贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0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%
111.471012508101428810135391011741101329510130740.10
211.421014056101385310139540.02
单位质量响应值RSD%判断
88323.8088787.570.38数据可信
供试品溶液-2024092721批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145506-455064.6134.757.974.614.757.95
246775-467754.7424.74
349601-496015.0285.03
440108-401084.0664.07
548994-489944.9674.97
650042-500425.0735.07
10min171273-712737.2257.343.117.287.393.13
273232-732327.4247.48
373661-736617.4687.52
468973-689736.9927.04
571682-716827.2677.32
675469-754697.6517.71
15min174638-746387.5677.671.947.707.801.88
277966-779667.9048.04
373697-736977.4717.61
476352-763527.7407.86
575816-758167.6867.82
675515-755157.6567.80
20min172648-726487.3657.572.247.587.792.20
276287-762877.7347.96
375874-758747.6927.91
475212-752127.6257.83
572486-724867.3487.57
675468-754687.6517.88
30min171982-719827.2977.462.507.597.762.50
276651-766517.7718.08
373977-739777.5007.81
471517-715177.2507.54
573230-732307.4247.73
674151-741517.5177.83
45min192020-920209.3298.686.829.719.066.57
285727-857278.6919.09
388389-883898.9619.35
478671-786717.9758.35
578482-784827.9568.34
690326-903269.1579.55
60min1191436-19143619.40714.5619.7619.8915.0419.17
2144052-14405214.60415.10
3122350-12235012.40412.89
4109409-10940911.09211.55
5140459-14045914.23914.71
6153928-15392815.60516.10
极限1190440-19044019.30618.1015.2520.0018.7414.87
2213842-21384221.67922.33
3184251-18425118.67919.31
4131070-13107013.28813.87
5178767-17876718.12318.76
6172876-17287617.52618.20
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.242548532550422559272546772550592551120.19
210.272561962557452559700.13
单位质量响应值RSD%判断
24913.2824924.050.04数据可信
供试品溶液-2024092721批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172573-7257329.04230.1122.0629.0430.1122.06
265622-6562226.26126.26
393625-9362537.46737.47
448783-4878319.52219.52
581466-8146632.60132.60
689384-8938435.77035.77
10min1176478-17647870.62369.5910.6070.9569.9210.66
2167324-16732466.96067.25
3191252-19125276.53676.95
4140402-14040256.18656.40
5180632-18063272.28672.65
6187304-18730474.95675.35
15min1212392-21239284.99585.043.3886.1086.153.51
2209369-20936983.78684.82
3217146-21714686.89888.16
4200820-20082080.36581.21
5213331-21333185.37186.54
6221942-22194288.81790.05
20min1227755-22775591.14390.250.8993.2092.311.02
2225626-22562690.29192.26
3225415-22541590.20792.44
4221881-22188188.79390.53
5225766-22576690.34792.46
6226729-22672990.73392.95
30min1238501-23850195.44493.461.3398.5196.511.39
2232092-23209292.87995.85
3231533-23153392.65595.89
4229983-22998392.03594.76
5233426-23342693.41396.53
6235677-23567794.31497.54
45min1242943-24294397.22195.661.07101.3599.751.14
2238026-23802695.25499.26
3239266-23926695.750100.01
4236782-23678294.75698.50
5236303-23630394.56498.72
6240898-24089896.403100.68
60min1238344-23834495.38194.031.12100.5999.191.18
2233965-23396593.62998.69
3234892-23489294.00099.33
4232841-23284193.17997.97
5231967-23196792.82998.04
6237867-23786795.190100.53
极限1217334-21733486.97385.991.1093.2492.191.07
2213677-21367785.51091.61
3212439-21243985.01491.39
4215410-21541086.20392.03
5212590-21259085.07591.31
6217821-21782187.16893.57
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0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%
111.471024628102298610214061021240101665410213830.30
211.421035880103524410355620.05
单位质量响应值RSD%判断
89048.2190679.681.29数据可信
供试品溶液-2024092721批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132065-320653.2044.4718.253.204.4718.25
251870-518705.1825.18
339415-394153.9383.94
446241-462414.6204.62
554277-542775.4235.42
644518-445184.4484.45
10min172956-729567.2897.904.837.327.954.90
277873-778737.7807.84
378784-787847.8717.92
481176-811768.1108.16
584505-845058.4438.50
679264-792647.9197.97
15min187566-875668.7498.874.658.879.014.52
286334-863348.6268.77
396989-969899.6909.82
486019-860198.5948.74
587105-871058.7038.86
688777-887778.8709.01
20min1108402-10840210.83010.883.0011.0411.112.95
2113708-11370811.36011.60
3111688-11168811.15911.40
4104972-10497210.48810.72
5107648-10764810.75511.01
6106691-10669110.65910.90
30min1115624-11562411.55211.845.8511.8912.205.73
2130129-13012913.00113.37
3112330-11233011.22311.59
4113149-11314911.30511.66
5123404-12340412.32912.70
6116185-11618511.60811.96
45min1128017-12801712.79012.8912.6213.2513.3812.24
2160111-16011115.99716.51
3130249-13024913.01313.50
4114698-11469811.45911.94
5121746-12174612.16412.67
6119210-11921011.91012.39
60min1147944-14794414.78115.4617.3315.3916.0916.77
2175569-17556917.54118.23
3197522-19752219.73420.37
4124559-12455912.44513.05
5138550-13855013.84214.48
6144187-14418714.40615.02
极限1219669-21966921.94719.8529.8422.7220.6528.81
2198059-19805919.78820.67
3305544-30554430.52731.38
4170132-17013216.99817.74
5149527-14952714.93915.74
6148960-14896014.88215.66
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.242592752590462580242579192560612580650.50
210.272623712619682621700.11
单位质量响应值RSD%判断
25201.6625527.750.91数据可信
供试品溶液-2024092721批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147880-4788018.82527.0821.2818.8227.0821.28
287193-8719334.28134.28
358112-5811222.84722.85
473953-7395329.07529.08
580838-8083831.78231.78
665291-6529125.67025.67
10min1131317-13131751.62964.5612.1451.8464.8612.18
2184700-18470072.61773.00
3154520-15452060.75161.01
4175053-17505368.82469.15
5180043-18004370.78671.14
6159574-15957462.73863.02
15min1185861-18586173.07379.924.7473.8680.944.85
2211360-21136083.09984.29
3202116-20211679.46480.39
4208564-20856481.99983.09
5210943-21094382.93584.07
6200865-20086578.97279.95
20min1211428-21142883.12586.442.0984.7288.342.25
2224133-22413388.12090.23
3221000-22100086.88988.70
4221555-22155587.10789.11
5222858-22285887.61989.68
6218134-21813485.76287.62
30min1232291-23229191.32892.280.7793.8595.150.92
2236480-23648092.97596.06
3233360-23336091.74894.53
4236804-23680493.10296.07
5234049-23404992.01995.05
6235345-23534592.52895.34
45min1239482-23948294.15593.830.8597.6997.720.76
2235165-23516592.45896.58
3239864-23986494.30598.10
4240106-24010694.40098.40
5240009-24000994.36298.42
6237295-23729593.29597.14
60min1239523-23952394.17193.550.6298.7598.490.46
2237743-23774393.47198.62
3239087-23908794.00098.84
4235440-23544092.56697.62
5237402-23740293.33798.44
6238531-23853193.78198.66
极限1241456-24145694.93193.470.99100.5699.440.78
2237150-23715093.23899.43
3239679-23967994.232100.12
4236549-23654993.00299.08
5236124-23612492.83598.98
6235434-23543492.56398.48
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0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%
111.471018694101767510175481017746101680810176940.07
211.421034348103245310334000.13
单位质量响应值RSD%判断
88726.5990490.371.40数据可信
供试品溶液-2024092721批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165876-658766.6004.8032.966.604.8032.97
236347-363473.6423.64
355619-556195.5735.57
464253-642536.4386.44
532319-323193.2383.24
633065-330653.3133.31
10min196556-965569.6748.5413.229.758.6013.34
283003-830038.3178.36
387967-879678.8148.88
498553-985539.8759.95
574690-746907.4847.52
670884-708847.1027.14
15min1103100-10310010.3309.247.9410.519.398.06
294877-948779.5069.64
387343-873438.7518.91
497011-970119.7209.90
587428-874288.7608.88
683672-836728.3848.50
20min1103134-10313410.3349.199.9110.639.449.98
294955-949559.5149.75
385630-856308.5808.84
4100538-10053810.07310.36
585548-855488.5728.79
680790-807908.0958.30
30min1103547-10354710.3759.9813.7810.7910.3413.63
293338-933389.3529.70
391185-911859.1369.49
4125073-12507312.53212.93
597840-978409.80310.11
686788-867888.6968.99
45min183814-838148.3988.462.178.928.922.09
283700-837008.3868.83
384946-849468.5118.97
485076-850768.5249.06
581871-818718.2038.62
687350-873508.7529.15
60min194001-940019.4188.993.5010.049.553.83
286455-864558.6629.20
389345-893458.9529.50
492959-929599.3149.95
586736-867368.6919.20
688951-889518.9129.41
极限1101995-10199510.2199.136.9210.949.796.72
284368-843688.4539.09
390688-906889.0879.73
488918-889188.9099.65
594247-942479.44310.05
686675-866758.6849.28
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.242568342575832575272567662578152573050.19
210.272614002613622613810.02
单位质量响应值RSD%判断
25127.4425450.930.91数据可信
供试品溶液-2024092721批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195437-9543737.63425.9838.3937.6325.9838.38
251511-5151120.31320.31
380801-8080131.86331.86
488357-8835734.84234.84
537621-3762114.83514.84
641555-4155516.38716.39
10min1184847-18484772.89260.8822.1173.3161.1722.18
2139100-13910054.85255.08
3179743-17974370.87971.23
4188934-18893474.50374.89
5119032-11903246.93847.10
6114688-11468845.22545.41
15min1212389-21238983.75277.5511.5784.9878.5211.74
2199173-19917378.54179.38
3215783-21578385.09186.23
4215862-21586285.12286.34
5168936-16893666.61767.30
6167890-16789066.20566.89
20min1223950-22395088.31185.858.9890.4787.689.16
2225335-22533588.85790.57
3232352-23235291.62593.71
4237787-23778793.76895.93
5195944-19594477.26878.69
6190846-19084675.25776.68
30min1234304-23430492.39491.845.8595.5394.626.05
2245774-24577496.91799.61
3242038-24203895.44498.55
4242973-24297395.81399.02
5213732-21373284.28286.57
6218538-21853886.17788.43
45min1233133-23313391.93291.883.4996.1095.683.81
2237889-23788993.80897.58
3237299-23729993.57597.74
4242926-24292695.794100.06
5224875-22487588.67691.90
6221887-22188787.49890.71
60min1227192-22719289.59091.261.8794.7896.081.99
2234364-23436492.41897.23
3228542-22854290.12295.33
4238541-23854194.06599.40
5231345-23134591.22795.43
6228574-22857490.13594.32
极限1235973-23597393.05294.361.1899.24100.200.71
2240710-24071094.920100.76
3236454-23645493.24299.45
4238320-23832093.978100.35
5242826-24282695.755100.98
6241460-24146095.216100.40
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0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%
111.471023663102339910207011019412101473810203830.36
211.421031378102377910275780.53
单位质量响应值RSD%判断
88961.0389980.560.81数据可信
供试品溶液-2024092721批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153219-532195.3404.8513.475.344.8513.49
242034-420344.2184.22
347126-471264.7294.73
459060-590605.9265.93
544769-447694.4924.49
643926-439264.4084.41
10min177525-775257.7797.874.197.847.924.20
272436-724367.2687.32
379868-798688.0148.07
481731-817318.2018.27
578349-783497.8627.91
680449-804498.0738.12
15min179760-797608.0038.113.688.158.253.64
278638-786387.8918.02
385969-859698.6268.77
480433-804338.0718.23
577755-777557.8027.94
682259-822598.2548.39
20min181387-813878.1678.361.858.408.591.84
281645-816458.1938.41
384101-841018.4398.68
483241-832418.3538.60
584020-840208.4318.65
685361-853618.5658.80
30min184688-846888.4988.282.278.828.602.19
283182-831828.3478.65
384472-844728.4768.81
481143-811438.1428.48
580481-804818.0768.39
680976-809768.1258.45
45min183101-831018.3398.191.308.768.611.30
280111-801118.0398.44
381904-819048.2198.64
481091-810918.1378.57
581328-813288.1618.57
682436-824368.2728.69
60min179167-791677.9448.052.088.468.562.00
279077-790777.9358.42
381643-816438.1928.71
478847-788477.9128.43
579770-797708.0048.50
682927-829278.3218.83
极限178205-782057.8478.136.188.458.725.87
276283-762837.6548.23
381105-811058.1388.75
490176-901769.0499.66
577969-779697.8248.41
682217-822178.2508.85
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.242596342589342588862581682566612584570.44
210.272619562612722616140.19
单位质量响应值RSD%判断
25239.9425473.610.66数据可信
供试品溶液-2024092721批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193412-9341236.73731.3718.5936.7431.3818.59
263796-6379625.08925.09
372064-7206428.34128.34
4102273-10227340.22240.22
570819-7081927.85127.85
676298-7629830.00630.01
10min1185744-18574473.04968.139.9073.4668.489.94
2144166-14416656.69756.98
3171300-17130067.36867.68
4193426-19342676.07076.52
5167089-16708965.71266.02
6177623-17762369.85570.19
15min1213055-21305583.78982.374.1085.0183.484.19
2192826-19282675.83476.74
3213501-21350183.96585.03
4216989-21698985.33786.63
5208685-20868582.07183.11
6211629-21162983.22984.34
20min1222139-22213987.36288.092.5589.5190.112.64
2213364-21336483.91185.66
3227723-22772389.55891.55
4229014-22901490.06692.31
5225599-22559988.72390.67
6226078-22607888.91190.95
30min1237857-23785793.54392.561.3696.6695.561.48
2230267-23026790.55893.24
3238832-23883293.92796.92
4237046-23704693.22596.47
5233647-23364791.88894.83
6234545-23454592.24195.26
45min1239540-23954094.20594.270.9398.3798.291.05
2235764-23576492.72096.41
3239322-23932294.12098.15
4241159-24115994.84299.12
5240113-24011394.43198.39
6242263-24226395.27699.32
60min1234314-23431492.15094.111.4397.3699.191.43
2235683-23568392.68897.41
3241858-24185895.117100.20
4241227-24122794.869100.20
5242286-24228695.285100.29
6240416-24041694.55099.66
极限1237926-23792693.57194.001.2299.80100.121.33
2234971-23497192.40898.16
3240665-24066594.648100.79
4243576-24357695.793102.18
5238947-23894793.972100.04
6237979-23797993.59199.75
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