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%
110.521805811803941803521807181802221804530.11
210.471804751806091805420.06
单位质量响应值RSD%判断
17153.3317243.740.38数据可信
供试品溶液-2024011221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%
5min18924-89244.6584.927.514.664.927.53
28263-82634.3134.31
39774-97745.1025.10
49878-98785.1565.16
510170-101705.3095.31
69542-95424.9814.98
10min114715-147157.6817.942.077.717.972.08
215256-152567.9647.99
315218-152187.9447.97
415703-157038.1978.23
515151-151517.9097.94
615206-152067.9377.97
15min115068-150687.8658.041.977.938.112.00
215166-151667.9177.98
315892-158928.2968.37
415318-153187.9968.07
515605-156058.1468.22
615375-153758.0268.10
20min115007-150077.8347.981.517.958.101.47
215446-154468.0638.17
315013-150137.8377.96
415562-155628.1238.24
515397-153978.0378.16
615317-153177.9958.11
30min114119-141197.3707.652.987.537.822.94
214464-144647.5507.71
314555-145557.5987.76
415086-150867.8758.04
515280-152807.9768.14
614458-144587.5477.71
45min115037-150377.8497.681.608.057.881.56
214774-147747.7127.91
314417-144177.5267.73
414883-148837.7697.98
514494-144947.5667.77
614653-146537.6497.85
60min114383-143837.5087.521.867.757.771.82
214391-143917.5127.75
314280-142807.4547.70
414821-148217.7367.99
514018-140187.3177.57
614543-145437.5917.84
极限113775-137757.1907.432.757.477.722.65
214905-149057.7808.06
314090-140907.3557.64
414412-144127.5237.82
514227-142277.4267.72
614012-140127.3147.60
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.741476971474711472441475831473571474700.13
210.731476611477351476980.04
单位质量响应值RSD%判断
13730.9113764.960.18数据可信
供试品溶液-2024011221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%
5min1108761-10876165.48365.3212.8265.4865.3212.82
287972-8797252.96752.97
3116536-11653670.16570.16
4113907-11390768.58268.58
597215-9721558.53258.53
6126509-12650976.16976.17
10min1143189-14318986.21288.464.1886.5888.824.18
2145535-14553587.62487.92
3138709-13870983.51583.90
4154916-15491693.27393.65
5145941-14594187.86988.19
6153238-15323892.26292.69
15min1146052-14605287.93690.063.9388.7890.923.92
2149459-14945989.98790.77
3140132-14013284.37185.23
4154681-15468193.13194.03
5151108-15110890.98091.79
6156068-15606893.96694.90
20min1145630-14563087.68290.264.6289.0191.614.60
2148940-14894089.67490.96
3139000-13900083.69085.01
4155989-15598993.91995.34
5152337-15233791.72093.04
6157543-15754394.85496.31
30min1139549-13954984.02089.774.3185.8491.624.28
2143439-14343986.36288.14
3150645-15064590.70192.49
4157120-15712094.60096.54
5151681-15168191.32593.15
6152140-15214091.60193.59
45min1148630-14863089.48894.864.9191.7797.214.84
2149987-14998790.30592.56
3159569-15956996.07498.37
4155029-15502993.34195.80
5167944-167944101.117103.45
6164157-16415798.836101.33
60min1149838-14983890.21597.346.4993.00100.226.40
2149545-14954590.03992.80
3162410-16241097.785100.61
4162796-16279698.017101.00
5169790-169790102.228105.13
6175640-175640105.750108.79
极限1161649-16164997.326101.192.42100.61104.622.33
2174050-174050104.793108.05
3169091-169091101.807105.18
4166702-166702100.369103.90
5169480-169480102.041105.51
6167453-167453100.821104.45
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%
110.521808321809151810061811771811151810090.08
210.471809431812811811120.14
单位质量响应值RSD%判断
17206.1817298.190.38数据可信
供试品溶液-2024011222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%
5min19943-99435.1745.746.175.175.746.18
210486-104865.4575.46
311486-114865.9775.98
411767-117676.1236.12
511286-112865.8735.87
611161-111615.8085.81
10min116127-161278.3928.541.708.428.571.71
216365-163658.5168.55
316828-168288.7578.79
416603-166038.6408.67
516437-164378.5538.59
616105-161058.3818.41
15min116370-163708.5198.421.598.598.501.54
216325-163258.4958.57
316183-161838.4218.50
416366-163668.5168.60
516161-161618.4108.49
615693-156938.1668.25
20min116241-162418.4518.301.598.578.421.53
216215-162158.4388.56
315612-156128.1248.25
415881-158818.2648.39
516003-160038.3288.45
615745-157458.1938.32
30min115124-151247.8707.811.178.047.981.17
214687-146877.6437.81
315034-150347.8238.00
415076-150767.8458.02
515175-151757.8978.07
614944-149447.7767.95
45min115245-152457.9337.850.788.158.070.79
215065-150657.8398.05
315182-151827.9008.12
414997-149977.8048.02
515110-151107.8638.08
614926-149267.7677.98
60min114562-145627.5787.561.247.847.821.22
214536-145367.5647.82
314835-148357.7207.98
414584-145847.5897.85
514340-143407.4627.72
614365-143657.4757.73
极限114636-146367.6167.462.517.927.772.44
214830-148307.7178.02
313922-139227.2457.55
414316-143167.4507.75
514404-144047.4957.80
613963-139637.2667.56
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.741477151477991479051478811478711478340.06
210.731483751485821484780.10
单位质量响应值RSD%判断
13764.8013837.650.38数据可信
供试品溶液-2024011222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%
5min1103346-10334661.98365.9812.1461.9865.9812.14
2112675-11267567.57867.58
3121575-12157572.91672.92
486941-8694152.14452.14
5112614-11261467.54267.54
6122929-12292973.72873.73
10min1147058-14705888.20090.123.5488.5490.493.57
2149394-14939489.60189.98
3158256-15825694.91695.32
4142589-14258985.52085.81
5152275-15227591.32991.70
6151990-15199091.15891.57
15min1153992-15399292.35992.942.1993.1993.812.21
2151985-15198591.15592.03
3161255-16125596.71597.65
4152694-15269491.58092.35
5156110-15611093.62994.51
6153714-15371492.19293.11
20min1154793-15479392.83993.051.3694.1994.431.39
2154585-15458592.71494.09
3158785-15878595.23396.70
4153441-15344192.02893.30
5156212-15621293.69095.09
6153036-15303691.78593.21
30min1149264-14926489.52390.822.6691.3992.722.63
2145929-14592987.52389.42
3157578-15757894.50996.51
4152253-15225391.31693.10
5153641-15364192.14894.07
6149937-14993789.92791.86
45min1156715-15671593.99292.962.0996.3595.362.08
2150388-15038890.19792.58
3159992-15999295.95798.48
4153760-15376092.22094.51
5155230-15523093.10195.54
6153839-15383992.26794.70
60min1153479-15347992.05193.143.6694.9396.063.63
2149377-14937789.59192.47
3164146-16414698.449101.51
4151600-15160090.92493.73
5160310-16031096.14899.10
6152893-15289391.70094.65
极限1166366-16636699.78097.761.41103.17101.201.34
2161382-16138296.791100.17
3163133-16313397.841101.45
4164440-16444098.625101.93
5162797-16279797.640101.13
6159836-15983695.86499.32
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%
110.521812011818451821991822661824081819840.27
210.471798211801251799730.12
单位质量响应值RSD%判断
17298.8617189.400.45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%
5min19448-94484.9195.598.374.925.588.38
210400-104005.4145.41
310399-103995.4145.41
410658-106585.5495.55
511461-114615.9675.97
612004-120046.2496.25
10min115449-154498.0438.272.188.078.302.18
216424-164248.5518.58
315889-158898.2728.30
415835-158358.2448.27
515632-156328.1388.17
616104-161048.3848.42
15min115796-157968.2248.331.478.308.401.44
216360-163608.5178.59
315846-158468.2508.33
415978-159788.3188.40
515793-157938.2228.30
616190-161908.4298.51
20min115500-155008.0708.345.408.198.465.32
215640-156408.1428.27
315796-157968.2248.35
416105-161058.3858.51
515364-153647.9998.12
617703-177039.2169.34
30min115085-150857.8547.992.038.028.161.99
215861-158618.2588.43
315477-154778.0588.23
415434-154348.0358.20
515055-150557.8388.01
615143-151437.8848.06
45min114095-140957.3387.541.687.547.751.68
214596-145967.5997.81
314770-147707.6907.90
414327-143277.4597.67
514476-144767.5367.75
614631-146317.6177.84
60min114541-145417.5707.581.467.827.841.45
214696-146967.6517.91
314301-143017.4457.70
414671-146717.6387.89
514320-143207.4557.71
614820-148207.7167.98
极限114696-146967.6517.482.947.947.782.86
214781-147817.6958.00
314215-142157.4017.70
414486-144867.5427.84
513616-136167.0897.38
614463-144637.5307.84
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.741479971484201485891487551487411485000.22
210.731465841466081465960.02
单位质量响应值RSD%判断
13826.8213662.260.85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%
5min1103968-10396862.61564.868.4862.6264.868.48
294756-9475657.06757.07
3119867-11986772.19072.19
4116494-11649470.15970.16
5105868-10586863.75963.76
6105175-10517563.34263.34
10min1139691-13969184.13089.613.2684.4889.973.27
2149452-14945290.00890.33
3152834-15283492.04592.45
4152999-15299992.14492.53
5149129-14912989.81490.17
6148632-14863289.51489.87
15min1143643-14364386.51092.543.4787.3293.403.46
2157145-15714594.64195.46
3153535-15353592.46793.38
4158829-15882995.65596.56
5153501-15350192.44793.30
6155292-15529293.52594.37
20min1143069-14306986.16493.004.0887.4694.374.06
2156879-15687994.48195.82
3153721-15372192.57994.01
4161772-16177297.42898.86
5153711-15371192.57393.94
6157331-15733194.75396.12
30min1143732-14373286.56392.983.9588.3494.863.93
2159359-15935995.97597.84
3155836-15583693.85395.79
4160833-16083396.86298.84
5153962-15396292.72494.61
6152558-15255891.87993.77
45min1139209-13920983.83992.535.0886.0994.945.03
2160525-16052596.67799.08
3154933-15493393.30995.77
4160427-16042796.61899.13
5153700-15370092.56694.96
6153060-15306092.18194.59
60min1146756-14675688.38494.944.4891.1197.864.43
2166846-166846100.484103.42
3154953-15495393.32196.30
4163155-16315598.261101.31
5155096-15509693.40796.32
6159002-15900295.76098.68
极限1168893-168893101.717100.571.20104.93104.021.10
2169179-169179101.889105.39
3164733-16473399.211102.71
4165284-16528499.543103.14
5165590-16559099.727103.16
6168245-168245101.326104.78
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%
110.521819861823501828591832341830111826880.28
210.471804961808901806930.16
单位质量响应值RSD%判断
17365.7817258.170.44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%
5min110763-107635.5815.336.945.585.336.92
29739-97395.0505.05
310838-108385.6205.62
49600-96004.9784.98
59561-95614.9584.96
611131-111315.7725.77
10min116532-165328.5738.641.048.608.661.04
216552-165528.5838.61
316793-167938.7088.74
416470-164708.5418.57
516921-169218.7758.80
616658-166588.6388.67
15min116588-165888.6028.612.138.688.692.12
216896-168968.7628.84
317130-171308.8838.96
416273-162738.4398.51
516573-165738.5948.67
616212-162128.4078.49
20min116187-161878.3948.342.688.528.462.64
216713-167138.6678.79
315631-156318.1068.23
416187-161878.3948.52
515553-155538.0658.19
616230-162308.4178.54
30min115046-150467.8038.032.547.988.212.45
215965-159658.2798.45
314988-149887.7727.95
415553-155538.0658.23
515722-157228.1538.32
615690-156908.1368.31
45min115589-155898.0848.012.418.308.232.35
215872-158728.2318.45
315021-150217.7908.01
414957-149577.7567.97
515563-155638.0718.28
615676-156768.1298.35
60min115304-153047.9367.852.328.208.112.28
215609-156098.0948.36
314925-149257.7408.00
414583-145837.5627.82
515255-152557.9118.17
615163-151637.8638.13
极限114983-149837.7707.751.858.088.051.79
215108-151087.8358.14
314520-145207.5307.83
414727-147277.6377.94
515293-152937.9318.23
615010-150107.7848.09
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.742955982968252970162972212973232967970.24
210.732936492940562938520.10
单位质量响应值RSD%判断
27634.7327386.020.64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%
5min1181373-18137354.57349.1415.9254.5749.1415.91
2149255-14925544.90944.91
3157386-15738647.35647.36
4196809-19680959.21859.22
5123055-12305537.02637.03
6171960-17196051.74151.74
10min1269746-26974681.16479.531.2181.4779.811.22
2265082-26508279.76080.01
3265289-26528979.82380.09
4263038-26303879.14579.47
5262190-26219078.89079.10
6260624-26062478.41978.71
15min1285371-28537185.86583.592.5086.6284.312.48
2284524-28452485.61086.30
3281303-28130384.64185.35
4272392-27239281.96082.73
5274935-27493582.72583.37
6268406-26840680.76081.48
20min1289095-28909586.98684.572.0688.2285.752.05
2287605-28760586.53787.71
3279472-27947284.09085.27
4276758-27675883.27484.50
5277165-27716583.39684.50
6276246-27624683.11984.29
30min1279041-27904183.96084.090.8785.6785.740.85
2282300-28230084.94186.59
3279334-27933484.04985.69
4280450-28045084.38486.07
5280591-28059184.42785.99
6275147-27514782.78984.42
45min1298649-29864989.86086.502.4992.0488.612.46
2293625-29362588.34990.47
3284952-28495285.73987.85
4283060-28306085.17087.33
5284729-28472985.67287.71
6279805-27980584.19086.28
60min1296919-29691989.34088.172.9992.0290.772.90
2295750-29575088.98891.60
3292516-29251688.01590.60
4278944-27894483.93186.56
5289071-28907186.97889.49
6305059-30505991.78994.35
极限1321944-32194496.87097.820.83100.05100.910.77
2326318-32631898.186101.29
3322351-32235196.992100.07
4326098-32609898.119101.21
5329125-32912599.030102.03
6324752-32475297.714100.79
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%
110.521830271833281835981837921837381834970.18
210.471812511818391815450.23
单位质量响应值RSD%判断
17442.6817339.540.42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%
5min19478-94784.8934.7113.044.894.7213.03
29403-94034.8544.85
310322-103225.3285.33
47607-76073.9273.93
57744-77443.9984.00
610239-102395.2865.29
10min116104-161048.3138.232.858.348.262.87
216311-163118.4208.45
316548-165488.5428.57
415362-153627.9307.95
515688-156888.0988.12
615630-156308.0688.10
15min116425-164258.4798.362.498.558.432.47
215836-158368.1758.25
316458-164588.4968.57
415879-158798.1978.26
516757-167578.6508.72
615816-158168.1648.24
20min116342-163428.4368.182.188.568.302.19
216113-161138.3188.44
315712-157128.1118.24
415534-155348.0198.13
515874-158748.1948.31
615444-154447.9728.09
30min114875-148757.6797.851.907.858.021.86
214979-149797.7327.90
315573-155738.0398.21
415265-152657.8808.04
515527-155278.0158.18
615079-150797.7847.95
45min115122-151227.8067.691.218.027.901.23
214888-148887.6857.89
315046-150467.7677.98
414892-148927.6877.89
514862-148627.6727.88
614602-146027.5387.74
60min114861-148617.6717.602.427.927.852.34
215075-150757.7828.03
314385-143857.4267.68
415008-150087.7477.99
514840-148407.6617.91
614191-141917.3267.57
极限114558-145587.5157.602.697.817.892.64
215040-150407.7648.06
315370-153707.9348.23
414383-143837.4257.71
514604-146047.5397.83
614393-143937.4307.72
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.742967422972152976222973822976942973310.13
210.732943862951282947570.18
单位质量响应值RSD%判断
27684.4527470.360.55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%
5min1185608-18560855.71150.0121.9755.7150.0121.97
2189250-18925056.80556.80
3128187-12818738.47638.48
4188672-18867256.63156.63
5111917-11191733.59333.59
6196113-19611358.86558.86
10min1249311-24931174.83278.654.9375.1478.934.95
2253827-25382776.18876.50
3255435-25543576.67076.88
4275857-27585782.80083.11
5257144-25714477.18377.37
6280638-28063884.23584.56
15min1263111-26311178.97483.165.2479.7083.885.24
2262940-26294078.92379.66
3269980-26998081.03681.68
4292468-29246887.78688.56
5277590-27759083.32083.94
6296346-29634688.95089.75
20min1265834-26583479.79283.174.9880.9684.354.98
2264431-26443179.37180.55
3266156-26615679.88880.98
4293530-29353088.10589.37
5279029-27902983.75284.83
6293508-29350888.09889.39
30min1254542-25454276.40283.426.0978.0185.066.05
2263873-26387379.20380.82
3275382-27538282.65884.19
4297627-29762789.33591.09
5281375-28137584.45686.00
6294651-29465188.44190.22
45min1288111-28811186.47885.684.4088.5187.794.42
2272009-27200981.64583.70
3271944-27194481.62683.62
4299777-29977789.98092.23
5281475-28147584.48786.50
6299484-29948489.89292.16
60min1295813-29581388.79087.223.3891.3089.803.42
2281119-28111984.38086.89
3281036-28103684.35586.80
4303003-30300390.94893.70
5283657-28365785.14187.62
6298949-29894989.73192.50
极限1330360-33036099.160100.161.19102.17103.221.27
2329399-32939998.871101.85
3332733-33273399.872102.79
4340224-340224102.120105.37
5333513-333513100.106103.06
6335847-335847100.807104.07
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2024-08-22 11:23:42 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-08-22 11:24:15 完成)
Current page cost:97 ms