依折麦布阿托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%
19.851642061642161641871642281646201642910.12
29.911657151657311657230.01
单位质量响应值RSD%判断
16679.2916722.810.19数据可信
供试品溶液-2022091401批-依折麦布-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%
5min110019-100195.3815.6715.515.385.6715.50
212153-121536.5286.53
311372-113726.1086.11
49493-94935.0995.10
512196-121966.5516.55
68096-80964.3484.35
10min116806-168069.0278.912.419.068.942.45
216506-165068.8668.90
316845-168459.0489.08
416803-168039.0259.05
516733-167338.9879.02
615806-158068.4908.51
15min116610-166108.9218.872.469.008.952.48
216548-165488.8888.97
316631-166318.9339.02
416859-168599.0559.13
516715-167158.9789.06
615714-157148.4408.51
20min116898-168989.0768.901.679.219.031.70
216501-165018.8639.00
316627-166278.9319.06
416572-165728.9019.03
516740-167408.9919.13
616084-160848.6398.76
30min115954-159548.5698.591.968.758.771.94
215523-155238.3388.52
316139-161398.6688.85
415958-159588.5718.75
516484-164848.8549.04
615940-159408.5628.73
45min115215-152158.1728.332.618.408.562.58
215210-152108.1698.40
315502-155028.3268.56
416080-160808.6378.86
515941-159418.5628.80
615156-151568.1408.35
60min115195-151958.1618.161.878.438.431.83
214745-147457.9208.20
315084-150848.1028.38
415421-154218.2838.56
515560-155608.3578.64
615125-151258.1248.38
极限115205-152058.1678.444.268.498.764.12
215628-156288.3948.71
315468-154688.3088.63
416969-169699.1149.43
515818-158188.4968.83
615145-151458.1358.44
依折麦布阿托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%
111.001549891550431550891550701550741550530.03
211.051561451565131563290.17
单位质量响应值RSD%判断
14095.7314147.420.26数据可信
供试品溶液-2022091401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%
5min162497-6249736.55635.488.8236.5635.488.82
268504-6850440.07040.07
357527-5752733.64933.65
453006-5300631.00431.00
559057-5905734.54434.54
663312-6331237.03337.03
10min1108379-10837963.39362.322.5963.6062.522.60
2105420-10542061.66361.89
3105030-10503061.43461.62
4102304-10230459.84060.01
5109016-10901663.76663.96
6109160-10916063.85064.06
15min1124756-12475672.97372.533.1373.5373.083.12
2120257-12025770.34170.91
3123298-12329872.12072.65
4119553-11955369.92970.43
5129936-12993676.00376.55
6126233-12623373.83774.40
20min1137073-13707380.17778.913.7181.1479.863.70
2131393-13139376.85577.81
3133813-13381378.27079.20
4127649-12764974.66575.56
5141676-14167682.87083.84
6137811-13781180.60981.58
30min1142005-14200583.06282.924.8384.4784.304.79
2134734-13473478.80980.19
3141126-14112682.54883.91
4133866-13386678.30179.61
5150999-15099988.32389.75
6147794-14779486.44887.87
45min1143632-14363284.01485.603.6185.8887.453.58
2141122-14112282.54584.37
3144967-14496784.79486.62
4144283-14428384.39486.14
5156108-15610891.31193.23
6147995-14799586.56688.46
60min1147499-14749986.27686.523.7988.6188.843.76
2139968-13996881.87084.15
3145115-14511584.88187.17
4146942-14694285.95088.16
5156350-15635091.45393.88
6151587-15158788.66791.05
极限1153794-15379489.95891.552.9792.7794.352.95
2150979-15097988.31191.05
3154406-15440690.31693.08
4156673-15667391.64294.33
5164160-16416096.02198.96
6159078-15907893.04895.92
依折麦布阿托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%
19.851669581678181681751673631675301675690.28
29.911653961658081656020.18
单位质量响应值RSD%判断
17012.0816710.601.27数据可信
供试品溶液-2022091401批-依折麦布-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%
5min19992-99925.3165.9012.125.325.9012.13
212583-125836.6956.69
310027-100275.3355.33
412417-124176.6066.61
511870-118706.3156.32
69646-96465.1325.13
10min116941-169419.0138.911.669.048.941.66
217082-170829.0889.13
316857-168578.9699.00
416462-164628.7598.80
516370-163708.7108.74
616746-167468.9108.94
15min117087-170879.0919.030.659.179.110.64
216994-169949.0429.13
317094-170949.0959.17
416924-169249.0049.09
516880-168808.9819.06
616828-168288.9539.03
20min116620-166208.8438.981.588.979.111.55
216867-168678.9749.11
317314-173149.2129.34
416823-168238.9519.09
516596-165968.8308.96
616996-169969.0439.17
30min116468-164688.7628.681.218.948.861.16
216355-163558.7028.89
316601-166018.8339.01
416064-160648.5478.73
516262-162628.6528.83
616178-161788.6078.79
45min115672-156728.3388.502.128.578.732.08
216200-162008.6198.86
316319-163198.6828.91
415566-155668.2828.51
515811-158118.4128.64
616316-163168.6818.91
60min115509-155098.2528.371.228.538.651.20
215885-158858.4528.74
315963-159638.4938.77
415540-155408.2688.55
515855-158558.4368.71
615656-156568.3308.60
极限115678-156788.3418.341.588.668.661.60
215966-159668.4958.83
315846-158468.4318.76
415393-153938.1908.51
515800-158008.4068.73
615363-153638.1748.49
依折麦布阿托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%
111.001571241581871576351576651574071576040.25
211.051564071562821563440.06
单位质量响应值RSD%判断
14327.6414148.780.89数据可信
供试品溶液-2022091401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%
5min160157-6015734.90035.376.1634.9035.376.16
259742-5974234.65934.66
354426-5442631.57531.58
464690-6469037.53037.53
563641-6364136.92136.92
663097-6309736.60636.61
10min1125147-12514772.60464.206.8272.8064.396.81
2106888-10688862.01162.20
3103824-10382460.23460.41
4107963-10796362.63562.84
5111764-11176464.84065.05
6108336-10833662.85163.05
15min1134289-13428977.90874.513.3678.5175.063.37
2126661-12666173.48374.02
3122933-12293371.32071.83
4129198-12919874.95575.51
5132224-13222476.71077.28
6125244-12524472.66173.21
20min1142599-14259982.72980.202.1983.7681.162.21
2136519-13651979.20280.15
3134106-13410677.80278.71
4138423-13842380.30681.28
5140561-14056181.54782.54
6137195-13719579.59480.55
30min1155319-15531990.10984.634.1291.6086.044.11
2145103-14510384.18285.57
3139787-13978781.09882.44
4143041-14304182.98684.40
5150782-15078287.47788.92
6141228-14122881.93483.33
45min1157887-15788791.59887.813.4093.5989.703.39
2151352-15135287.80789.66
3143956-14395683.51685.31
4147284-14728485.44787.33
5152133-15213388.26090.19
6155562-15556290.25092.10
60min1159405-15940592.47989.403.5294.9891.773.51
2152903-15290388.70791.05
3145404-14540484.35686.61
4150818-15081887.49789.85
5157645-15764591.45893.88
6158377-15837791.88394.24
极限1159582-15958292.58292.502.2095.5995.372.20
2160377-16037793.04395.88
3152555-15255588.50591.23
4161078-16107893.45096.29
5162337-16233794.18097.11
6160705-16070593.23396.10
依折麦布阿托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%
19.851665431675451674641674541682651674540.37
29.911683511688061685780.20
单位质量响应值RSD%判断
17000.4117010.900.05数据可信
供试品溶液-2022091402批-依折麦布-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%
5min111079-110795.8445.755.505.845.755.50
211132-111325.8725.87
310721-107215.6555.66
411880-118806.2676.27
510292-102925.4295.43
610312-103125.4395.44
10min116841-168418.8838.792.148.928.822.13
217237-172379.0929.12
316310-163108.6038.63
416579-165798.7458.78
516764-167648.8438.87
616300-163008.5988.63
15min116875-168758.9018.861.348.988.941.31
217037-170378.9879.07
316838-168388.8828.96
416446-164468.6758.76
516958-169588.9459.02
616602-166028.7578.84
20min116377-163778.6398.702.138.778.832.14
217048-170488.9939.13
316318-163188.6088.74
416343-163438.6218.75
516792-167928.8588.99
616109-161098.4978.62
30min116513-165138.7108.532.348.898.712.32
216600-166008.7568.94
316236-162368.5648.74
415706-157068.2858.46
516267-162678.5818.76
615743-157438.3048.48
45min115688-156888.2758.251.968.508.481.95
215898-158988.3868.62
315965-159658.4218.65
415249-152498.0448.27
515754-157548.3108.54
615279-152798.0608.28
60min115154-151547.9948.242.378.278.512.34
216226-162268.5598.84
315707-157078.2858.56
415438-154388.1438.41
515773-157738.3208.59
615427-154278.1388.40
极限115400-154008.1238.131.728.448.451.67
215568-155688.2128.54
315783-157838.3258.64
414983-149837.9038.22
515346-153468.0958.41
615404-154048.1258.44
依折麦布阿托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%
111.001560191568021568031569791571711567550.28
211.051578291580451579370.10
单位质量响应值RSD%判断
14250.4514292.940.22数据可信
供试品溶液-2022091402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%
5min158073-5807333.61133.686.5633.6133.686.56
259701-5970134.55334.55
355051-5505131.86231.86
461144-6114435.38835.39
552546-5254630.41230.41
662653-6265336.26236.26
10min1108355-10835562.71362.671.7562.9062.861.75
2109646-10964663.46063.65
3105070-10507060.81160.99
4107714-10771462.34262.54
5108338-10833862.70362.87
6110588-11058864.00564.21
15min1128675-12867574.47374.552.8475.0175.092.83
2128083-12808374.13074.68
3124473-12447372.04172.56
4125824-12582472.82373.37
5131381-13138176.03976.56
6134440-13444077.81078.37
20min1139460-13946080.71580.182.2781.6681.132.27
2139056-13905680.48181.44
3133749-13374977.41078.32
4135921-13592178.66779.61
5141977-14197782.17283.11
6141092-14109281.66082.65
30min1151284-15128487.55985.802.6688.9687.192.64
2147760-14776085.51986.92
3144183-14418383.44984.79
4143153-14315382.85384.24
5150173-15017386.91688.31
6152898-15289888.49389.94
45min1153330-15333088.74387.793.4690.6389.663.42
2148986-14898686.22988.11
3146865-14686585.00186.81
4145985-14598584.49286.34
5156020-15602090.30092.18
6158928-15892891.98393.92
60min1154966-15496689.69090.683.5192.0793.043.48
2156521-15652190.59092.95
3150885-15088587.32889.61
4151699-15169987.79990.11
5160728-16072893.02495.41
6165217-16521795.62398.07
极限1165091-16509195.55095.641.9598.4298.501.96
2162279-16227993.92296.78
3162934-16293494.30197.07
4163133-16313394.41697.22
5167426-16742696.90199.80
6170569-17056998.720101.70
依折麦布阿托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%
19.851657821667881669381672981676461668900.43
29.911649281649801649540.03
单位质量响应值RSD%判断
16943.1516645.211.26数据可信
供试品溶液-2022091402批-依折麦布-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%
5min111600-116006.1966.088.916.206.088.93
212221-122216.5286.53
310710-107105.7215.72
411975-119756.3976.40
512137-121376.4836.48
69646-96465.1535.15
10min116826-168268.9889.011.229.029.051.26
217112-171129.1419.18
316794-167948.9719.00
416875-168759.0149.05
517077-170779.1229.16
616555-165558.8438.87
15min117199-171999.1879.081.149.279.161.16
217177-171779.1759.26
316933-169339.0459.13
416805-168058.9779.06
517134-171349.1539.24
616764-167648.9559.03
20min116538-165388.8348.861.998.979.001.98
216982-169829.0719.21
316917-169179.0379.17
416078-160788.5888.72
516551-165518.8418.98
616479-164798.8038.93
30min116106-161068.6038.711.438.798.891.41
216504-165048.8169.00
315954-159548.5228.70
416507-165078.8189.00
516462-164628.7948.98
616311-163118.7138.89
45min115621-156218.3448.372.538.588.602.49
216406-164068.7649.00
315725-157258.4008.63
415255-152558.1498.38
515489-154898.2748.51
615489-154898.2748.50
60min115438-154388.2478.351.438.538.631.40
215939-159398.5148.80
315406-154068.2298.51
415455-154558.2568.53
515774-157748.4268.71
615751-157518.4148.68
极限115236-152368.1398.271.608.468.601.55
215661-156618.3668.70
315753-157538.4158.74
415134-151348.0848.41
515526-155268.2948.62
615601-156018.3348.65
依折麦布阿托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%
111.001544851557321553781563651561081556140.48
211.051542841543911543380.05
单位质量响应值RSD%判断
14146.7313967.240.91数据可信
供试品溶液-2022091402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%
5min161388-6138836.07431.9630.4136.0731.9630.41
264728-6472838.03638.04
343731-4373125.69825.70
459761-5976135.11735.12
570653-7065341.51841.52
626036-2603615.30015.30
10min1109947-10994764.60862.029.2564.8162.209.31
2108784-10878463.92564.14
3100409-10040959.00459.15
4107313-10731363.06163.26
5117649-11764969.13469.37
689110-8911052.36452.45
15min1135150-13515079.41975.446.9179.9875.966.96
2128250-12825075.36475.93
3123318-12331872.46672.94
4125182-12518273.56174.11
5141633-14163383.22883.84
6116723-11672368.59068.97
20min1146390-14639086.02380.766.4987.0281.706.54
2137999-13799981.09382.08
3132561-13256177.89778.77
4131521-13152177.28678.24
5149393-14939387.78888.87
6126709-12670974.45875.22
30min1157093-15709392.31387.136.1993.7988.526.23
2144859-14485985.12486.56
3139686-13968682.08483.39
4146157-14615785.88787.27
5161841-16184195.10396.67
6140013-14001382.27683.45
45min1163291-16329195.95589.915.6597.9591.785.69
2152181-15218189.42691.34
3145594-14559485.55687.32
4145623-14562385.57387.43
5164120-16412096.44298.54
6147197-14719786.49888.13
60min1167763-16776398.58394.294.95101.1196.664.95
2152989-15298989.90192.31
3152467-15246789.59591.83
4156109-15610991.73594.07
5171420-171420100.732103.36
6161961-16196195.17497.28
极限1170921-170921100.43998.012.57103.51100.902.58
2160851-16085194.52197.43
3166449-16644997.811100.55
4162698-16269895.60798.45
5171136-171136100.565103.75
6168630-16863099.092101.73
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