托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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1000
标示量(mg)15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%
1 16.533953863969033982323973263956463966990.30
2 16.583978423949903964160.51
单位质量响应值RSD%判断
23998.7323909.290.27数据可信
加速6月-供试品溶液-2025050421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%
5min119573-195734.8984.169.304.904.169.29
216489-164894.1264.13
315692-156923.9273.93
415647-156473.9153.92
516857-168574.2184.22
615464-154643.8703.87
10min138416-384169.6139.154.839.629.164.82
237737-377379.4439.45
338273-382739.5779.58
434660-346608.6738.68
535400-354008.8588.87
634869-348698.7258.73
15min163748-6374815.95215.324.8115.9815.344.79
263001-6300115.76515.79
364702-6470216.19016.21
458044-5804414.52414.55
559243-5924314.82414.85
658488-5848814.63514.66
20min185423-8542321.37521.013.9921.4321.063.98
286167-8616721.56221.61
388805-8880522.22222.27
480290-8029020.09120.14
581601-8160120.41920.47
681447-8144720.38120.43
30min1120630-12063030.18530.032.5330.2730.112.53
2122600-12260030.67830.76
3124153-12415331.06731.15
4116014-11601429.03029.11
5118361-11836129.61829.70
6118250-11825029.59029.67
45min1160709-16070940.21439.591.7440.3539.731.74
2156146-15614639.07239.21
3162180-16218040.58240.72
4154906-15490638.76238.89
5157757-15775739.47639.61
6157700-15770039.46139.59
60min1190132-19013247.57747.101.4947.7847.291.50
2189549-18954947.43147.63
3191506-19150647.92148.13
4183644-18364445.95346.14
5187194-18719446.84247.04
6187227-18722746.85047.04
90min1227320-22732056.88256.601.1357.1756.881.14
2228174-22817457.09657.38
3228428-22842857.16057.45
4221535-22153555.43555.70
5225378-22537856.39656.67
6226377-22637756.64656.92
120min1254151-25415163.59663.181.0163.9763.551.02
2253478-25347863.42863.80
3254946-25494663.79564.18
4248308-24830862.13462.49
5250494-25049462.68163.05
6253615-25361563.46263.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1287034-28703471.82571.150.7272.3171.620.72
2285754-28575471.50471.99
3285040-28504071.32671.81
4281722-28172270.49570.96
5284009-28400971.06871.54
6282416-28241670.66971.14
240min1305419-30541976.42576.070.4577.0376.670.45
2303884-30388476.04176.64
3304503-30450376.19676.80
4301493-30149375.44376.02
5304601-30460176.22076.81
6304215-30421576.12476.71
极限1308676-30867677.24077.200.4777.9777.920.47
2307405-30740576.92277.65
3310556-31055677.71178.44
4308971-30897177.31478.02
5306394-30639476.66977.39
6309011-30901177.32478.04
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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1000
标示量(mg)15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%
1 16.534043813980093984964012164004874005180.64
2 16.583989853974813982330.27
单位质量响应值RSD%判断
24229.7624018.880.62数据可信
加速6月-供试品溶液-2025050621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%
5min114504-145043.6043.677.923.603.677.91
214638-146383.6373.64
314504-145043.6043.60
417061-170614.2394.24
513833-138333.4373.44
614035-140353.4873.49
10min132233-322338.0097.952.408.017.962.40
231419-314197.8077.81
332268-322688.0188.02
432483-324838.0718.08
532883-328838.1708.18
630787-307877.6507.66
15min155164-5516413.70613.564.0913.7313.584.08
253489-5348913.29013.31
354676-5467613.58513.60
455830-5583013.87213.89
557372-5737214.25514.27
650838-5083812.63212.65
20min177102-7710219.15719.233.1019.2019.273.10
276925-7692519.11319.15
377400-7740019.23119.27
479209-7920919.68119.72
580315-8031519.95620.00
673338-7333818.22218.26
30min1114682-11468228.49528.412.3728.5728.482.37
2114291-11429128.39828.47
3113256-11325628.14028.21
4116392-11639228.92029.00
5117548-11754829.20729.28
6109800-10980027.28227.35
45min1151717-15171737.69738.381.6137.8238.501.61
2155904-15590438.73738.86
3152829-15282937.97338.09
4156471-15647138.87839.00
5157628-15762839.16539.29
6152370-15237037.85937.97
60min1183377-18337745.56346.121.5945.7546.301.59
2187197-18719746.51246.70
3184638-18463845.87746.06
4188147-18814746.74846.94
5188896-18889646.93547.12
6181403-18140345.07345.25
90min1223286-22328655.47955.750.6855.7456.020.68
2225187-22518755.95256.21
3223846-22384655.61955.88
4226787-22678756.34956.62
5224654-22465455.81956.09
6222553-22255355.29755.55
120min1250061-25006162.13262.260.8962.4862.620.89
2251019-25101962.37062.73
3248865-24886561.83562.19
4252579-25257962.75863.12
5253399-25339962.96163.32
6247533-24753361.50461.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1282470-28247070.18570.360.5170.6470.820.52
2284246-28424670.62671.09
3281276-28127669.88870.34
4284430-28443070.67271.14
5284672-28467270.73271.20
6282022-28202270.07370.52
240min1299972-29997274.53375.481.0275.1176.061.02
2305351-30535175.87076.45
3304537-30453775.66876.24
4305359-30535975.87276.46
5307459-30745976.39476.98
6300081-30008174.56075.13
极限1306374-30637476.12476.420.4176.8277.120.42
2308363-30836376.61877.32
3308402-30840276.62877.33
4308903-30890376.75277.46
5307532-30753276.41277.12
6305767-30576775.97376.66
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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1000
标示量(mg)15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%
1 16.534012394000323968123994613999073994900.41
2 16.583987433987913987670.01
单位质量响应值RSD%判断
24167.5724051.090.35数据可信
加速6月-供试品溶液-2025050821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%
5min124821-248216.1715.795.686.175.805.66
224846-248466.1776.18
322485-224855.5905.59
423551-235515.8555.86
521706-217065.3975.40
622425-224255.5755.58
10min150704-5070412.60611.894.9712.6211.904.98
250561-5056112.57012.58
347027-4702711.69211.70
447381-4738111.78011.79
544655-4465511.10211.11
646586-4658611.58211.59
15min177034-7703419.15218.463.6719.1818.493.68
277565-7756519.28419.32
373046-7304618.16118.19
473994-7399418.39618.43
570208-7020817.45517.48
673604-7360418.29918.33
20min1100488-10048824.98324.392.9625.0524.452.97
2102198-10219825.40825.47
396798-9679824.06624.12
497513-9751324.24424.30
593943-9394323.35623.41
697632-9763224.27324.33
30min1135619-13561933.71733.351.8833.8233.451.89
2137559-13755934.20034.31
3133339-13333933.15133.25
4133645-13364533.22733.33
5130068-13006832.33732.43
6134590-13459033.46233.56
45min1172427-17242742.86942.741.3743.0342.901.37
2175148-17514843.54543.71
3171340-17134042.59842.75
4171496-17149642.63742.79
5168031-16803141.77641.93
6173056-17305643.02543.18
60min1200323-20032349.80449.711.0750.0449.941.07
2202343-20234350.30650.54
3198500-19850049.35149.58
4198586-19858649.37249.60
5197412-19741249.08049.30
6202473-20247350.33950.57
90min1235971-23597158.66758.930.7458.9859.240.74
2239105-23910559.44659.77
3237152-23715258.96059.27
4237585-23758559.06859.38
5234179-23417958.22158.52
6238100-23810059.19659.51
120min1260594-26059464.78964.720.6865.2065.130.68
2260676-26067664.80965.23
3261145-26114564.92665.33
4261011-26101164.89265.30
5256808-25680863.84764.25
6261710-26171065.06665.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1294061-29406173.10972.710.5473.6373.230.54
2291865-29186572.56373.09
3293100-29310072.87073.38
4293044-29304472.85673.37
5289577-28957771.99472.50
6293111-29311172.87373.39
240min1312715-31271577.74777.110.5478.3977.750.54
2309825-30982577.02877.68
3310149-31014977.10977.74
4310672-31067277.23977.88
5307565-30756576.46677.09
6309951-30995177.06077.70
极限1316263-31626378.62978.120.6079.4078.890.60
2313156-31315677.85678.63
3314367-31436778.15878.92
4314711-31471178.24379.01
5311133-31113377.35478.11
6315778-31577878.50879.28
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