依折麦布瑞舒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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934827154833944833284836914837074833670.09
211.014841554820184830860.32
单位质量响应值RSD%判断
44223.8843877.020.56数据可信
供试品溶液-2024030821批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1317172-31717261.52666.9414.8161.5366.9414.81
2401429-40142977.87177.87
3386653-38665375.00575.00
4311015-31101560.33260.33
5274358-27435853.22153.22
6379736-37973673.66373.66
10min1473524-47352491.85695.123.7491.9695.233.75
2518322-518322100.546100.68
3502104-50210497.40097.53
4490281-49028195.10795.21
5489282-48928294.91395.00
6468530-46853090.88791.01
15min1499434-49943496.88297.053.1397.1497.323.13
2523873-523873101.623101.92
3505282-50528298.01798.30
4495466-49546696.11396.37
5502238-50223897.42697.67
6475556-47555692.25092.52
20min1503666-50366697.70397.232.8998.1297.662.89
2522775-522775101.410101.88
3505254-50525498.01198.46
4494948-49494896.01296.43
5502251-50225197.42997.84
6478514-47851492.82493.25
30min1506019-50601998.16097.332.6998.7497.932.69
2522366-522366101.331101.97
3504633-50463397.89198.50
4494502-49450295.92696.50
5501376-50137697.25997.83
6481680-48168093.43894.02
45min1507636-50763698.47397.302.7099.2298.062.70
2521655-521655101.193102.00
3503860-50386097.74198.52
4494110-49411095.85096.59
5500967-50096797.18097.91
6481228-48122893.35194.09
60min1507116-50711698.37397.182.5999.2898.102.60
2520209-520209100.912101.89
3503438-50343897.65998.60
4493510-49351095.73396.63
5499893-49989396.97197.87
6481791-48179193.46094.35
极限1505071-50507197.97696.872.5199.0597.952.51
2518568-518568100.594101.74
3501291-50129197.24398.35
4491081-49108195.26296.32
5498358-49835896.67497.73
6481894-48189493.48094.53
依折麦布瑞舒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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.044326784330924330594333504334164331190.07
211.034273454321984297720.80
单位质量响应值RSD%判断
39231.7938963.920.49数据可信
供试品溶液-2024030821批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169263-16926338.96337.1020.2538.9637.1020.25
2169594-16959439.04039.04
3191887-19188744.17144.17
4124227-12422728.59628.60
5118414-11841427.25827.26
6193599-19359944.56544.57
10min1406076-40607693.47690.316.9793.5490.376.98
2394435-39443590.79790.86
3415308-41530895.60295.68
4375770-37577086.50086.55
5345880-34588079.62079.67
6416446-41644695.86495.94
15min1431119-43111999.24197.252.9499.4697.462.95
2428527-42852798.64498.86
3431105-43110599.23899.47
4417478-41747896.10196.29
5399355-39935591.92992.11
6427278-42727898.35798.59
20min1432253-43225399.50298.201.5099.8998.571.52
2430357-43035799.06699.45
3431436-43143699.31499.71
4422732-42273297.31197.66
5415714-41571495.69596.03
6426969-42696998.28698.68
30min1432253-43225399.50298.580.85100.0599.120.87
2430766-43076699.16099.71
3430859-43085999.18199.75
4424692-42469297.76298.28
5423385-42338597.46197.95
6427400-42740098.38598.95
45min1431867-43186799.41398.680.61100.1399.380.62
2430792-43079299.16699.88
3430235-43023599.03899.77
4426241-42624198.11898.80
5427077-42707798.31198.96
6425831-42583198.02498.75
60min1431030-43103099.22198.690.49100.1099.550.50
2430408-43040899.07799.95
3430127-43012799.01399.91
4426650-42665098.21299.05
5427829-42782998.48499.30
6426191-42619198.10799.00
极限1429455-42945598.85898.690.4199.9199.720.40
2429157-42915798.79099.83
3430086-43008699.003100.06
4427175-42717598.33399.34
5430408-43040899.077100.06
6426087-42608798.08399.14
依折麦布瑞舒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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934834724834524834804836674836904835520.03
211.014823254848934836090.38
单位质量响应值RSD%判断
44240.8143924.520.51数据可信
供试品溶液-2024030821批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1375051-37505172.70176.379.3972.7076.379.39
2366915-36691571.12471.12
3457357-45735788.65588.65
4355300-35530068.87268.87
5403011-40301178.12078.12
6406367-40636778.77178.77
10min1483297-48329793.68396.084.0193.8096.214.01
2500366-50036696.99297.11
3517606-517606100.334100.48
4503465-50346597.59397.71
5507088-50708898.29598.43
6462117-46211789.57889.71
15min1494914-49491495.93597.163.4396.2197.443.42
2507682-50768298.41098.69
3519339-519339100.670100.98
4505301-50530197.94998.23
5509898-50989898.84099.13
6470110-47011091.12791.41
20min1494612-49461295.87797.322.8796.3197.772.88
2508368-50836898.54398.99
3518149-518149100.439100.92
4504558-50455897.80598.25
5509467-50946798.75699.21
6477121-47712192.48692.92
30min1493438-49343895.64997.312.4296.2597.922.43
2507543-50754398.38398.99
3517400-517400100.294100.94
4503010-50301097.50498.11
5507772-50777298.42899.05
6482980-48298093.62294.21
45min1492621-49262195.49196.972.8696.2597.742.86
2507903-50790398.45399.23
3516224-516224100.066100.88
4502335-50233597.37498.14
5506696-50669698.21999.01
6475696-47569692.21092.95
60min1491797-49179795.33196.722.7696.2597.652.76
2505877-50587798.06099.00
3514954-51495499.820100.80
4500849-50084997.08698.01
5504709-50470997.83498.78
6475486-47548692.16993.07
极限1489612-48961294.90796.482.9095.9897.582.91
2504381-50438197.77098.87
3515059-51505999.840100.99
4499881-49988196.89897.99
5503893-50389397.67698.79
6473499-47349991.78492.83
依折麦布瑞舒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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.044337414336164334874337294337654336680.03
211.034327904348734338320.34
单位质量响应值RSD%判断
39281.5239332.000.10数据可信
供试品溶液-2024030821批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1203988-20398846.70745.9710.6946.7145.9710.69
2206764-20676447.34247.34
3189895-18989543.48043.48
4164701-16470137.71137.71
5211787-21178748.49348.49
6227454-22745452.08052.08
10min1420657-42065796.31793.233.4596.3993.303.45
2400395-40039591.67891.76
3401873-40187392.01692.09
4390625-39062589.44189.50
5427727-42772797.93698.02
6401679-40167991.97292.06
15min1438001-438001100.28898.641.67100.5398.871.67
2431174-43117498.72598.96
3435932-43593299.815100.04
4421393-42139396.48696.70
5435633-43563399.74699.99
6422592-42259296.76097.00
20min1438642-438642100.43599.521.01100.8499.911.01
2434350-43435099.45299.85
3439243-439243100.573100.96
4432208-43220898.96299.33
5435833-43583399.792100.20
6427503-42750397.88598.29
30min1437939-437939100.27499.690.63100.85100.250.63
2434216-43421699.42299.98
3439320-439320100.590101.15
4432414-43241499.00999.55
5435257-43525799.660100.24
6433148-43314899.17799.74
45min1436882-436882100.03299.330.98100.77100.050.98
2435010-43501099.604100.33
3438495-438495100.401101.13
4431666-43166698.83899.54
5434082-43408299.391100.13
6426629-42662997.68598.41
60min1436306-43630699.90099.040.90100.8199.940.90
2432643-43264399.06299.96
3436850-436850100.025100.92
4430688-43068898.61499.48
5432571-43257199.04599.95
6426336-42633697.61798.51
极限1434431-43443199.47198.881.04100.5499.941.04
2432103-43210398.938100.00
3437809-437809100.244101.31
4429727-42972798.39499.43
5432512-43251299.032100.10
6424543-42454397.20798.26
依折麦布瑞舒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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934829514833334835094835504835144833710.06
211.014820984822334821660.02
单位质量响应值RSD%判断
44224.2543793.460.70数据可信
供试品溶液-2024030921批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1468205-46820590.91177.4317.1790.9177.4217.17
2347583-34758367.49067.49
3489650-48965095.07595.07
4326645-32664563.42463.42
5349969-34996967.95367.95
6410495-41049579.70579.71
10min1483095-48309593.80295.122.4893.9595.252.48
2470571-47057191.37091.48
3504066-50406697.87498.03
4489485-48948595.04395.15
5491869-49186995.50695.62
6500315-50031597.14697.28
15min1484820-48482094.13797.072.0694.4497.352.06
2493619-49361995.84696.11
3504106-50410697.88298.20
4495804-49580496.27096.53
5510287-51028799.08299.35
6510852-51085299.19299.49
20min1484338-48433894.04497.161.9994.5197.621.98
2497809-49780996.65997.08
3503392-50339297.74398.23
4496073-49607396.32296.75
5510290-51029099.08399.52
6510568-51056899.13799.60
30min1483648-48364893.91097.101.9894.5397.711.97
2499935-49993597.07297.66
3502348-50234897.54198.19
4495051-49505196.12496.71
5509044-50904498.84199.44
6510517-51051799.12799.75
45min1481209-48120993.43696.802.0594.2197.582.04
2498320-49832096.75897.51
3501452-50145297.36798.18
4493866-49386695.89496.64
5508049-50804998.64799.41
6508434-50843498.72299.51
60min1481556-48155693.50396.621.9294.4497.551.91
2497368-49736896.57497.48
3500316-50031697.14698.12
4492841-49284195.69596.60
5506669-50666998.38099.31
6506782-50678298.40199.36
极限1479849-47984993.17296.381.9894.2697.471.97
2496366-49636696.37997.45
3498321-49832196.75997.89
4491699-49169995.47396.54
5505737-50573798.19999.29
6506113-50611398.27299.39
依折麦布瑞舒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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.044331814334994335894337024336244335190.05
211.034326034325134325580.02
单位质量响应值RSD%判断
39268.0339216.500.10数据可信
供试品溶液-2024030921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234180-23418053.70844.8935.5653.7144.8935.56
2167192-16719238.34538.34
3320416-32041673.48673.49
4139082-13908231.89831.90
5149041-14904134.18234.18
6164360-16436037.69537.70
10min1397074-39707491.06788.045.5291.1688.125.54
2375560-37556086.13386.20
3416767-41676795.58395.71
4386157-38615788.56388.62
5371388-37138885.17685.23
6356409-35640981.74181.80
15min1422171-42217196.82397.591.9397.0697.801.94
2414512-41451295.06695.27
3434228-43422899.58899.87
4427303-42730398.00098.20
5435087-43508799.78599.98
6419674-41967496.25096.45
20min1425902-42590297.67899.251.2898.0899.641.27
2425707-42570797.63498.00
3434373-43437399.621100.07
4435992-43599299.992100.36
5438042-438042100.463100.83
6436486-436486100.106100.47
30min1425873-42587397.67299.471.1098.24100.021.09
2430418-43041898.71499.24
3434058-43405899.549100.16
4436489-436489100.106100.64
5437256-437256100.282100.82
6438306-438306100.523101.05
45min1424055-42405597.25599.211.1697.9899.921.15
2429278-42927898.45399.15
3433509-43350999.423100.20
4435477-43547799.874100.57
5436430-436430100.093100.79
6436760-436760100.169100.86
60min1424109-42410997.26799.011.0498.1699.901.03
2428700-42870098.32099.18
3432643-43264399.224100.17
4434435-43443599.635100.50
5434985-43498599.761100.63
6435500-43550099.880100.74
极限1422611-42261196.92498.861.1997.9899.911.17
2427747-42774798.10199.12
3431274-43127498.910100.02
4433736-43373699.475100.51
5435607-43560799.904100.94
6435464-43546499.871100.90
依折麦布瑞舒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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934814204818434820174815724820154817730.06
211.014808284805124806700.05
单位质量响应值RSD%判断
44078.0443657.580.68数据可信
供试品溶液-2024030921批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1466667-46666790.90478.7719.0890.9078.7719.08
2439835-43983585.67785.68
3276642-27664253.88853.89
4406510-40651079.18579.19
5355478-35547869.24569.24
6481152-48115293.72593.73
10min1498520-49852097.10896.612.4197.2696.742.42
2504461-50446198.26698.41
3487632-48763294.98795.08
4503426-50342698.06498.20
5475735-47573592.67092.79
6505885-50588598.54398.70
15min1498695-49869597.14298.061.0797.4698.351.08
2507874-50787498.93099.24
3495070-49507096.43696.68
4508517-50851799.05699.35
5504457-50445798.26598.53
6505711-50571198.50998.83
20min1497572-49757296.92498.011.0897.4098.471.09
2507636-50763698.88499.36
3495133-49513396.44996.86
4507292-50729298.81799.28
5505918-50591898.54998.98
6505416-50541698.45298.94
30min1497643-49764396.93897.941.0997.5798.561.10
2506264-50626498.61799.25
3494176-49417696.26296.83
4506249-50624998.61499.24
5506247-50624798.61499.21
6506226-50622698.60999.26
45min1496086-49608696.63497.661.0797.4398.451.08
2505113-50511398.39399.19
3493081-49308196.04996.78
4505051-50505198.38199.17
5504838-50483898.33999.10
6504086-50408698.19399.01
60min1494324-49432496.29197.441.1197.2598.391.12
2504401-50440198.25499.22
3491996-49199695.83896.73
4503355-50335598.05099.00
5503571-50357198.09299.02
6503773-50377398.13299.11
极限1494304-49430496.28797.241.1197.4198.351.12
2503178-50317898.01699.14
3490268-49026895.50196.55
4502312-50231297.84798.96
5503055-50305597.99299.08
6502166-50216697.81998.96
依折麦布瑞舒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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.044318164321444324154319414323524321340.06
211.034312164309064310610.06
单位质量响应值RSD%判断
39142.5739080.780.12数据可信
供试品溶液-2024030921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204609-20460947.08342.4429.1747.0842.4429.18
2177019-17701940.73440.73
3100664-10066423.16423.16
4176386-17638640.58840.59
5180447-18044741.52341.52
6267559-26755961.56861.57
10min1409177-40917794.15692.397.1594.2392.467.16
2383827-38382788.32388.39
3351669-35166980.92380.96
4421438-42143896.97797.04
5415838-41583895.68995.76
6427041-42704198.26798.37
15min1428621-42862198.63098.772.8898.8798.992.90
2419532-41953296.53996.75
3410983-41098394.57194.74
4443372-443372102.025102.25
5440433-440433101.348101.58
6432317-43231799.48199.75
20min1430576-43057699.08099.701.4799.48100.091.48
2432052-43205299.42099.80
3424434-42443497.66798.00
4442479-442479101.819102.22
5438426-438426100.886101.28
6431722-43172299.34499.78
30min1432018-43201899.412100.180.9299.98100.740.91
2432962-43296299.629100.17
3434329-43432999.944100.44
4441496-441496101.593102.16
5439017-439017101.022101.59
6432261-43226199.468100.07
45min1430689-43068999.106100.020.9999.84100.740.97
2431829-43182999.368100.08
3436975-436975100.553101.21
4440544-440544101.374102.11
5437619-437619100.701101.43
6430291-43029199.01499.78
60min1429541-42954198.84299.870.9999.74100.760.97
2431133-43113399.208100.08
3437214-437214100.608101.44
4439465-439465101.125102.03
5436638-436638100.475101.38
6430092-43009298.96999.90
极限1429411-42941198.81299.690.9899.87100.740.96
2430274-43027499.011100.05
3436339-436339100.406101.40
4438368-438368100.873101.95
5436292-436292100.395101.46
6428684-42868498.64599.74
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