苯磺酸氨氯地平缬沙坦片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.172406312410222406782408462405312407420.09
214.092430872430542430700.01
单位质量响应值RSD%判断
16989.5617251.241.09数据可信
长期6月-供试品溶液-2023112221批-苯磺酸氨氯地平-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%
5min190016-9001634.08633.304.5134.0933.304.51
286538-8653832.76932.77
386708-8670832.83332.83
482753-8275331.33631.34
587134-8713432.99532.99
694514-9451435.78935.79
10min1141701-14170153.65751.495.3553.7151.555.34
2133597-13359750.58850.64
3129432-12943249.01149.07
4128406-12840648.62348.68
5135629-13562951.35851.41
6147168-14716855.72755.79
15min1170578-17057864.59262.865.3564.7463.005.35
2161800-16180061.26861.41
3157410-15741059.60659.74
4157931-15793159.80359.94
5167693-16769363.49963.64
6180605-18060568.38968.54
20min1190970-19097072.31471.194.0272.5771.444.02
2184111-18411169.71669.96
3183523-18352369.49469.73
4178445-17844567.57167.80
5191218-19121872.40772.65
6199791-19979175.65475.92
30min1218276-21827682.65380.064.0483.0380.424.04
2206281-20628178.11178.47
3206045-20604578.02278.37
4200039-20003975.74876.09
5215973-21597381.78182.15
6221935-22193584.03984.43
45min1234245-23424588.70086.223.5589.2186.723.55
2223381-22338184.58685.07
3220415-22041583.46383.94
4218016-21801682.55583.03
5232952-23295288.21188.71
6237148-23714889.80090.33
60min1241523-24152391.45688.483.8692.1289.123.86
2226861-22686185.90486.53
3224497-22449785.00985.63
4225285-22528585.30785.92
5243826-24382692.32892.98
6239979-23997990.87291.55
极限1269149-269149101.91796.243.09102.7397.033.07
2247056-24705693.55194.32
3253189-25318995.87496.64
4254507-25450796.37397.12
5251931-25193195.39796.20
6249137-24913794.33995.17
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.044679051468263146806344682961467651446803580.06
216.064722937472176347223500.02
单位质量响应值RSD%判断
291792.89294044.210.55数据可信
长期6月-供试品溶液-2023112221批-缬沙坦-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%
5min13759753-375975371.55169.085.4871.5569.085.48
23487392-348739266.36866.37
33525886-352588667.10067.10
43459218-345921865.83165.83
53575661-357566168.04768.05
63972527-397252775.60075.60
10min14589254-458925487.33782.875.1987.4682.995.19
24203654-420365479.99980.11
34207270-420727080.06780.18
44103505-410350578.09378.20
54366433-436643383.09683.21
64658457-465845788.65488.78
15min14944751-494475194.10289.084.5694.3789.334.56
24490982-449098285.46785.71
34597273-459727387.49087.73
44435314-443531484.40784.65
54702884-470288489.49989.75
64912787-491278793.49493.77
20min15132669-513266997.67892.114.3598.1092.514.34
24650315-465031588.49988.89
34729949-472994990.01490.41
44624449-462444988.00788.39
54862992-486299292.54692.95
65039992-503999295.91596.34
30min15298277-5298277100.83094.914.09101.4195.464.09
24796146-479614691.27491.81
34894139-489413993.13993.68
44785411-478541191.07091.60
55006445-500644595.27695.83
65142163-514216397.85998.45
45min15389145-5389145102.55996.493.74103.3197.203.74
24901078-490107893.27193.96
34992102-499210295.00395.70
44883315-488331592.93393.61
55099969-509996997.05697.77
65154842-515484298.10098.85
60min15443205-5443205103.58897.343.52104.5198.213.52
24993986-499398695.03995.88
35034855-503485595.81796.67
44937405-493740593.96294.80
55129748-512974897.62398.50
65149676-514967698.00298.92
极限15747168-5747168109.373100.754.52110.47101.794.50
25088767-508876796.84397.84
35340291-5340291101.630102.64
45261516-5261516100.131101.12
55183935-518393598.65499.69
65143278-514327897.88098.96
苯磺酸氨氯地平缬沙坦片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.172413982413002410932408612404522410210.16
214.092402442404812403620.07
单位质量响应值RSD%判断
17009.2417059.050.21数据可信
长期6月-供试品溶液-2023112221批-苯磺酸氨氯地平-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%
5min195604-9560436.38333.1913.4836.3833.1913.48
290340-9034034.38034.38
370186-7018626.71026.71
496248-9624836.62836.63
574679-7467928.42028.42
696279-9627936.64036.64
10min1142898-14289854.38151.726.2054.4451.776.21
2131788-13178850.15350.21
3127178-12717848.39948.44
4141800-14180053.96354.02
5126465-12646548.12848.17
6145317-14531755.30255.36
15min1177815-17781567.66964.493.9367.8264.633.94
2163915-16391562.38062.52
3165608-16560863.02463.15
4173279-17327965.94366.09
5161486-16148661.45561.58
6174708-17470866.48766.64
20min1196893-19689374.93072.692.7275.1972.942.73
2185262-18526270.50370.75
3189038-18903871.94072.17
4191722-19172272.96273.22
5185968-18596870.77271.00
6197109-19710975.01275.28
30min1222414-22241484.64281.922.8685.0382.292.85
2209953-20995379.90080.26
3220069-22006983.75084.10
4206155-20615578.45478.84
5217042-21704282.59882.95
6215958-21595882.18582.57
45min1238712-23871290.84488.742.5191.3789.242.50
2226607-22660786.23886.73
3238057-23805790.59591.08
4225171-22517185.69186.20
5235055-23505589.45389.94
6235417-23541789.59090.12
60min1243936-24393692.83291.841.8593.5192.491.85
2236746-23674690.09690.74
3242713-24271392.36793.01
4234828-23482889.36690.02
5243745-24374592.76093.39
6245968-24596893.60694.28
极限1251162-25116295.58294.890.7096.4295.700.70
2249040-24904094.77595.56
3250035-25003595.15395.95
4251080-25108095.55196.36
5247546-24754694.20695.00
6247137-24713794.05194.88
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.044709032470693047020184694808468998347005540.18
216.064683046468357946833120.01
单位质量响应值RSD%判断
293052.00291613.450.35数据可信
长期6月-供试品溶液-2023112221批-缬沙坦-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%
5min13773892-377389271.96367.2612.4471.9667.2612.45
23596205-359620568.57568.58
32914917-291491755.58455.58
43831861-383186173.06973.07
53059720-305972058.34558.34
63985892-398589276.00676.01
10min14519422-451942286.18083.164.9986.3083.274.99
24279003-427900381.59581.71
34120539-412053978.57378.67
44470529-447052985.24785.37
54130828-413082878.77078.87
64646137-464613788.59688.72
15min14802285-480228591.57389.313.1391.8489.563.14
24534224-453422486.46286.71
34601522-460152287.74587.97
44702034-470203489.66289.93
54558185-455818586.91987.15
64902265-490226593.48093.75
20min14942294-494229494.24392.662.3794.6693.062.37
24688815-468881589.41089.80
34861762-486176292.70893.08
44825859-482585992.02392.44
54813580-481358091.78992.16
65022900-502290095.78096.21
30min15054426-505442696.38195.852.1196.9596.402.10
24849132-484913292.46793.01
35116336-511633697.56298.09
44955569-495556994.49695.06
55058933-505893396.46796.99
65123986-512398697.70898.30
45min15109207-510920797.42697.551.8498.1698.271.82
24974051-497405194.84995.55
35229778-522977899.725100.41
45043623-504362396.17596.90
55168974-516897498.56699.25
65169767-516976798.58199.33
60min15120567-512056797.64397.971.4498.5498.851.43
25019161-501916195.70996.56
35237041-523704199.864100.72
45110761-511076197.45698.34
55176376-517637698.70799.56
65163630-516363098.46499.38
极限15125341-512534197.73498.550.9998.7999.590.98
25109358-510935897.42998.44
35242858-524285899.975100.99
45211078-521107899.369100.42
55171210-517121098.60899.62
65149649-514964998.19799.28
苯磺酸氨氯地平缬沙坦片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.172411362411942412152411362410832411530.03
214.092407942409742408840.06
单位质量响应值RSD%判断
17018.5617096.100.33数据可信
长期6月-供试品溶液-2023112421批-苯磺酸氨氯地平-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%
5min187865-8786533.39333.514.5633.3933.524.56
292529-9252935.16535.17
386185-8618532.75432.75
481400-8140030.93630.94
590261-9026134.30334.30
690872-9087234.53534.54
10min1131375-13137549.92849.453.0749.9849.513.07
2130657-13065749.65549.71
3127946-12794648.62548.68
4123800-12380047.05047.10
5131253-13125349.88249.94
6135739-13573951.58751.64
15min1163357-16335762.08361.623.5562.2261.763.55
2165415-16541562.86563.01
3157106-15710659.70759.84
4153700-15370058.41358.54
5163815-16381562.25762.40
6169440-16944064.39564.54
20min1185169-18516970.37270.153.0570.6170.393.05
2187141-18714171.12271.37
3180296-18029668.52168.76
4176291-17629166.99867.23
5186202-18620270.76571.01
6192395-19239573.11973.37
30min1212047-21204780.58779.155.4380.9579.515.42
2215159-21515981.77082.13
3210337-21033779.93780.29
4185940-18594070.66571.00
5209318-20931879.55079.91
6216842-21684282.41082.78
45min1230915-23091587.75887.822.7288.2588.312.73
2235820-23582089.62290.12
3226920-22692086.24086.72
4221190-22119084.06284.52
5233106-23310688.59189.09
6238548-23854890.65991.17
60min1244176-24417692.79891.122.6193.4491.762.61
2237193-23719390.14490.79
3237300-23730090.18590.81
4230608-23060887.64188.24
5240754-24075491.49792.14
6248581-24858194.47295.13
极限1256680-25668097.55096.731.1198.3497.521.10
2249626-24962694.86995.67
3255043-25504396.92897.70
4253351-25335196.28597.03
5257560-25756097.88498.68
6254953-25495396.89397.71
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.044702579470366847004234699141470105847013740.04
216.064697652469775346977020.01
单位质量响应值RSD%判断
293103.12292509.460.15数据可信
长期6月-供试品溶液-2023112421批-缬沙坦-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%
5min13559323-355932367.76269.223.2567.7669.223.25
23629046-362904669.08969.09
33543291-354329167.45667.46
43533269-353326967.26667.27
53723404-372340470.88570.89
63827575-382757572.86972.87
10min14369191-436919183.18083.603.3583.2983.723.35
24348631-434863182.78882.90
34252455-425245580.95781.07
44264967-426496781.19581.31
54466567-446656785.03485.15
64646011-464601188.45088.57
15min14753286-475328690.49290.102.7090.7490.362.70
24692269-469226989.33089.58
34612042-461204287.80388.05
44600993-460099387.59387.84
54797209-479720991.32891.59
64940874-494087494.06394.33
20min14957940-495794094.38893.622.3694.7994.032.36
24863068-486306892.58292.98
34819629-481962991.75592.15
44785352-478535291.10291.50
54988528-498852894.97095.38
65091791-509179196.93697.36
30min15134886-513488697.75796.802.1398.3297.362.14
25037836-503783695.90996.47
34999649-499964995.18295.73
44954279-495427994.31894.86
55131841-513184197.69998.27
65250353-525035399.955100.54
45min15220437-522043799.38698.411.83100.1199.131.83
25156110-515611098.16198.88
35086532-508653296.83697.54
45045147-504514796.04896.75
55201918-520191899.03399.77
65304563-5304563100.987101.74
60min15307235-5307235101.03899.261.64101.93100.141.64
25197241-519724198.94499.82
35133613-513361397.73398.60
45104426-510442697.17798.04
55233597-523359799.636100.53
65306301-5306301101.020101.94
极限15372665-5372665102.284101.100.68103.34102.150.68
25279972-5279972100.519101.56
35313427-5313427101.156102.19
45275622-5275622100.436101.46
55325173-5325173101.379102.44
65296941-5296941100.842101.93
苯磺酸氨氯地平缬沙坦片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.172414392413302413782413022412652413430.03
214.092439592440022439800.02
单位质量响应值RSD%判断
17031.9717315.831.17数据可信
长期6月-供试品溶液-2023112421批-苯磺酸氨氯地平-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%
5min190660-9066034.22333.796.8034.2233.786.80
289011-8901133.60133.60
388105-8810533.25933.26
496552-9655236.44736.45
593809-9380935.41235.41
678861-7886129.76929.77
10min1139690-13969052.73150.374.6952.7950.424.69
2129786-12978648.99349.05
3129388-12938848.84348.90
4140959-14095953.21053.27
5135417-13541751.11851.18
6125302-12530247.30047.35
15min1167750-16775063.32461.642.4063.4761.782.40
2161664-16166461.02661.16
3157517-15751759.46159.60
4167663-16766363.29163.44
5162250-16225061.24861.39
6162821-16282161.46361.59
20min1188847-18884771.28868.603.0271.5468.843.02
2176543-17654366.64366.88
3175444-17544466.22866.46
4187045-18704570.60770.86
5179846-17984667.89068.14
6182601-18260168.93069.16
30min1213976-21397680.77477.812.3681.1478.172.36
2205358-20535877.52077.87
3201666-20166676.12776.47
4206971-20697178.12978.50
5200603-20060375.72576.08
6208244-20824478.61078.96
45min1235331-23533188.83585.552.7189.3486.032.71
2220217-22021783.12983.61
3219558-21955882.88183.35
4228670-22867086.32086.82
5225340-22534085.06385.55
6230594-23059487.04787.52
60min1241840-24184091.29289.991.5991.9490.621.59
2236217-23621789.16989.79
3232843-23284387.89688.51
4241626-24162691.21191.86
5236358-23635889.22289.85
6241460-24146091.14891.77
极限1254795-25479596.18296.560.9896.9997.330.97
2253643-25364395.74796.51
3255014-25501496.26597.02
4256202-25620296.71397.51
5254478-25447896.06396.84
6260563-26056398.36099.13
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.044708261470550647064024704878470426147058620.04
216.064753969475569847548340.03
单位质量响应值RSD%判断
293382.92296066.870.65数据可信
长期6月-供试品溶液-2023112421批-缬沙坦-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%
5min13624773-362477368.56066.637.2168.5666.627.20
23501183-350118366.22266.22
33424928-342492864.78064.78
43812166-381216672.10472.10
53686073-368607369.71969.72
63085825-308582558.36658.37
10min14389070-438907083.01681.472.5383.1381.582.54
24272692-427269280.81580.92
34162481-416248178.73078.84
44451714-445171484.20184.32
54350090-435009082.27982.39
64218812-421881279.79679.89
15min14700891-470089188.91487.681.8889.1787.931.88
24610316-461031687.20187.45
34494136-449413685.00385.24
44741594-474159489.68489.94
54606847-460684787.13587.39
64661338-466133888.16688.40
20min14845713-484571391.65390.661.7692.0591.051.76
24769626-476962690.21490.60
34660266-466026688.14588.53
44882201-488220192.34392.75
54743602-474360289.72290.12
64857560-485756091.87792.25
30min14993844-499384494.45593.541.6795.0194.091.67
24951117-495111793.64794.19
34809182-480918290.96291.49
45021401-502140194.97695.54
54889134-488913492.47493.02
65009786-500978694.75695.29
45min15089283-508928396.26095.661.5396.9796.361.53
25075664-507566496.00296.70
34928203-492820393.21393.89
45112203-511220396.69397.42
55003965-500396594.64695.35
65134718-513471897.11997.81
60min15103018-510301896.52096.571.2697.3997.421.26
25124420-512442096.92497.78
34997438-499743894.52395.36
45166700-516670097.72498.61
55073963-507396395.97096.83
65167164-516716497.73398.58
极限15132207-513220797.07299.111.0798.10100.131.06
25246354-524635499.231100.25
35236130-523613099.037100.03
45263082-526308299.547100.59
55279976-527997699.867100.89
65281864-528186499.902100.92
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