奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.524530204527734524954524844517574525060.11
213.504586544535994561260.79
单位质量响应值RSD%判断
33469.3833787.110.67数据可信
长期6月-供试品溶液-2024102421批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118778-187784.1673.1550.194.173.1550.19
216821-168213.7333.73
315448-154483.4283.43
415267-152673.3883.39
518817-188174.1764.18
6-0.0000.00
10min154870-5487012.1779.6418.8612.229.6718.90
236226-362268.0398.08
340767-407679.0479.08
447345-4734510.50710.54
548259-4825910.70910.76
633099-330997.3457.35
15min188895-8889519.72716.7811.9219.9116.9312.01
265345-6534514.50114.63
375371-7537116.72616.86
478187-7818717.35117.51
580213-8021317.80117.97
665782-6578214.59814.68
20min1118970-11897026.40123.279.4726.8023.609.55
291761-9176120.36320.66
3106056-10605623.53623.86
4106839-10683923.70924.06
5110027-11002724.41724.78
695394-9539421.17021.41
30min1165011-16501136.61933.775.1737.3134.355.27
2140857-14085731.25931.78
3150629-15062933.42734.01
4154665-15466534.32334.93
5152389-15238933.81834.45
6149417-14941733.15833.64
45min1220536-22053648.94146.614.0350.0447.574.12
2195526-19552643.39044.26
3211234-21123446.87647.83
4212911-21291147.24848.24
5213612-21361247.40448.41
6206298-20629845.78146.63
60min1256457-25645756.91255.832.7458.5657.312.78
2240525-24052553.37654.72
3257742-25774257.19758.68
4256361-25636156.89158.41
5246190-24619054.63456.17
6252091-25209155.94357.30
极限1285129-28512963.27563.161.6365.5565.261.69
2275608-27560861.16263.10
3289180-28918064.17466.29
4286378-28637863.55265.70
5285342-28534263.32265.47
6285915-28591563.44965.43
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.524525034491694495724483764481674495570.39
213.504465484475944470710.17
单位质量响应值RSD%判断
33251.2633116.370.29数据可信
长期6月-供试品溶液-2024102521批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110996-109962.4732.5052.032.472.5052.06
214172-141723.1873.19
312030-120302.7052.71
4-0.0000.00
512779-127792.8742.87
616609-166093.7353.74
10min144422-444229.9908.4119.8510.028.4419.90
241058-410589.2339.27
331336-313367.0477.08
425420-254205.7175.72
542722-427229.6089.64
639459-394598.8748.92
15min174074-7407416.65814.4613.4116.8014.5813.51
268511-6851115.40715.55
357898-5789813.02013.13
450517-5051711.36011.42
569370-6937015.60015.74
665492-6549214.72814.87
20min199877-9987722.46120.229.2722.7820.509.38
294766-9476621.31121.62
383690-8369018.82119.07
476730-7673017.25517.45
592924-9292420.89721.21
691579-9157920.59520.90
30min1150191-15019133.77630.847.6334.3531.357.72
2144916-14491632.58933.14
3131507-13150729.57430.04
4120365-12036527.06827.45
5138688-13868831.18931.73
6137197-13719730.85431.39
45min1205062-20506246.11543.633.9047.0644.484.02
2196030-19603044.08444.99
3192481-19248143.28644.08
4182258-18225840.98741.67
5197187-19718744.34445.24
6191079-19107942.97143.85
60min1243898-24389854.84953.712.5956.3155.042.71
2237186-23718653.33954.74
3238119-23811953.54954.82
4227910-22791051.25352.39
5244960-24496055.08856.47
6240875-24087554.16955.52
极限1283825-28382563.82863.271.6665.9065.211.73
2281991-28199163.41565.41
3276370-27637062.15164.02
4278592-27859262.65164.36
5289082-28908265.01067.01
6278297-27829762.58564.54
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.524459364478674476024473214473314472110.17
213.504480304450454465380.48
单位质量响应值RSD%判断
33077.7433076.890.01数据可信
长期6月-供试品溶液-2024102621批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112962-129622.9243.6619.862.923.6619.89
212794-127942.8862.89
317554-175543.9603.96
415157-151573.4203.42
517629-176293.9773.98
621174-211744.7774.78
10min149294-4929411.12110.465.2011.1510.505.14
246338-4633810.45410.49
348943-4894311.04211.09
444619-4461910.06610.10
545739-4573910.31910.36
643154-431549.7369.79
15min178262-7826217.65716.693.9917.8116.843.93
275827-7582717.10717.26
374767-7476716.86817.03
472871-7287116.44016.59
572067-7206716.25916.42
669965-6996515.78515.95
20min1100233-10023322.61321.584.5622.9721.924.52
298191-9819122.15322.49
396728-9672821.82322.18
497852-9785222.07622.41
592155-9215520.79121.13
688634-8863419.99720.33
30min1142707-14270732.19630.834.8432.8031.414.80
2139418-13941831.45432.04
3140871-14087131.78232.38
4139911-13991131.56532.14
5130830-13083029.51630.09
6126086-12608628.44629.00
45min1185097-18509741.75942.352.8842.7243.272.87
2193864-19386443.73744.67
3190908-19090843.07044.02
4192514-19251443.43344.36
5182821-18282141.24642.14
6181075-18107540.85241.73
60min1225811-22581150.94551.662.2952.3753.062.28
2229999-22999951.89053.31
3233037-23303752.57554.00
4234170-23417052.83154.24
5230863-23086352.08453.44
6220087-22008749.65350.98
极限1256683-25668357.91058.111.3759.9060.071.38
2256807-25680757.93859.93
3256807-25680757.93859.95
4262092-26209259.13061.13
5260765-26076558.83160.77
6252136-25213656.88458.76
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