755.10
217209-172099.2319.31
316929-169299.0809.16
415201-152018.1548.23
515334-153348.2258.30
616445-164458.8218.90
20min116506-165068.8548.713.728.978.843.71
216717-167178.9679.10
316622-166228.9169.04
415746-157468.4468.56
515248-152488.1798.30
616622-166228.9169.04
30min115789-157898.4698.602.418.648.772.34
216056-160568.6128.80
315502-155028.3158.49
416005-160058.5858.75
516660-166608.9369.10
616136-161368.6558.83
45min116035-160358.6018.682.388.828.902.32
216670-166708.9429.17
315798-157988.4748.70
415764-157648.4568.67
516574-165748.8909.10
616199-161998.6898.91
60min116290-162908.7388.611.909.008.881.82
216296-162968.7419.02
315854-158548.5048.78
415847-158478.5008.76
516351-163518.7709.03
615635-156358.3868.66
极限115960-159608.5618.492.148.878.812.10
216271-162718.7289.06
315501-155018.3158.63
415512-155128.3208.63
516148-161488.6628.97
615608-156088.3728.69
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%
110.873156663171313177843183233179183173640.33
210.933158603173423166010.34
单位质量响应值RSD%判断
29196.3228966.240.56数据可信
供试品溶液-2024011621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%
5min1114494-11449432.52038.4439.4132.5238.4439.41
264929-6492918.44218.44
3215547-21554761.22361.22
4177114-17711450.30750.31
5129510-12951036.78636.79
6110486-11048631.38231.38
10min1201500-20150057.23365.3710.7157.4165.5910.77
2207265-20726558.87158.97
3265313-26531375.35875.70
4239620-23962068.06168.34
5220613-22061362.66262.87
6246630-24663070.05270.23
15min1235514-23551466.89474.907.0667.3975.487.10
2250237-25023771.07671.51
3272622-27262277.43478.19
4274142-27414277.86678.52
5262254-26225474.49075.04
6287458-28745881.64882.21
20min1250400-25040071.12378.606.5371.9979.596.56
2261897-26189774.38875.21
3278698-27869879.16080.35
4287987-28798781.79982.89
5280672-28067279.72180.69
6300598-30059885.38186.40
30min1281329-28132979.90878.773.6681.1780.203.67
2269695-26969576.60377.84
3295177-29517783.84185.47
4268661-26866176.30977.85
5278486-27848679.10080.51
6270664-27066476.87878.37
45min1306457-30645787.04581.825.2588.7583.695.10
2289779-28977982.30883.97
3304162-30416286.39388.49
4268085-26808576.14678.11
5282137-28213780.13781.99
6277786-27778678.90180.82
60min1312284-31228488.70082.335.6090.8984.655.42
2295019-29501983.79685.92
3303091-30309186.08988.66
4272446-27244677.38479.78
5282289-28228980.18082.47
6274070-27407077.84680.20
极限1334612-33461295.04295.220.5397.7398.000.59
2336493-33649395.57698.16
3337226-33722695.78498.84
4334399-33439994.98197.80
5332474-33247494.43597.17
6336223-33622395.49998.29
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%
111.181855631859711862451859781861461859810.15
211.181854951874591864770.75
单位质量响应值RSD%判断
16635.1516679.520.19数据可信
供试品溶液-2024011821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%
5min19817-98175.2875.716.435.295.716.43
211163-111636.0126.01
310108-101085.4435.44
411070-110705.9615.96
511414-114146.1476.15
610082-100825.4295.43
10min115138-151388.1528.322.768.188.352.76
216030-160308.6328.67
315845-158458.5338.56
414904-149048.0268.06
515336-153368.2598.29
615397-153978.2928.32
15min116461-164618.8658.783.068.948.853.04
216454-164548.8618.94
316761-167619.0269.10
415443-154438.3168.39
515990-159908.6118.69
616685-166858.9859.06
20min116195-161958.7218.732.128.858.862.14
216852-168529.0759.21
315995-159958.6148.74
416185-161858.7168.84
516164-161648.7058.83
615854-158548.5388.66
30min116455-164558.8618.691.989.038.871.95
216339-163398.7998.98
316433-164338.8509.03
415976-159768.6038.78
515666-156668.4368.61
615967-159678.5998.77
45min115939-159398.5838.481.598.818.711.57
216117-161178.6798.91
315718-157188.4648.69
415407-154078.2978.52
515602-156028.4028.63
615719-157198.4658.69
60min116249-162498.7508.412.339.028.682.26
215685-156858.4478.72
315312-153128.2468.52
415298-152988.2388.50
515406-154068.2968.57
615752-157528.4838.75
极限115710-157108.4608.351.518.788.671.50
215683-156838.4468.77
315706-157068.4588.78
415414-154148.3018.61
515128-151288.1478.46
615420-154208.3048.62
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%
110.873125033139973139453141973142113137710.23
210.933135603166743151170.70
单位质量响应值RSD%判断
28865.7828830.470.09数据可信
供试品溶液-2024011821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%
5min1192692-19269255.17346.6020.6555.1746.6020.65
2173431-17343149.65849.66
3203813-20381358.35758.36
4123930-12393035.48535.48
5157347-15734745.05345.05
6125219-12521935.85435.85
10min1261633-26163374.91371.548.2275.2271.808.24
2260635-26063574.62774.90
3261005-26100574.73375.06
4208675-20867559.74959.95
5255150-25515073.05673.31
6252005-25200572.15672.36
15min1281076-28107680.48076.666.1081.2077.316.13
2273934-27393478.43579.13
3272176-27217677.93178.67
4235393-23539367.39967.93
5269311-26931177.11177.77
6274455-27445578.58479.18
20min1295646-29564684.65279.424.1885.8280.504.20
2285437-28543781.72882.85
3268579-26857976.90178.07
4264179-26417975.64276.55
5277264-27726479.38880.47
6273057-27305778.18479.22
30min1306509-30650987.76282.054.0389.4083.573.98
2287446-28744682.30483.88
3273476-27347678.30479.90
4285409-28540981.72083.04
5277314-27731479.40380.93
6289204-28920482.80784.28
45min1311626-31162689.22784.493.6091.3586.473.53
2293415-29341584.01386.05
3282679-28267980.93982.97
4301331-30133186.27988.06
5285474-28547481.73983.71
6295985-29598584.74986.68
60min1316232-31623290.54685.085.3793.1787.535.23
2297570-29757085.20287.71
3278539-27853979.75382.24
4308815-30881588.42290.68
5277721-27772179.51981.94
6304047-30404787.05789.46
极限1322607-32260792.37195.162.0895.5098.081.93
2329013-32901394.20597.18
3341376-34137697.745100.67
4338345-33834596.87799.63
5328814-32881494.14897.01
6333860-33386095.59398.48
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%
111.181867851873521886261894491894771883380.66
211.181865111873271869190.31
单位质量响应值RSD%判断
16845.9716719.050.54数据可信
供试品溶液-2024011821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%
5min18901-89014.7585.6110.384.765.6110.36
212312-123126.5816.58
310210-102105.4575.46
410492-104925.6085.61
510542-105425.6355.63
610518-105185.6225.62
10min114102-141027.5388.037.107.568.067.10
216442-164428.7888.82
314999-149998.0178.05
415391-153918.2278.26
513509-135097.2217.25
615640-156408.3608.39
15min115834-158348.4638.554.248.538.634.23
216528-165288.8348.92
315999-159998.5528.63
416582-165828.8638.94
514754-147547.8867.96
616307-163078.7168.79
20min116054-160548.5818.592.678.708.722.69
216379-163798.7558.89
316246-162468.6848.81
416256-162568.6898.82
515231-152318.1418.26
616304-163048.7158.84
30min116156-161568.6368.670.998.808.841.04
216524-165248.8329.02
316135-161358.6248.79
416076-160768.5938.77
516248-162488.6858.85
616176-161768.6468.82
45min116124-161248.6188.541.758.838.761.66
215923-159238.5118.74
315706-157068.3958.61
415792-157928.4418.66
516466-164668.8019.01
615841-158418.4678.69
60min115874-158748.4858.382.768.748.642.64
215635-156358.3578.64
315356-153568.2088.47
415101-151018.0728.34
516353-163538.7419.00
615695-156958.3898.66
极限115764-157648.4268.362.378.738.672.31
216209-162098.6648.99
315114-151148.0798.39
415500-155008.2858.60
515781-157818.4358.74
615473-154738.2708.59
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%
110.873148973163993185833187443195293176300.61
210.933151173160423155800.21
单位质量响应值RSD%判断
29220.7928872.830.85数据可信
供试品溶液-2024011821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%
5min1175903-17590350.02340.4735.7250.0240.4635.72
2199887-19988756.84456.84
374255-7425521.11721.12
4114183-11418332.47132.47
5105799-10579930.08730.09
6183748-18374852.25452.25
10min1232771-23277166.19561.2821.3366.4761.5021.37
2273382-27338277.74478.06
3151699-15169943.14043.26
4219698-21969862.47762.66
5170955-17095548.61648.78
6244344-24434469.48669.78
15min1258877-25887773.61970.0812.5974.2670.6412.70
2292429-29242983.16183.91
3207965-20796559.14159.50
4241415-24141568.65369.18
5217454-21745461.83962.28
6260377-26037774.04674.72
20min1269577-26957776.66274.878.4577.7275.838.60
2299936-29993685.29586.51
3237810-23781067.62868.31
4253435-25343572.07272.98
5246975-24697570.23471.02
6271999-27199977.35178.44
30min1280967-28096779.90181.235.0181.3882.605.13
2314237-31423789.36291.05
3276876-27687678.73879.80
4276451-27645178.61779.93
5281714-28171480.11381.28
6283645-28364580.66382.18
45min1304539-30453986.60485.804.1488.5387.624.12
2318014-31801490.43692.62
3305454-30545486.86588.36
4285201-28520181.10582.85
5308534-30853487.74189.36
6288576-28857682.06584.03
60min1319626-31962690.89587.994.6793.3090.294.52
2315178-31517889.63092.31
3317839-31783990.38792.37
4292035-29203583.04985.25
5321797-32179791.51293.62
6290018-29001882.47584.90
极限1334085-33408595.00795.260.7097.9298.050.85
2338637-33863796.30199.48
3332397-33239794.52797.01
4336030-33603095.56098.22
5335776-33577695.48898.10
6332927-33292794.67797.56
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