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%
114.172411402410512410772410462412182411060.04
214.092431742431942431840.01
单位质量响应值RSD%判断
17015.2417259.331.01数据可信
加速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%
5min184910-8491032.12031.483.0232.1231.483.03
285502-8550232.34432.34
382875-8287531.35131.35
482813-8281331.32731.33
578603-7860329.73529.73
684599-8459932.00332.00
10min1129244-12924448.89248.344.5448.9548.394.54
2124511-12451147.10147.15
3122333-12233346.27746.33
4127791-12779148.34248.39
5124372-12437247.04947.10
6138454-13845452.37652.43
15min1155178-15517858.70259.254.2658.8459.384.26
2154173-15417358.32258.45
3153799-15379958.18058.31
4153020-15302057.88658.02
5153409-15340958.03358.16
6170152-17015264.36764.51
20min1175192-17519266.27366.883.8166.5167.113.81
2174383-17438365.96766.20
3172689-17268965.32665.55
4173733-17373365.72165.95
5174329-17432965.94766.17
6190417-19041772.03372.28
30min1194987-19498773.76175.174.5574.1075.514.54
2193531-19353173.21173.55
3191607-19160772.48372.82
4194295-19429573.50073.84
5202209-20220976.49376.83
6215593-21559381.55681.92
45min1209160-20916079.12380.833.9979.5981.303.99
2213205-21320580.65381.11
3207859-20785978.63179.09
4205528-20552877.74978.21
5217505-21750582.28082.74
6228764-22876486.53987.04
60min1215594-21559481.55784.043.4282.1584.643.42
2221136-22113683.65384.25
3217341-21734182.21882.80
4217762-21776282.37782.97
5225107-22510785.15585.75
6236037-23603789.29089.94
极限1246047-24604793.07794.361.7893.8195.111.77
2250791-25079194.87195.61
3251026-25102694.96095.68
4242295-24229591.65792.39
5254175-25417596.15196.89
6252365-25236595.46796.26
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%
116.044618662461541046170244617450461858346174260.03
216.064651838465133046515840.01
单位质量响应值RSD%判断
287869.45289637.860.44数据可信
加速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%
5min13414893-341489365.92567.224.5565.9267.224.55
23460136-346013666.79866.80
33311506-331150663.92963.93
43468144-346814466.95366.95
53454441-345444166.68866.69
63782069-378206973.01373.01
10min14047318-404731878.13480.034.5378.2480.144.54
24181576-418157680.72680.84
33923972-392397275.75375.86
44087750-408775078.91579.03
54149643-414964380.10980.22
64481507-448150786.51686.64
15min14331854-433185483.62785.783.9083.8786.023.90
24456786-445678686.03986.28
34248673-424867382.02182.25
44380655-438065584.56984.81
54493377-449337786.74586.99
64747956-474795691.66091.93
20min14494189-449418986.76188.923.5687.1489.313.57
24624249-462424989.27289.66
34420655-442065585.34185.71
44530624-453062487.46487.85
54688194-468819490.50690.90
64879460-487946094.19994.62
30min14596939-459693988.74591.683.6489.2792.223.64
24788047-478804792.43492.97
34569419-456941988.21388.72
44657829-465782989.92090.45
54869858-486985894.01394.55
65012130-501213096.76097.34
45min14707180-470718090.87393.423.2491.5494.113.24
24878915-487891594.18894.88
34669267-466926790.14190.80
44751766-475176691.73392.41
54961221-496122195.77796.47
65067308-506730897.82598.56
60min14702975-470297590.79294.143.2391.6194.983.24
24929841-492984195.17196.02
34724886-472488691.21592.02
44806650-480665092.79393.63
54997823-499782396.48497.34
65096723-509672398.39399.29
极限15030756-503075697.11999.211.7498.09100.221.74
25213713-5213713100.651101.66
35132651-513265199.087100.05
45036615-503661597.23398.22
55237700-5237700101.114102.13
65183996-5183996100.078101.14
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%
114.172415632414092418522419882417522417130.10
214.092437622437002437310.02
单位质量响应值RSD%判断
17058.0817298.150.99数据可信
加速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%
5min182122-8212230.99231.925.7230.9931.925.72
289071-8907133.61433.61
375970-7597028.67028.67
486701-8670132.72032.72
587790-8779033.13133.13
685886-8588632.41232.41
10min1122969-12296946.40747.014.6646.4647.064.66
2127240-12724048.01948.07
3113807-11380742.94943.00
4125305-12530547.28947.34
5130082-13008249.09149.15
6127993-12799348.30348.36
15min1151956-15195657.34657.942.3757.4858.072.37
2154604-15460458.34658.48
3147676-14767655.73155.85
4152657-15265757.61157.74
5157944-15794459.60659.74
6156266-15626658.97359.11
20min1173477-17347765.46865.700.5665.6965.920.57
2174161-17416165.72665.96
3173617-17361765.52165.73
4172817-17281765.21965.45
5175322-17532266.16566.40
6175084-17508466.07566.31
30min1195460-19546073.76475.372.4574.1075.712.43
2197737-19773774.62474.97
3205998-20599877.74178.06
4193563-19356373.04873.39
5202151-20215176.29076.64
6203435-20343576.77477.12
45min1211790-21179079.92781.862.9180.3882.322.90
2212144-21214480.06180.53
3226293-22629385.40085.85
4211112-21111279.67180.13
5218069-21806982.29782.77
6222107-22210783.82184.29
60min1219641-21964182.89084.982.9683.4885.582.94
2221084-22108483.43584.04
3234691-23469188.57089.16
4219769-21976982.93883.53
5223477-22347784.33884.95
6232381-23238187.69888.31
极限1230422-23042286.95993.843.8487.6994.583.82
2255854-25585496.55697.30
3254315-25431595.97696.72
4246909-24690993.18193.91
5249931-24993194.32195.07
6254519-25451996.05396.81
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%
116.044640076464037546401144642010464255646410260.03
216.064678187467223346752100.10
单位质量响应值RSD%判断
289340.77291108.970.44数据可信
加速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%
5min13491348-349134867.05966.776.6167.0666.776.61
23587888-358788868.91468.91
33028087-302808758.16158.16
43482271-348227166.88566.88
53646565-364656570.04170.04
63621456-362145669.55869.56
10min14139706-413970679.51279.655.6279.6279.765.62
24225550-422555081.16181.28
33726822-372682271.58271.68
44086156-408615678.48478.60
54323979-432397983.05283.17
64377971-437797184.08984.20
15min14440286-444028685.28686.573.5385.5386.813.53
24534588-453458887.09787.35
34326557-432655783.10183.32
44365796-436579683.85584.10
54648023-464802389.27689.53
64726700-472670090.78791.04
20min14595092-459509288.25990.253.0088.6590.643.00
24690294-469029490.08890.48
34664733-466473389.59789.95
44521885-452188586.85387.24
54818143-481814392.54392.95
64902768-490276894.16994.58
30min14726366-472636690.78193.583.2591.3194.123.23
24824810-482481092.67193.22
34979403-497940395.64196.14
44664873-466487389.59990.13
54977228-497722895.59996.16
65061094-506109497.21097.77
45min14792585-479258592.05295.313.3992.7496.003.38
24908760-490876094.28494.98
35086731-508673197.70298.37
44753797-475379791.30791.98
55074301-507430197.46398.18
65156372-515637299.04099.77
60min14821417-482141792.60695.993.2993.4496.843.28
24964271-496427195.35096.21
35096815-509681597.89698.72
44792752-479275292.05692.88
55127599-512759998.48799.37
65181187-518118799.516100.41
极限15141806-514180698.760100.441.6999.75101.461.70
25307771-5307771101.948102.96
35164419-516441999.194100.18
45142720-514272098.77899.76
55322443-5322443102.230103.27
65297480-5297480101.750102.81
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%
114.172428452430862435372431302423612429920.18
214.092433692435182434440.05
单位质量响应值RSD%判断
17148.3417277.790.54数据可信
加速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%
5min190205-9020533.97233.968.6733.9733.968.68
289677-8967733.77333.77
399225-9922537.36937.37
480731-8073130.40430.40
582401-8240131.03331.03
698756-9875637.19237.19
10min1144078-14407854.26150.566.3854.3250.626.38
2132139-13213949.76549.82
3139606-13960652.57752.64
4123701-12370146.58746.64
5125185-12518547.14647.20
6140776-14077653.01853.08
15min1171367-17136764.53861.563.9464.6961.703.94
2162579-16257961.22961.37
3163831-16383161.70061.85
4160134-16013460.30860.44
5153531-15353157.82157.95
6169255-16925563.74363.89
20min1193818-19381872.99469.333.5473.2569.583.54
2179300-17930067.52667.77
3182990-18299068.91669.17
4182627-18262768.77969.01
5176262-17626266.38266.61
6189554-18955471.38871.64
30min1216488-21648881.53177.593.7881.9177.953.78
2199479-19947975.12675.48
3202306-20230676.19076.56
4201414-20141475.85476.20
5200958-20095875.68376.02
6215469-21546981.14881.52
45min1235934-23593488.85584.673.1089.3785.163.10
2218858-21885882.42482.90
3218537-21853782.30382.80
4222790-22279083.90584.37
5222209-22220983.68684.15
6230547-23054786.82687.34
60min1242096-24209691.17687.492.7991.8488.122.79
2227011-22701185.49486.11
3225887-22588785.07185.70
4229080-22908086.27486.88
5231705-23170587.26287.87
6238099-23809989.67090.33
极限1251741-25174194.80894.432.4695.6295.212.45
2249571-24957193.99194.75
3240932-24093290.73791.51
4255224-25522496.12096.87
5248251-24825193.49494.24
6258762-25876297.45298.26
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%
116.044663175467907946829724671110466689446726460.18
216.064670622467296346717920.04
单位质量响应值RSD%判断
291312.09290896.140.11数据可信
加速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%
5min13915621-391562174.98168.678.0774.9868.678.07
23680485-368048570.47870.48
33724645-372464571.32471.32
43147873-314787360.27960.28
53321993-332199363.61363.61
63727243-372724371.37371.37
10min14604799-460479988.17882.394.9488.3082.514.94
24409760-440976084.44384.56
34278047-427804781.92182.04
44033987-403398777.24777.35
54098014-409801478.47378.58
64392071-439207184.10484.22
15min14868536-486853693.22888.703.3293.5088.963.32
24697481-469748189.95290.21
34524246-452424686.63586.89
44560238-456023887.32487.55
54442190-444219085.06485.30
64700901-470090190.01890.28
20min15000521-500052195.75591.573.1096.1891.973.11
24828515-482851592.46292.87
34639009-463900988.83389.23
44755479-475547991.06391.44
54603647-460364788.15688.53
64865167-486516793.16493.57
30min15125301-512530198.14594.082.9598.7394.632.95
24952281-495228194.83295.39
34745085-474508590.86491.41
44900273-490027393.83694.36
54761199-476119991.17391.70
64994908-499490895.64896.21
45min15177402-517740299.14395.492.6099.8996.192.60
25023423-502342396.19496.91
34807261-480726192.05592.75
44967288-496728895.11995.80
54891051-489105193.65994.34
65052103-505210396.74397.47
60min15178375-517837599.16195.972.38100.0896.842.38
25049463-504946396.69397.57
34840726-484072692.69593.55
44993700-499370095.62596.47
54927203-492720394.35195.18
65080601-508060197.28998.17
极限15174153-517415399.08098.481.17100.1699.511.18
25215033-521503399.863100.90
35102491-510249197.70898.72
45119866-511986698.04199.04
55056627-505662796.83097.82
65189535-518953599.375100.42
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