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)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251773011782031783371781971779691780010.24
210.281746861753751750300.28
单位质量响应值RSD%判断
17365.9517026.261.40数据可信
供试品溶液-X007293批-依折麦布-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%
5min19321-93214.8635.2616.154.865.2616.16
211646-116466.0766.08
37647-76473.9893.99
411727-117276.1186.12
510951-109515.7135.71
69178-91784.7884.79
10min114069-140697.3407.649.417.377.679.40
216267-162678.4868.52
313841-138417.2217.24
412776-127766.6656.70
516186-161868.4448.48
614711-147117.6757.70
15min115667-156678.1738.352.788.248.422.80
216529-165298.6238.70
315705-157058.1938.26
416281-162818.4948.56
516406-164068.5598.64
615487-154878.0808.15
20min116131-161318.4168.451.088.538.571.06
216437-164378.5758.70
316347-163478.5288.64
416270-162708.4888.61
516009-160098.3528.48
616035-160358.3658.48
30min115874-158748.2818.291.658.448.461.61
215955-159558.3248.50
315845-158458.2668.42
416307-163078.5078.67
515487-154878.0808.25
615909-159098.3008.46
45min116325-163258.5178.202.088.728.411.96
215381-153818.0248.25
315730-157308.2068.41
415567-155678.1218.33
515559-155598.1178.33
615720-157208.2018.41
60min115847-158478.2678.281.148.528.531.11
215781-157818.2338.50
316007-160078.3518.60
416019-160198.3578.61
515967-159678.3308.59
615549-155498.1128.36
极限115474-154748.0738.151.828.378.461.74
215881-158818.2858.60
316033-160338.3648.66
415660-156608.1708.47
515273-152737.9688.28
615465-154658.0688.37
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521596851603951604861603741600391601960.21
210.521562271575821569040.62
单位质量响应值RSD%判断
15227.7614914.831.47数据可信
供试品溶液-X007293批-瑞舒伐他汀钙-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%
5min177489-7748942.47343.1821.7242.4743.1821.72
296580-9658052.93852.94
388791-8879148.66848.67
462052-6205234.01234.01
554964-5496430.12730.13
692820-9282050.87750.88
10min1128579-12857970.47765.955.5770.7166.195.60
2119828-11982865.68065.97
3118833-11883365.13565.41
4117366-11736664.33164.52
5110315-11031560.46660.63
6126989-12698969.60569.89
15min1146408-14640880.24973.805.5080.8874.415.45
2123499-12349967.69268.35
3132117-13211772.41673.05
4134852-13485273.91574.46
5134227-13422773.57374.08
6136747-13674774.95475.62
20min1153271-15327184.01177.456.6185.0878.466.55
2126281-12628169.21770.25
3139279-13927976.34277.38
4141478-14147877.54778.50
5138728-13872876.04076.95
6148764-14876481.54182.63
30min1155500-15550085.23379.595.9986.7781.045.94
2130456-13045671.50672.93
3145072-14507279.51780.98
4147115-14711580.63782.02
5141692-14169277.66479.00
6151371-15137182.97084.51
45min1152002-15200283.31580.916.2085.3382.806.13
2131061-13106171.83773.65
3147299-14729980.73882.64
4148855-14885581.59183.43
5147808-14780881.01782.78
6158697-15869786.98588.98
60min1160241-16024187.83183.806.3690.3186.146.29
2134714-13471473.84076.06
3153016-15301683.87186.22
4154042-15404284.43486.72
5153142-15314283.94086.16
6162138-16213888.87191.35
极限1177606-17760697.35098.110.59100.31100.920.59
2179151-17915198.196100.82
3179931-17993198.624101.44
4179875-17987598.593101.35
5177788-17778897.449100.13
6179661-17966198.476101.45
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)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251736421741341741261742271743631740980.16
210.281743341750021746680.28
单位质量响应值RSD%判断
16985.1716991.050.03数据可信
供试品溶液-2023120823批-依折麦布-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%
5min17799-77994.1185.4818.244.125.4818.22
212166-121666.4246.42
312799-127996.7586.76
410681-106815.6405.64
59755-97555.1515.15
69065-90654.7874.79
10min112660-126606.6857.969.496.717.999.51
215597-155978.2368.27
317084-170849.0219.06
415192-151928.0228.05
515118-151187.9838.01
614813-148137.8227.85
15min115770-157708.3278.463.548.398.543.57
216502-165028.7148.80
316440-164408.6818.77
416569-165698.7498.82
515659-156598.2688.34
615182-151828.0178.09
20min115052-150527.9488.443.458.058.563.51
215817-158178.3528.48
316370-163708.6448.78
416575-165758.7528.88
515801-158018.3438.46
616275-162758.5948.71
30min116271-162718.5928.561.698.748.731.61
216440-164408.6818.86
315814-158148.3508.53
416341-163418.6298.80
515952-159528.4238.59
616481-164818.7038.86
45min116525-165258.7268.602.198.928.822.09
215943-159438.4188.64
316492-164928.7088.94
416282-162828.5978.82
515802-158028.3448.56
616710-167108.8239.03
60min115253-152538.0548.241.688.308.511.69
215578-155788.2268.50
315510-155108.1908.47
415981-159818.4398.71
515498-154988.1838.44
615837-158378.3628.62
极限115560-155608.2168.301.428.518.611.48
215941-159418.4178.73
315963-159638.4298.75
415835-158358.3618.68
515412-154128.1388.44
615632-156328.2548.56
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521559131566711565111564891565851564340.20
210.521555501568891562200.61
单位质量响应值RSD%判断
14870.1514849.810.10数据可信
供试品溶液-2023120823批-瑞舒伐他汀钙-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%
5min193459-9345951.95050.2922.8351.9550.2922.83
2118249-11824965.72965.73
354142-5414230.09530.10
495877-9587753.29453.29
591758-9175851.00451.00
689351-8935149.66649.67
10min1133512-13351274.21369.8512.2074.5070.1312.23
2139084-13908477.31177.68
395945-9594553.33253.50
4124580-12458069.24969.54
5129464-12946471.96372.25
6131421-13142173.05173.33
15min1155020-15502086.16977.2311.1286.8777.9011.15
2146375-14637581.36382.16
3110222-11022261.26861.73
4135162-13516275.13175.81
5143177-14317779.58680.27
6143671-14367179.86080.54
20min1151565-15156584.24879.077.5185.4380.177.58
2145690-14569080.98382.23
3123021-12302168.38269.19
4139162-13916277.35478.45
5151843-15184384.40385.53
6142234-14223479.06280.19
30min1159715-15971588.77883.047.3690.4384.587.42
2151885-15188584.42686.12
3131316-13131672.99374.18
4143087-14308779.53681.06
5160568-16056889.25390.85
6149783-14978383.25884.82
45min1166562-16656292.58485.386.1594.7387.376.16
2150231-15023183.50785.67
3144588-14458880.37081.96
4148999-14899982.82284.79
5164418-16441891.39393.48
6146754-14675481.57483.60
60min1159831-15983188.84386.204.6391.5088.674.69
2150145-15014583.45986.09
3144638-14463880.39882.43
4153638-15363885.40187.83
5164734-16473491.56894.17
6157456-15745687.52390.00
极限1175031-17503197.29298.051.72100.44101.001.74
2181105-181105100.668103.76
3176471-17647198.092100.57
4173554-17355496.47199.38
5178696-17869699.329102.44
6173511-17351196.44799.41
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)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251768821785131793441796031794391787560.64
210.281760181774291767240.57
单位质量响应值RSD%判断
17439.6117191.051.02数据可信
供试品溶液-2023121221批-依折麦布-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%
5min110484-104845.4324.8225.885.434.8225.87
29693-96935.0225.02
35193-51932.6902.69
410792-107925.5915.59
57866-78664.0754.08
611806-118066.1166.12
10min117983-179839.3178.4211.599.358.4511.62
216424-164248.5098.54
312708-127086.5846.60
417697-176979.1689.20
516236-162368.4128.43
616499-164998.5488.58
15min117242-172428.9338.835.859.018.905.92
216999-169998.8078.88
315292-152927.9237.97
418279-182799.4709.55
517588-175889.1129.18
616847-168478.7288.81
20min116915-169158.7638.762.638.898.882.70
216717-167178.6618.78
316282-162828.4358.53
417423-174239.0279.16
517395-173959.0129.13
616679-166798.6418.77
30min117215-172158.9198.692.229.108.862.22
216767-167678.6878.86
316761-167618.6848.83
417141-171418.8809.07
516555-165558.5778.75
616212-162128.3998.58
45min116119-161198.3518.593.148.588.813.15
216066-160668.3248.54
316173-161738.3798.57
417227-172278.9259.16
517067-170678.8429.06
616810-168108.7098.93
60min116782-167828.6948.601.968.978.871.83
216512-165128.5558.82
317013-170138.8149.05
416520-165208.5598.84
516065-160658.3238.59
616747-167478.6768.95
极限116387-163878.4908.344.138.818.653.89
215969-159698.2738.59
316944-169448.7789.06
416427-164278.5118.84
515846-158468.2108.52
614996-149967.7698.09
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.523162883191733201943205533202313192880.55
210.523163893187203175540.52
单位质量响应值RSD%判断
30350.5730185.740.39数据可信
供试品溶液-2023121221批-瑞舒伐他汀钙-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%
5min1147828-14782840.34248.9414.9440.3448.9414.94
2194798-19479853.16053.16
3152019-15201941.48541.49
4201032-20103254.86154.86
5211440-21144057.70157.70
6168942-16894246.10446.10
10min1231739-23173963.24170.706.9763.4670.977.00
2261675-26167571.41071.71
3250195-25019568.27768.51
4277705-27770575.78576.09
5279491-27949176.27276.59
6253560-25356069.19669.45
15min1263041-26304171.78376.684.4772.3677.344.50
2275251-27525175.11575.81
3282316-28231677.04377.65
4291321-29132179.50080.23
5298162-29816281.36782.11
6275718-27571875.24275.88
20min1277874-27787475.83179.793.3576.8080.893.37
2287041-28704178.33279.44
3303809-30380982.90883.95
4292127-29212779.72080.89
5302714-30271482.60983.81
6290831-29083179.36780.43
30min1292246-29224679.75382.772.6581.1584.302.63
2302435-30243582.53384.08
3315329-31532986.05287.55
4297410-29741081.16282.77
5304768-30476883.17084.83
6307523-30752383.92285.42
45min1298332-29833281.41484.475.0383.2586.464.95
2299883-29988381.83783.84
3300317-30031781.95583.93
4335674-33567491.60493.67
5301022-30102282.14884.27
6321886-32188687.84189.81
60min1306602-30660283.67085.283.1085.9687.742.99
2311074-31107484.89187.35
3330569-33056990.21192.64
4302706-30270682.60785.18
5309943-30994384.58287.16
6314131-31413185.72588.18
极限1364328-36432899.42497.781.36102.18100.721.28
2356784-35678497.365100.29
3351590-35159095.94898.88
4362271-36227198.862101.89
5354588-35458896.76699.81
6360306-36030698.326101.26
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)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251743351758801762691766071769021759990.58
210.281783721794581789150.43
单位质量响应值RSD%判断
17170.6317404.180.96数据可信
供试品溶液-2023121221批-依折麦布-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%
5min110545-105455.4725.3110.145.475.3010.10
29168-91684.7574.76
311338-113385.8835.88
410633-106335.5185.52
510934-109345.6745.67
68728-87284.5294.53
10min116924-169248.7828.395.038.818.425.03
216627-166278.6288.65
316197-161978.4058.44
416724-167248.6788.71
515832-158328.2158.25
614722-147227.6397.66
15min117362-173629.0099.063.329.099.143.29
217819-178199.2479.32
316800-168008.7188.80
418422-184229.5599.64
517155-171558.9028.98
617167-171678.9088.98
20min117198-171988.9249.041.939.059.171.95
216918-169188.7798.90
317648-176489.1589.29
417536-175369.1009.23
517863-178639.2699.40
617392-173929.0259.14
30min117100-171008.8738.951.939.059.121.86
216713-167138.6738.85
317525-175259.0949.27
417102-171028.8749.06
517529-175299.0969.27
617499-174999.0819.25
45min117093-170938.8708.764.029.108.994.00
216499-164998.5628.78
317953-179539.3169.55
417222-172228.9379.17
516468-164688.5468.77
616062-160628.3358.55
60min116171-161718.3918.301.848.678.571.78
215666-156668.1298.40
315680-156808.1378.42
416031-160318.3198.60
516429-164298.5258.80
615943-159438.2738.54
极限116276-162768.4468.502.448.778.822.34
215882-158828.2418.56
316401-164018.5118.84
416016-160168.3118.64
516893-168938.7669.09
616757-167578.6959.01
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.523119953148913154483157873163553148950.55
210.523206893223743215320.38
单位质量响应值RSD%判断
29932.9830563.881.48数据可信
供试品溶液-2023121221批-瑞舒伐他汀钙-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%
5min1143254-14325439.12340.3642.3339.1240.3642.33
2159723-15972343.62143.62
367959-6795918.56018.56
4221210-22121060.41360.41
5209009-20900957.08157.08
685461-8546123.34023.34
10min1237505-23750564.86361.1924.0065.0861.4124.06
2208592-20859256.96757.21
3175789-17578948.00848.11
4284112-28411277.59177.93
5282588-28258877.17577.49
6155716-15571642.52642.66
15min1273032-27303274.56675.4916.2175.1476.0616.29
2280741-28074176.67177.23
3271328-27132874.10074.47
4322468-32246888.06788.83
5314592-31459285.91686.66
6196400-19640053.63754.00
20min1294765-29476580.50179.3112.5181.4980.2912.62
2284901-28490177.80778.79
3288197-28819778.70779.49
4316405-31640586.41187.67
5332008-33200890.67291.90
6226088-22608861.74562.41
30min1314846-31484685.98585.287.0187.4286.707.11
2295327-29532780.65482.07
3329627-32962790.02291.24
4319715-31971587.31589.05
5336015-33601591.76693.49
6277996-27799675.92176.93
45min1334373-33437391.31889.107.5993.2390.997.56
2305882-30588283.53785.40
3361650-36165098.767100.49
4324722-32472288.68290.90
5338709-33870992.50294.74
6292097-29209779.77281.20
60min1334389-33438991.32287.155.1893.7589.555.28
2303585-30358582.91085.24
3305408-30540883.40785.68
4319654-31965487.29890.01
5343312-34331293.75996.51
6308396-30839684.22386.10
极限1367028-367028100.23699.181.57103.17102.061.34
2362447-36244798.985101.77
3360548-36054898.466101.20
4354392-35439296.78599.98
5363568-36356899.291102.56
6371082-371082101.343103.68
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