依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.311702121704561695401702821705771702130.24
211.361705711708821707260.13
单位质量响应值RSD%判断
15049.7815028.700.10数据可信
供试品溶液-CLB01071批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118477-11847767.45665.285.4767.4665.285.47
2113599-11359964.67964.68
3106783-10678360.79860.80
4123813-12381370.49470.49
5109007-10900762.06462.06
6116289-11628966.21166.21
10min1156157-15615788.91088.252.8389.2888.622.84
2153684-15368487.50287.86
3152339-15233986.73687.07
4159574-15957490.85591.25
5148499-14849984.55084.89
6159780-15978090.97391.34
15min1169897-16989796.73394.206.7097.6095.056.67
2164709-16470993.77994.62
3144039-14403982.01082.83
4174991-17499199.633100.53
5167134-16713495.16095.97
6171884-17188497.86498.74
20min1171425-17142597.60398.402.8799.0199.782.87
2167674-16767495.46796.83
3167603-16760395.42796.70
4180413-180413102.720104.17
5174821-17482199.536100.88
6175047-17504799.665101.08
30min1178352-178352101.547101.703.36103.50103.623.36
2172891-17289198.438100.33
3174826-17482699.539101.34
4188569-188569107.364109.38
5174443-17444399.321101.22
6182668-182668104.004105.97
45min1179900-179900102.428101.183.12104.94103.663.12
2172372-17237298.142100.59
3171755-17175597.791100.15
4186906-186906106.417109.03
5178051-178051101.375103.82
6177223-177223100.904103.45
60min1175687-175687100.029101.023.20103.11104.073.19
2170781-17078197.236100.23
3176072-176072100.249103.15
4185963-185963105.880109.09
5173643-17364398.866101.88
6182412-182412103.858106.97
极限1170492-17049297.07299.343.74100.71102.963.71
2168936-16893696.18699.71
3169388-16938896.44399.90
4183152-183152104.280108.08
5172657-17265798.304101.86
6182281-182281103.784107.47
依折麦布瑞舒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对照品来源工作对照品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%
111.081849981836851860191853341846781849430.47
211.171855121856471855800.06
单位质量响应值RSD%判断
16691.6116614.150.33数据可信
供试品溶液-CLB01071批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18239-82394.4424.5826.134.444.5826.16
212365-123656.6666.67
36759-67593.6443.64
48498-84984.5814.58
56005-60053.2373.24
69082-90824.8964.90
10min116121-161218.6918.933.958.728.963.99
217499-174999.4349.47
316283-162838.7788.80
416682-166828.9939.02
515732-157328.4818.50
617097-170979.2179.24
15min118236-182369.8319.308.539.909.378.51
218751-1875110.10910.20
314753-147537.9538.02
416405-164058.8448.92
517317-173179.3369.40
618035-180359.7239.80
20min117058-170589.1969.624.639.329.744.56
218323-183239.87810.02
318233-182339.8299.94
417554-175549.4639.59
519010-1901010.24810.37
616863-168639.0919.22
30min117969-179699.6879.454.209.879.644.25
218674-1867410.06710.27
317083-170839.2099.38
416910-169109.1169.29
516787-167879.0509.22
617798-177989.5959.78
45min116701-167019.0039.161.809.249.401.64
216768-167689.0409.30
317132-171329.2369.45
417201-172019.2739.50
517448-174489.4069.63
616751-167519.0309.27
60min117338-173389.3479.293.369.639.573.17
216598-165988.9489.25
318233-182339.82910.10
417262-172629.3069.59
517224-172249.2859.56
616726-167269.0179.30
极限117429-174299.3969.162.909.739.502.87
217286-172869.3199.68
316391-163918.8369.16
416356-163568.8189.15
517170-171709.2569.58
617364-173649.3619.70
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.311693671704551697061699121717461702370.55
211.361723561719251721400.18
单位质量响应值RSD%判断
15051.9015153.170.48数据可信
供试品溶液-CLB01071批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102748-10274858.25663.947.4958.2663.947.48
2118848-11884867.38567.38
3109434-10943462.04762.05
4122526-12252669.47069.47
5118900-11890067.41467.41
6104141-10414159.04659.05
10min1154686-15468687.70487.551.8988.0387.901.89
2150495-15049585.32885.70
3154151-15415187.40187.75
4159057-15905790.18290.57
5152435-15243586.42886.80
6155628-15562888.23888.57
15min1169293-16929395.98695.430.7396.8096.280.71
2167566-16756695.00795.86
3167049-16704994.71495.54
4167360-16736094.89095.78
5168480-16848095.52596.38
6170176-17017696.48797.30
20min1172929-17292998.04897.532.3399.3998.902.31
2165511-16551193.84295.22
3168832-16883295.72597.08
4175231-17523199.353100.77
5174058-17405898.688100.07
6175544-17554499.530100.88
30min1175264-17526499.37198.352.05101.26100.262.02
2167640-16764095.04996.95
3171425-17142597.19599.08
4173001-17300198.088100.05
5176584-176584100.120102.05
6176873-176873100.284102.19
45min1175816-17581699.68498.601.66102.13101.071.63
2170017-17001796.39698.82
3171290-17129097.11899.55
4174307-17430798.829101.34
5174217-17421798.778101.27
6177825-177825100.823103.29
60min1175021-17502199.23499.462.00102.23102.471.94
2174446-17444698.908101.87
3175579-17557999.550102.52
4175362-17536299.427102.49
5170609-17060996.73299.77
6181476-181476102.894105.92
极限1177916-177916100.87599.522.58104.42103.082.51
2170175-17017596.486100.00
3172021-17202197.533101.05
4175194-17519499.332102.94
5174975-17497599.208102.78
6182924-182924103.715107.31
依折麦布瑞舒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对照品来源工作对照品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%
111.081853171854401862931861081851001856520.28
211.171850981858081854530.28
单位质量响应值RSD%判断
16755.6016602.780.65数据可信
供试品溶液-CLB01071批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110594-105945.7026.129.355.706.129.30
212901-129016.9446.94
310660-106605.7385.74
411878-118786.3936.39
512048-120486.4856.48
610154-101545.4655.47
10min116636-166368.9549.025.458.999.065.42
216949-169499.1239.16
316310-163108.7798.81
418240-182409.8189.85
515467-154678.3258.36
616960-169609.1299.16
15min116302-163028.7759.103.758.869.183.74
217808-178089.5859.67
316914-169149.1049.18
417420-174209.3769.47
516159-161598.6988.78
616814-168149.0509.13
20min116792-167929.0389.256.179.179.386.12
216919-169199.1079.25
317242-172429.2819.41
419206-1920610.33810.48
516770-167709.0279.16
616127-161278.6808.81
30min116849-168499.0699.453.619.259.643.64
218094-180949.7399.93
317953-179539.6639.85
418311-183119.85610.06
517080-170809.1939.37
617046-170469.1759.35
45min116332-163328.7918.885.979.029.125.89
218341-183419.87210.12
316092-160928.6628.90
416740-167409.0109.26
515693-156938.4478.68
615757-157578.4818.71
60min116960-169609.1299.116.649.419.406.53
218053-180539.71710.02
316706-167068.9929.28
417978-179789.6779.98
514956-149568.0508.33
616950-169509.1239.40
极限116253-162538.7488.946.699.089.286.58
216609-166098.9409.30
317450-174509.3939.73
418319-183199.86010.22
515470-154708.3278.65
615555-155558.3738.70
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.311714271704111703241706961712871708290.30
211.361727571734731731150.30
单位质量响应值RSD%判断
15104.2415239.000.63数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110769-11076962.51962.292.3762.5262.292.37
2110760-11076062.51362.51
3106349-10634960.02460.02
4110753-11075362.50962.51
5109161-10916161.61161.61
6114373-11437364.55364.55
10min1149267-14926784.24784.771.6484.5985.121.63
2150312-15031284.83785.18
3152931-15293186.31586.65
4147746-14774683.38983.74
5147665-14766583.34383.69
6153245-15324586.49286.85
15min1161977-16197791.42190.911.7692.2491.731.75
2159144-15914489.82290.64
3165245-16524593.26594.08
4158409-15840989.40790.22
5158521-15852189.47090.28
6163147-16314792.08192.92
20min1166951-16695194.22893.840.9695.5595.160.96
2164393-16439392.78494.10
3166602-16660294.03195.36
4164503-16450392.84694.15
5166563-16656394.00995.31
6168567-16856795.14096.49
30min1167448-16744894.50894.842.0296.3696.682.00
2163240-16324092.13393.97
3171294-17129496.67998.53
4167740-16774094.67396.50
5166033-16603393.71095.53
6172418-17241897.31399.19
45min1169658-16965895.75695.571.6698.1397.941.65
2167570-16757094.57796.92
3173477-17347797.911100.30
4167107-16710794.31696.66
5166449-16644993.94596.29
6171751-17175196.93799.36
60min1169758-16975895.81294.781.7198.7297.681.67
2164421-16442192.80095.67
3171236-17123696.64699.58
4165808-16580893.58396.46
5170392-17039296.17099.04
6165911-16591193.64196.60
极限1167411-16741194.48894.091.3497.9297.511.32
2163874-16387492.49195.88
3167986-16798694.81298.28
4168084-16808494.86798.26
5163905-16390592.50995.91
6168940-16894095.35098.83
依折麦布瑞舒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对照品来源工作对照品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%
111.081864801877241869221870201866281869550.26
211.171878371899321888840.79
单位质量响应值RSD%判断
16873.1916909.940.16数据可信
供试品溶液-CLB03646批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18390-83904.4594.317.864.464.317.85
28341-83414.4334.43
37525-75253.9994.00
49071-90714.8214.82
58020-80204.2624.26
67319-73193.8903.89
10min117559-175599.3328.953.539.368.983.54
216162-161628.5908.61
316097-160978.5558.58
417160-171609.1209.15
516915-169158.9909.01
617191-171919.1379.16
15min119189-1918910.1999.654.2810.289.734.30
218037-180379.5869.66
317618-176189.3649.43
418967-1896710.08110.16
517174-171749.1289.20
618007-180079.5709.64
20min117739-177399.4289.341.769.569.471.79
217467-174679.2839.41
317015-170159.0439.16
417661-176619.3869.52
517689-176899.4019.53
617894-178949.5109.64
30min117268-172689.1789.222.329.369.402.29
216771-167718.9139.09
317570-175709.3389.51
417906-179069.5179.70
517058-170589.0669.24
617487-174879.2949.47
45min118717-187179.9489.514.6010.189.744.53
216806-168068.9329.16
318240-182409.6949.92
418822-1882210.00310.24
517377-173779.2369.46
617367-173679.2309.46
60min117752-177529.4359.255.049.739.544.94
216335-163358.6828.96
316374-163748.7028.98
418352-183529.75410.05
518188-181889.6679.94
617458-174589.2799.56
极限117286-172869.1878.903.069.539.233.02
216608-166088.8279.15
315792-157928.3938.72
416968-169689.0189.37
516863-168638.9629.29
616902-169028.9839.32
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.311690761689251693181698691689791692330.23
211.361707731722181714960.60
单位质量响应值RSD%判断
14963.1315096.480.63数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104341-10434159.44664.307.1359.4564.307.13
2115109-11510965.58165.58
3118371-11837167.44067.44
4109466-10946662.36662.37
5124835-12483571.12271.12
6105079-10507959.86759.87
10min1145347-14534782.80984.893.3083.1485.243.31
2145812-14581283.07383.44
3147935-14793584.28384.66
4145678-14567882.99783.34
5157950-15795089.98990.38
6151245-15124586.16986.50
15min1155959-15595988.85591.773.4689.6492.603.47
2158869-15886990.51291.34
3161100-16110091.78492.63
4157598-15759889.78890.60
5171663-17166397.80298.70
6161225-16122591.85592.67
20min1129270-12927073.64991.369.8774.9392.709.76
2160987-16098791.71993.05
3165309-16530994.18195.53
4163876-16387693.36594.67
5172912-17291298.51399.95
6169794-16979496.73798.06
30min1165354-16535494.20796.213.7595.9098.053.75
2164667-16466793.81695.65
3166409-16640994.80896.68
4163302-16330293.03894.86
5178927-178927101.940103.93
6174519-17451999.429101.29
45min1165599-16559994.34796.043.0396.5698.423.04
2166418-16641894.81397.17
3165464-16546494.27096.67
4163794-16379493.31895.66
5175187-17518799.809102.36
6174933-17493399.665102.08
60min1167520-16752095.44194.235.0798.1897.144.97
2159224-15922490.71593.60
3153006-15300687.17290.10
4164714-16471493.84396.70
5175887-175887100.208103.31
6172039-17203998.016100.98
极限1165894-16589494.51595.973.3097.7999.413.29
2164651-16465193.80797.20
3165953-16595394.54897.96
4163342-16334293.06196.44
5174239-17423999.269102.93
6176640-176640100.637104.15
依折麦布瑞舒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对照品来源工作对照品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%
111.081870011867781859851861291868461865480.25
211.171877061872181874620.19
单位质量响应值RSD%判断
16836.4616782.630.23数据可信
供试品溶液-CLB03646批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19169-91694.8975.9813.424.905.9813.38
212717-127176.7926.79
313002-130026.9446.94
411060-110605.9075.91
511293-112936.0316.03
69943-99435.3105.31
10min116695-166958.9169.404.368.949.444.41
218133-181339.6849.72
318103-181039.6689.71
417284-172849.2319.26
518560-185609.9129.95
616846-168468.9979.03
15min117662-176629.4339.363.479.519.443.44
218110-181109.6729.76
317397-173979.2919.38
416763-167638.9539.04
518259-182599.7529.84
616937-169379.0469.13
20min113384-133847.1489.1211.437.289.2611.30
219162-1916210.23410.38
317892-178929.5569.70
417659-176599.4319.57
517108-171089.1379.28
617249-172499.2129.34
30min117076-170769.1209.474.299.299.664.24
217045-170459.1039.31
317533-175339.3649.56
418610-186109.93910.13
518767-1876710.02310.22
617404-174049.2959.48
45min117260-172609.2189.351.489.449.601.49
217513-175139.3539.61
317476-174769.3339.58
417346-173469.2649.51
518002-180029.6149.86
617502-175029.3479.58
60min116331-163318.7228.794.438.999.084.32
217487-174879.3399.64
315369-153698.2088.51
416594-165948.8629.16
516924-169249.0399.34
616061-160618.5788.86
极限118481-184819.8709.264.0610.199.603.86
217680-176809.4429.80
316467-164678.7959.14
417484-174849.3389.68
517023-170239.0929.44
616922-169229.0389.37
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