氨氯地平阿托伐他汀钙片项目信息
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%
114.999397892745928349309692910931130.54
214.999399794116940560.09
单位质量响应值RSD%判断
6211.676274.580.72数据可信
供试品溶液-24081401批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170923-7092373.64478.834.7173.6478.834.71
277897-7789780.88680.89
372508-7250875.29075.29
480187-8018783.26483.26
575813-7581378.72278.72
678167-7816781.16681.17
10min183714-8371486.92690.462.4087.0590.592.40
288242-8824291.62891.76
385909-8590989.20589.33
489772-8977293.21793.36
587504-8750490.86190.99
687579-8757990.93991.07
15min188602-8860292.00294.031.3792.2794.311.38
290965-9096594.45594.74
389783-8978393.22893.50
492272-9227295.81296.11
590828-9082894.31394.60
690861-9086194.34794.63
20min190567-9056794.04295.491.1694.4695.921.16
292123-9212395.65896.10
391196-9119694.69595.12
493667-9366797.26197.71
591878-9187895.40395.84
692319-9231995.86196.31
30min192288-9228895.82996.650.6596.4197.250.66
292733-9273396.29196.90
393157-9315796.73197.32
493985-9398597.59198.21
592839-9283996.40197.00
693487-9348797.07497.68
45min192506-9250696.05596.840.7596.7997.600.75
292281-9228195.82296.59
393509-9350997.09797.85
493935-9393597.53998.32
593709-9370997.30598.06
693650-9365097.24398.01
极限192648-9264896.20397.130.8897.1098.060.88
292415-9241595.96196.89
394183-9418397.79798.71
494260-9426097.87798.82
593622-9362297.21498.14
694138-9413897.75098.68
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613688133693303691073701113694963693710.14
211.563732563733583733070.02
单位质量响应值RSD%判断
31814.9032292.991.06数据可信
供试品溶液-24081401批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127060-12706032.74434.944.8232.7434.944.82
2141939-14193936.57836.58
3128814-12881433.19633.20
4142857-14285736.81536.81
5136747-13674735.24035.24
6136102-13610235.07435.07
10min1211112-21111254.40557.603.9954.4657.663.99
2235434-23543460.67360.73
3217508-21750856.05356.11
4231474-23147459.65259.71
5223244-22324457.53157.59
6222280-22228057.28357.34
15min1260100-26010067.02969.993.2567.1770.143.25
2283897-28389773.16273.32
3265855-26585568.51268.66
4279358-27935871.99272.15
5271933-27193370.07870.23
6268353-26835369.15669.31
20min1291071-29107175.01077.252.5575.2777.522.55
2310206-31020679.94280.23
3294495-29449575.89376.16
4307609-30760979.27279.55
5299385-29938577.15377.42
6295732-29573276.21276.48
30min1324531-32453183.63384.731.3484.0285.131.35
2335758-33575886.52686.94
3325105-32510583.78184.17
4332217-33221785.61486.03
5328443-32844384.64185.04
6326653-32665384.18084.58
45min1341409-34140987.98388.580.8288.5089.120.83
2346763-34676389.36389.92
3339855-33985587.58288.11
4345497-34549789.03689.59
5346065-34606589.18389.72
6342728-34272888.32388.86
极限1352438-35243890.82591.770.6291.4992.460.62
2356291-35629191.81892.53
3358354-35835492.35093.02
4354918-35491891.46492.17
5358027-35802792.26592.96
6356638-35663891.90792.59
氨氯地平阿托伐他汀钙片项目信息
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%
114.999373493554934169340993475935180.15
214.999471494517946160.15
单位质量响应值RSD%判断
6238.696311.940.83数据可信
供试品溶液-24081402批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170151-7015172.47066.805.1272.4766.805.12
264388-6438866.51666.52
365622-6562267.79167.79
464088-6408866.20666.21
559900-5990061.88061.88
663849-6384965.95965.96
10min182232-8223284.95080.503.2885.0780.623.28
277681-7768180.24980.36
379380-7938082.00482.12
475796-7579678.30178.41
575332-7533277.82277.93
677136-7713679.68679.80
15min187339-8733990.22686.352.6490.4986.602.65
283436-8343686.19486.44
384736-8473687.53787.79
481331-8133184.01984.26
581745-8174584.44784.68
682951-8295185.69385.94
20min190007-9000792.98289.482.3093.3989.872.30
286453-8645389.31089.70
387138-8713890.01890.41
484224-8422487.00887.39
585151-8515187.96588.34
686756-8675689.62490.01
30min193985-9398597.09193.102.4197.6693.632.41
290554-9055493.54794.08
388933-8893391.87292.42
488218-8821891.13491.66
588379-8837991.30091.82
690634-9063493.63094.16
45min195718-9571898.88295.192.5099.6195.882.50
293073-9307396.14996.84
390045-9004593.02193.72
490520-9052093.51294.19
590102-9010293.08093.75
693424-9342496.51297.20
极限196500-9650099.69096.682.37100.5897.532.36
293910-9391097.01497.87
390105-9010593.08393.94
493775-9377596.87497.71
592263-9226395.31396.14
694967-9496798.10698.96
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613614403616473623503622103628143620920.16
211.563671253671223671240.01
单位质量响应值RSD%判断
31187.9431758.131.29数据可信
供试品溶液-24081402批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128195-12819533.64731.544.5933.6531.544.59
2121227-12122731.81831.82
3122957-12295732.27232.27
4120718-12071831.68531.68
5113807-11380729.87129.87
6114050-11405029.93529.93
10min1198202-19820252.02250.463.9052.0850.523.91
2191911-19191150.37150.42
3203540-20354053.42353.48
4186943-18694349.06749.12
5189889-18988949.84049.89
6183069-18306948.05048.10
15min1238939-23893962.71461.844.0862.8661.984.08
2234805-23480561.62961.77
3251355-25135565.97366.12
4226685-22668559.49859.63
5237156-23715662.24662.38
6224717-22471758.98159.11
20min1263546-26354669.17368.944.1169.4269.184.11
2260692-26069268.42368.66
3281190-28119073.80474.06
4250743-25074365.81266.05
5266148-26614869.85570.09
6253703-25370366.58966.82
30min1296025-29602577.69777.513.7978.0677.863.78
2293782-29378277.10977.46
3315259-31525982.74683.12
4282748-28274874.21274.56
5296614-29661477.85278.20
6287335-28733575.41675.76
45min1321141-32114184.28983.853.1684.7884.333.16
2320416-32041684.09984.58
3336512-33651288.32488.84
4305688-30568880.23380.70
5318154-31815483.50583.99
6314874-31487482.64483.11
极限1344683-34468390.46891.241.5091.1091.861.51
2341566-34156689.65090.27
3353965-35396592.90593.57
4346511-34651190.94891.55
5354056-35405692.92993.55
6344912-34491290.52991.13
氨氯地平阿托伐他汀钙片项目信息
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%
114.999439494260941719425994267942700.09
214.999319193138931640.05
单位质量响应值RSD%判断
6288.866215.080.84数据可信
供试品溶液-24081403批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168982-6898271.52875.255.4871.5375.255.48
277254-7725480.10680.11
369671-6967172.24372.24
477764-7776480.63480.63
572101-7210174.76274.76
669640-6964072.21172.21
10min181297-8129784.29888.623.8284.4288.743.83
290260-9026093.59293.73
384048-8404887.15087.27
488303-8830391.56291.70
585033-8503388.17288.30
683838-8383886.93387.05
15min186465-8646589.65793.042.5789.9293.312.57
292740-9274096.16396.45
389023-8902392.30992.57
492017-9201795.41395.70
588830-8883092.10992.38
689267-8926792.56292.83
20min188641-8864191.91394.822.2492.3295.252.24
293843-9384397.30797.76
390943-9094394.30094.72
493546-9354696.99997.44
589898-8989893.21693.64
691810-9181095.19995.62
30min192303-9230395.71096.471.6796.2797.061.67
294499-9449997.98798.60
393167-9316796.60697.18
493904-9390497.37097.98
590306-9030693.63994.22
694058-9405897.53098.11
45min193681-9368197.13997.101.6497.8697.841.64
294827-9482798.32799.10
393583-9358397.03797.77
493949-9394997.41798.19
590757-9075794.10794.84
695043-9504398.55199.29
极限195144-9514498.65697.991.3299.5498.901.31
295034-9503498.54299.48
394180-9418097.65698.56
494396-9439697.88098.81
592309-9230995.71696.61
695958-9595899.500100.40
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613664333665863663693666863664973665140.04
211.563622433622523622480.01
单位质量响应值RSD%判断
31568.8231336.330.53数据可信
供试品溶液-24081403批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127407-12740733.46035.488.3133.4635.488.31
2146473-14647338.46738.47
3122795-12279532.24932.25
4149945-14994539.37939.38
5137006-13700635.98135.98
6126976-12697633.34733.35
10min1202981-20298153.30757.546.4253.3657.606.43
2237325-23732562.32762.39
3208326-20832654.71154.76
4232963-23296361.18161.25
5222542-22254258.44458.50
6210385-21038555.25255.31
15min1252363-25236366.27670.654.9866.4270.814.98
2285694-28569475.02975.20
3257212-25721267.54967.69
4281287-28128773.87274.04
5273745-27374571.89172.05
6263850-26385069.29369.44
20min1286769-28676975.31278.773.9075.5779.043.91
2315144-31514482.76483.06
3287441-28744175.48875.75
4310115-31011581.44381.73
5303146-30314679.61379.89
6297047-29704778.01178.27
30min1324719-32471985.27887.242.4085.6687.652.41
2345118-34511890.63591.07
3323179-32317984.87485.26
4334932-33493287.96088.39
5333948-33394887.70288.11
6331271-33127186.99987.39
45min1345797-34579790.81492.171.8491.3492.721.85
2362634-36263495.23595.82
3344583-34458390.49591.02
4349211-34921191.71092.28
5352159-35215992.48493.04
6351345-35134592.27192.81
极限1360498-36049894.67495.941.0295.3596.641.03
2370153-37015397.21097.95
3361899-36189995.04295.72
4365484-36548495.98496.71
5365307-36530795.93796.65
6368464-36846496.76697.46
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