替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014975495006425000614990224991494992850.24
211.025007334997745002540.14
单位质量响应值RSD%判断
45348.3245395.100.08数据可信
供试品溶液-E43216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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min11671-16710.3310.3794.370.330.3794.06
21653-16530.3280.33
35207-52071.0331.03
41380-13800.2740.27
5-0.0000.00
61236-12360.2450.25
20min12760-27600.5470.4523.640.550.4523.26
23040-30400.6030.60
32097-20970.4160.42
41686-16860.3340.34
51981-19810.3930.39
61918-19180.3800.38
30min13763-37630.7461.0447.440.751.0447.07
24828-48280.9580.96
35690-56901.1291.14
43549-35490.7040.71
59984-99841.9801.98
63552-35520.7050.71
45min18653-86531.7161.9920.361.732.0020.20
210300-103002.0432.05
310800-108002.1422.16
47500-75001.4881.50
513418-134182.6622.67
69442-94421.8731.88
60min116065-160653.1873.3213.803.213.3413.81
218831-188313.7353.76
317182-171823.4083.43
412426-124262.4652.48
518107-181073.5923.62
617818-178183.5343.55
极限1140752-14075227.92026.465.8827.9626.505.90
2132484-13248426.28026.32
3135320-13532026.84226.89
4125557-12555724.90624.93
5142785-14278528.32328.37
6123438-12343824.48524.52
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014996494982454992264998704983044990590.16
211.025015095005305010200.14
单位质量响应值RSD%判断
45327.7945464.610.22数据可信
供试品溶液-F73104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%
5min1-0.0000.26124.030.000.26124.01
21990-19900.3950.39
31806-18060.3580.36
43948-39480.7830.78
5-0.0000.00
6-0.0000.00
10min12914-29140.5780.10244.950.580.10244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min14839-48390.9590.34107.280.960.34107.15
2-0.0000.00
3-0.0000.00
41660-16600.3290.33
51100-11000.2180.22
62728-27280.5410.54
20min11247-12470.2470.3661.080.260.3660.62
2-0.0000.00
31620-16200.3210.32
43052-30520.6050.61
52333-23330.4630.46
62660-26600.5270.53
30min14858-48580.9631.1335.060.971.1435.11
24372-43720.8670.87
36275-62751.2441.25
49561-95611.8961.91
54408-44080.8740.88
64851-48510.9620.97
45min17287-72871.4452.2027.351.462.2127.31
27736-77361.5341.54
314174-141742.8102.82
414304-143042.8362.86
511333-113332.2472.26
611651-116512.3102.32
60min113524-135242.6813.8116.792.703.8316.72
218859-188593.7393.75
323043-230434.5684.59
419571-195713.8803.92
521351-213514.2334.25
618893-188933.7463.77
极限1103468-10346820.51320.983.6520.5521.023.63
2104914-10491420.80020.84
3105552-10555220.92620.98
4102344-10234420.29020.35
5113276-11327622.45822.50
6105243-10524320.86520.91
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014973484982024971594976004989664978550.15
211.025011415020715016060.14
单位质量响应值RSD%判断
45218.4445517.790.47数据可信
供试品溶液-F66942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%
5min13383-33830.6710.6212.290.670.6212.21
22960-29600.5870.59
32981-29810.5910.59
43704-37040.7350.73
53125-31250.6200.62
62593-25930.5140.51
10min12590-25900.5140.4221.120.520.4220.65
21775-17750.3520.36
31933-19330.3830.39
42707-27070.5370.54
51969-19690.3910.39
61629-16290.3230.33
15min12365-23650.4690.4341.940.480.4441.14
21834-18340.3640.37
33813-38130.7560.76
41994-19940.3960.40
51916-19160.3800.39
61078-10780.2140.22
20min12563-25630.5080.3820.480.520.3920.33
21463-14630.2900.30
32173-21730.4310.44
41950-19500.3870.40
51733-17330.3440.35
61678-16780.3330.34
30min13821-38210.7580.5330.690.770.5430.43
21876-18760.3720.38
33259-32590.6470.66
42691-26910.5340.55
52554-25540.5070.52
61680-16800.3330.34
45min16739-67391.3371.0931.471.351.1031.29
25383-53831.0681.08
38239-82391.6341.65
44582-45820.9090.92
54541-45410.9010.91
63470-34700.6880.70
60min113275-132752.6332.1019.642.662.1219.67
28464-84641.6791.70
312728-127282.5252.55
48342-83421.6551.67
510773-107732.1372.15
610039-100391.9922.00
极限191157-9115718.08417.324.1818.1217.354.16
286711-8671117.20217.23
382314-8231416.32916.37
485673-8567316.99617.02
591988-9198818.24918.28
686058-8605817.07217.10
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014997474999044980334978234993134989640.20
211.025032945043895038420.16
单位质量响应值RSD%判断
45319.1645720.690.63数据可信
供试品溶液-F90166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%
5min15166-51661.0211.1330.671.021.1330.76
24776-47760.9440.94
35523-55231.0921.09
45994-59941.1851.19
58993-89931.7781.78
63886-38860.7680.77
10min12752-27520.5440.5513.320.550.5513.35
22814-28140.5560.56
32912-29120.5760.58
43344-33440.6610.67
52452-24520.4850.49
62295-22950.4540.46
15min12126-21260.4200.4218.090.430.4318.38
21927-19270.3810.39
32138-21380.4230.43
42708-27080.5350.55
52194-21940.4340.45
61537-15370.3040.31
20min12268-22680.4480.4314.700.460.4414.10
22090-20900.4130.42
31891-18910.3740.39
42727-27270.5390.55
52098-20980.4150.43
61861-18610.3680.38
30min12528-25280.5000.5525.920.510.5625.63
22626-26260.5190.53
32411-24110.4770.49
44229-42290.8360.85
52506-25060.4950.51
62345-23450.4640.47
45min16272-62721.2400.8534.051.260.8733.37
23935-39350.7780.79
33131-31310.6190.64
46072-60721.2011.22
53129-31290.6190.64
63354-33540.6630.68
60min112980-129802.5661.2955.972.591.3255.19
25771-57711.1411.16
34155-41550.8220.84
48644-86441.7091.74
54069-40690.8050.83
63594-35940.7110.73
极限190254-9025417.84517.4210.8717.8817.4510.83
288455-8845517.48917.52
385692-8569216.94316.97
471819-7181914.20014.24
5101255-10125520.02020.05
691180-9118018.02818.05
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