培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661541251557881559421558351556671554710.49
215.611554091553741553920.02
单位质量响应值RSD%判断
9927.919954.640.20数据可信
供试品溶液-6087549批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161109-6110938.34241.4250.0438.3441.4250.05
2132571-13257183.18083.18
349842-4984231.27331.27
446067-4606728.90428.90
556142-5614235.22535.23
650354-5035431.59431.59
10min1149982-14998294.10490.275.9594.2690.445.97
2148349-14834993.07993.41
3134244-13424484.22984.35
4140509-14050988.16088.28
5155102-15510297.31797.46
6135038-13503884.72884.85
15min1153206-15320696.12795.483.3596.6696.013.32
2147754-14775492.70693.41
3147409-14740992.49092.95
4153646-15364696.40396.87
5161079-161079101.067101.60
6149970-14997094.09794.56
20min1152867-15286795.91496.302.7496.8397.212.68
2147630-14763092.62893.70
3152274-15227495.54296.37
4154828-15482897.14598.00
5160524-160524100.718101.65
6152784-15278495.86296.70
30min1152353-15235395.59296.492.6396.8997.782.55
2147469-14746992.52793.97
3155627-15562797.64698.86
4154354-15435496.84798.09
5159734-159734100.223101.56
6153158-15315896.09797.32
45min1152352-15235295.59196.452.6897.2798.132.60
2147329-14732992.43994.26
3155626-15562697.64599.25
4154003-15400396.62798.26
5159855-159855100.299102.04
6153155-15315596.09597.70
60min1151618-15161895.13195.952.6297.1998.012.55
2146776-14677692.09394.28
3154584-15458496.99298.99
4153384-15338496.23998.25
5159002-15900299.764101.90
6152143-15214395.46097.45
极限1150905-15090594.68395.582.6497.1398.032.56
2146160-14616091.70694.26
3153602-15360296.37598.76
4152845-15284595.90098.30
5158508-15850899.454101.99
6151955-15195595.34297.72
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.353025363024233023453021743021073023170.06
212.323019423017663018540.05
单位质量响应值RSD%判断
24479.1124501.140.07数据可信
供试品溶液-6087549批-吲达帕胺-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163803-6380320.46720.7239.1720.4720.7239.16
2115170-11517036.94536.94
352879-5287916.96316.96
449817-4981715.98015.98
555605-5560517.83717.84
650278-5027816.12816.13
10min1175406-17540656.26753.7711.5556.3553.8511.59
2200168-20016864.21064.36
3149637-14963748.00148.07
4157628-15762850.56450.63
5172675-17267555.39155.46
6150168-15016848.17148.24
15min1229854-22985473.73371.585.6474.0471.885.66
2230376-23037673.90174.31
3204889-20488965.72565.98
4223966-22396671.84472.11
5238183-23818376.40576.70
6211658-21165867.89668.15
20min1253389-25338981.28379.893.9681.8880.473.95
2245712-24571278.82079.52
3235814-23581475.64576.17
4253277-25327781.24781.80
5263758-26375884.60985.21
6242303-24230377.72778.26
30min1272605-27260587.44786.903.3888.3787.803.34
2258261-25826182.84683.86
3266160-26616085.37986.20
4277914-27791489.15090.03
5283799-28379991.03891.97
6266617-26661785.52686.37
45min1281216-28121690.20990.233.3691.4991.483.29
2265134-26513485.05086.40
3282194-28219490.52391.69
4287545-28754592.23993.47
5292999-29299993.98995.29
6278582-27858289.36490.55
60min1282653-28265390.67091.003.5192.3192.613.44
2266316-26631685.42987.12
3286877-28687792.02593.55
4290120-29012093.06594.67
5295219-29521994.70196.38
6280858-28085890.09491.63
极限1283309-28330990.88191.753.3392.8893.733.25
2269968-26996886.60188.63
3292690-29269093.89095.79
4291151-29115193.39695.37
5296276-29627695.04097.10
6282801-28280190.71892.62
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661545081549881544081545041543971545610.16
215.611551821551561551690.02
单位质量响应值RSD%判断
9869.809940.360.51数据可信
供试品溶液-6087549批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1141900-14190089.35939.8162.1189.3639.8162.11
244343-4434327.92427.92
362298-6229839.23139.23
444743-4474328.17628.18
542047-4204726.47826.48
643972-4397227.69127.69
10min1145092-14509291.37089.0311.5891.7389.1911.58
2150843-15084394.99195.10
3144506-14450691.00191.16
4140471-14047188.46088.57
5110139-11013969.35869.46
6157191-15719198.98999.10
15min1144358-14435890.90797.443.4791.6397.953.36
2154642-15464297.38497.88
3158771-15877199.984100.50
4156533-15653398.57499.04
5155331-15533197.81798.20
6158721-15872199.952100.46
20min1143956-14395690.65497.333.5191.7498.243.40
2154840-15484097.50898.39
3158023-15802399.513100.43
4155292-15529297.79398.65
5156413-15641398.49999.27
6158836-158836100.025100.93
30min1143823-14382390.57097.884.1692.0299.174.02
2154478-15447897.28098.55
3157426-15742699.137100.46
4155886-15588698.16799.42
5163436-163436102.921104.09
6157510-15751099.190100.50
45min1143604-14360490.43397.023.4792.2498.713.36
2153964-15396496.95798.62
3157559-15755999.221100.94
4154958-15495897.58399.23
5156483-15648398.543100.12
6157843-15784399.399101.10
60min1143149-14314990.14697.103.6292.3299.183.50
2154272-15427297.15199.20
3157351-15735199.090101.20
4155695-15569598.047100.08
5156741-15674198.705100.68
6157979-15797999.485101.59
极限1143228-14322890.19696.603.3492.7399.063.22
2153393-15339396.59799.03
3156467-15646798.533101.04
4154965-15496597.587100.01
5155944-15594498.203100.57
6156347-15634798.457100.96
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.352951002953262942842940332941032945690.21
212.322942162941962942060.01
单位质量响应值RSD%判断
23851.7423880.360.09数据可信
供试品溶液-6087549批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113452-11345237.34518.6950.5737.3518.6850.59
245350-4535014.92814.93
359174-5917419.47819.48
442662-4266214.04314.04
538019-3801912.51512.51
641935-4193513.80413.80
10min1201477-20147766.32050.3618.0266.4750.4418.06
2147516-14751648.55848.62
3157539-15753951.85751.94
4138757-13875745.67545.73
5118434-11843438.98539.04
6154197-15419750.75750.81
15min1232812-23281276.63572.045.4777.0572.325.53
2217360-21736071.54971.80
3224085-22408573.76274.05
4214408-21440870.57770.82
5198403-19840365.30865.51
6226079-22607974.41974.68
20min1246728-24672881.21681.671.9381.9482.231.94
2247148-24714881.35481.89
3250306-25030682.39382.97
4245286-24528680.74181.26
5242713-24271379.89480.36
6256420-25642084.40684.96
30min1258704-25870485.15889.202.5186.2090.102.42
2269802-26980288.81189.68
3276908-27690891.15092.06
4270055-27005588.89489.74
5273610-27361090.06490.85
6276891-27689191.14492.04
45min1262933-26293386.55091.812.9887.9493.062.88
2279378-27937891.96393.18
3284618-28461893.68894.96
4278757-27875791.75992.96
5282016-28201692.83193.98
6285777-28577794.06995.33
60min1261513-26151386.08293.364.0087.8294.983.88
2286247-28624794.22495.81
3289678-28967895.35397.00
4284170-28417093.54095.11
5286560-28656094.32795.85
6293657-29365796.66398.30
极限1264390-26439087.02993.503.5189.1195.493.40
2286196-28619694.20796.17
3290587-29058795.65397.68
4285737-28573794.05696.00
5285965-28596594.13196.03
6291396-29139695.91997.94
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661552931554191552631551621550591552390.09
215.611553971553281553620.04
单位质量响应值RSD%判断
9913.099952.720.29数据可信
供试品溶液-6087549批-培哚普利-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165575-6557541.17930.2721.3341.1830.2721.33
246444-4644429.16529.17
347253-4725329.67329.67
446705-4670529.32929.33
533444-3344421.00221.00
649777-4977731.25831.26
10min1149715-14971594.01682.3719.1394.1882.4919.13
2136007-13600785.40885.52
3145936-14593691.64391.76
4130055-13005581.67081.79
582033-8203351.51451.60
6143237-14323789.94890.07
15min1149673-14967393.99095.492.4394.5395.942.34
2152347-15234795.66996.13
3148599-14859993.31593.80
4153491-15349196.38796.83
5158596-15859699.59399.88
6149678-14967893.99394.48
20min1149853-14985394.10395.532.7895.0296.372.69
2151866-15186695.36796.21
3148751-14875193.41194.27
4153732-15373296.53897.37
5159810-159810100.355101.04
6148782-14878293.43094.29
30min1149377-14937793.80495.552.7095.1096.772.60
2151908-15190895.39396.62
3148459-14845993.22794.46
4153596-15359696.45397.67
5159628-159628100.241101.33
6150008-15000894.20095.43
45min1149469-14946993.86195.402.7495.5397.002.64
2151926-15192695.40497.01
3148029-14802992.95794.56
4153194-15319496.20197.80
5159492-159492100.156101.65
6149447-14944793.84895.46
60min1149138-14913893.65495.142.7495.7097.122.64
2151875-15187595.37297.36
3147562-14756292.66494.64
4152663-15266395.86797.85
5158973-15897399.830101.72
6148816-14881693.45195.44
极限1148336-14833693.15094.592.8495.5796.952.75
2150829-15082994.71597.08
3145718-14571891.50693.85
4151820-15182095.33897.71
5158214-15821499.353101.64
6148895-14889593.50195.86
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.352992702992312994832992302993562993140.04
212.322962882957022959950.14
单位质量响应值RSD%判断
24235.9524025.570.62数据可信
供试品溶液-6087549批-吲达帕胺-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167340-6734021.92415.5426.4521.9215.5426.45
244816-4481614.59114.59
347973-4797315.61815.62
447446-4744615.44715.45
527901-279019.0849.08
650870-5087016.56216.56
10min1179950-17995058.58647.0119.7158.6747.0719.72
2138721-13872145.16345.22
3156669-15666951.00651.07
4141818-14181846.17146.23
594493-9449330.76430.80
6154665-15466550.35450.42
15min1227311-22731174.00568.995.8974.3369.245.95
2207706-20770667.62267.86
3216876-21687670.60770.87
4212484-21248469.17869.42
5190159-19015961.90962.07
6216964-21696470.63670.90
20min1249676-24967681.28679.271.5281.9079.801.56
2238570-23857077.67078.18
3241218-24121878.53279.08
4244029-24402979.44779.97
5243262-24326279.19879.60
6244177-24417779.49680.05
30min1264854-26485486.22786.962.5987.1787.812.50
2263252-26325285.70686.53
3260434-26043484.78885.65
4268308-26830887.35288.19
5280137-28013791.20391.93
6265686-26568686.49887.37
45min1273519-27351989.04890.713.2490.3491.903.14
2275410-27541089.66490.83
3270055-27005587.92189.12
4280397-28039791.28892.48
5295626-29562696.24697.33
6276718-27671890.09091.30
60min1275666-27566689.74791.733.4691.3993.283.36
2279477-27947790.98892.51
3272706-27270688.78490.34
4283525-28352592.30693.86
5300152-30015297.71999.19
6279006-27900690.83592.41
极限1276098-27609889.88892.083.4591.8994.003.35
2280859-28085991.43893.32
3273127-27312788.92190.83
4283828-28382892.40594.33
5301009-30100997.99899.86
6282066-28206691.83193.77
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303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4000
标示量(mg)2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%
115.661538751537931539071539121537541538480.05
215.611535221535241535230.01
单位质量响应值RSD%判断
9824.279834.910.08数据可信
供试品溶液-6087549批-培哚普利-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%
5min153359-5335933.86035.2011.6033.8635.2011.60
253937-5393734.22634.23
348827-4882730.98430.98
462122-6212239.42039.42
550035-5003531.75031.75
664536-6453640.95240.95
10min1145728-14572892.47485.957.8092.6186.097.78
2147909-14790993.85893.99
3120762-12076276.63176.76
4137639-13763987.34187.50
5133653-13365384.81184.94
6126947-12694780.55680.72
15min1158804-158804100.77195.234.11101.2895.724.11
2155162-15516298.46098.97
3143347-14334790.96391.39
4147408-14740893.54094.05
5151434-15143496.09596.56
6144286-14428691.55992.04
20min1154571-15457198.08595.232.5498.9996.092.55
2154106-15410697.79098.70
3148735-14873594.38295.18
4147397-14739793.53394.41
5150699-15069995.62896.48
6144906-14490691.95292.80
30min1154204-15420497.85294.902.7699.1596.152.75
2153580-15358097.45698.75
3149087-14908794.60595.78
4146787-14678793.14694.40
5150321-15032195.38896.62
6143355-14335590.96892.19
45min1153625-15362597.48594.682.5199.1896.312.51
2153181-15318197.20398.89
3148450-14845094.20195.75
4146333-14633392.85894.49
5149482-14948294.85696.47
6144150-14415091.47293.06
60min1153124-15312497.16794.882.3899.2596.892.38
2152416-15241696.71898.79
3147703-14770393.72795.65
4151533-15153396.15798.16
5148656-14865694.33296.33
6143729-14372991.20593.16
极限1152726-15272696.91493.882.7299.3996.272.71
2152526-15252696.78799.25
3147133-14713393.36595.67
4144728-14472891.83994.22
5147704-14770493.72896.10
6142892-14289290.67492.99
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.352978672976742978872977492980512978460.05
212.322971142973862972500.07
单位质量响应值RSD%判断
24117.0924127.440.04数据可信
供试品溶液-6087549批-吲达帕胺-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%
5min155564-5556418.09618.8011.6118.1018.8011.62
255834-5583418.18418.18
349530-4953016.13116.13
466943-6694321.80221.80
553777-5377717.51417.51
664687-6468721.06721.07
10min1154713-15471350.38650.545.7650.4650.625.76
2160421-16042152.24552.32
3141448-14144846.06646.13
4165140-16514053.78253.87
5148300-14830048.29748.37
6161133-16113352.47752.56
15min1220331-22033171.75670.123.9172.0370.403.91
2225895-22589573.56873.85
3201846-20184665.73665.98
4215828-21582870.29070.59
5217942-21794270.97871.24
6209989-20998968.38868.68
20min1248112-24811280.80479.173.2081.3679.733.19
2253632-25363282.60183.18
3233413-23341376.01776.53
4241252-24125278.57079.15
5246529-24652980.28880.84
6235626-23562676.73777.31
30min1272344-27234488.69586.493.2889.5887.373.26
2276679-27667990.10791.01
3259858-25985884.62985.44
4262259-26225985.41186.31
5269135-26913587.65088.52
6253222-25322282.46883.34
45min1285141-28514192.86390.432.9694.1091.652.95
2287937-28793793.77495.04
3274109-27410989.27090.42
4274034-27403489.24690.49
5279286-27928690.95692.18
6265518-26551886.47287.68
60min1288584-28858493.98491.442.9095.5993.022.88
2290841-29084194.71996.36
3277694-27769490.43891.95
4277549-27754990.39191.99
5281243-28124391.59493.18
6268629-26862987.48689.04
极限1289755-28975594.36691.893.2596.3593.843.23
2294965-29496596.06398.08
3279335-27933590.97292.85
4277708-27770890.44292.40
5282010-28201091.84393.79
6269112-26911287.64389.54
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