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%
114.232460882458022455982451372453552455960.16
214.202444922446522445720.05
单位质量响应值RSD%判断
17259.0317223.380.15数据可信
稳定性考察-长期3月-供试品溶液-2023112221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%
5min166354-6635424.94827.6410.9324.9527.6410.93
273526-7352627.64527.65
362774-6277423.60223.60
475185-7518528.26928.27
584978-8497831.95131.95
678180-7818029.39529.39
10min1124923-12492346.97048.983.2547.0149.033.25
2133309-13330950.12350.17
3132943-13294349.98550.02
4130264-13026448.97849.03
5134823-13482350.69250.75
6125423-12542347.15847.21
15min1154394-15439458.05161.055.1958.1761.185.19
2150814-15081456.70556.83
3168862-16886263.49063.61
4167997-16799763.16563.29
5171407-17140764.44764.59
6160793-16079360.45760.58
20min1171777-17177764.58669.514.7064.8069.744.70
2176219-17621966.25766.48
3192819-19281972.49872.73
4190137-19013771.49071.72
5190378-19037871.58071.83
6187939-18793970.66370.89
30min1193108-19310872.60777.614.4672.9377.964.46
2196442-19644273.86074.19
3212892-21289280.04580.39
4211027-21102779.34479.70
5214547-21454780.66781.03
6210518-21051879.15379.50
45min1211455-21145579.50584.123.5579.9584.593.55
2216000-21600081.21481.67
3227236-22723685.43885.92
4229880-22988086.43386.92
5228901-22890186.06486.56
6228891-22889186.06186.54
60min1215889-21588981.17286.964.3581.7587.584.35
2223101-22310183.88484.48
3232481-23248187.41088.04
4243294-24329491.47692.11
5237340-23734089.23789.88
6235620-23562088.59189.21
极限1233765-23376587.89393.123.7988.6193.883.78
2243479-24347991.54692.28
3243127-24312791.41392.18
4255833-25583396.19196.97
5250641-25064194.23895.03
6259163-25916397.44398.21
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对照品来源中检院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%
115.934678326467437646777264670799467078646744030.08
216.074648945465239346506690.06
单位质量响应值RSD%判断
293433.96289400.680.98数据可信
稳定性考察-长期3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%
5min13280092-328009263.06366.494.5363.0666.494.53
23471729-347172966.74766.75
33329121-332912164.00564.01
43716276-371627671.44971.45
53534461-353446167.95367.95
63418579-341857965.72565.73
10min13966615-396661576.26282.214.2376.3782.324.23
24209574-420957480.93381.04
34326296-432629683.17783.28
44509864-450986486.70686.83
54352829-435282983.68783.80
64289717-428971782.47482.58
15min14284812-428481282.37988.753.9782.6189.003.97
24537573-453757387.23987.49
34697555-469755590.31590.56
44803540-480354092.35392.62
54698117-469811790.32690.58
64673836-467383689.85990.11
20min14449639-444963985.54891.943.9285.9292.343.92
24686779-468677990.10890.50
34855675-485567593.35593.75
44974632-497463295.64296.06
54849954-484995493.24593.65
64876469-487646993.75594.15
30min14617146-461714688.76994.883.6689.2895.423.66
24859192-485919293.42293.96
34959561-495956195.35295.90
45129902-512990298.62799.20
54989574-498957495.92996.49
65053433-505343397.15797.71
45min14702455-470245590.40996.263.4991.0796.973.49
24938443-493844394.94695.64
35013821-501382196.39597.11
45202392-5202392100.021100.76
55063140-506314097.34498.06
65120938-512093898.45599.17
60min14741092-474109291.15296.833.3791.9697.693.37
24980674-498067495.75896.61
35025948-502594896.62997.50
45230569-5230569100.563101.47
55093802-509380297.93398.81
65144939-514493998.91699.80
极限15170319-517031999.404100.451.66100.37101.481.66
25161493-516149399.234100.25
35142004-514200498.86099.89
45319986-5319986102.282103.36
55211240-5211240100.191101.23
65343854-5343854102.741103.78
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%
114.232441582443722443722441762439712442100.07
214.202451852453422452640.05
单位质量响应值RSD%判断
17161.6317272.110.46数据可信
稳定性考察-长期3月-供试品溶液-2023112221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%
5min184374-8437431.76931.461.8131.7731.461.82
283678-8367831.50731.51
383774-8377431.54331.54
484127-8412731.67631.68
580588-8058830.34330.34
684803-8480331.93031.93
10min1134755-13475550.73950.262.4550.7950.312.45
2138595-13859552.18452.24
3135271-13527150.93350.99
4130517-13051749.14349.20
5130955-13095549.30849.36
6130803-13080349.25149.30
15min1161120-16112060.66661.572.2060.8061.712.20
2170646-17064664.25264.39
3163762-16376261.66061.80
4162190-16219061.06961.20
5161866-16186660.94761.08
6161617-16161760.85360.99
20min1176376-17637666.41067.652.0066.6567.891.99
2176728-17672866.54266.79
3185906-18590669.99870.24
4177914-17791466.98967.23
5179800-17980067.69967.93
6181267-18126768.25268.49
30min1191725-19172572.18974.892.6072.5475.242.59
2207212-20721278.02078.38
3196394-19639473.94774.30
4201077-20107775.71076.06
5197624-19762474.41074.76
6199303-19930375.04375.39
45min1210672-21067279.32381.703.0979.7982.173.08
2224589-22458984.56385.05
3223099-22309984.00284.48
4219339-21933982.58783.06
5207898-20789878.27978.75
6216233-21623381.41781.89
60min1218496-21849682.26983.402.0882.8784.022.07
2226358-22635885.22985.86
3228280-22828085.95386.57
4219387-21938782.60583.22
5219123-21912382.50583.11
6217376-21737681.84782.46
极限1237550-23755089.44391.572.8890.1892.322.87
2247909-24790993.34494.11
3249654-24965494.00194.76
4250327-25032794.25495.00
5239936-23993690.34291.08
6233837-23383788.04588.79
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对照品来源中检院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%
115.934645607464787046476034644835463960246451030.08
216.074665603466835446669780.05
单位质量响应值RSD%判断
291594.66290415.560.29数据可信
稳定性考察-长期3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%
5min13574267-357426768.81368.242.3768.8168.242.37
23675589-367558970.76470.76
33566103-356610368.65668.66
43521364-352136467.79467.79
53424218-342421865.92465.92
63505517-350551767.48967.49
10min14191296-419129680.69281.392.6180.8181.502.61
24397542-439754284.66384.78
34321760-432176083.20483.32
44196339-419633980.78980.90
54102611-410261178.98579.09
64156195-415619580.01680.13
15min14468134-446813486.02287.162.6686.2787.412.66
24701837-470183790.52190.78
34642854-464285489.38689.64
44507525-450752586.78087.03
54389526-438952684.50984.75
64454222-445422285.75486.00
20min14621104-462110488.96789.942.6089.3690.332.60
24833573-483357393.05793.47
34796734-479673492.34892.75
44661401-466140189.74390.14
54518744-451874486.99687.38
64597339-459733988.50988.90
30min14761721-476172191.67492.492.4692.2193.042.46
24951901-495190195.33695.90
34924877-492487794.81595.37
44810564-481056492.61593.16
54640769-464076989.34689.87
64735078-473507891.16191.70
45min14856734-485673493.50394.092.3494.2094.792.34
25014625-501462596.54397.27
35011200-501120096.47797.19
44906132-490613294.45495.15
54725458-472545890.97691.65
64810286-481028692.60993.30
60min14890912-489091294.16194.912.2795.0195.762.27
25045542-504554297.13898.02
35058396-505839697.38698.26
44954285-495428595.38196.24
54771770-477177091.86892.70
64857561-485756193.51994.36
极限15176896-517689699.667100.591.45100.67101.601.46
25306220-5306220102.157103.20
35273078-5273078101.519102.56
45293682-5293682101.916102.93
55124833-512483398.66599.65
65173166-517316699.595100.59
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%
114.232447142447132447882445172446932446850.05
214.202438212439992439100.06
单位质量响应值RSD%判断
17195.0117176.760.08数据可信
稳定性考察-长期3月-供试品溶液-2023112421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%
5min175988-7598828.66330.316.7628.6630.326.76
281431-8143130.71630.72
384597-8459731.91031.91
479895-7989530.13630.14
572766-7276627.44727.45
687516-8751633.01133.01
10min1117442-11744244.29945.833.3544.3545.883.35
2120765-12076545.55345.60
3122277-12227746.12346.18
4121694-12169445.90345.95
5118084-11808444.54144.59
6128813-12881348.58848.64
15min1142761-14276153.84955.152.8153.9755.272.81
2143504-14350454.13054.26
3145479-14547954.87555.00
4148295-14829555.93756.06
5143633-14363354.17854.30
6153512-15351257.90558.04
20min1161305-16130560.84462.303.4661.0662.523.45
2161135-16113560.78061.00
3161764-16176461.01761.24
4166485-16648562.79863.02
5164315-16431561.98062.19
6176012-17601266.39266.62
30min1186505-18650570.35069.803.3570.6670.133.35
2173399-17339965.40665.72
3187312-18731270.65470.98
4188270-18827071.01571.34
5183758-18375869.31369.63
6191108-19110872.08672.43
45min1208935-20893578.81078.332.2579.2478.772.25
2199602-19960275.29075.72
3209712-20971279.10379.54
4207727-20772778.35578.80
5206293-20629377.81478.24
6213671-21367180.59781.06
60min1216194-21619481.54879.752.7682.1180.322.75
2202065-20206576.21976.77
3218645-21864582.47383.05
4212287-21228780.07580.65
5209172-20917278.90079.46
6210160-21016079.27279.87
极限1251168-25116894.74192.491.7695.4493.201.76
2237749-23774989.67990.36
3246250-24625092.88593.60
4244663-24466392.28792.99
5245743-24574392.69493.38
6245669-24566992.66693.40
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对照品来源中检院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%
115.934658003465972546619764655557466097346592470.06
216.074656835465881246578240.04
单位质量响应值RSD%判断
292482.55289845.920.65数据可信
稳定性考察-长期3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%
5min13160962-316096260.82462.783.1560.8262.783.15
23208826-320882661.74561.74
33310247-331024763.69663.70
43326306-332630664.00564.01
53158454-315845460.77560.78
63411602-341160265.64665.65
10min13899099-389909975.02776.622.3875.1376.722.38
23894782-389478274.94475.05
34019700-401970077.34877.45
44065038-406503878.22078.33
53904250-390425075.12675.23
64108205-410820579.05179.16
15min14267715-426771582.12082.892.0482.3583.122.04
24211141-421114181.03181.26
34371266-437126684.11284.35
44371022-437102284.10884.34
54215073-421507381.10781.33
64411347-441134784.88485.12
20min14475325-447532586.11586.501.7886.4886.881.78
24398606-439860684.63885.00
34581413-458141388.15688.53
44530156-453015687.17087.55
54411530-441153084.88785.25
64576379-457637988.05988.44
30min14694714-469471490.33690.211.6590.8490.721.66
24567536-456753687.88988.39
34800254-480025492.36792.89
44687406-468740690.19690.72
54652704-465270489.52890.03
64726763-472676390.95391.48
45min14826659-482665992.87592.491.6293.5393.151.62
24682115-468211590.09490.74
34924924-492492494.76695.44
44795992-479599292.28592.96
54797475-479747592.31492.97
64811522-481152292.58493.26
60min14897016-489701694.22993.841.2195.0494.651.21
24800072-480007292.36493.16
34977792-497779295.78396.62
44855679-485567993.43494.26
54869268-486926893.69594.50
64859583-485958393.50994.34
极限15269240-5269240101.391100.121.73102.36101.091.72
25133874-513387498.78799.74
35299152-5299152101.967102.96
45248886-5248886101.000101.98
55204540-5204540100.146101.11
65061974-506197497.40398.39
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%
114.232433232437502438832438102437792437090.10
214.202472242469452470840.08
单位质量响应值RSD%判断
17126.4217400.281.13数据可信
稳定性考察-长期3月-供试品溶液-2023112421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%
5min174304-7430427.90330.796.0127.9030.796.01
284455-8445531.71531.72
378197-7819729.36529.37
484040-8404031.56031.56
588045-8804533.06433.06
682855-8285531.11531.11
10min1119245-11924544.78045.622.4944.8345.672.49
2123720-12372046.46146.51
3122382-12238245.95846.01
4118832-11883244.62544.68
5125948-12594847.29747.35
6118692-11869244.57244.62
15min1132037-13203749.58455.415.5049.7155.545.49
2151999-15199957.08057.21
3149367-14936756.09256.22
4148214-14821455.65955.79
5155583-15558358.42658.56
6148120-14812055.62455.75
20min1160422-16042260.24363.042.4260.4563.262.42
2168718-16871863.35963.58
3171250-17125064.31064.53
4171686-17168664.47364.69
5167514-16751462.90763.14
6167573-16757362.92963.15
30min1177363-17736366.60570.053.3266.9170.373.31
2191776-19177672.01872.35
3188378-18837870.74271.07
4192154-19215472.16072.49
5189102-18910271.01471.35
6180401-18040167.74668.07
45min1184665-18466569.34774.404.2369.7674.844.23
2202807-20280776.16076.61
3196754-19675473.88774.33
4204474-20447476.78677.23
5207030-20703077.74678.20
6192977-19297772.46972.91
60min1200608-20060875.33478.652.5475.8779.212.54
2213450-21345080.15780.74
3209045-20904578.50379.07
4215979-21597981.10781.68
5209855-20985578.80779.39
6207641-20764177.97678.53
极限1246877-24687792.71092.361.6193.3793.061.60
2250379-25037994.02594.74
3246143-24614392.43493.13
4249135-24913593.55894.27
5243693-24369391.51492.23
6239456-23945689.92390.61
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对照品来源中检院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%
115.934640861464481446475294647672464717946456110.07
216.074700401469802846992140.04
单位质量响应值RSD%判断
291626.55292421.530.20数据可信
稳定性考察-长期3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%
5min13216377-321637761.70763.262.7761.7163.262.77
23282594-328259462.97762.98
33267147-326714762.68162.68
43303449-330344963.37763.38
53472472-347247266.62066.62
63241563-324156362.19062.19
10min13834014-383401473.55675.962.4573.6676.062.45
23913037-391303775.07275.18
33978891-397889176.33576.44
44053903-405390377.77577.88
54082801-408280178.32978.44
63892882-389288274.68574.79
15min14118190-411819079.00881.912.5579.2382.152.55
24214017-421401780.84681.08
34332796-433279683.12583.36
44381872-438187284.06784.30
54375128-437512883.93784.18
64196072-419607280.50280.73
20min14275799-427579982.03284.932.6182.3985.302.60
24378262-437826283.99784.36
34505258-450525886.43486.80
44549688-454968887.28687.66
54525623-452562386.82587.21
64326066-432606682.99683.36
30min14467114-446711485.70288.182.4186.2088.692.40
24544993-454499387.19687.70
34676494-467649489.71990.23
44710447-471044790.37090.89
54694485-469448590.06490.59
64484730-448473086.04086.54
45min14594466-459446688.14590.102.0888.7890.762.08
24651551-465155189.24089.89
34765923-476592391.43592.10
44800402-480040292.09692.77
54780462-478046291.71492.39
64585863-458586387.98088.62
60min14682856-468285689.84191.231.9090.6292.031.90
24713415-471341590.42791.23
34833214-483321492.72693.54
44837790-483779092.81393.64
54830184-483018492.66893.50
64632586-463258688.87789.67
极限15327261-5327261102.204100.401.73103.14101.361.72
25242334-5242334100.575101.52
35279306-5279306101.284102.25
45220026-5220026100.147101.13
55265500-5265500101.019102.00
65064408-506440897.16198.10
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