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DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911709321708411705161706181707291707270.10
29.991708581709201708890.03
单位质量响应值RSD%判断
17227.7517106.010.51数据可信
供试品溶液-B24120811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%
5min110282-102825.3775.124.745.385.124.75
29364-93644.8974.90
39197-91974.8104.81
410114-101145.2895.29
510171-101715.3195.32
69565-95655.0025.00
10min115506-155068.1098.181.608.148.211.62
215266-152667.9848.01
315830-158308.2788.31
415947-159478.3408.37
515748-157488.2368.27
615526-155268.1198.15
15min114589-145897.6297.942.617.708.012.58
215433-154338.0718.14
315697-156978.2098.28
415169-151697.9338.01
514894-148947.7897.86
615310-153108.0078.08
20min115029-150297.8607.903.147.988.023.09
215703-157038.2128.33
315665-156658.1928.31
414880-148807.7827.90
514833-148337.7577.88
614539-145397.6037.72
30min113735-137357.1837.434.217.347.594.16
214643-146437.6587.82
315091-150917.8928.06
414399-143997.5307.69
513710-137107.1707.33
613653-136537.1407.30
45min113868-138687.2527.433.837.457.643.79
214823-148237.7527.96
314988-149887.8388.05
413987-139877.3157.52
513768-137687.2007.40
613841-138417.2387.44
60min113344-133446.9787.182.607.227.422.52
214113-141137.3817.63
313919-139197.2797.53
413295-132956.9537.20
513658-136587.1437.38
614062-140627.3547.59
极限113546-135467.0847.262.827.367.552.75
214036-140367.3407.63
314479-144797.5727.86
413831-138317.2337.52
513396-133967.0067.29
614065-140657.3557.64
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对照品来源工作对照品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%
110.963025713016083016343023303018163019920.15
210.973014273019703016980.13
单位质量响应值RSD%判断
27554.0127502.100.14数据可信
供试品溶液-B24120811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%
5min1197118-19711859.14749.9415.7659.1549.9415.76
2142306-14230642.70042.70
3182363-18236354.71954.72
4129461-12946138.84638.85
5183396-18339655.02955.03
6163987-16398749.20649.21
10min1277941-27794183.39880.064.7083.7380.334.70
2279097-27909783.74583.98
3261738-26173878.53778.84
4262034-26203478.62578.84
5273579-27357982.09082.40
6246404-24640473.93574.21
15min1279658-27965883.91482.825.1284.7183.545.10
2293869-29386988.17888.88
3264763-26476379.44480.18
4269820-26982080.96281.61
5289636-28963686.90887.67
6258338-25833877.51678.20
20min1292305-29230587.70886.035.7788.9787.215.74
2310154-31015493.06494.26
3280327-28032784.11485.30
4274934-27493482.49683.60
5297747-29774789.34190.59
6264739-26473979.43780.55
30min1281243-28124384.38988.142.8986.1389.802.85
2307222-30722292.18493.89
3294482-29448288.36290.01
4293172-29317287.96989.53
5296397-29639788.93690.68
6290042-29004287.02988.59
45min1302766-30276690.84790.386.0393.0692.535.96
2329352-32935298.825101.05
3306349-30634991.92294.06
4289283-28928386.80288.85
5304216-30421691.28293.52
6275276-27527682.59984.64
60min1288481-28848186.56190.204.7589.2892.854.69
2323251-32325196.99499.76
3309622-30962292.90595.56
4286682-28668286.02188.55
5303614-30361491.10293.84
6291967-29196787.60790.11
极限1322669-32266996.81997.812.00100.02100.971.99
2326066-32606697.839101.15
3324252-32425297.294100.46
4331465-33146599.459102.47
5334868-334868100.480103.73
6316584-31658494.99497.98
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DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911705821709711710521710351710501709380.12
29.991708511707771708140.04
单位质量响应值RSD%判断
17249.0417098.500.62数据可信
供试品溶液-B24120811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%
5min19799-97995.1224.983.125.124.983.06
29817-98175.1325.13
39591-95915.0145.01
49589-95895.0135.01
59290-92904.8564.86
69060-90604.7364.74
10min115625-156258.1687.952.648.207.982.64
215722-157228.2198.25
315188-151887.9407.97
415115-151157.9017.93
514709-147097.6897.72
614887-148877.7827.81
15min114981-149817.8317.653.167.917.723.18
214947-149477.8147.89
314399-143997.5277.60
414619-146197.6427.71
514989-149897.8367.91
613819-138197.2247.29
20min114893-148937.7857.703.377.907.813.35
215457-154578.0808.20
314559-145597.6117.72
414824-148247.7497.86
514656-146567.6617.77
613937-139377.2867.40
30min113939-139397.2877.362.497.457.522.46
214539-145397.6007.76
313502-135027.0587.21
414264-142647.4577.61
514024-140247.3317.49
614193-141937.4197.57
45min114160-141607.4027.521.807.607.711.79
214671-146717.6697.87
314116-141167.3797.57
414350-143507.5027.70
514718-147187.6947.89
614251-142517.4507.64
60min113838-138387.2347.232.697.487.472.66
214195-141957.4217.67
313231-132316.9177.15
413676-136767.1497.39
514250-142507.4497.69
613823-138237.2267.46
极限113924-139247.2797.361.997.567.641.95
214129-141297.3867.67
313667-136677.1447.42
414514-145147.5877.87
514150-141507.3977.68
614103-141037.3727.65
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对照品来源工作对照品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%
110.963015153019353023373015933024173019590.14
210.973012743001133006940.28
单位质量响应值RSD%判断
27551.0027410.570.37数据可信
供试品溶液-B24120811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%
5min1183424-18342455.13350.517.0055.1350.517.00
2169349-16934950.90250.90
3157534-15753447.35147.35
4152827-15282745.93645.94
5178491-17849153.65053.65
6166634-16663450.08650.09
10min1259259-25925977.92778.735.1078.2379.015.07
2280720-28072084.37884.66
3265060-26506079.67179.93
4271746-27174681.68081.94
5247335-24733574.34374.64
6247457-24745774.38074.66
15min1265863-26586379.91281.696.1280.6582.406.09
2294983-29498388.66589.42
3271603-27160381.63782.34
4277196-27719683.31884.03
5276663-27666383.15883.87
6244286-24428673.42674.12
20min1279283-27928383.94685.035.7185.1386.205.68
2307045-30704592.29093.53
3280098-28009884.19185.35
4292266-29226687.84889.02
5280323-28032384.25885.43
6258302-25830277.63978.74
30min1292698-29269887.97887.554.1389.6389.194.13
2308954-30895492.86494.62
3282719-28271984.97886.61
4299573-29957390.04491.70
5288323-28832386.66388.30
6275304-27530482.75084.28
45min1297540-29754089.43391.103.3991.5793.233.41
2320321-32032196.28198.55
3296366-29636689.08091.18
4307781-30778192.51194.67
5304801-30480191.61693.74
6291697-29169787.67789.67
60min1293214-29321488.13390.594.1890.7793.224.16
2322026-32202696.79399.60
3290557-29055787.33489.93
4305439-30543991.80894.48
5307157-30715792.32494.96
6289889-28988987.13489.61
极限1323240-32324097.15898.492.01100.28101.632.04
2336490-336490101.141104.49
3319418-31941896.00999.09
4334286-334286100.478103.66
5327329-32732998.387101.53
6325213-32521397.751100.71
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DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911716791722941727791726751744641727780.60
29.991708191708361708280.01
单位质量响应值RSD%判断
17434.7117099.901.38数据可信
供试品溶液-B24120812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%
5min17341-73413.8174.277.233.824.277.23
28821-88214.5874.59
38020-80204.1704.17
47865-78654.0904.09
58884-88844.6194.62
68373-83734.3544.35
10min114649-146497.6177.763.417.647.793.44
215011-150117.8057.83
314235-142357.4027.42
415506-155068.0638.09
515503-155038.0618.09
614676-146767.6317.66
15min115457-154578.0378.051.988.108.121.98
215580-155808.1018.17
315196-151967.9017.97
415212-152127.9107.98
516031-160318.3368.41
615470-154708.0448.11
20min114283-142837.4277.584.187.537.694.17
214164-141647.3657.48
313801-138017.1767.28
415299-152997.9558.07
515257-152577.9338.05
614668-146687.6277.74
30min114325-143257.4487.544.187.607.694.12
213896-138967.2257.38
313807-138077.1797.33
415169-151697.8878.04
515210-152107.9098.07
614552-145527.5667.72
45min113265-132656.8977.205.597.097.405.51
212985-129856.7526.95
313629-136297.0877.27
414572-145727.5777.78
514986-149867.7928.00
613654-136547.1007.30
60min114200-142007.3837.585.277.617.815.21
214170-141707.3687.60
314204-142047.3867.61
415992-159928.3158.56
514914-149147.7558.00
613960-139607.2597.49
极限114174-141747.3707.385.047.647.664.91
213431-134316.9847.26
313767-137677.1587.43
415526-155268.0738.36
514199-141997.3837.67
614083-140837.3237.60
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对照品来源工作对照品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%
110.963013943017873008582995802987193004680.43
210.973002443015083008760.30
单位质量响应值RSD%判断
27414.9627427.160.04数据可信
供试品溶液-B24120812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%
5min1172124-17212451.84950.7714.7351.8550.7814.73
2185608-18560855.91055.91
3177037-17703753.32953.33
4118704-11870435.75735.76
5180618-18061854.40754.41
6177233-17723353.38853.39
10min1265940-26594080.10979.063.0080.4079.342.97
2269405-26940581.15281.46
3249584-24958475.18275.48
4270307-27030781.42481.62
5257847-25784777.67177.97
6261628-26162878.81079.11
15min1284845-28484585.80384.554.0786.5485.284.04
2297407-29740789.58790.35
3267843-26784380.68281.40
4288388-28838886.87187.52
5270934-27093481.61382.35
6274712-27471282.75183.49
20min1277320-27732083.53784.424.0384.7585.614.00
2298273-29827389.84891.11
3266639-26663980.31981.48
4288354-28835486.86087.99
5273465-27346582.37583.56
6277521-27752183.59784.79
30min1291712-29171287.87288.573.0989.5590.243.05
2303396-30339691.39193.15
3286155-28615586.19887.81
4306976-30697692.47094.09
5290822-29082287.60489.25
6285208-28520885.91387.57
45min1288808-28880886.99791.274.7989.1693.424.66
2301089-30108990.69792.96
3309140-30914093.12295.21
4321152-32115296.74098.87
5313758-31375894.51396.64
6283955-28395585.53587.67
60min1305758-30575892.10396.524.0094.7599.183.92
2327356-32735698.609101.38
3318696-31869696.00098.60
4338026-338026101.823104.49
5326675-32667598.404101.06
6306099-30609992.20694.82
极限1341008-341008102.721101.793.68105.88104.983.58
2332785-332785100.244103.56
3323933-32393397.578100.72
4359989-359989108.439111.67
5330791-33079199.644102.85
6338903-338903102.087105.21
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DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911705381706661706021706251706021706070.03
29.991696751702821699780.26
单位质量响应值RSD%判断
17215.6417014.810.83数据可信
供试品溶液-B24120812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%
5min18613-86134.5184.412.224.524.412.25
28320-83204.3644.36
38226-82264.3154.31
48546-85464.4834.48
58183-81834.2924.29
68549-85494.4844.48
10min114672-146727.6967.692.587.727.722.56
215317-153178.0358.06
314191-141917.4447.47
414772-147727.7497.77
514492-144927.6027.63
614516-145167.6147.64
15min115294-152948.0227.903.148.097.963.13
215861-158618.3208.39
314918-149187.8257.89
414865-148657.7977.87
514923-149237.8287.89
614479-144797.5957.66
20min114285-142857.4937.593.457.617.703.43
215444-154448.1018.22
314432-144327.5707.68
414335-143357.5197.63
514008-140087.3487.46
614316-143167.5097.62
30min114148-141487.4217.443.437.587.603.42
215051-150517.8958.06
314355-143557.5307.68
414092-140927.3927.55
513711-137117.1927.34
613774-137747.2257.38
45min113349-133497.0027.234.187.207.424.11
214826-148267.7777.98
314053-140537.3727.56
413342-133426.9997.19
513491-134917.0777.27
613621-136217.1457.34
60min113884-138847.2837.464.097.527.694.02
215199-151997.9738.22
314581-145817.6487.88
413680-136807.1767.41
514180-141807.4387.67
613786-137867.2317.46
极限113634-136347.1527.263.897.437.543.86
214896-148967.8148.11
313793-137937.2357.51
413507-135077.0857.36
513833-138337.2567.53
613420-134207.0397.31
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对照品来源工作对照品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%
110.963023613025463025283024303025043024740.03
210.973012673011413012040.03
单位质量响应值RSD%判断
27597.9927457.060.37数据可信
供试品溶液-B24120812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%
5min1185496-18549655.66149.838.2755.6649.838.27
2152180-15218045.66445.66
3148996-14899644.70944.71
4172220-17222051.67751.68
5165074-16507449.53349.53
6172428-17242851.74051.74
10min1263712-26371279.13177.711.7579.4477.981.75
2263498-26349879.06779.32
3256964-25696477.10677.35
4261494-26149478.46578.75
5253373-25337376.02876.30
6254760-25476076.44576.73
15min1283866-28386685.17883.602.0785.9384.312.07
2280531-28053184.17884.87
3279293-27929383.80684.48
4284601-28460185.39986.12
5270676-27067681.22081.92
6272713-27271381.83282.54
20min1288694-28869486.62785.202.6187.8586.372.60
2288790-28879086.65687.82
3275965-27596582.80883.95
4291210-29121087.38288.58
5273541-27354182.08083.23
6285391-28539185.63686.80
30min1302330-30233090.71988.842.9392.4290.492.90
2303672-30367291.12192.76
3297582-29758289.29490.90
4301454-30145490.45692.14
5281717-28171784.53386.14
6289702-28970286.93088.57
45min1311758-31175893.54893.441.9495.7695.581.91
2322152-32215296.66798.81
3312959-31295993.90896.01
4307572-30757292.29294.48
5304733-30473391.44093.51
6309171-30917192.77194.90
60min1324511-32451197.37496.562.40100.1099.222.34
2334555-334555100.388103.07
3322783-32278396.85699.48
4315135-31513594.56197.26
5320967-32096796.31198.89
6312871-31287193.88296.52
极限1333360-333360100.030100.182.09103.30103.382.05
2347763-347763104.352107.59
3329049-32904998.736101.89
4331595-33159599.500102.72
5330203-33020399.082102.20
6331294-33129499.410102.57
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DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911703331704501703231704211702111703480.06
29.991704231699191701710.21
单位质量响应值RSD%判断
17189.5117034.130.65数据可信
供试品溶液-B24120911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%
5min18536-85364.4784.946.714.484.946.71
29225-92254.8404.84
39288-92884.8734.87
49984-99845.2385.24
510292-102925.4005.40
69147-91474.7994.80
10min116220-162208.5108.571.758.538.591.74
215913-159138.3498.38
316490-164908.6518.68
416349-163498.5778.61
516757-167578.7928.82
616230-162308.5158.54
15min115656-156568.2148.253.108.298.333.07
215546-155468.1568.23
316489-164898.6518.73
414999-149997.8697.95
515914-159148.3498.43
615755-157558.2668.34
20min116317-163178.5618.222.178.688.342.15
215589-155898.1798.30
315529-155298.1478.27
415561-155618.1648.28
515736-157368.2568.38
615328-153288.0428.16
30min114770-147707.7497.802.797.917.962.72
214481-144817.5977.76
315543-155438.1558.32
415145-151457.9468.11
514498-144987.6067.78
614711-147117.7187.88
45min115302-153028.0287.862.828.248.082.78
214962-149627.8508.06
315562-155628.1658.38
414920-149207.8288.04
514854-148547.7938.01
614324-143247.5157.72
60min114500-145007.6077.623.247.867.873.15
213734-137347.2067.46
314907-149077.8218.08
414862-148627.7978.05
514898-148987.8168.07
614240-142407.4717.72
极限114869-148697.8017.671.988.107.971.97
214417-144177.5647.85
314994-149947.8678.17
414546-145467.6327.93
514692-146927.7088.01
614216-142167.4587.75
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对照品来源工作对照品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%
110.963016383018123016963013903014023015880.07
210.973028133028133028130.00
单位质量响应值RSD%判断
27517.1527603.740.23数据可信
供试品溶液-B24120911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%
5min184688-8468825.38137.2030.2825.3837.2030.28
276867-7686723.03723.04
3123833-12383337.11337.11
4144914-14491443.43243.43
5139093-13909341.68741.69
6175272-17527252.53052.53
10min1239982-23998271.92473.736.1672.0673.946.15
2261339-26133978.32578.45
3223251-22325166.91067.12
4242527-24252772.68772.93
5244409-24440973.25173.48
6264524-26452479.27979.57
15min1244726-24472673.34678.826.5573.8979.446.55
2279688-27968883.82484.39
3240950-24095072.21472.79
4267179-26717980.07580.72
5263304-26330478.91479.55
6282073-28207384.53985.27
20min1265350-26535079.52783.285.8780.4784.335.88
2290662-29066287.11388.14
3251105-25110575.25876.24
4285044-28504485.42986.52
5282398-28239884.63685.71
6292692-29269287.72188.92
30min1260972-26097278.21587.376.1679.6088.886.16
2288248-28824886.39087.90
3283664-28366485.01686.41
4301639-30163990.40391.97
5309320-30932092.70594.25
6305178-30517891.46493.15
45min1282906-28290684.78992.544.6686.6194.544.69
2303665-30366591.01093.00
3308068-30806892.33094.20
4317974-31797495.29997.37
5320731-32073196.12598.19
6319313-31931395.70097.90
60min1276674-27667482.92192.796.5885.2295.306.52
2292702-29270287.72490.22
3318301-31830195.39797.78
4318250-31825095.38197.98
5329324-32932498.700101.30
6322279-32227996.58999.32
极限1328652-32865298.49998.181.54101.25101.211.44
2326322-32632297.801100.79
3333837-333837100.053102.97
4319520-31952095.76298.89
5331541-33154199.365102.51
6325556-32555697.571100.84
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DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
19.911721271722681717391721151721721720840.12
29.991717901716971717440.04
单位质量响应值RSD%判断
17364.6817191.590.71数据可信
供试品溶液-B24120911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%
5min18836-88364.5914.853.694.594.853.68
29743-97435.0625.06
39243-92434.8034.80
49123-91234.7404.74
59685-96855.0325.03
69373-93734.8704.87
10min116298-162988.4688.223.708.498.243.69
216461-164618.5538.58
315148-151487.8717.90
415080-150807.8367.86
516085-160858.3588.39
615797-157978.2088.24
15min115882-158828.2528.013.008.328.083.00
215788-157888.2038.28
314842-148427.7127.78
414896-148967.7407.81
515734-157348.1758.25
615315-153157.9588.03
20min115884-158848.2538.101.608.378.211.59
215846-158468.2348.35
315544-155448.0778.19
415427-154278.0168.13
515550-155508.0808.20
615231-152317.9148.03
30min115298-152987.9497.573.098.117.743.02
214536-145367.5537.72
314840-148407.7117.87
414027-140277.2887.45
514525-145257.5477.71
614236-142367.3977.56
45min115407-154078.0057.742.108.217.952.07
215163-151637.8798.09
314624-146247.5997.80
414705-147057.6417.84
514843-148437.7127.92
614691-146917.6337.84
60min114400-144007.4827.462.897.747.702.85
214840-148407.7117.96
313837-138377.1907.43
414208-142087.3827.62
514818-148187.6997.95
614015-140157.2827.53
极限114576-145767.5747.581.577.877.871.52
214732-147327.6557.95
314761-147617.6707.95
414560-145607.5657.85
514774-147747.6777.97
614168-141687.3627.65
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对照品来源工作对照品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%
110.963038083047503047813044983041353043940.14
210.973046983044543045760.06
单位质量响应值RSD%判断
27773.1827764.450.03数据可信
供试品溶液-B24120911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%
5min1119972-11997235.68635.3914.6935.6935.3914.69
2107357-10735731.93431.93
3112543-11254333.47733.48
496930-9693028.83228.83
5131533-13153339.12539.13
6145520-14552043.28643.29
10min1251229-25122974.73070.904.6874.9371.104.66
2250955-25095574.64874.83
3224642-22464266.82167.01
4234262-23426269.68369.84
5228997-22899768.11768.33
6240100-24010071.41971.66
15min1265492-26549278.97277.003.7079.5977.593.68
2272372-27237281.01981.61
3249393-24939374.18374.74
4262383-26238378.04778.59
5248032-24803273.77974.37
6255490-25549075.99776.63
20min1278743-27874382.91481.862.9283.9782.882.90
2288140-28814085.70986.75
3270690-27069080.51881.49
4277409-27740982.51783.50
5265183-26518378.88079.89
6271080-27108080.63481.69
30min1283379-28337984.29384.853.3985.8186.323.37
2299065-29906588.95990.48
3274874-27487481.76383.18
4274339-27433981.60483.04
5288951-28895185.95087.39
6290842-29084286.51388.02
45min1305846-30584690.97690.103.1692.9692.043.15
2312723-31272393.02195.03
3287889-28788985.63487.51
4294578-29457887.62489.52
5307070-30707091.34093.26
6309213-30921391.97793.97
60min1296537-29653788.20790.494.7390.6992.934.65
2318025-31802594.59897.13
3284021-28402184.48486.83
4300279-30027989.32091.70
5323219-32321996.14398.57
6303145-30314590.17292.67
极限1329927-32992798.13997.201.39101.12100.151.39
2331554-33155498.623101.68
3324536-32453696.53599.35
4322951-32295196.06498.94
5330767-33076798.389101.35
6320972-32097295.47598.48
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