厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 15.102137629213830921368062138584213555821373770.06
215.182149526214762421485750.07
单位质量响应值RSD%判断
141548.15141539.860.01数据可信
供试品溶液-25091401批-厄贝沙坦-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%
5min1570730-57073024.13728.5919.6424.1428.5919.63
2502856-50285621.26721.27
3608515-60851525.73525.74
4807069-80706934.13334.13
5749676-74967631.70531.71
6816806-81680634.54434.54
10min11499365-149936563.41171.497.6763.6871.817.69
21647611-164761169.68169.92
31752497-175249774.11774.40
41715907-171590772.56972.95
51640109-164010969.36469.72
61886897-188689779.80180.18
15min11727433-172743373.05779.946.0774.0381.056.11
21826706-182670677.25578.27
31948216-194821682.39483.50
41959644-195964482.87784.06
51834477-183447777.58478.71
62044511-204451186.46687.74
20min11927704-192770481.52683.364.0283.3185.364.08
21892740-189274080.04881.92
31985834-198583483.98586.01
42066976-206697687.41789.52
51893597-189359780.08482.07
62059863-205986387.11689.35
30min12053241-205324186.83687.473.2789.5390.403.31
21993764-199376484.32087.08
32011306-201130685.06288.02
42173944-217394491.94095.02
52058866-205886687.07489.95
62118341-211834189.58992.79
45min12072799-207279987.66389.942.0991.3293.842.17
22096137-209613788.65092.35
32108389-210838989.16893.07
42195854-219585492.86796.97
52156531-215653191.20495.05
62130558-213055890.10694.30
60min12093698-209369888.54790.131.0793.1895.031.22
22119796-211979689.65094.33
32131341-213134190.13995.03
42160668-216066891.37996.51
52142107-214210790.59495.45
62139553-213955390.48695.68
极限12136455-213645590.35592.371.1795.9798.271.29
22178981-217898192.15397.83
32191892-219189292.70098.60
42209904-220990493.46199.61
52195585-219558592.85698.72
62191694-219169492.69198.89
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.231620261620571620421620581619121620190.04
210.301629681627771628720.09
单位质量响应值RSD%判断
15837.6315812.820.12数据可信
供试品溶液-25091401批-非奈利酮-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%
5min171139-7113940.51445.8918.2340.5145.8918.23
264239-6423936.58536.58
367731-6773138.57338.57
492216-9221652.51852.52
588747-8874750.54250.54
699418-9941856.61956.62
10min1142877-14287781.37091.747.3381.8292.257.35
2157864-15786489.90590.31
3165184-16518494.07494.50
4163399-16339993.05793.64
5158100-15810090.03990.60
6179060-179060101.976102.61
15min1157329-15732989.60096.905.1690.9598.435.22
2165445-16544594.22295.63
3171129-17112997.45998.93
4176424-176424100.475102.09
5168061-16806195.71297.27
6182517-182517103.945105.71
20min1174827-17482799.56599.733.18101.92102.333.24
2168840-16884096.15698.61
3171391-17139197.609100.17
4181943-181943103.618106.35
5171909-17190997.904100.53
6181738-181738103.501106.42
30min1181727-181727103.495102.813.29106.95106.523.30
2175733-175733100.081103.60
3170985-17098597.377101.02
4186165-186165106.022109.91
5183722-183722104.631108.34
6184821-184821105.257109.32
45min1181384-181384103.300104.352.33107.91109.202.34
2183483-183483104.495109.13
3175921-175921100.188104.91
4186703-186703106.329111.39
5187839-187839106.976111.85
6184003-184003104.791110.03
60min1181890-181890103.588104.201.93109.34110.221.93
2185079-185079105.404111.20
3176438-176438100.483106.32
4183861-183861104.710110.95
5186309-186309106.104112.17
6184251-184251104.932111.33
极限1181657-181657103.455104.152.00110.36111.331.99
2184737-184737105.209112.17
3176375-176375100.447107.40
4183917-183917104.742112.15
5187089-187089106.549113.79
6183528-183528104.521112.09
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 15.102154342215456621552652147803214923221522420.17
215.182164736216374921642420.04
单位质量响应值RSD%判断
142532.58142571.940.02数据可信
供试品溶液-25091401批-厄贝沙坦-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%
5min146134-461341.9371.738.131.941.738.18
241414-414141.7391.74
341624-416241.7481.75
436711-367111.5421.54
542922-429221.8021.80
638289-382891.6081.61
10min179379-793793.3333.193.593.353.213.62
273677-736773.0943.11
378559-785593.2993.32
472752-727523.0553.07
574645-746453.1353.15
677209-772093.2423.26
15min194920-949203.9863.862.934.043.912.94
289005-890053.7383.79
394761-947613.9794.04
489718-897183.7683.82
589732-897323.7683.82
692898-928983.9013.95
20min1102674-1026744.3124.221.774.414.321.79
299943-999434.1974.29
3102179-1021794.2914.39
498376-983764.1314.22
598827-988274.1504.25
6101158-1011584.2484.35
30min1108816-1088164.5694.521.024.724.671.10
2106802-1068024.4854.63
3109070-1090704.5804.73
4106319-1063194.4654.60
5107378-1073784.5094.65
6108075-1080754.5384.68
45min1108050-1080504.5374.915.904.745.115.65
2108254-1082544.5464.74
3122561-1225615.1475.35
4119447-1194475.0165.20
5121310-1213105.0945.29
6122015-1220155.1245.32
60min1127314-1273145.3465.381.825.605.641.81
2128079-1280795.3785.62
3132878-1328785.5805.84
4126917-1269175.3305.57
5126849-1268495.3275.58
6127260-1272605.3445.60
极限1128188-1281885.3835.431.465.695.741.40
2128572-1285725.3995.70
3130281-1302815.4715.79
4132738-1327385.5745.88
5127627-1276275.3595.67
6128681-1286815.4045.71
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.231630951630181631801626331626891629230.16
210.301637551635521636540.09
单位质量响应值RSD%判断
15926.0015888.740.17数据可信
供试品溶液-25091401批-非奈利酮-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%
5min146328-4632826.24821.7112.5826.2521.7112.58
237777-3777721.40321.40
339062-3906222.13122.13
433446-3344618.94918.95
539929-3992922.62222.62
633340-3334018.88918.89
10min1100285-10028556.81853.768.2257.1154.008.20
285401-8540148.38548.62
3104758-10475859.35259.60
489925-8992550.94951.16
588886-8888650.36050.61
6100057-10005756.68956.90
15min1124101-12410170.31268.076.6871.2368.916.67
2110861-11086162.81063.59
3130341-13034173.84774.75
4118183-11818366.95967.74
5111346-11134663.08563.90
6126041-12604171.41172.25
20min1134802-13480276.37475.354.4978.0876.954.52
2126843-12684371.86573.34
3141498-14149880.16881.89
4131820-13182074.68576.21
5126081-12608171.43372.95
6136924-13692477.57779.21
30min1141147-14114779.96980.272.6782.5282.702.74
2137085-13708577.66879.94
3147756-14775683.71486.33
4140875-14087579.81582.17
5139148-13914878.83781.14
6144069-14406981.62584.12
45min1136779-13677977.49585.527.2680.9488.847.06
2137636-13763677.98081.11
3162539-16253992.08995.64
4155450-15545088.07391.31
5155345-15534588.01391.19
6157886-15788689.45392.86
60min1158662-15866289.89392.183.2494.2096.453.25
2159302-15930290.25594.26
3172993-17299398.012102.58
4162439-16243992.03396.25
5160727-16072791.06395.22
6162024-16202491.79896.19
极限1160349-16034990.84993.552.8596.1598.852.81
2162232-16223291.91596.92
3169952-16995296.289101.95
4171997-17199797.448102.69
5162564-16256492.10497.27
6163618-16361892.70198.12
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 15.102149254215182021507902150953215656221518760.13
215.182144718214435621445370.02
单位质量响应值RSD%判断
142508.34141273.850.62数据可信
供试品溶液-25091401批-厄贝沙坦-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%
5min1291586-29158612.30212.9620.0612.3012.9620.06
2192785-1927858.1338.13
3365292-36529215.41115.41
4320792-32079213.53413.53
5322215-32221513.59413.59
6350144-35014414.77214.77
10min1998297-99829742.11839.0811.3042.2539.2211.24
2917487-91748738.70838.80
3788514-78851433.26733.44
41088199-108819945.91046.06
5898318-89831837.89938.05
6867040-86704036.58036.74
15min11315167-131516755.48652.307.1056.0952.887.09
21235319-123531952.11752.64
31109577-110957746.81247.35
41355818-135581857.20157.86
51190044-119004450.20750.78
61232121-123212151.98252.55
20min11461927-146192761.67859.405.1462.9060.565.17
21415570-141557059.72260.82
31307202-130720255.15056.21
41511855-151185563.78465.08
51371187-137118757.84958.98
61379242-137924258.18959.34
30min11653703-165370369.76968.723.7171.6870.543.77
21645340-164534069.41671.18
31529573-152957364.53266.21
41709748-170974872.13374.14
51599093-159909367.46569.24
61636101-163610169.02670.82
45min11741383-174138373.46873.463.3376.1576.043.38
21753517-175351773.98076.51
31649301-164930169.58371.97
41819027-181902776.74479.55
51709494-170949472.12274.64
61773960-177396074.84277.40
60min11815163-181516376.58177.262.8680.0880.662.92
21835456-183545677.43780.79
31747558-174755873.72876.89
41900907-190090780.19883.86
51819745-181974576.77480.10
61868740-186874078.84182.23
极限11941987-194198781.93181.904.0386.2886.164.00
21988238-198823883.88288.10
31789623-178962375.50379.49
42003978-200397884.54789.10
51946830-194683082.13586.31
61977379-197737983.42487.69
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.231629401629041629171629251633031629980.11
210.301626221625171625700.05
单位质量响应值RSD%判断
15933.3315783.500.67数据可信
供试品溶液-25091401批-非奈利酮-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%
5min119419-1941911.03611.8020.9811.0411.8020.98
212824-128247.2887.29
324944-2494414.17614.18
421497-2149712.21712.22
521869-2186912.42912.43
624050-2405013.66813.67
10min170317-7031739.96337.1610.3840.0937.3010.33
262677-6267735.62135.70
358203-5820333.07833.24
476529-7652943.49443.63
563693-6369336.19936.34
660937-6093734.63234.78
15min194312-9431253.60050.486.1354.1751.036.14
285960-8596048.85449.33
383236-8323647.30547.83
496881-9688155.06055.68
585728-8572848.72249.26
686864-8686449.36749.90
20min1106090-10609060.29457.974.3261.4659.084.36
299738-9973856.68457.70
398566-9856656.01857.07
4108952-10895261.92163.15
599844-9984456.74457.83
698809-9880956.15657.24
30min1120927-12092768.72667.702.5170.5669.452.60
2117260-11726066.64268.29
3116999-11699966.49468.17
4124402-12440270.70172.62
5116923-11692366.45168.16
6118267-11826767.21568.92
45min1128692-12869273.13972.991.9075.7475.501.98
2126381-12638171.82674.22
3127283-12728372.33974.75
4132826-13282675.48978.19
5126363-12636371.81674.27
6129052-12905273.34475.80
60min1134802-13480276.61277.341.7080.0280.651.75
2133025-13302575.60278.79
3136137-13613777.37180.59
4139903-13990379.51183.05
5135674-13567477.10780.36
6136962-13696277.83981.11
极限1143124-14312481.34181.371.7885.6085.551.82
2143117-14311781.33785.37
3138834-13883478.90382.98
4146799-14679983.43087.86
5143685-14368581.66085.77
6143509-14350981.56085.70
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