地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90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%
110.031660249165800916589211657563166084016591160.09
210.151655684165606016558720.02
单位质量响应值RSD%判断
165415.35163140.100.98数据可信
供试品溶液-ACSB23064批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12978-29780.1810.189.590.180.189.66
23484-34840.2120.21
32697-26970.1640.16
42997-29970.1820.18
52776-27760.1690.17
62812-28120.1710.17
15min13186-31860.1940.217.710.190.217.91
23811-38110.2320.23
33251-32510.1980.20
43531-35310.2150.22
53372-33720.2050.21
63102-31020.1890.19
30min13348-33480.2040.2215.500.200.2214.79
23407-34070.2070.21
33065-30650.1860.19
44622-46220.2810.28
53361-33610.2040.21
63428-34280.2080.21
45min13351-33510.2040.202.500.200.202.54
23407-34070.2070.21
33282-32820.2000.20
43199-31990.1950.20
53427-34270.2080.21
63279-32790.1990.20
60min13431-34310.2090.213.270.210.213.62
23395-33950.2060.21
33462-34620.2110.21
43255-32550.1980.20
53529-35290.2150.22
63269-32690.1990.20
90min13208-32080.1950.218.750.200.218.81
23519-35190.2140.22
33924-39240.2390.24
43130-31300.1900.19
53325-33250.2020.20
63235-32350.1970.20
120min13430-34300.2090.207.420.210.208.08
23521-35210.2140.22
33212-32120.1950.20
42934-29340.1780.18
53296-32960.2000.20
62983-29830.1810.18
极限13213-32130.1950.205.540.200.205.80
23533-35330.2150.22
33269-32690.1990.20
43067-30670.1870.19
53484-34840.2120.21
63169-31690.1930.19
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90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%
110.031661247165959416603651659989166284116608070.08
210.151684438167808516812620.27
单位质量响应值RSD%判断
165583.95165641.580.03数据可信
供试品溶液-ACSB23064批-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%
5min15965-59650.3600.4114.030.360.4114.20
26012-60120.3630.36
36494-64940.3920.39
47391-73910.4460.45
56682-66820.4030.40
68493-84930.5120.51
15min19232-92320.5570.658.360.560.668.13
210741-107410.6480.65
311626-116260.7010.70
410882-108820.6560.66
511774-117740.7100.71
610695-106950.6450.65
30min111659-116590.7030.714.670.700.714.66
211751-117510.7090.71
312558-125580.7580.76
412136-121360.7320.73
511791-117910.7110.71
610915-109150.6580.66
45min112527-125270.7560.734.240.760.734.21
212113-121130.7310.73
312149-121490.7330.74
411038-110380.6660.67
512085-120850.7290.73
612231-122310.7380.74
60min110446-104460.6300.709.140.630.719.16
210421-104210.6290.63
312776-127760.7710.77
412693-126930.7660.77
511517-115170.6950.70
612259-122590.7390.74
90min111230-112300.6770.706.310.680.716.28
211060-110600.6670.67
312822-128220.7730.78
410937-109370.6600.67
511613-116130.7010.71
612199-121990.7360.74
120min111510-115100.6940.704.850.700.715.01
210911-109110.6580.66
312339-123390.7440.75
412337-123370.7440.75
511400-114000.6880.69
611473-114730.6920.70
极限111907-119070.7180.724.770.730.734.77
211815-118150.7130.72
312796-127960.7720.78
412509-125090.7550.76
511750-117500.7090.72
611206-112060.6760.68
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90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%
110.031664513166113616581301658871165978616604870.16
210.151692970168801516904920.21
单位质量响应值RSD%判断
165552.04166550.940.43数据可信
供试品溶液-ACSB23064批-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%
5min1457263-45726327.51025.563.8327.5125.563.83
2423479-42347925.47825.48
3415838-41583825.01825.02
4415487-41548724.99725.00
5415318-41531824.98724.99
6421676-42167625.36925.37
15min1593930-59393035.73234.521.7635.7834.561.76
2567847-56784734.16334.21
3570858-57085834.34434.39
4572557-57255734.44734.49
5569896-56989634.28634.33
6567601-56760134.14834.19
30min1670490-67049040.33839.670.9840.4439.770.98
2659770-65977039.69339.79
3652511-65251139.25739.36
4655973-65597339.46539.56
5655389-65538939.43039.53
6661991-66199139.82739.93
45min1718216-71821643.21042.511.1843.3842.671.18
2705853-70585342.46642.63
3699605-69960542.09042.25
4712613-71261342.87343.04
5695536-69553641.84542.01
6707298-70729842.55342.72
60min1749169-74916945.07244.131.4145.3244.361.41
2729600-72960043.89544.13
3724690-72469043.59943.83
4742832-74283244.69144.93
5723675-72367543.53843.77
6730911-73091143.97444.21
90min1784079-78407947.17246.631.0947.4946.941.10
2775136-77513646.63446.94
3768657-76865746.24446.55
4785310-78531047.24647.56
5763817-76381745.95346.26
6773488-77348846.53546.84
120min1811313-81131348.81148.361.0149.2148.741.01
2801660-80166048.23048.62
3798078-79807848.01448.40
4811787-81178748.83949.23
5791592-79159247.62448.01
6808020-80802048.61349.00
极限1835360-83536050.25749.461.1850.7449.931.19
2820216-82021649.34649.81
3818659-81865949.25349.72
4831330-83133050.01550.49
5808674-80867448.65249.11
6818517-81851749.24449.71
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