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%
110.261729081728251728211728461727171728230.04
210.261732861744381738620.47
单位质量响应值RSD%判断
16844.3516945.610.43数据可信
供试品溶液-2023120823批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19461-94615.0235.248.655.025.248.65
211452-114526.0806.08
39001-90014.7794.78
49977-99775.2975.30
59957-99575.2875.29
69421-94215.0025.00
10min116828-168288.9358.944.108.968.974.10
217524-175249.3049.34
315843-158438.4128.44
417642-176429.3679.40
516886-168868.9668.99
616324-163248.6678.70
15min116937-169378.9939.261.739.079.341.74
217551-175519.3199.40
317394-173949.2359.31
417848-178489.4769.56
517527-175279.3069.39
617342-173429.2089.28
20min117932-179329.5219.322.019.659.441.96
217770-177709.4359.57
317833-178339.4689.59
417197-171979.1319.26
517092-170929.0759.21
617444-174449.2629.39
30min117204-172049.1349.242.299.319.422.25
217539-175399.3129.50
317863-178639.4849.66
417189-171899.1269.31
517774-177749.4379.62
616821-168218.9319.11
45min117407-174079.2429.061.729.479.291.68
216977-169779.0149.26
317220-172209.1439.37
417006-170069.0299.26
517225-172259.1469.38
616563-165638.7949.02
60min117136-171369.0989.001.709.389.281.68
217017-170179.0359.33
317279-172799.1749.45
416911-169118.9799.26
516909-169098.9789.26
616437-164378.7279.00
极限117194-171949.1299.081.749.469.411.72
217512-175129.2989.64
317209-172099.1379.47
416709-167098.8729.21
517178-171789.1219.46
616798-167988.9199.24
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%
110.821581881572231569091570091565781571810.39
210.861569341581191575260.54
单位质量响应值RSD%判断
14526.8914505.160.11数据可信
供试品溶液-2023120823批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142884-4288424.40220.2525.3924.4020.2525.39
250603-5060328.79428.79
331664-3166418.01818.02
430391-3039117.29317.29
528862-2886216.42316.42
629126-2912616.57316.57
10min185988-8598848.92942.8910.1949.0743.0010.22
282130-8213046.73446.89
375573-7557343.00343.10
473632-7363241.89941.99
569510-6951039.55339.64
665433-6543337.23337.33
15min1105473-10547360.01756.176.6360.4256.536.64
299426-9942656.57657.00
3106144-10614460.39960.74
496705-9670555.02855.36
595858-9585854.54654.86
688713-8871350.48050.78
20min1124588-12458870.89465.786.5471.6366.446.54
2114740-11474065.29066.02
3124914-12491471.07971.75
4111549-11154963.47464.11
5111196-11119663.27363.89
6106599-10659960.65861.24
30min1131291-13129174.70873.034.3375.8474.064.34
2125354-12535471.33072.43
3137949-13794978.49779.57
4126450-12645071.95372.94
5126939-12693972.23273.20
6122102-12210269.47970.40
45min1142656-14265681.17578.733.0582.7280.163.02
2130834-13083474.44875.94
3141694-14169480.62882.13
4138878-13887879.02580.41
5139011-13901179.10180.47
6137060-13706077.99179.29
60min1143196-14319681.48279.843.2583.4881.713.20
2131466-13146674.80876.71
3143963-14396381.91983.87
4142197-14219780.91482.74
5140985-14098580.22482.03
6140058-14005879.69781.43
极限1147790-14779084.09684.161.5186.5586.471.54
2151582-15158286.25488.58
3149180-14918084.88787.30
4146052-14605283.10785.38
5147312-14731283.82486.08
6145460-14546082.77184.95
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%
110.261749261758071763151763761765111759870.37
210.261747311758181752740.44
单位质量响应值RSD%判断
17152.7317083.240.29数据可信
供试品溶液-2023120823批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15856-58563.0694.9026.733.074.9026.77
210830-108305.6755.68
37694-76944.0324.03
412986-129866.8056.81
59980-99805.2305.23
68702-87024.5604.56
10min114530-145307.6148.476.337.638.506.38
216542-165428.6698.70
315331-153318.0348.06
417219-172199.0239.06
516580-165808.6888.72
616829-168298.8198.84
15min116627-166278.7138.982.638.779.062.68
216999-169998.9088.99
316678-166788.7408.81
417718-177189.2859.37
517531-175319.1879.26
617297-172979.0649.14
20min117541-175419.1929.100.909.309.220.83
217335-173359.0849.21
317531-175319.1879.30
417394-173949.1159.25
517128-171288.9769.10
617299-172999.0659.19
30min117216-172169.0228.961.049.189.130.94
216986-169868.9019.08
317355-173559.0959.26
417048-170488.9349.12
517122-171228.9729.15
616854-168548.8329.01
45min117498-174989.1698.902.179.389.132.02
217093-170938.9579.19
317158-171588.9919.21
416412-164128.6008.84
516962-169628.8899.12
616777-167778.7929.02
60min116945-169458.8808.751.729.149.021.64
216410-164108.5998.88
316711-167118.7579.02
416762-167628.7849.07
517054-170548.9379.21
616330-163308.5578.83
极限117282-172829.0568.772.389.379.092.20
216545-165458.6709.00
316992-169928.9049.22
416181-161818.4798.82
516881-168818.8469.17
616494-164948.6438.96
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%
110.821618541609431613411612921613441613550.21
210.861583431603411593420.89
单位质量响应值RSD%判断
14912.6614672.381.15数据可信
供试品溶液-2023120823批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129880-2988016.68620.0916.9916.6920.0916.99
241400-4140023.11923.12
332295-3229518.03418.03
435478-3547819.81219.81
545295-4529525.29425.29
631552-3155217.61917.62
10min175551-7555142.19040.5511.7342.2840.6611.71
276888-7688842.93643.06
377995-7799543.55543.65
459491-5949133.22133.33
581051-8105145.26145.40
664683-6468336.12136.22
15min1105684-10568459.01754.3311.1959.3454.6711.17
299824-9982455.74456.11
3106343-10634359.38559.73
481537-8153745.53245.83
5104586-10458658.40458.80
685819-8581947.92448.22
20min1123530-12353068.98363.9810.2869.6464.6210.26
2117055-11705565.36766.04
3127860-12786071.40172.07
497811-9781154.62055.17
5118238-11823866.02766.74
6102953-10295357.49258.06
30min1134802-13480275.27771.497.6476.3272.487.67
2129424-12942472.27473.31
3139667-13966777.99479.06
4114577-11457763.98364.83
5131618-13161873.49974.58
6118010-11801065.90066.78
45min1143434-14343480.09777.925.4481.5579.315.51
2141852-14185279.21480.66
3148769-14876983.07784.58
4129264-12926472.18573.39
5142567-14256779.61381.10
6131323-13132373.33474.58
60min1142289-14228979.45879.103.9181.3680.923.98
2139826-13982678.08379.96
3147225-14722582.21484.18
4137889-13788977.00178.61
5148505-14850582.92984.86
6134123-13412374.89876.56
极限1147887-14788782.58482.272.3484.9384.542.45
2145185-14518581.07583.39
3152190-15219084.98787.41
4144342-14434280.60582.64
5150465-15046584.02486.42
6143872-14387280.34282.42
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%
110.261723871721741723401723391725411723560.08
210.261709561716301712930.28
单位质量响应值RSD%判断
16798.8316695.220.44数据可信
供试品溶液-X007293批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19616-96165.1515.6814.225.155.6814.20
29575-95755.1295.13
39326-93264.9955.00
413201-132017.0717.07
510335-103355.5365.54
611530-115306.1766.18
10min116458-164588.8169.133.898.849.163.93
216662-166628.9258.95
316258-162588.7088.74
417840-178409.5569.60
517593-175939.4249.45
617433-174339.3389.37
15min117529-175299.3899.490.819.479.570.83
217640-176409.4499.53
317727-177279.4959.57
417959-179599.6209.71
517752-177529.5099.59
617699-176999.4809.57
20min118342-183429.8259.811.059.959.951.00
218523-185239.92210.05
318350-183509.8299.96
418353-183539.8319.98
518392-183929.8519.99
617953-179539.6169.76
30min117636-176369.4479.510.919.639.700.89
217671-176719.4659.65
317929-179299.6039.79
417551-175519.4019.60
517834-178349.5539.74
617928-179289.6039.80
45min118178-181789.7379.572.249.979.812.13
218155-181559.7259.96
317973-179739.6279.86
417359-173599.2989.55
518188-181889.7429.99
617376-173769.3079.55
60min117762-177629.5149.421.469.809.711.37
217575-175759.4149.71
317990-179909.6369.93
417320-173209.2779.58
517476-174769.3619.66
617364-173649.3019.60
极限118082-180829.6859.522.3810.039.872.25
217600-176009.4279.77
318441-184419.87810.22
417343-173439.2909.65
517767-177679.5179.87
617409-174099.3259.67
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%
110.821569261551821551881552301554031555860.49
210.861533451541641537540.38
单位质量响应值RSD%判断
14379.4814157.831.10数据可信
供试品溶液-X007293批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110586-105866.12913.1335.156.1313.1335.14
229771-2977117.23517.24
331639-3163918.31718.32
424998-2499814.47214.47
516749-167499.6969.70
622314-2231412.91812.92
10min144070-4407025.51337.6218.2725.5537.6918.29
274930-7493043.37943.47
370526-7052640.82940.93
475956-7595643.97344.05
563114-6311436.53836.59
661288-6128835.48135.55
15min171611-7161141.45754.9213.8441.6355.2013.88
2106945-10694561.91362.25
3105316-10531660.97061.30
4100626-10062658.25558.58
595469-9546955.27055.53
689203-8920351.64251.91
20min194272-9427254.57767.6510.4254.9868.2410.47
2127420-12742073.76774.45
3126458-12645873.21073.88
4119220-11922069.02069.67
5120094-12009469.52670.09
6113676-11367665.81066.37
30min1110324-11032463.86975.577.7464.5876.537.80
2134181-13418177.68178.77
3137740-13774079.74180.82
4131676-13167676.23177.26
5133988-13398877.56978.52
6135265-13526578.30879.23
45min1136493-13649379.01983.863.1880.0885.243.30
2147400-14740085.33486.86
3147926-14792685.63887.16
4142919-14291982.74084.19
5148801-14880186.14587.53
6145602-14560284.29385.65
60min1142218-14221882.33483.801.6683.8485.651.71
2141689-14168982.02784.02
3147211-14721185.22487.22
4144365-14436583.57785.49
5146014-14601484.53186.39
6147047-14704785.12986.95
极限1150588-15058887.17985.941.7789.1488.251.65
2143995-14399583.36285.81
3151185-15118587.52589.99
4147018-14701885.11387.49
5149132-14913286.33688.67
6148719-14871986.09788.40
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%
110.261728101738191747691756281760511746150.76
210.261723761725451724600.07
单位质量响应值RSD%判断
17019.0116808.970.88数据可信
供试品溶液-X007293批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112464-124646.6115.919.716.615.919.74
212269-122696.5076.51
310108-101085.3615.36
411438-114386.0666.07
59940-99405.2725.27
610661-106615.6545.65
10min116775-167758.8979.123.238.939.163.23
217977-179779.5349.57
316717-167178.8668.90
417765-177659.4229.46
516754-167548.8868.92
617201-172019.1239.15
15min117620-176209.3459.461.039.439.550.98
217649-176499.3609.45
317955-179559.5239.60
417803-178039.4429.53
518011-180119.5529.63
618039-180399.5679.65
20min117124-171249.0829.572.869.229.712.80
218071-180719.5849.73
318600-186009.86510.00
417913-179139.5009.64
518211-182119.6599.79
618392-183929.7559.89
30min117409-174099.2339.421.419.429.611.37
217558-175589.3129.51
317908-179089.4989.68
417707-177079.3919.58
518063-180639.5809.77
617935-179359.5129.70
45min117769-177699.4249.541.129.669.781.11
218122-181229.6119.86
318153-181539.6289.87
417704-177049.3909.63
518090-180909.5949.83
618116-181169.6089.85
60min117141-171419.0919.312.409.389.602.31
216962-169628.9969.30
317810-178109.4469.74
417606-176069.3389.63
517725-177259.4019.69
618064-180649.5819.88
极限117586-175869.3279.391.529.679.741.45
217509-175099.2869.64
317860-178609.4729.82
417494-174949.2789.63
517616-176169.3439.69
618184-181849.6449.99
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%
110.821575081572591587921585141596301583410.62
210.861549711563731556720.64
单位质量响应值RSD%判断
14634.1014334.441.47数据可信
供试品溶液-X007293批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121923-2192312.50314.2539.0712.5014.2539.07
220374-2037411.62011.62
319390-1939011.05911.06
415578-155788.8858.88
542192-4219224.06424.06
630445-3044517.36417.36
10min173777-7377742.07840.4620.0042.1540.5420.00
246605-4660526.58026.65
363763-6376336.36636.43
473490-7349041.91441.96
585796-8579648.93249.07
682191-8219146.87646.97
15min1100835-10083557.51057.4412.2857.8157.7412.32
277546-7754644.22744.44
3100070-10007057.07357.34
4103695-10369559.14159.42
5112378-11237864.09364.50
6109755-10975562.59762.95
20min1114245-11424565.15868.539.0465.7869.159.09
2100892-10089257.54258.00
3123961-12396170.69971.28
4123887-12388770.65771.27
5128875-12887573.50274.26
6129057-12905773.60674.31
30min1132937-13293775.81976.665.7876.8077.665.87
2119381-11938168.08768.86
3137034-13703478.15579.13
4138014-13801478.71479.72
5139239-13923979.41380.58
6139887-13988779.78280.90
45min1148222-14822284.53684.571.9385.9486.002.06
2143892-14389282.06783.22
3149245-14924585.12086.53
4146657-14665783.64485.08
5149239-14923985.11686.73
6152403-15240386.92188.48
60min1142348-14234881.18683.393.0883.0685.293.16
2140602-14060280.19081.80
3146204-14620483.38585.27
4148387-14838784.63086.54
5146491-14649183.54985.63
6153273-15327387.41789.46
极限1150350-15035085.75085.402.2588.0887.772.29
2146112-14611283.33385.39
3150167-15016785.64587.99
4150038-15003885.57287.95
5146424-14642483.51186.06
6155362-15536288.60891.13
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