奥美沙坦酯片项目信息
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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.132352322354812351252353522351602352700.07
211.112350132348252349190.06
单位质量响应值RSD%判断
21138.3621144.820.03数据可信
供试品溶液-SD901YA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%
5min1121714-12171451.71050.8411.6051.7150.8411.60
2121025-12102551.41751.42
3138701-13870158.92758.93
495318-9531840.49640.50
5120724-12072451.29051.29
6120455-12045551.17551.18
10min1186033-18603379.03678.762.5379.1278.842.54
2186594-18659479.27479.36
3192701-19270181.86981.97
4178324-17832475.76175.83
5183294-18329477.87277.96
6185290-18529078.72078.81
15min1209292-20929288.91888.661.0389.1488.881.04
2209586-20958689.04389.26
3209944-20994489.19589.43
4204722-20472286.97687.17
5207892-20789288.32388.54
6210636-21063689.48989.71
20min1218880-21888092.99192.830.6493.3693.200.65
2219195-21919593.12593.49
3217897-21789792.57392.96
4216078-21607891.80192.14
5218830-21883092.97093.33
6220164-22016493.53793.90
30min1224538-22453895.39595.900.6595.9296.420.65
2225470-22547095.79196.31
3224234-22423495.26695.80
4225005-22500595.59396.09
5227469-22746996.64097.16
6227586-22758696.69097.21
45min1226336-22633696.15996.180.5196.8496.860.51
2226490-22649096.22496.91
3224940-22494095.56696.26
4225296-22529695.71796.37
5227538-22753896.66997.35
6227781-22778196.77397.46
60min1223750-22375095.06095.370.5395.9096.200.53
2224132-22413295.22296.06
3223062-22306294.76895.62
4224051-22405195.18896.00
5226037-22603796.03296.87
6225812-22581295.93696.78
极限1222545-22254594.54894.760.4695.5595.760.46
2222397-22239794.48595.49
3222584-22258494.56595.58
4222054-22205494.34095.31
5224184-22418495.24596.24
6224452-22445295.35896.36
奥美沙坦酯片项目信息
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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.132365712363762366052358442359052362600.16
211.112354902345332350120.29
单位质量响应值RSD%判断
21227.3121153.200.25数据可信
供试品溶液-SD901YA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%
5min1113892-11389248.27644.8218.9848.2844.8218.99
2123237-12323752.23752.24
3110368-11036846.78246.78
4112031-11203147.48747.49
5108791-10879146.11446.11
666115-6611528.02528.02
10min1182593-18259377.39775.827.6977.4875.907.70
2186666-18666679.12379.21
3182696-18269677.44077.52
4187558-18755879.50179.58
5182606-18260677.40277.48
6151193-15119364.08764.13
15min1206784-20678487.65187.653.0187.8687.853.02
2211208-21120889.52689.74
3206689-20668987.61087.82
4211863-21186389.80490.02
5209225-20922588.68588.89
6194898-19489882.61282.77
20min1217686-21768692.27292.771.2092.6393.121.22
2221002-22100293.67794.05
3216954-21695491.96192.31
4221711-22171193.97894.34
5220601-22060193.50793.86
6215169-21516991.20591.50
30min1224426-22442695.12996.240.9395.6496.740.92
2227436-22743696.40596.93
3224823-22482395.29795.80
4229548-22954897.30097.82
5227089-22708996.25796.77
6229004-22900497.06997.51
45min1225770-22577095.69896.810.9396.3797.470.91
2228790-22879096.97897.66
3226552-22655296.03096.69
4229907-22990797.45298.13
5227872-22787296.58997.26
6231442-23144298.10398.71
60min1222652-22265294.37795.441.0295.2096.271.00
2225020-22502095.38096.23
3223420-22342094.70295.53
4226885-22688596.17197.01
5224266-22426695.06195.89
6228789-22878996.97897.75
极限1220288-22028893.37594.521.0294.3695.500.99
2222564-22256494.33995.34
3221779-22177994.00794.99
4224279-22427995.06696.07
5222234-22223494.20095.19
6226768-22676896.12197.05
奥美沙坦酯片项目信息
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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.132346622352312346832350182354262350040.15
211.112343942342662343300.04
单位质量响应值RSD%判断
21114.4721091.810.08数据可信
供试品溶液-SD901YA批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100630-10063042.83139.4825.9742.8339.4825.97
243955-4395518.70818.71
398393-9839341.87841.88
4102319-10231943.54943.55
5106281-10628145.23645.24
6105027-10502744.70244.70
10min1161617-16161768.78867.3910.0968.8667.4610.10
2126248-12624853.73453.77
3169551-16955172.16572.23
4162480-16248069.15569.23
5164513-16451370.02170.10
6165547-16554770.46170.54
15min1185952-18595279.14678.925.3579.3379.105.37
2166652-16665270.93171.05
3195985-19598583.41683.61
4185941-18594179.14179.33
5188603-18860380.27480.47
6189423-18942380.62380.81
20min1198124-19812484.32685.173.4084.6485.483.42
2190042-19004280.88681.13
3211056-21105689.83190.16
4198745-19874584.59184.91
5200903-20090385.50985.84
6201811-20181185.89686.22
30min1212407-21240790.40691.692.1290.8692.142.13
2212025-21202590.24390.62
3223778-22377895.24595.72
4212212-21221290.32390.78
5214920-21492091.47591.94
6217146-21714692.42392.89
45min1220998-22099894.06295.331.9794.6795.931.97
2222707-22270794.78995.31
3232247-23224798.85099.49
4219891-21989193.59194.20
5223305-22330595.04495.66
6224648-22464895.61696.24
60min1224309-22430995.47196.601.8696.2497.361.86
2227166-22716696.68797.37
3234304-23430499.725100.53
4221785-22178594.39795.16
5226637-22663796.46297.24
6227547-22754796.84997.63
极限1225905-22590596.15197.201.4597.0898.121.45
2228200-22820097.12797.97
3234395-23439599.764100.73
4224956-22495695.74796.67
5228191-22819197.12498.06
6228516-22851697.26298.21
奥美沙坦酯片项目信息
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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.132336482338422338592333872343702338210.16
211.112359012364062361540.16
单位质量响应值RSD%判断
21008.1821255.990.83数据可信
供试品溶液-SD901YA批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103079-10307943.81438.3333.3043.8138.3333.31
2105135-10513544.68844.69
3108189-10818945.98645.99
430167-3016712.82312.82
590432-9043238.43938.44
6104014-10401444.21244.21
10min1166707-16670770.86066.1513.6370.9366.2213.65
2167244-16724471.08871.16
3166471-16647170.75970.84
4112946-11294648.00848.03
5157936-15793667.13267.20
6162463-16246369.05669.13
15min1190927-19092781.15578.417.1081.3578.587.13
2190853-19085381.12381.32
3192368-19236881.76781.96
4158197-15819767.24367.34
5185454-18545478.82879.00
6189015-18901580.34280.53
20min1203420-20342086.46585.014.0386.7985.324.07
2204901-20490187.09487.42
3205452-20545287.32987.66
4184081-18408178.24578.46
5199928-19992884.98185.29
6202193-20219385.94386.27
30min1216145-21614591.87491.621.7892.3492.071.83
2218591-21859192.91393.39
3219380-21938093.24993.73
4208926-20892688.80589.15
5213562-21356290.77691.22
6216680-21668092.10192.57
45min1222844-22284494.72195.650.9595.3496.240.97
2227396-22739696.65697.28
3227805-22780596.83097.46
4223856-22385695.15195.64
5223294-22329494.91295.51
6224940-22494095.61296.23
60min1224679-22467995.50196.670.9796.2897.420.97
2229932-22993297.73498.52
3229481-22948197.54298.34
4227648-22764896.76397.41
5225002-22500295.63896.40
6227795-22779596.82697.60
极限1226815-22681596.40997.360.8497.3598.280.82
2230587-23058798.01298.96
3229095-22909597.37898.33
4230451-23045197.95498.77
5226617-22661796.32597.24
6230819-23081998.11199.05
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