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%
19.851639081639531640341640631640371639990.04
29.911661331674651667990.57
单位质量响应值RSD%判断
16649.6416831.380.77数据可信
供试品溶液-2022091403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%
5min18452-84524.5294.708.094.534.708.12
28009-80094.2924.29
39081-90814.8664.87
49926-99265.3195.32
59000-90004.8234.82
68178-81784.3824.38
10min115391-153918.2478.021.798.278.041.79
214727-147277.8927.92
315133-151338.1098.14
414929-149298.0008.03
514939-149398.0058.03
614664-146647.8587.88
15min115024-150248.0518.021.218.128.091.23
214662-146627.8577.92
315168-151688.1288.20
414851-148517.9588.03
515000-150008.0388.11
615074-150748.0788.15
20min115099-150998.0918.052.178.218.172.15
214507-145077.7747.89
315460-154608.2848.40
415138-151388.1128.23
515130-151308.1088.22
614812-148127.9378.05
30min114734-147347.8957.811.118.067.971.12
214381-143817.7067.86
314796-147967.9298.09
414557-145577.8017.96
514563-145637.8047.96
614444-144447.7407.90
45min114406-144067.7207.761.337.927.961.30
214392-143927.7127.91
314763-147637.9118.12
414200-142007.6097.82
514581-145817.8138.02
614523-145237.7827.98
60min113932-139327.4667.532.107.717.772.09
213627-136277.3027.54
314439-144397.7377.99
413869-138697.4327.68
514279-142797.6527.90
614121-141217.5677.81
极限113682-136827.3327.421.337.627.711.29
213915-139157.4567.74
314143-141437.5797.87
413677-136777.3297.62
513942-139427.4717.76
613744-137447.3657.65
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%
111.001556961558411558221564231557381559040.19
211.051575601596461586030.94
单位质量响应值RSD%判断
14173.0914353.210.90数据可信
供试品溶液-2022091403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%
5min173953-7395342.82948.168.0642.8348.168.06
289453-8945351.80651.81
380397-8039746.56146.56
487463-8746350.65350.65
589860-8986052.04152.04
677795-7779545.05445.05
10min1105404-10540461.04362.222.3461.2862.492.35
2111330-11133064.47564.76
3106623-10662361.74962.01
4106385-10638561.61261.89
5109724-10972463.54563.83
6105169-10516960.90761.16
15min1111254-11125464.43166.251.7465.0166.861.76
2116459-11645967.44668.09
3114183-11418366.12866.73
4116122-11612267.25167.87
5115243-11524366.74267.38
6113087-11308765.49366.08
20min1116421-11642167.42469.382.4868.3670.362.48
2120670-12067069.88570.91
3122035-12203570.67571.64
4123382-12338271.45572.45
5120229-12022969.62970.64
6116087-11608767.23068.18
30min1124568-12456872.14273.414.1173.4574.784.05
2123910-12391071.76173.17
3133963-13396377.58378.94
4132773-13277376.89478.29
5123345-12334571.43472.83
6121983-12198370.64571.97
45min1131757-13175776.30578.144.8478.0279.914.76
2132366-13236676.65878.47
3145558-14555884.29886.09
4140351-14035181.28383.10
5129663-12966375.09376.89
6129830-12983075.18976.91
60min1132950-13295076.99679.876.0479.1382.085.94
2132620-13262076.80579.04
3151060-15106087.48589.75
4145723-14572384.39486.67
5133705-13370577.43479.65
6131384-13138476.08978.23
极限1153807-15380789.07590.041.6591.6492.691.64
2152957-15295788.58391.24
3159071-15907192.12494.87
4155942-15594290.31293.05
5153232-15323288.74291.39
6157835-15783591.40893.97
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%
19.851642631641481641721641571642671642010.04
29.911667521672901670210.23
单位质量响应值RSD%判断
16670.1516853.780.78数据可信
供试品溶液-2022091403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%
5min110697-106975.7255.3710.605.725.3710.58
29716-97165.2005.20
310716-107165.7355.73
410487-104875.6125.61
57998-79984.2804.28
610576-105765.6605.66
10min114806-148067.9247.971.197.968.001.17
214739-147397.8887.92
315172-151728.1208.15
414808-148087.9257.96
514766-147667.9027.93
615040-150408.0498.08
15min114542-145427.7827.962.597.868.042.55
214339-143397.6747.75
314941-149417.9968.07
415383-153838.2338.31
515156-151568.1118.18
614901-149017.9758.05
20min114295-142957.6507.882.787.778.002.75
214138-141387.5667.68
314886-148867.9678.09
415086-150868.0748.19
515013-150138.0358.15
614979-149798.0168.14
30min113792-137927.3817.562.037.547.732.03
213752-137527.3607.52
314198-141987.5987.76
414351-143517.6807.85
514355-143557.6827.84
614352-143527.6817.85
45min113673-136737.3177.461.597.527.661.58
213631-136317.2957.49
314021-140217.5047.71
414095-140957.5437.75
514130-141307.5627.76
614042-140427.5157.72
60min113087-130877.0047.262.607.257.502.57
213143-131437.0347.27
313800-138007.3857.63
413899-138997.4387.69
513690-136907.3277.57
613748-137487.3587.61
极限113455-134557.2017.391.617.487.681.63
213628-136287.2937.57
313873-138737.4247.72
414031-140317.5097.80
513902-139027.4407.72
613973-139737.4787.77
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%
111.001560041558921558961558171558631558940.05
211.051580321582051581180.08
单位质量响应值RSD%判断
14172.1814309.320.69数据可信
供试品溶液-2022091403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%
5min191817-9181753.25746.1626.4753.2646.1626.47
294297-9429754.69654.70
392393-9239353.59253.59
440741-4074123.63123.63
569665-6966540.40840.41
688549-8854951.36251.36
10min1114522-11452266.42757.7824.9166.7258.0424.92
2120709-12070970.01670.32
3113531-11353165.85266.15
457409-5740933.29933.43
581520-8152047.28547.51
6109995-10999563.80164.09
15min1119913-11991369.55460.2924.3970.2260.8724.40
2126479-12647973.36374.06
3116500-11650067.57568.24
461887-6188735.89736.21
583916-8391648.67549.16
6114966-11496666.68567.32
20min1120321-12032169.79161.1823.9870.8462.0924.00
2126622-12662273.44674.55
3118656-11865668.82569.86
463586-6358636.88237.40
584858-8485849.22149.98
6118765-11876568.88869.90
30min1120860-12086070.10461.7323.3871.5462.9823.41
2127455-12745573.92975.44
3119253-11925369.17170.59
465160-6516037.79538.52
586291-8629150.05251.08
6119503-11950369.31670.71
45min1122668-12266871.15262.8622.4872.9864.4622.53
2128669-12866974.63376.55
3120986-12098670.17771.98
468204-6820439.56140.49
588228-8822851.17652.48
6121518-12151870.48572.26
60min1124930-12493072.46463.0722.0274.6965.0222.07
2127073-12707373.70776.04
3122689-12268971.16473.36
471128-7112841.25742.41
586020-8602049.89551.49
6120599-12059969.95272.12
极限1153346-15334688.94786.434.7391.5788.725.14
2154799-15479989.78992.53
3153535-15353589.05691.65
4143027-14302782.96184.34
5137547-13754779.78381.65
6151748-15174888.02090.58
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%
19.851632931633211634061635411635521634230.08
29.911637331638441637880.05
单位质量响应值RSD%判断
16591.1716527.550.28数据可信
供试品溶液-2022091801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%
5min18827-88274.7824.447.674.784.447.67
28205-82054.4454.44
38075-80754.3744.37
48959-89594.8534.85
57833-78334.2434.24
67275-72753.9413.94
10min114708-147087.9678.102.717.998.122.72
215080-150808.1698.19
314792-147928.0138.04
415656-156568.4818.51
514485-144857.8477.87
615006-150068.1298.15
15min115457-154578.3738.392.708.448.462.70
215490-154908.3918.46
314972-149728.1108.18
416237-162378.7968.87
515285-152858.2808.35
615438-154388.3638.43
20min115636-156368.4708.362.818.598.482.80
215606-156068.4548.57
315132-151328.1978.31
415836-158368.5788.70
514707-147077.9678.08
615726-157268.5198.63
30min115145-151458.2048.093.118.378.263.09
214782-147828.0088.17
315010-150108.1318.29
415356-153568.3188.49
514085-140857.6307.79
615260-152608.2668.43
45min114359-143597.7787.972.337.998.172.30
214595-145957.9068.11
314546-145467.8808.08
415109-151098.1858.40
514472-144727.8408.04
615164-151648.2148.42
60min114497-144977.8537.963.318.118.213.29
214621-146217.9208.17
314631-146317.9268.17
415235-152358.2538.52
513936-139367.5497.79
615210-152108.2398.49
极限114816-148168.0268.012.188.328.302.16
214892-148928.0678.36
314558-145587.8868.18
414968-149688.1088.42
514270-142707.7308.02
615176-151768.2218.52
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%
111.003101203102063102743104883105983103370.07
211.053107393110563108980.08
单位质量响应值RSD%判断
28212.4528135.570.20数据可信
供试品溶液-2022091801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%
5min1144235-14423542.28733.2732.7042.2933.2732.70
2103407-10340730.31730.32
393272-9327227.34527.35
4164770-16477048.30748.31
560602-6060217.76717.77
6114620-11462033.60433.60
10min1204417-20441759.93158.886.8660.1759.066.92
2186138-18613854.57254.74
3206050-20605060.40960.56
4220536-22053664.65664.92
5183724-18372453.86453.96
6204115-20411559.84260.03
15min1215661-21566163.22761.716.0663.8062.226.12
2194448-19444857.00857.48
3211573-21157362.02962.52
4231035-23103567.73568.36
5200263-20026358.71359.11
6209991-20999161.56562.08
20min1220178-22017864.55163.125.3865.4763.985.44
2197489-19748957.90058.69
3216744-21674463.54564.38
4230432-23043267.55868.56
5206700-20670060.60061.32
6220256-22025664.57465.44
30min1224586-22458665.84464.075.5667.1265.285.62
2199961-19996158.62459.73
3219368-21936864.31465.50
4234593-23459368.77870.16
5209753-20975361.49562.56
6222965-22296565.36966.59
45min1223713-22371365.58864.935.9167.2366.495.93
2198741-19874158.26759.70
3224200-22420065.73167.27
4233561-23356168.47570.24
5215290-21529063.11864.52
6233370-23337068.41970.00
60min1234361-23436168.71067.336.3570.7269.266.36
2203946-20394659.79361.55
3231562-23156267.88969.80
4243049-24304971.25773.40
5223098-22309865.40867.16
6242007-24200770.95172.91
极限1279696-27969682.00182.093.7684.3984.393.82
2261426-26142676.64578.74
3282803-28280382.91285.20
4294077-29407786.21788.75
5280775-28077582.31784.43
6281313-28131382.47584.83
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%
19.851641411641511645631645571646001644020.15
29.911625201629811627500.21
单位质量响应值RSD%判断
16690.5616422.811.15数据可信
供试品溶液-2022091801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%
5min18858-88584.8004.656.414.804.656.42
29488-94885.1415.14
38540-85404.6274.63
48017-80174.3444.34
58046-80464.3604.36
68515-85154.6144.61
10min114751-147517.9938.131.908.028.161.87
215364-153648.3258.35
314654-146547.9407.97
414899-148998.0738.10
515185-151858.2288.25
615217-152178.2458.27
15min115070-150708.1658.262.668.248.332.64
215704-157048.5098.58
315026-150268.1428.21
414638-146387.9318.00
515581-155818.4428.51
615465-154658.3798.45
20min115186-151868.2288.291.908.348.401.90
215658-156588.4848.61
315062-150628.1618.28
414977-149778.1158.23
515245-152458.2608.38
615642-156428.4758.59
30min114661-146617.9448.212.678.118.382.66
215583-155838.4438.61
315023-150238.1408.30
414755-147557.9958.15
515563-155638.4328.60
615376-153768.3318.50
45min114686-146867.9578.052.168.168.262.16
215278-152788.2788.49
314754-147547.9948.20
414566-145667.8928.09
515255-152558.2668.48
614628-146287.9268.14
60min114319-143197.7587.913.208.018.163.16
215111-151118.1888.45
314202-142027.6957.95
414049-140497.6127.86
514788-147888.0138.27
615099-150998.1818.44
极限114553-145537.8857.892.138.188.192.12
215013-150138.1348.44
314259-142597.7268.02
414184-141847.6857.97
514659-146597.9438.24
614735-147357.9848.28
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%
111.003118983117163126723123673123233121950.13
211.053082793089093085940.15
单位质量响应值RSD%判断
28381.3627927.061.15数据可信
供试品溶液-2022091801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%
5min1151965-15196544.58737.8712.2944.5937.8712.29
2145391-14539142.65842.66
3117099-11709934.35734.36
4120216-12021635.27235.27
5113695-11369533.35833.36
6126122-12612237.00537.00
10min1214615-21461562.96961.073.8463.2261.283.85
2216947-21694763.65363.89
3195584-19558457.38557.58
4203501-20350159.70859.90
5212102-21210262.23162.42
6206184-20618460.49560.70
15min1223703-22370365.63564.343.3566.2364.893.35
2224484-22448465.86466.45
3207680-20768060.93461.44
4225354-22535466.12066.65
5221910-22191065.10965.64
6212655-21265562.39462.94
20min1229098-22909867.21865.513.6268.1866.413.62
2227998-22799866.89567.85
3211450-21145062.04062.89
4232938-23293868.34569.24
5219494-21949464.40065.29
6218586-21858664.13465.02
30min1231630-23163067.96167.743.7569.3069.023.72
2235574-23557469.11870.45
3221134-22113464.88166.07
4244842-24484271.83773.11
5228788-22878867.12768.38
6223383-22338365.54166.79
45min1243711-24371171.50669.695.3473.2271.345.29
2248464-24846472.90074.61
3224720-22472065.93467.49
4253371-25337174.34076.01
5230986-23098667.77269.40
6223879-22387965.68767.30
60min1250043-25004373.36371.564.8275.4773.604.79
2257198-25719875.46377.58
3224179-22417965.77567.69
4250759-25075973.57475.66
5237741-23774169.75471.75
6243513-24351371.44873.42
极限1285266-28526683.69882.991.8786.2285.421.90
2286069-28606983.93486.47
3274675-27467580.59182.88
4284409-28440983.44785.94
5288469-28846984.63887.03
6278169-27816981.61683.99
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