缬沙坦氨氯地平片项目信息
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%
115.002545602547372547882551842549132548360.10
215.182562422567482564950.14
单位质量响应值RSD%判断
16989.0716896.900.39数据可信
长期24月-供试品溶液-2023112221批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109596-10959641.93353.7811.0941.9353.7811.10
2148659-14865956.87856.88
3140418-14041853.72553.73
4147112-14711256.28756.29
5146392-14639256.01156.01
6151194-15119457.84857.85
10min1166597-16659763.74271.715.6863.8171.805.69
2193138-19313873.89773.99
3188165-18816571.99472.08
4192510-19251073.65673.75
5188203-18820372.00872.10
6195943-19594374.97075.07
15min1186604-18660471.39777.363.9971.5777.574.00
2205887-20588778.77478.99
3202490-20249077.47577.68
4207687-20768779.46379.68
5202251-20225177.38377.60
6208295-20829579.69679.92
20min1199276-19927676.24580.472.8776.5480.812.88
2211986-21198681.10881.46
3209988-20998880.34480.68
4214067-21406781.90482.25
5209754-20975480.25480.60
6216819-21681982.95783.31
30min1211353-21135380.86683.622.0681.2984.092.08
2220075-22007584.20384.69
3217913-21791383.37683.85
4222920-22292085.29185.78
5215911-21591182.61083.09
6223087-22308785.35585.85
45min1218827-21882783.72586.121.6984.2886.731.71
2225829-22582986.40487.03
3224729-22472985.98486.60
4229433-22943387.78388.41
5223375-22337585.46686.08
6228297-22829787.34987.98
60min1224728-22472885.98387.591.4386.6888.341.45
2229437-22943787.78588.55
3227665-22766587.10787.86
4232709-23270989.03789.81
5226414-22641486.62887.38
6232570-23257088.98489.76
90min1231484-23148488.56889.431.1789.4190.331.18
2233203-23320389.22690.14
3233048-23304889.16790.07
4237255-23725590.77691.70
5230644-23064488.24789.15
6236739-23673990.57991.51
120min1234997-23499789.91290.371.1690.9091.421.16
2235772-23577290.20991.27
3235541-23554190.12091.17
4239796-23979691.74892.82
5232308-23230888.88389.93
6238801-23880191.36892.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1237812-23781290.98990.860.9692.1392.060.96
2236509-23650990.49191.70
3236901-23690190.64191.84
4240641-24064192.07293.30
5234033-23403389.54390.74
6238989-23898991.44092.67
缬沙坦氨氯地平片项目信息
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%
116.674840862484499148470344852683484440848459960.09
216.694871568488276848771680.17
单位质量响应值RSD%判断
290701.62292220.970.37数据可信
长期24月-供试品溶液-2023112221批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1222931-2229314.2645.7913.014.265.7913.05
2322393-3223936.1666.17
3317656-3176566.0756.08
4317755-3177556.0776.08
5311313-3113135.9545.95
6324687-3246876.2106.21
10min1499547-4995479.55411.478.279.5611.488.28
2622389-62238911.90411.91
3616520-61652011.79111.80
4622561-62256111.90711.92
5608725-60872511.64211.65
6628773-62877312.02612.04
15min1724983-72498313.86615.976.4913.8916.006.49
2857469-85746916.40016.43
3849881-84988116.25516.28
4864518-86451816.53516.56
5851184-85118416.28016.31
6860981-86098116.46716.50
20min1923681-92368117.66619.655.0317.7119.705.04
21049221-104922120.06720.12
31036474-103647419.82319.88
41061828-106182820.30820.37
51039988-103998819.89119.95
61052737-105273720.13420.19
30min11188853-118885322.73825.345.4822.8125.435.50
21328791-132879125.41425.51
31331034-133103425.45725.55
41365996-136599626.12626.22
51402677-140267726.82726.92
61331724-133172425.47025.56
45min11491291-149129128.52231.224.3428.6431.354.34
21661172-166117231.77131.90
31662086-166208631.78931.92
41687086-168708632.26732.40
51645158-164515831.46531.60
61648469-164846931.52831.66
60min11743564-174356433.34735.883.5633.5136.063.57
21907357-190735736.48036.67
31886456-188645636.08036.27
41929785-192978536.90937.10
51888357-188835736.11636.30
61899952-189995236.33836.52
90min12118771-211877140.52342.862.7940.7443.112.81
22250284-225028443.03843.29
32260604-226060443.23643.48
42299796-229979643.98544.24
52253697-225369743.10443.35
62263578-226357843.29343.54
120min12401937-240193745.93947.982.1546.2248.292.17
22530364-253036448.39548.71
32522063-252206348.23648.55
42552217-255221748.81349.14
52512506-251250648.05448.37
62532884-253288448.44348.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12578409-257840949.31451.302.0649.6751.692.07
22700483-270048351.64952.05
32703616-270361651.70952.11
42740735-274073552.41952.82
52676184-267618451.18451.58
62693060-269306051.50751.91
缬沙坦氨氯地平片项目信息
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%
115.002567992566852571552570142573282569960.11
215.182565062568942567000.11
单位质量响应值RSD%判断
17133.0716910.410.93数据可信
长期24月-供试品溶液-2023112221批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142028-14202854.09253.303.1754.0953.303.17
2139280-13928053.04553.05
3133440-13344050.82150.82
4146964-14696455.97255.97
5139002-13900252.93952.94
6138926-13892652.91052.91
10min1187206-18720671.29871.032.9671.3971.122.96
2187720-18772071.49471.58
3178463-17846367.96868.05
4194899-19489974.22874.32
5182870-18287069.64769.73
6187821-18782171.53271.62
15min1203892-20389277.65376.412.7577.8676.622.75
2201098-20109876.58976.80
3193551-19355173.71573.91
4208839-20883979.53779.75
5195824-19582474.58074.78
6200593-20059376.39776.60
20min1210145-21014580.03479.192.4380.3779.532.43
2209677-20967779.85680.19
3202064-20206476.95777.28
4215283-21528381.99182.34
5202364-20236477.07177.40
6208093-20809379.25379.59
30min1219863-21986383.73682.272.5184.2182.732.51
2216786-21678682.56483.03
3208822-20882279.53179.98
4223379-22337985.07585.56
5211025-21102580.37080.83
6216154-21615482.32382.79
45min1225451-22545185.86484.732.2486.4885.342.24
2224563-22456385.52686.13
3215306-21530682.00082.58
4228434-22843487.00087.63
5217761-21776182.93583.53
6223337-22333785.05985.66
60min1229292-22929287.32786.122.2888.0886.862.28
2228623-22862387.07287.82
3219358-21935883.54384.26
4232322-23232288.48189.25
5220486-22048683.97384.70
6226688-22668886.33587.08
90min1234486-23448689.30587.652.2790.2088.542.27
2231189-23118988.04988.94
3222691-22269184.81385.67
4236561-23656190.09591.02
5225777-22577785.98886.86
6230087-23008787.62988.52
120min1237143-23714390.31788.272.6491.3789.302.64
2234909-23490989.46690.51
3222273-22227384.65385.65
4237961-23796190.62891.70
5227471-22747186.63387.65
6230839-23083987.91688.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1237836-23783690.58189.281.9491.7890.471.95
2235019-23501989.50890.70
3228518-22851887.03288.17
4240705-24070591.67392.90
5230298-23029887.71088.87
6234201-23420189.19690.38
缬沙坦氨氯地平片项目信息
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%
116.674871673487755648792894880186488193548781280.09
216.694892381490414048982600.17
单位质量响应值RSD%判断
292629.15293484.720.21数据可信
长期24月-供试品溶液-2023112221批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1314822-3148225.9885.924.885.995.924.86
2310306-3103065.9025.90
3285731-2857315.4355.44
4333230-3332306.3396.34
5310706-3107065.9105.91
6313299-3132995.9595.96
10min1623515-62351511.86011.524.5311.8711.544.52
2602951-60295111.46911.48
3555578-55557810.56810.58
4635010-63501012.07912.09
5604505-60450511.49911.51
6613629-61362911.67211.68
15min1865673-86567316.46615.964.4516.5015.994.46
2829130-82913015.77115.80
3771950-77195014.68414.71
4878897-87889716.71816.75
5843295-84329516.04116.07
6846634-84663416.10416.13
20min11059932-105993220.16219.524.5820.2219.584.58
21014049-101404919.28919.34
3942387-94238717.92617.98
41077816-107781620.50220.56
51030872-103087219.60919.66
61032292-103229219.63619.69
30min11351170-135117025.70124.894.1825.7924.984.19
21287429-128742924.48924.58
31211347-121134723.04223.12
41363578-136357825.93726.03
51320512-132051225.11825.21
61316115-131611525.03525.12
45min11675477-167547731.87030.923.9032.0031.053.91
21595306-159530630.34530.47
31513813-151381328.79528.91
41686373-168637332.07732.21
51641205-164120531.21831.35
61641047-164104731.21531.35
60min11916213-191621336.44935.403.6236.6435.593.62
21831580-183158034.83935.02
31744403-174440333.18133.35
41930670-193067036.72436.91
51874487-187448735.65635.84
61870487-187048735.57935.76
90min12289867-228986743.55742.352.9143.8042.592.91
22168138-216813841.24141.48
32127869-212786940.47540.70
42275982-227598243.29343.54
52233239-223323942.48042.72
62262845-226284543.04343.28
120min12553185-255318548.56547.532.6748.8947.842.67
22436568-243656846.34746.65
32410884-241088445.85946.15
42509251-250925147.73048.05
52498016-249801647.51647.83
62585406-258540649.17849.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12720129-272012951.74150.402.5852.1450.782.58
22604005-260400549.53249.91
32538241-253824148.28148.65
42704825-270482551.45051.85
52677020-267702050.92151.31
62652050-265205050.44650.84
缬沙坦氨氯地平片项目信息
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%
115.002539612539962538782535552532302537240.13
215.182551252555552553400.12
单位质量响应值RSD%判断
16914.9316820.820.40数据可信
长期24月-供试品溶液-2023112421批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1145989-14598956.10655.756.2656.1155.756.26
2153340-15334058.93158.93
3154619-15461959.42259.42
4148238-14823856.97056.97
5133392-13339251.26451.26
6134827-13482751.81651.82
10min1183394-18339470.48170.733.2170.5770.823.21
2189956-18995673.00373.10
3190034-19003473.03373.13
4186043-18604371.49971.59
5175121-17512167.30167.39
6179648-17964869.04169.13
15min1198643-19864376.34176.582.0976.5576.792.10
2203038-20303878.03078.25
3204486-20448678.58778.81
4199801-19980176.78677.00
5193336-19333674.30274.50
6196282-19628275.43475.64
20min1206529-20652979.37279.581.3279.7179.921.33
2207698-20769879.82180.17
3211299-21129981.20581.56
4207650-20765079.80380.14
5202813-20281377.94478.27
6206507-20650779.36479.69
30min1214512-21451282.44077.7818.1382.9178.2518.03
2218846-21884684.10684.59
3219037-21903784.17984.67
4216755-21675583.30283.78
5127599-12759949.03849.49
6217547-21754783.60684.07
45min1220937-22093784.90985.851.0885.5286.451.11
2224855-22485586.41587.04
3225986-22598686.85087.48
4223377-22337785.84786.46
5220051-22005184.56985.10
6225110-22511086.51387.11
60min1223703-22370385.97287.321.1686.7288.061.18
2229255-22925588.10688.87
3229030-22903088.01988.79
4227379-22737987.38588.14
5224247-22424786.18186.86
6229675-22967588.26789.01
90min1229681-22968188.27089.340.9689.1690.230.96
2233065-23306589.57090.48
3234002-23400289.93090.85
4230917-23091788.74589.65
5231417-23141788.93789.75
6235706-23570690.58591.48
120min1230974-23097488.76790.151.2389.8191.191.23
2235056-23505690.33591.40
3236062-23606290.72291.79
4233290-23329089.65790.71
5232885-23288589.50190.47
6239213-23921391.93392.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1233748-23374889.83390.830.8391.0292.020.84
2237253-23725391.18092.39
3237404-23740491.23892.46
4235257-23525790.41391.61
5235255-23525590.41291.53
6239167-23916791.91593.11
缬沙坦氨氯地平片项目信息
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%
116.674874964487274248733494863833486219748694170.13
216.694883204489086048870320.12
单位质量响应值RSD%判断
292106.60292811.980.18数据可信
长期24月-供试品溶液-2023112421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1319398-3193986.0886.076.946.096.076.97
2321707-3217076.1326.13
3333065-3330656.3486.35
4329808-3298086.2866.29
5330918-3309186.3076.31
6274569-2745695.2335.23
10min1608839-60883911.60511.345.2111.6111.355.22
2611542-61154211.65611.67
3619690-61969011.81211.82
4618471-61847111.78811.80
5564115-56411510.75210.76
6547969-54796910.44410.45
15min1848161-84816116.16615.704.2216.2015.734.22
2836152-83615215.93715.97
3847480-84748016.15316.18
4849615-84961516.19416.22
5792842-79284215.11215.14
6768047-76804714.63914.67
20min11057708-105770820.16019.664.6520.2219.724.65
21056930-105693020.14520.20
31035610-103561019.73919.80
41086267-108626720.70520.76
5999244-99924419.04619.10
6953332-95333218.17118.22
30min11323918-132391825.23425.082.8325.3225.172.83
21307847-130784724.92825.02
31328166-132816625.31525.41
41334702-133470225.44025.53
51354140-135414025.81025.90
61246623-124662323.76123.84
45min11641974-164197431.29730.952.4331.4331.082.44
21627088-162708831.01331.14
31650865-165086531.46631.60
41667658-166765831.78631.92
51593355-159335530.37030.50
61562011-156201129.77329.89
60min11886851-188685135.96435.571.9036.1535.761.92
21878413-187841335.80335.99
31873559-187355935.71135.90
41910203-191020336.40936.60
51836674-183667435.00835.19
61812824-181282434.55334.72
90min12244786-224478642.78642.401.5843.0342.641.59
22234704-223470442.59442.84
32244771-224477142.78643.03
42252849-225284942.94043.19
52212056-221205642.16342.40
62159298-215929841.15741.38
120min12511521-251152147.87147.531.0848.1947.841.09
22504346-250434647.73448.05
32512428-251242847.88848.20
42510746-251074647.85648.18
52475796-247579647.19047.50
62446484-244648446.63146.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12684631-268463151.17050.711.0451.5751.101.05
22659467-265946750.69051.08
32668049-266804950.85451.25
42692443-269244351.31951.72
52638339-263833950.28850.67
62620033-262003349.93950.31
缬沙坦氨氯地平片项目信息
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%
115.002554692561022560782562572561782560170.13
215.182563872562022562940.06
单位质量响应值RSD%判断
17067.8016883.660.77数据可信
长期24月-供试品溶液-2023112421批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1145589-14558955.59849.0215.5755.6049.0215.57
2104057-10405739.73739.74
3117066-11706644.70544.71
4111218-11121842.47242.47
5140896-14089653.80553.81
6151383-15138357.81057.81
10min1185419-18541970.80864.5311.4270.9064.6111.43
2146949-14694956.11756.18
3160425-16042561.26361.34
4149210-14921056.98057.05
5180149-18014968.79568.89
6191728-19172873.21773.31
15min1199401-19940176.14770.509.1076.3670.699.11
2165832-16583263.32863.49
3178983-17898368.35068.53
4166076-16607663.42163.59
5192924-19292473.67473.88
6204448-20444878.07578.29
20min1207474-20747479.23073.777.9679.5774.077.97
2176763-17676367.50267.77
3188101-18810171.83272.12
4175871-17587167.16267.43
5198987-19898775.98976.32
6211802-21180280.88381.23
30min1214782-21478282.02177.896.0582.4978.326.07
2189349-18934972.30972.69
3202362-20236277.27877.69
4190384-19038472.70473.09
5207937-20793779.40779.86
6219022-21902283.64084.12
45min1221813-22181384.70681.393.9985.3181.954.02
2202115-20211577.18477.68
3211400-21140080.73081.27
4205163-20516378.34878.85
5215657-21565782.35582.94
6222642-22264285.02385.65
60min1225732-22573286.20383.703.6886.9584.403.71
2209067-20906779.83980.47
3217515-21751583.06583.74
4212379-21237981.10381.74
5219790-21979083.93484.66
6230549-23054988.04288.81
90min1230054-23005487.85385.573.1688.7486.403.19
2216351-21635182.62083.38
3218290-21829083.36184.17
4220964-22096484.38285.15
5224215-22421585.62386.49
6234600-23460089.58990.50
120min1231809-23180988.52386.713.4189.5687.693.45
2213742-21374281.62482.52
3226561-22656186.51987.47
4225011-22501185.92786.84
5228625-22862587.30788.31
6236689-23668990.38791.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1233465-23346589.15685.806.8490.3486.926.79
2223381-22338185.30586.34
3194945-19494574.44675.54
4229003-22900387.45288.51
5229306-22930687.56888.72
6237921-23792190.85792.07
缬沙坦氨氯地平片项目信息
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%
116.674901354490962149140924917226491604549116680.14
216.694897751490020348989770.04
单位质量响应值RSD%判断
294641.15293527.680.27数据可信
长期24月-供试品溶液-2023112421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1346332-3463326.5655.3419.016.565.3319.01
2236460-2364604.4824.48
3255287-2552874.8394.84
4215432-2154324.0844.08
5303233-3032335.7485.75
6332068-3320686.2946.29
10min1656247-65624712.43910.6014.4012.4510.6014.40
2516336-5163369.7879.79
3515631-5156319.7749.78
4444235-4442358.4218.43
5592075-59207511.22311.23
6629276-62927611.92811.94
15min1893746-89374616.94114.8111.7116.9714.8311.72
2743539-74353914.09414.12
3721685-72168513.68013.70
4652610-65261012.37012.39
5811589-81158915.38415.41
6863272-86327216.36316.39
20min11083740-108374020.54218.2210.4220.6018.2710.42
2920917-92091717.45617.50
3896797-89679716.99917.05
4819546-81954615.53515.58
5995148-99514818.86318.92
61051040-105104019.92319.98
30min11372884-137288426.02323.637.9826.1223.727.99
21198316-119831622.71422.79
31188083-118808322.52022.60
41110087-111008721.04221.11
51273463-127346324.13924.22
61338045-133804525.36325.45
45min11694984-169498432.12928.489.8832.2728.609.85
21520522-152052228.82228.94
31470034-147003427.86527.98
41473474-147347427.93028.03
51600390-160039030.33630.46
61255074-125507423.79023.92
60min11937713-193771336.73034.594.8036.9234.764.81
21765472-176547233.46533.63
31731371-173137132.81832.98
41758416-175841633.33133.48
51836622-183662234.81334.99
61918302-191830236.36236.53
90min12284094-228409443.29541.364.2143.5541.594.22
22118690-211869040.16040.38
32044776-204477638.75938.97
42176217-217621741.25041.45
52193305-219330541.57441.81
62275054-227505443.12443.36
120min12537762-253776248.10346.324.0448.4346.624.04
22358504-235850444.70644.99
32293362-229336243.47143.75
42469175-246917546.80347.08
52467534-246753446.77247.08
62536436-253643648.07848.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12692009-269200951.02749.832.3751.4350.212.38
22566715-256671548.65249.01
32542924-254292448.20148.55
42664663-266466350.50950.86
52626970-262697049.79450.18
62681107-268110750.82151.21
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