非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.203985885398691639889413986858398129239859780.08
210.364044862404198340434220.06
单位质量响应值RSD%判断
390782.16390291.700.09数据可信
供试品溶液-4226A批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11126893-112689325.96922.2213.0925.9722.2213.10
2753276-75327617.35917.36
31033908-103390823.82723.83
41005272-100527223.16723.17
5937861-93786121.61321.61
6926903-92690321.36121.36
10min12275736-227573652.44551.392.8952.5051.442.90
22102604-210260448.45548.49
32228828-222882851.36451.42
42265422-226542252.20752.26
52257149-225714952.01652.06
62249908-224990851.85051.90
15min12668387-266838761.49463.211.9261.6763.371.91
22697488-269748862.16462.31
32738062-273806263.09963.27
42764842-276484263.71663.88
52779883-277988364.06364.23
62808290-280829064.71864.88
20min13010685-301068569.38268.581.0269.6968.881.01
22964590-296459068.32068.60
32923380-292338067.37067.68
42995817-299581769.03969.35
52981022-298102268.69869.00
62979199-297919968.65668.96
30min13304341-330434176.14975.420.9476.6175.880.94
23272011-327201175.40475.84
33236053-323605374.57675.03
43254331-325433174.99775.46
53255905-325590575.03375.49
63314273-331427376.37876.84
45min13542187-354218781.63081.160.6982.2681.780.69
23512223-351222380.94081.54
33486994-348699480.35880.98
43533308-353330881.42682.05
53506964-350696480.81981.44
63550155-355015581.81482.44
60min13691433-369143385.07084.370.8085.8985.180.80
23658381-365838184.30885.09
33613146-361314683.26684.07
43671000-367100084.59985.41
53645350-364535084.00884.81
63687279-368727984.97485.78
极限13806108-380610887.71387.592.4788.7288.582.44
23850821-385082188.74389.71
33807193-380719387.73888.72
43618703-361870383.39484.39
53838624-383862488.46289.45
63882512-388251289.47390.47
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.203990864398739839856593986937399278539887290.08
210.364078124407783740779800.01
单位质量响应值RSD%判断
391051.86393627.410.47数据可信
供试品溶液-4226A批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1613692-61369214.07816.8432.2214.0816.8432.22
2512227-51222711.75011.75
3920450-92045021.11521.11
41057671-105767124.26324.26
5473592-47359210.86410.86
6827323-82732318.97818.98
10min11880662-188066243.14244.188.7343.1744.228.75
21761612-176161240.41140.44
32108035-210803548.35748.40
42113229-211322948.47748.53
51721044-172104439.48039.50
61971598-197159845.22845.27
15min12522386-252238657.86258.773.2957.9958.903.31
22443319-244331956.04956.16
32679924-267992461.47661.63
42609213-260921359.85460.02
52516382-251638257.72557.84
62600413-260041359.65259.79
20min12814330-281433064.55965.592.7264.8265.862.74
22774903-277490363.65563.90
32965714-296571468.03268.32
42873900-287390065.92666.22
52794968-279496864.11564.36
62932138-293213867.26267.54
30min13194105-319410573.27173.912.2873.6774.332.29
23154616-315461672.36572.75
33308655-330865575.89976.34
43183799-318379973.03573.48
53170543-317054372.73173.11
63321237-332123776.18876.61
45min13482595-348259579.88980.452.3180.4581.022.31
23423649-342364978.53779.08
33580294-358029482.13082.74
43451082-345108279.16679.77
53473383-347338379.67880.22
63631041-363104183.29483.89
60min13673687-367368784.27384.622.2385.0185.382.24
23633706-363370683.35684.07
33753907-375390786.11386.91
43622435-362243583.09783.88
53626729-362672983.19683.92
63823218-382321887.70388.48
极限13890239-389023989.24089.271.1190.1790.221.11
23878776-387877688.97789.88
33896895-389689589.39390.38
43829069-382906987.83788.80
53892066-389206689.28290.19
63963250-396325090.91591.89
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.204061058406046540601744053273405726040584460.08
210.364123553412503741242950.03
单位质量响应值RSD%判断
397886.86398097.970.04数据可信
供试品溶液-4226A批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1568874-56887412.86419.2539.9812.8619.2539.98
2489837-48983711.07711.08
3828950-82895018.74518.75
41347538-134753830.47330.47
51167577-116757726.40326.40
6703982-70398215.91915.92
10min12117446-211744647.88349.7412.8847.9149.7812.90
21700200-170020038.44738.47
32237372-223737250.59550.64
42437943-243794355.13055.20
52493568-249356856.38856.45
62211095-221109550.00150.04
15min12768806-276880662.61263.096.8462.7563.246.87
22431260-243126054.97955.09
32828280-282828063.95764.11
42923300-292330066.10666.30
52971180-297118067.18967.37
62816609-281660963.69363.84
20min13125025-312502570.66870.684.2170.9470.974.24
22872247-287224764.95265.18
33155697-315569771.36171.66
43206178-320617872.50372.84
53244674-324467473.37373.71
63148270-314827071.19371.48
30min13513392-351339279.45079.402.1079.8879.852.14
23366156-336615676.12176.50
33548121-354812180.23580.69
43543505-354350580.13180.63
53568290-356829080.69281.19
63527620-352762079.77280.22
45min13823374-382337486.46086.360.9487.0786.990.98
23749176-374917684.78285.33
33839822-383982286.83287.46
43837927-383792786.78987.47
53844455-384445586.93787.61
63818645-381864586.35386.98
60min13993218-399321890.30190.380.6091.1091.200.64
23956795-395679589.47790.21
34022878-402287890.97191.80
43988836-398883690.20291.07
54018606-401860690.87591.74
63999758-399975890.44991.26
极限14115833-411583393.07392.930.4294.0793.940.45
24085009-408500992.37693.31
34115938-411593893.07694.10
44091075-409107592.51493.58
54127756-412775693.34394.41
64120504-412050493.17994.20
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