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%
114.232488062489892486862488122487762488140.05
214.202479642480672480160.03
单位质量响应值RSD%判断
17485.1717465.920.08数据可信
稳定性考察-加速3月-供试品溶液-2023112521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%
5min120641-206417.6579.7820.627.669.7820.61
229687-2968711.01211.01
324765-247659.1879.19
420137-201377.4707.47
529207-2920710.83410.83
633748-3374812.51912.52
10min168328-6832825.34628.119.3725.3628.129.37
282249-8224930.51030.53
373134-7313427.12927.14
467761-6776125.13625.15
578741-7874129.20929.23
684387-8438731.30331.32
15min1109990-10999040.80142.284.3140.8642.344.32
2119846-11984644.45744.53
3113422-11342242.07442.13
4107682-10768239.94440.00
5113488-11348842.09842.16
6119456-11945644.31244.38
20min1142490-14249052.85653.432.0152.9853.562.02
2147775-14777554.81754.96
3142308-14230852.78952.92
4140058-14005851.95452.08
5146137-14613754.20954.35
6145416-14541653.94254.09
30min1182417-18241767.66768.251.6567.8868.481.65
2190133-19013370.52970.76
3183484-18348468.06368.28
4182380-18238067.65367.86
5182801-18280167.81068.04
6182771-18277167.79868.04
45min1213799-21379979.30879.742.2979.6380.072.28
2220459-22045981.77982.13
3219697-21969781.49681.83
4216846-21684680.43980.76
5208381-20838177.29877.64
6210527-21052778.09578.44
60min1229912-22991285.28584.632.8985.7485.102.88
2231747-23174785.96686.45
3238693-23869388.54389.01
4220981-22098181.97282.43
5223982-22398283.08683.55
6223571-22357182.93383.41
极限1254104-25410494.25993.452.0694.8694.062.05
2253552-25355294.05594.69
3256842-25684295.27595.89
4251474-25147493.28493.87
5241968-24196889.75790.37
6253540-25354094.05094.67
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
115.934588681459037545893394588992459072845896230.02
216.074588351458865645885040.01
单位质量响应值RSD%判断
288111.93285532.300.64数据可信
稳定性考察-加速3月-供试品溶液-2023112521批-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%
5min11489299-148929929.09134.0214.5029.0934.0214.50
21891811-189181136.95436.95
31630985-163098531.85931.86
41460802-146080228.53428.53
51891775-189177536.95336.95
62086144-208614440.75040.75
10min12884652-288465256.34760.037.2256.4060.087.23
23313901-331390164.73264.79
32943794-294379457.50257.56
42805656-280565654.80454.85
53193537-319353762.38162.44
63296367-329636764.38964.46
15min13728775-372877572.83674.684.0872.9874.844.09
24029187-402918778.70478.87
33708554-370855472.44172.59
43633012-363301270.96571.10
53887455-388745575.93576.10
63952248-395224877.20177.38
20min14239798-423979882.81883.592.8883.0883.872.90
24452532-445253286.97387.27
34174060-417406081.53481.80
44127118-412711880.61780.87
54305164-430516484.09584.39
64376580-437658085.49085.79
30min14766733-476673393.11193.081.4793.5193.501.48
24880237-488023795.32895.77
34733836-473383692.46892.87
44688798-468879891.58891.98
54715443-471544392.10992.54
64807147-480714793.90094.35
45min15062006-506200698.87898.581.2999.4499.161.29
25094597-509459799.515100.12
35101666-510166699.653100.21
45010266-501026697.86898.41
54932176-493217696.34296.93
65079497-507949799.22099.82
60min15145171-5145171100.503100.211.54101.22100.951.53
25156447-5156447100.723101.49
35216682-5216682101.900102.63
45101365-510136599.647100.35
54988973-498897397.45298.20
65173532-5173532101.057101.82
极限15188313-5188313101.345101.721.36102.23102.631.36
25228474-5228474102.130103.07
35285470-5285470103.243104.14
45169238-5169238100.973101.85
55097905-509790599.579100.49
65275019-5275019103.039103.98
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%
114.232487402488872490262489832489862489240.05
214.202483372484002483680.02
单位质量响应值RSD%判断
17492.9017490.700.01数据可信
稳定性考察-加速3月-供试品溶液-2023112521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%
5min120351-203517.5426.6716.177.546.6716.19
219338-193387.1677.17
321147-211477.8377.84
417626-176266.5326.53
516277-162776.0326.03
613308-133084.9324.93
10min163058-6305823.36921.319.8423.3821.339.84
261627-6162722.83922.85
361856-6185622.92422.94
455037-5503720.39720.41
554982-5498220.37620.39
648526-4852617.98417.99
15min199685-9968536.94435.516.7037.0035.566.71
2100538-10053837.26037.31
3101361-10136137.56537.62
490122-9012233.39933.44
597481-9748136.12736.17
685690-8569031.75731.80
20min1129282-12928247.91246.335.3448.0346.445.35
2129429-12942947.96748.08
3130822-13082248.48348.60
4113984-11398442.24342.34
5126701-12670146.95647.06
6119833-11983344.41044.50
30min1170221-17022163.08460.365.6163.2860.545.61
2167023-16702361.89962.09
3171899-17189963.70663.90
4147104-14710454.51754.69
5161786-16178659.95860.14
6159121-15912158.97159.14
45min1204873-20487375.92773.166.7276.2273.446.71
2205804-20580476.27276.57
3200993-20099374.48974.79
4171031-17103163.38563.65
5203982-20398275.59675.88
6197745-19774573.28573.55
60min1221219-22121981.98479.657.0382.4180.057.01
2218360-21836080.92581.35
3221720-22172082.17082.60
4184629-18462968.42468.79
5217960-21796080.77781.18
6225595-22559583.60683.99
极限1241686-24168689.57090.132.5790.1390.672.56
2241408-24140889.46690.02
3245638-24563891.03491.60
4235603-23560387.31587.80
5240732-24073289.21689.76
6254115-25411594.17694.70
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
115.934605743460694846080144610135461057246082820.05
216.074615817461896846173920.05
单位质量响应值RSD%判断
289283.24287329.930.48数据可信
稳定性考察-加速3月-供试品溶液-2023112521批-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%
5min11433030-143303027.84825.219.2127.8525.219.22
21367941-136794126.58326.58
31384191-138419126.89926.90
41262372-126237224.53124.53
51224370-122437023.79323.79
61113242-111324221.63321.63
10min12794885-279488554.31250.646.0254.3650.686.02
22742091-274209153.28653.33
32637378-263737851.25151.30
42532345-253234549.21049.25
52570162-257016249.94549.98
62359484-235948445.85145.89
15min13658093-365809371.08666.734.8871.2266.864.88
23543860-354386068.86769.00
33474760-347476067.52467.65
43232282-323228262.81262.93
53448998-344899867.02367.15
63246409-324640963.08663.20
20min14158328-415832880.80776.614.3681.0676.854.36
24031558-403155878.34478.59
33993732-399373277.60977.85
43666040-366604071.24171.47
53975115-397511577.24777.48
63829793-382979374.42374.64
30min14680599-468059990.95687.374.4891.3587.744.47
24575818-457581888.92089.30
34556612-455661288.54788.92
44101876-410187679.71080.06
54541040-454104088.24488.61
64520830-452083087.85288.19
45min14984305-498430596.85894.124.6297.4094.634.61
24911316-491131695.44095.97
34892342-489234295.07195.59
44396896-439689685.44385.92
54885173-488517394.93295.44
64989818-498981896.96597.45
60min15090357-509035798.91996.594.6999.6297.254.68
25048017-504801798.09698.78
34982198-498219896.81797.50
44510756-451075687.65688.28
55030202-503020297.75098.42
65160051-5160051100.274100.92
极限15159938-5159938100.27199.791.54101.14100.621.53
25122512-512251299.544100.39
35063140-506314098.39099.23
45045834-504583498.05498.82
55154485-5154485100.165101.00
65263849-5263849102.291103.11
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%
114.232482542483002483792483432481832482920.04
214.202511422511782511600.02
单位质量响应值RSD%判断
17448.4917687.320.97数据可信
稳定性考察-加速3月-供试品溶液-BDJL7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%
5min116625-166256.1359.2330.856.139.2330.85
238059-3805914.04414.04
326869-268699.9159.92
427875-2787510.28610.29
521154-211547.8067.81
619482-194827.1897.19
10min172764-7276426.85132.5811.4726.8632.6011.48
2100431-10043137.06037.08
391306-9130633.69333.71
497154-9715435.85135.87
584450-8445031.16331.18
683654-8365430.87030.88
15min1126793-12679346.78853.168.2446.8453.228.25
2158542-15854258.50458.59
3137419-13741950.71050.78
4156215-15621557.64657.72
5142971-14297152.75852.82
6142337-14233752.52452.59
20min1158913-15891358.64166.056.7358.7766.206.74
2190967-19096770.47070.65
3179357-17935766.18566.34
4191459-19145970.65170.82
5178964-17896466.04066.19
6174208-17420864.28564.44
30min1182924-18292467.50278.817.4767.7379.087.47
2218285-21828580.55080.85
3219128-21912880.86181.13
4229805-22980584.80185.09
5217495-21749580.25980.52
6213802-21380278.89679.15
45min1198937-19893773.41185.227.5773.7585.627.56
2227348-22734883.89584.33
3240447-24044788.72889.13
4250013-25001392.25892.69
5236577-23657787.30087.70
6232267-23226785.71086.10
60min1208710-20871077.01788.936.9477.4889.476.94
2244707-24470790.30090.87
3248909-24890991.85192.40
4256030-25603094.47995.06
5248095-24809591.55192.09
6239578-23957888.40888.94
极限1245549-24554990.61192.272.3791.2192.962.38
2244218-24421890.12090.84
3255209-25520994.17694.88
4259080-25908095.60496.35
5246570-24657090.98891.68
6249653-24965392.12692.81
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
115.934599297460121146037984607587460838246040550.09
216.074664171466431646642440.01
单位质量响应值RSD%判断
289017.89290245.430.30数据可信
稳定性考察-加速3月-供试品溶液-BDJL7批-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%
5min11356106-135610626.23233.2418.6126.2333.2418.61
22252457-225245743.57143.57
31769075-176907534.22034.22
41868187-186818736.13836.14
51534671-153467129.68629.69
61528917-152891729.57529.57
10min13312056-331205664.06768.966.2264.1169.016.23
23881980-388198075.09275.16
33518149-351814968.05468.11
43788231-378823173.27873.34
53436232-343623266.46966.52
63452823-345282366.79066.84
15min14089304-408930479.10284.874.4679.2585.044.46
24551097-455109788.03588.23
34339904-433990483.94984.12
44650976-465097689.96790.15
54343562-434356284.02084.18
64351373-435137384.17184.33
20min14369739-436973984.52791.734.4284.8192.044.43
24843644-484364493.69494.04
34731542-473154291.52591.84
45006915-500691596.85297.18
54741864-474186491.72592.03
64759141-475914192.05992.36
30min14541506-454150687.84996.524.6788.2796.984.67
25028199-502819997.26497.76
35044600-504460097.58198.04
45232330-5232330101.212101.71
55039445-503944597.48197.93
65052890-505289097.74198.20
45min14643304-464330489.81898.134.4190.3998.764.40
25083388-508338898.33198.99
35133282-513328299.29699.92
45299430-5299430102.510103.17
55158169-515816999.778100.39
65120859-512085999.05699.67
60min14703593-470359390.98598.413.9691.7099.203.97
25087376-508737698.40899.23
35144194-514419499.507100.30
45295797-5295797102.440103.27
55175613-5175613100.115100.90
65117250-511725098.98699.77
极限15125436-512543699.14499.811.40100.02100.771.40
25099006-509900698.63399.62
35136227-513622799.353100.31
45292577-5292577102.378103.38
55189218-5189218100.378101.33
65117433-511743398.99099.94
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%
114.232475852477322476852477982479172477430.06
214.202465872466122466000.01
单位质量响应值RSD%判断
17409.9117366.200.18数据可信
稳定性考察-加速3月-供试品溶液-BDJL7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%
5min118145-181456.7659.1723.386.769.1723.39
216900-169006.3016.30
328902-2890210.77510.78
428279-2827910.54310.54
530267-3026711.28411.28
625157-251579.3799.38
10min176699-7669928.59531.5311.1028.6131.5511.11
269582-6958225.94125.95
390660-9066033.79933.82
489635-8963533.41733.43
593737-9373734.94734.97
687183-8718332.50332.52
15min1131233-13123348.92651.195.7248.9851.265.74
2125902-12590246.93846.99
3140701-14070152.45552.53
4142932-14293253.28753.36
5147128-14712854.85154.93
6135956-13595650.68650.76
20min1169341-16934163.13365.843.9863.2766.003.99
2166025-16602561.89762.03
3181263-18126367.57867.74
4181250-18125067.57367.73
5181873-18187367.80567.97
6179935-17993567.08267.24
30min1214901-21490180.11880.931.0680.3681.191.08
2215186-21518680.22480.46
3220063-22006382.04382.32
4215436-21543680.31880.59
5219599-21959981.87082.15
6217232-21723280.98781.25
45min1236521-23652188.17888.641.3288.5689.031.30
2241234-24123489.93690.30
3240329-24032989.59890.01
4234311-23431187.35587.76
5234237-23423787.32787.74
6239859-23985989.42389.82
60min1240113-24011389.51890.263.0690.0490.803.03
2249035-24903592.84493.36
3243097-24309790.63091.19
4246651-24665191.95592.51
5228325-22832585.12385.69
6245331-24533191.46392.01
极限1253230-25323094.40892.681.9595.0893.371.92
2254492-25449294.87895.55
3242678-24267890.47491.19
4243524-24352490.78991.50
5248624-24862492.69193.40
6248976-24897692.82293.52
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DZP67822106602对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
115.934589780459303545934444594401459732045935960.06
216.074584937458449745847170.01
单位质量响应值RSD%判断
288361.33285296.640.76数据可信
稳定性考察-加速3月-供试品溶液-BDJL7批-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%
5min11416018-141601827.65932.5215.4727.6632.5215.46
21290905-129090525.21525.22
31854623-185462336.22736.23
41841529-184152935.97135.97
51914391-191439137.39437.39
61671282-167128232.64532.65
10min13271388-327138863.90066.286.1563.9566.346.15
23052266-305226659.62059.66
33513244-351324468.62568.68
43497665-349766568.32068.38
53639574-363957471.09271.15
63386007-338600766.13966.19
15min14218812-421881282.40683.082.8882.5683.252.89
24047247-404724779.05579.20
34314737-431473784.28084.45
44301620-430162084.02484.20
54409805-440980586.13786.32
64228042-422804282.58782.75
20min14695196-469519691.71291.401.2592.0091.701.26
24575442-457544289.37389.65
34698814-469881491.78292.10
44677662-467766291.36991.68
54752920-475292092.83993.16
64674956-467495691.31691.62
30min15036139-503613998.37197.690.5998.8198.140.56
25041061-504106198.46898.89
34978167-497816797.23997.71
44984480-498448097.36297.83
54981651-498165197.30797.79
64985622-498562297.38597.84
45min15133992-5133992100.283100.031.18100.89100.641.16
25233549-5233549102.227102.81
35059202-505920298.82299.45
45096777-509677799.556100.18
55091933-509193399.461100.10
65109786-510978699.810100.43
60min15143298-5143298100.465100.281.36101.24101.061.34
25264821-5264821102.838103.59
35058667-505866798.81199.61
45110738-511073899.829100.62
55107552-510755299.766100.57
65118131-511813199.973100.76
极限15153383-5153383100.662100.201.34101.60101.151.32
25251261-5251261102.573103.50
35048036-504803698.60499.56
45105318-510531899.723100.68
55118502-511850299.980100.95
65101489-510148999.648100.60
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