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
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