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)360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%
110.041693746169116516923851690195169204316919070.08
210.081693848169369816937730.01
单位质量响应值RSD%判断
168516.63168033.040.21数据可信
供试品溶液-ACSB24026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%
5min11559106-155910623.14023.571.0823.1423.571.07
21585996-158599623.53923.54
31605063-160506323.82223.82
41585615-158561523.53323.53
51605773-160577323.83323.83
61586891-158689123.55223.55
15min11627474-162747424.15524.391.2124.1924.431.22
21643590-164359024.39424.43
31668838-166883824.76924.81
41666159-166615924.72924.77
51630837-163083724.20524.24
61623480-162348024.09524.13
30min11597576-159757623.71124.381.5523.7924.461.54
21648159-164815924.46224.54
31654279-165427924.55324.63
41673869-167386924.84324.92
51643532-164353224.39324.47
61637397-163739724.30224.38
45min11588402-158840223.57524.161.7923.6924.281.80
21624989-162498924.11824.24
31667822-166782224.75424.88
41652628-165262824.52824.65
51626706-162670624.14324.26
61606578-160657823.84523.96
60min11581956-158195623.47923.831.0323.6423.991.02
21607837-160783723.86324.02
31631152-163115224.20924.37
41605274-160527423.82523.99
51611109-161110923.91224.07
61595268-159526823.67723.84
90min11601157-160115723.76423.951.0323.9624.151.03
21592958-159295823.64223.84
31617657-161765724.00924.21
41626206-162620624.13624.34
51637268-163726824.30024.50
61605648-160564823.83124.03
120min1-0.0000.00-0.240.240.00
2-0.0000.24
3-0.0000.24
4-0.0000.24
5-0.0000.24
6-0.0000.24
极限1-0.0000.00-0.240.240.00
2-0.0000.24
3-0.0000.24
4-0.0000.24
5-0.0000.24
6-0.0000.24
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)360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%
110.041692716169413516947661694980169422716941650.06
210.081701329170118017012540.01
单位质量响应值RSD%判断
168741.53168775.200.02数据可信
供试品溶液-ACSB24026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%
5min11618-16180.0240.025.540.020.0218.85
21686-16860.0250.02
31802-18020.0270.03
41644-16440.0240.02
51664-16640.0250.02
61525-15250.0230.02
15min12046-20460.0300.036.670.030.030.00
22041-20410.0300.03
32238-22380.0330.03
42066-20660.0310.03
51831-18310.0270.03
61973-19730.0290.03
30min12408-24080.0360.047.710.040.0410.65
22402-24020.0360.04
32817-28170.0420.04
42463-24630.0360.04
52380-23800.0350.04
62296-22960.0340.03
45min12623-26230.0390.043.080.040.040.00
22681-26810.0400.04
32764-27640.0410.04
42681-26810.0400.04
52558-25580.0380.04
62581-25810.0380.04
60min12748-27480.0410.044.350.040.040.00
22798-27980.0410.04
32892-28920.0430.04
42692-26920.0400.04
52637-26370.0390.04
62600-26000.0380.04
90min12763-27630.0410.042.540.040.040.00
22747-27470.0410.04
32829-28290.0420.04
42687-26870.0400.04
52777-27770.0410.04
62659-26590.0390.04
120min12750-27500.0410.042.940.040.040.00
22706-27060.0400.04
32745-27450.0410.04
42629-26290.0390.04
52691-26910.0400.04
62600-26000.0380.04
极限12677-26770.0400.043.020.040.040.00
22694-26940.0400.04
32529-25290.0370.04
42550-25500.0380.04
52638-26380.0390.04
62613-26130.0390.04
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)360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%
110.041704444170745717084041710323171034517081950.15
210.081714084171601217150480.08
单位质量响应值RSD%判断
170138.94170143.650.01数据可信
供试品溶液-ACSB24026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%
5min18410-84100.1230.1218.160.120.1217.18
28283-82830.1220.12
39542-95420.1400.14
45301-53010.0780.08
58444-84440.1240.12
67457-74570.1090.11
15min19540-95400.1400.148.210.140.147.56
28555-85550.1260.13
310248-102480.1500.15
48091-80910.1190.12
59497-94970.1390.14
69458-94580.1390.14
30min19096-90960.1340.1511.250.130.1512.37
29614-96140.1410.14
311232-112320.1650.17
410382-103820.1520.15
58769-87690.1290.13
611555-115550.1700.17
45min110475-104750.1540.1615.300.150.1616.79
28225-82250.1210.12
310372-103720.1520.15
412759-127590.1870.19
512622-126220.1850.19
611522-115220.1690.17
60min19358-93580.1370.1614.150.140.1614.64
28270-82700.1210.12
311247-112470.1650.17
412217-122170.1790.18
511544-115440.1690.17
611191-111910.1640.17
90min110697-106970.1570.166.530.160.166.09
29964-99640.1460.15
311308-113080.1660.17
411361-113610.1670.17
59938-99380.1460.15
611416-114160.1680.17
120min111052-110520.1620.1713.480.160.1712.45
29136-91360.1340.14
313782-137820.2020.20
411515-115150.1690.17
511361-113610.1670.17
612570-125700.1850.19
极限112235-122350.1800.169.750.180.168.84
29478-94780.1390.14
311551-115510.1700.17
411044-110440.1620.16
511107-111070.1630.16
69803-98030.1440.15
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)360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%
110.041701748170196817037911703240170422617029950.07
210.081702362170424017033010.08
单位质量响应值RSD%判断
169621.02168978.270.27数据可信
供试品溶液-ACSB24026批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1811251-81125111.96811.911.0711.9711.911.05
2812286-81228611.98311.98
3817723-81772312.06312.06
4807709-80770911.91511.92
5794867-79486711.72611.73
6799161-79916111.78911.79
15min11018405-101840515.02414.840.8715.0414.860.86
21006879-100687914.85314.87
31011190-101119014.91714.94
41006090-100609014.84214.86
5992337-99233714.63914.66
61002379-100237914.78714.81
30min11106316-110631616.32016.122.1816.3716.172.18
21104609-110460916.29516.34
31095903-109590316.16716.21
41108720-110872016.35616.40
51045561-104556115.42415.47
61096748-109674816.17916.22
45min11150470-115047016.97216.990.6817.0417.060.68
21155011-115501117.03917.11
31155747-115574717.05017.12
41161760-116176017.13817.21
51138691-113869116.79816.87
61149519-114951916.95817.03
60min11179319-117931917.39717.420.7017.5017.520.70
21179789-117978917.40417.50
31183277-118327717.45617.56
41195256-119525617.63217.73
51172271-117227117.29317.39
61174155-117415517.32117.42
90min11225541-122554118.07918.040.8218.2118.170.81
21225314-122531418.07618.21
31222468-122246818.03418.16
41238788-123878818.27518.40
51213006-121300617.89418.02
61211365-121136517.87018.00
120min11253468-125346818.49118.301.8418.6518.461.84
21255978-125597818.52818.69
31242504-124250418.32918.49
41259481-125948118.58018.74
51198130-119813017.67517.83
61234634-123463418.21318.37
极限11264105-126410518.64818.610.6418.8418.800.65
21264865-126486518.65918.85
31261056-126105618.60318.79
41270847-127084718.74818.94
51260667-126066718.59718.78
61246885-124688518.39418.58
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