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%
19.961665939166687116660171665515166925916667200.10
210.251691627169033116909790.06
单位质量响应值RSD%判断
167341.37164973.561.01数据可信
供试品溶液-2025031021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%
5min11840-18400.0280.0442.060.030.0438.73
21739-17390.0260.03
34535-45350.0680.07
41843-18430.0280.03
52486-24860.0370.04
62553-25530.0380.04
15min12463-24630.0370.0322.520.040.0324.50
21566-15660.0240.02
31675-16750.0250.03
42105-21050.0320.03
52818-28180.0420.04
62607-26070.0390.04
30min12819-28190.0420.0551.490.040.0552.59
22534-25340.0380.04
32621-26210.0390.04
42644-26440.0400.04
53064-30640.0460.05
67083-70830.1060.11
45min13263-32630.0490.0661.970.050.0662.74
22920-29200.0440.04
32850-28500.0430.04
49362-93620.1410.14
53229-32290.0490.05
63174-31740.0480.05
60min13161-31610.0480.051.910.050.050.00
23134-31340.0470.05
33209-32090.0480.05
43027-30270.0460.05
53091-30910.0460.05
63125-31250.0470.05
90min12980-29800.0450.055.540.050.058.45
23094-30940.0470.05
33060-30600.0460.05
43358-33580.0500.05
52884-28840.0430.04
63244-32440.0490.05
120min12918-29180.0440.044.660.040.0412.18
23093-30930.0460.05
32975-29750.0450.05
43144-31440.0470.05
52900-29000.0440.04
62743-27430.0410.04
极限12942-29420.0440.053.230.040.058.45
23174-31740.0480.05
33112-31120.0470.05
43193-31930.0480.05
53029-30290.0460.05
63104-31040.0470.05
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%
19.961671431167208416682291669996166967916702840.10
210.251696458169712916967940.03
单位质量响应值RSD%判断
167699.20165540.880.92数据可信
供试品溶液-2025031021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%
5min16384-63840.0960.0634.350.100.0639.73
22997-29970.0450.04
33747-37470.0560.06
43658-36580.0550.05
52725-27250.0410.04
63456-34560.0520.05
15min14463-44630.0670.0432.860.070.0431.53
22450-24500.0370.04
32372-23720.0360.04
42654-26540.0400.04
51779-17790.0270.03
62656-26560.0400.04
30min13972-39720.0600.0516.840.060.0418.60
22747-27470.0410.04
33030-30300.0450.05
42965-29650.0440.04
52534-25340.0380.04
62903-29030.0440.04
45min110028-100280.1500.0669.300.150.0667.49
22997-29970.0450.05
33043-30430.0460.05
42961-29610.0440.04
52730-27300.0410.04
63126-31260.0470.05
60min13483-34830.0520.054.440.050.050.00
23116-31160.0470.05
33145-31450.0470.05
43077-30770.0460.05
53197-31970.0480.05
63287-32870.0490.05
90min13359-33590.0500.0661.060.050.0659.64
23104-31040.0470.05
33020-30200.0450.05
43036-30360.0460.05
59190-91900.1380.14
62849-28490.0430.04
120min13080-30800.0460.053.340.050.0511.07
23022-30220.0450.05
32966-29660.0440.04
43203-32030.0480.05
53062-30620.0460.05
62965-29650.0440.04
极限13021-30210.0450.054.570.050.050.00
23224-32240.0480.05
33063-30630.0460.05
43311-33110.0500.05
53335-33350.0500.05
63077-30770.0460.05
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%
19.961664848166744016659051664887166507216656300.07
210.251724021172375217238860.02
单位质量响应值RSD%判断
167231.93168184.000.41数据可信
供试品溶液-2025031121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%
5min11781-17810.0270.0213.490.030.0218.85
21268-12680.0190.02
31329-13290.0200.02
41310-13100.0200.02
51578-15780.0230.02
61536-15360.0230.02
15min12557-25570.0380.047.850.040.0410.65
22915-29150.0430.04
32873-28730.0430.04
42646-26460.0390.04
52729-27290.0410.04
62332-23320.0350.03
30min13131-31310.0470.048.350.050.0411.92
22581-25810.0380.04
33101-31010.0460.05
42976-29760.0440.04
52674-26740.0400.04
62757-27570.0410.04
45min13205-32050.0480.054.250.050.0511.07
23016-30160.0450.05
33263-32630.0490.05
42954-29540.0440.04
53148-31480.0470.05
62992-29920.0450.04
60min13147-31470.0470.0513.840.050.0515.58
23109-31090.0460.05
34090-40900.0610.06
42905-29050.0430.04
52986-29860.0440.04
63112-31120.0460.05
90min13122-31220.0460.052.540.050.058.45
23127-31270.0470.05
33075-30750.0460.05
43138-31380.0470.05
53175-31750.0470.05
62980-29800.0440.04
120min16332-63320.0940.0536.200.090.0632.02
23027-30270.0450.05
33624-36240.0540.05
43032-30320.0450.05
53066-30660.0460.05
62916-29160.0430.04
极限12866-28660.0430.056.490.040.058.45
23453-34530.0510.05
33342-33420.0500.05
43189-31890.0470.05
53396-33960.0510.05
63124-31240.0470.05
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%
19.961673434167117316720761672001167309616723560.06
210.251751384174996217506730.06
单位质量响应值RSD%判断
167907.23170797.371.21数据可信
供试品溶液-2025031121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%
5min12888-28880.0430.0318.920.040.0312.90
22097-20970.0310.03
32171-21710.0320.03
41886-18860.0280.03
51924-19240.0280.03
61862-18620.0270.03
15min13292-32920.0490.047.080.050.0411.92
22939-29390.0430.04
33278-32780.0480.05
42898-28980.0430.04
52852-28520.0420.04
62828-28280.0420.04
30min13421-34210.0500.059.210.050.0511.07
23097-30970.0460.05
33654-36540.0540.05
43292-32920.0490.05
52955-29550.0440.04
62849-28490.0420.04
45min13327-33270.0490.0532.020.050.0537.57
23099-30990.0460.05
32927-29270.0430.04
45802-58020.0860.09
52984-29840.0440.04
63027-30270.0450.04
60min13280-32800.0480.0642.390.050.0640.83
27404-74040.1090.11
33349-33490.0490.05
43222-32220.0480.05
53471-34710.0510.05
63119-31190.0460.05
90min13380-33800.0500.055.980.050.058.45
23131-31310.0460.05
33001-30010.0440.04
43497-34970.0520.05
53183-31830.0470.05
63234-32340.0480.05
120min13231-32310.0480.11136.160.050.12134.46
228905-289050.4260.43
33219-32190.0470.05
43016-30160.0440.04
54471-44710.0660.07
63104-31040.0460.05
极限13222-32220.0480.052.840.050.050.00
23143-31430.0460.05
33272-32720.0480.05
43278-32780.0480.05
53117-31170.0460.05
63047-30470.0450.05
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