沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342775692775932770942776752786232777110.21
227.252792682786402789540.16
单位质量响应值RSD%判断
10157.6810236.840.55数据可信
加速6月-供试品溶液-SDR926批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104294-10429416.56517.2516.2416.5617.2516.25
2103529-10352916.44316.44
3104835-10483516.65116.65
483910-8391013.32713.33
5118395-11839518.80518.80
6136727-13672721.71621.72
10min1216942-21694234.45734.575.2834.4834.605.28
2197018-19701831.29231.32
3218492-21849234.70334.73
4217186-21718634.49634.52
5230376-23037636.59036.62
6226063-22606335.90535.94
15min1301899-30189947.95045.1310.0648.0445.2110.06
2233771-23377137.13037.21
3306565-30656548.69248.78
4266092-26609242.26342.34
5296104-29610447.03047.12
6300232-30023247.68647.78
20min1313435-31343549.78349.196.5849.9549.356.57
2270765-27076543.00543.15
3329863-32986352.39252.56
4312685-31268549.66449.81
5320851-32085150.96151.13
6310482-31048249.31449.49
30min1313298-31329849.76151.102.8750.0151.342.86
2319054-31905450.67550.89
3331726-33172652.68852.94
4319246-31924650.70650.94
5334256-33425653.09053.35
6312614-31261449.65249.91
45min1314772-31477249.99551.443.0150.3351.783.00
2325079-32507951.63251.93
3330760-33076052.53452.88
4321042-32104250.99151.31
5338615-33861553.78254.13
6313084-31308449.72750.07
60min1314526-31452649.95651.333.0850.3751.753.07
2323914-32391451.44751.83
3330457-33045752.48652.92
4320114-32011450.84351.25
5338257-33825753.72554.16
6311807-31180749.52449.95
极限1313646-31364649.81651.263.1750.3151.763.16
2324991-32499151.61852.09
3329174-32917452.28252.80
4317962-31796250.50250.99
5338566-33856653.77454.30
6311894-31189449.53850.04
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344814244822674826824829654829174824510.14
227.254845944828104837020.27
单位质量响应值RSD%判断
17646.3417750.530.42数据可信
加速6月-供试品溶液-SDR926批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176875-17687515.29215.9317.4015.2915.9317.39
2175923-17592315.21015.21
3176331-17633115.24515.25
4139448-13944812.05612.06
5201031-20103117.38117.38
6235796-23579620.38720.39
10min1370157-37015732.00332.265.6532.0332.285.66
2336216-33621629.06929.09
3373388-37338832.28232.31
4372239-37223932.18332.20
5397074-39707434.33034.36
6389675-38967533.69133.72
15min1520634-52063445.01342.2410.6245.0942.3210.61
2397179-39717934.33934.41
3529118-52911845.74745.83
4455875-45587539.41439.49
5510583-51058344.14444.23
6517822-51782244.77044.86
20min1542223-54222346.88046.197.1247.0346.347.11
2461196-46119639.87440.01
3571698-57169849.42849.58
4540885-54088546.76446.90
5553342-55334247.84148.00
6536447-53644746.38046.55
30min1541180-54118046.79048.102.9247.0248.322.92
2550197-55019747.56947.77
3574955-57495549.71049.95
4553262-55326247.83448.05
5577493-57749349.92950.17
6540691-54069146.74746.99
45min1544983-54498347.11848.473.0447.4348.773.03
2562011-56201148.59148.87
3573601-57360149.59349.91
4555475-55547548.02548.32
5585909-58590950.65750.98
6541424-54142446.81147.13
60min1544836-54483647.10648.423.0847.4948.813.07
2561588-56158848.55448.91
3573310-57331049.56749.97
4554815-55481547.96848.35
5585486-58548650.62051.03
6540044-54004446.69147.09
极限1542882-54288246.93748.333.1847.4048.803.17
2563392-56339248.71049.15
3570313-57031349.30849.79
4550882-55088247.62848.09
5586376-58637650.69751.19
6540117-54011746.69847.17
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.342781152782962783202786762781132783040.09
227.252783012781562782280.04
单位质量响应值RSD%判断
10179.3710210.200.22数据可信
长期6月-供试品溶液-SDR926批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190213-9021314.33216.1817.7414.3316.1817.74
292212-9221214.64914.65
3102801-10280116.33216.33
495600-9560015.18815.19
5137641-13764121.86621.87
692757-9275714.73614.74
10min1209407-20940733.26832.858.4433.2932.878.44
2208275-20827533.08833.11
3208678-20867833.15233.18
4201762-20176232.05332.08
5233410-23341037.08137.12
6178980-17898028.43428.46
15min1295578-29557846.95744.1211.0347.0444.2011.02
2304475-30447548.37148.45
3254203-25420340.38440.47
4242930-24293038.59338.67
5314489-31448949.96250.06
6254620-25462040.45040.52
20min1324367-32436751.53148.837.2951.6948.987.29
2325713-32571351.74551.90
3312253-31225349.60649.76
4266229-26622942.29542.44
5316946-31694650.35250.53
6298643-29864347.44447.58
30min1327294-32729451.99651.261.9552.2451.491.95
2325817-32581751.76152.01
3321921-32192151.14251.37
4313340-31334049.77949.99
5317580-31758050.45350.72
6329909-32990952.41152.63
45min1326996-32699651.94951.671.1852.2851.991.16
2326295-32629551.83752.17
3324059-32405951.48251.80
4324079-32407951.48551.78
5319294-31929450.72551.07
6330827-33082752.55752.86
60min1331752-33175252.70452.191.9353.1252.601.89
2323206-32320651.34651.77
3333298-33329852.95053.35
4326343-32634351.84552.23
5320116-32011650.85651.29
6336449-33644953.45053.84
极限1325569-32556951.72251.561.0452.2352.051.01
2324436-32443651.54252.05
3321796-32179651.12251.61
4326836-32683651.92352.39
5319658-31965850.78351.30
6328925-32892552.25552.74
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344840984835474838654836634842114838770.06
227.254833234818614825920.22
单位质量响应值RSD%判断
17698.5017709.800.05数据可信
长期6月-供试品溶液-SDR926批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1150356-15035612.99514.7718.8113.0014.7718.80
2153506-15350613.26713.27
3173028-17302814.95514.95
4160904-16090413.90713.91
5234320-23432020.25220.25
6153216-15321613.24213.24
10min1358456-35845630.98130.539.0831.0030.559.08
2355622-35562230.73630.76
3355877-35587730.75830.78
4344445-34444529.77029.79
5402454-40245434.78434.82
6302317-30231726.12926.15
15min1508700-50870043.96741.2411.6544.0441.3211.64
2525446-52544645.41445.49
3436138-43613837.69537.77
4413289-41328935.72035.79
5544568-54456847.06747.16
6434687-43468737.57037.64
20min1560695-56069548.46145.777.7948.6145.917.79
2563075-56307548.66648.82
3538965-53896546.58346.72
4453564-45356439.20139.33
5546647-54664747.24747.42
6514109-51410944.43444.56
30min1565680-56568048.89248.262.0349.1248.482.03
2565473-56547348.87449.10
3558322-55832248.25648.47
4540735-54073546.73646.93
5549339-54933947.47947.73
6570426-57042649.30249.50
45min1566878-56687848.99548.651.3349.3048.951.30
2565797-56579748.90249.21
3561189-56118948.50348.80
4559182-55918248.33048.61
5551213-55121347.64147.97
6572895-57289549.51549.80
60min1570776-57077649.33249.432.1349.7249.812.10
2581782-58178250.28350.68
3582032-58203250.30550.68
4563145-56314548.67249.03
5552654-55265447.76648.17
6581234-58123450.23650.60
极限1563984-56398448.74548.640.9949.2249.100.95
2561875-56187548.56349.04
3559204-55920448.33248.79
4566455-56645548.95949.40
5554598-55459847.93448.42
6570336-57033649.29449.74
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345569475567195569095570215567765568740.03
227.255581175584325582740.04
单位质量响应值RSD%判断
20368.4720487.120.42数据可信
加速6月-供试品溶液-TAWW4批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1222849-22284917.66914.7116.6517.6714.7116.68
2150893-15089311.96411.96
3166423-16642313.19513.19
4213224-21322416.90516.91
5202301-20230116.03916.04
6157836-15783612.51412.51
10min1420878-42087833.36931.858.0933.4031.878.09
2351977-35197727.90627.93
3388621-38862130.81230.83
4438288-43828834.75034.78
5426310-42631033.80033.83
6384019-38401930.44730.47
15min1572292-57229245.37444.165.7245.4644.245.72
2493548-49354839.13139.20
3567463-56746344.99145.06
4580550-58055046.02946.11
5568718-56871845.09145.17
6559629-55962944.37044.44
20min1627736-62773649.77048.645.7149.9348.805.72
2542865-54286543.04143.17
3621291-62129149.25949.41
4626102-62610249.64049.80
5625860-62586049.62149.78
6637323-63732350.53050.68
30min1655108-65510851.94050.853.2752.1851.093.27
2608401-60840148.23748.44
3668567-66856753.00753.24
4628798-62879849.85450.10
5645586-64558651.18551.43
6642024-64202450.90351.13
45min1628883-62888349.86150.581.7450.1950.891.71
2646806-64680651.28251.57
3654050-65405051.85652.17
4629408-62940849.90250.23
5627336-62733649.73850.06
6640981-64098150.82051.13
60min1626396-62639649.66450.832.6650.0851.232.62
2648836-64883651.44351.81
3652410-65241051.72652.13
4627071-62707149.71750.13
5625828-62582849.61950.03
6665974-66597452.80253.20
极限1624657-62465749.52650.452.1450.0250.932.10
2652744-65274451.75352.21
3651684-65168451.66952.16
4624668-62466849.52750.02
5624716-62471649.53050.02
6639228-63922850.68151.17
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349661919654299674379667469670429665690.09
227.259687309703059695180.12
单位质量响应值RSD%判断
35353.6635578.640.45数据可信
加速6月-供试品溶液-TAWW4批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383497-38349716.54613.6617.5616.5513.6617.56
2253980-25398010.95810.96
3282326-28232612.18112.18
4366425-36642515.80915.81
5346838-34683814.96414.96
6266731-26673111.50811.51
10min1727243-72724331.37729.678.4931.4029.708.50
2599480-59948025.86425.88
3659367-65936728.44828.47
4758585-75858532.72932.76
5721336-72133631.12231.15
6660523-66052328.49828.52
15min1989334-98933442.68541.525.7842.7641.595.78
2851498-85149836.73836.80
3979443-97944342.25842.33
41003684-100368443.30443.38
5982566-98256642.39342.47
6967171-96717141.72841.80
20min11087752-108775246.93145.795.8547.0845.935.85
2936233-93623340.39440.52
31071397-107139746.22546.36
41082816-108281646.71846.87
51086524-108652446.87847.03
61102770-110277047.57947.71
30min11108441-110844147.82347.442.7848.0547.662.79
21048327-104832745.23045.42
31140360-114036049.20149.42
41087097-108709746.90347.13
51102442-110244247.56547.79
61111333-111133347.94848.16
45min11087541-108754146.92247.691.8047.2347.991.76
21121613-112161348.39248.66
31133312-113331248.89649.19
41091437-109143747.09047.40
51086155-108615546.86247.17
61111898-111189847.97348.27
60min11085437-108543746.83147.732.1247.2248.112.08
21124027-112402748.49648.84
31128357-112835748.68349.06
41085767-108576746.84547.23
51084176-108417646.77747.16
61130437-113043748.77249.15
极限11082383-108238346.69947.512.0247.1647.971.99
21125520-112552048.56048.99
31128307-112830748.68149.14
41083163-108316346.73347.20
51080598-108059846.62247.08
61107443-110744347.78048.24
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345556055561365549505551935557735555310.09
227.255574425578835576620.06
单位质量响应值RSD%判断
20319.3520464.660.51数据可信
长期6月-供试品溶液-TAWW4批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1209665-20966516.65214.6512.8016.6514.6512.81
2204410-20441016.23516.24
3198678-19867815.78015.78
4152740-15274012.13112.13
5161589-16158912.83412.83
6179927-17992714.29114.29
10min1405569-40556932.21229.528.8932.2429.548.89
2412156-41215632.73532.76
3380815-38081530.24630.27
4356103-35610328.28328.30
5337636-33763626.81726.84
6337395-33739526.79726.82
15min1558006-55800644.31942.525.0844.4042.595.08
2560324-56032444.50344.58
3532963-53296342.33042.41
4554693-55469344.05644.12
5496392-49639239.42639.49
6509722-50972240.48440.55
20min1629056-62905649.96248.604.2750.1248.754.26
2622136-62213649.41349.57
3592749-59274947.07947.23
4650960-65096051.70251.84
5589203-58920346.79746.93
6587541-58754146.66546.80
30min1637346-63734650.62151.182.8150.8651.412.80
2640824-64082450.89751.14
3666988-66698852.97553.20
4663413-66341352.69152.92
5639255-63925550.77250.98
6618489-61848949.12349.34
45min1636719-63671950.57151.372.6450.8951.682.63
2641424-64142450.94551.27
3668386-66838653.08653.40
4665701-66570152.87353.19
5643913-64391351.14251.44
6624658-62465849.61349.91
60min1634997-63499750.43451.282.7050.8451.682.69
2641266-64126650.93251.34
3668802-66880253.11953.52
4662409-66240952.61153.01
5644776-64477651.21151.59
6621941-62194149.39749.78
极限1634014-63401450.35651.122.7150.8551.602.70
2637817-63781750.65851.15
3665253-66525352.83753.33
4662193-66219352.59453.08
5642996-64299651.07051.53
6619578-61957849.21049.67
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349641289631579635269619319640319633550.10
227.259672979677299675130.04
单位质量响应值RSD%判断
35236.1035505.060.54数据可信
长期6月-供试品溶液-TAWW4批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1360350-36035015.58913.6713.3215.5913.6713.31
2351588-35158815.21015.21
3341609-34160914.77914.78
4258795-25879511.19611.20
5275736-27573611.92911.93
6307814-30781413.31713.32
10min1698127-69812730.20227.669.2330.2327.689.24
2713873-71387330.88330.91
3654194-65419428.30128.33
4612999-61299926.51926.54
5578601-57860125.03125.05
6577856-57785624.99925.02
15min1963048-96304841.66339.975.0941.7440.045.09
2967066-96706641.83741.91
3919557-91955739.78139.85
4957833-95783341.43741.50
5856327-85632737.04637.11
6880291-88029138.08338.15
20min11089376-108937647.12845.804.4047.2745.934.39
21076952-107695246.59146.74
31026271-102627144.39844.54
41127753-112775348.78848.92
51016453-101645343.97344.10
61014837-101483743.90344.03
30min11105605-110560547.83048.262.8548.0548.472.84
21109317-110931747.99148.21
31155094-115509449.97150.18
41147780-114778049.65549.87
51106082-110608247.85148.05
61068750-106875046.23646.44
45min11102936-110293647.71548.452.5848.0248.742.57
21112279-111227948.11948.42
31155987-115598750.01050.31
41152010-115201049.83850.13
51114331-111433148.20848.48
61081991-108199146.80947.09
60min11099849-109984947.58148.382.7147.9648.752.71
21109894-110989448.01648.40
31158054-115805450.09950.48
41147529-114752949.64450.02
51117816-111781648.35848.72
61076628-107662846.57746.93
极限11096770-109677047.44848.232.7047.9148.682.69
21105136-110513647.81048.27
31151080-115108049.79750.26
41147552-114755249.64550.11
51114858-111485848.23048.67
61073675-107367546.44946.88
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.341116182111570211152531115674111613811157900.04
227.251115305111494511151250.03
单位质量响应值RSD%判断
40811.6340922.020.20数据可信
加速6月-供试品溶液-TYN28批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1353133-35313313.99512.0015.4714.0012.0015.47
2215438-2154388.5388.54
3300645-30064511.91511.91
4328191-32819113.00713.01
5304690-30469012.07512.08
6314826-31482612.47712.48
10min1701264-70126427.79225.769.1727.8225.789.18
2533535-53353521.14521.16
3658884-65888426.11226.13
4666452-66645226.41226.43
5684313-68431327.12027.14
6656213-65621326.00726.03
15min11001254-100125439.68136.417.4039.7536.477.41
2805540-80554031.92531.97
3889695-88969535.26035.32
4962428-96242838.14238.21
5909782-90978236.05636.12
6943405-94340537.38837.45
20min11198737-119873747.50744.166.9647.6444.286.97
2996743-99674339.50239.60
31096038-109603843.43743.56
41169143-116914346.33546.46
51058886-105888641.96542.09
61166226-116622646.21946.35
30min11271921-127192150.40849.604.0250.6249.804.01
21239025-123902549.10449.27
31296199-129619951.37051.56
41266013-126601350.17450.38
51156432-115643245.83146.03
61279903-127990350.72450.93
45min11269670-126967050.31950.331.5950.6250.611.58
21271673-127167350.39850.65
31297500-129750051.42251.70
41264687-126468750.12150.41
51236336-123633648.99849.27
61280139-128013950.73351.02
60min11267204-126720450.22150.580.9250.6050.940.91
21279098-127909850.69251.03
31295980-129598051.36151.73
41262055-126205550.01750.39
51275691-127569150.55750.91
61277533-127753350.63051.00
极限11245839-124583949.37450.511.5049.8450.961.46
21281533-128153350.78951.21
31292101-129210151.20851.66
41257992-125799249.85650.31
51293073-129307351.24651.68
61276922-127692250.60651.06
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.341935574193528319352661935435193612319355360.02
227.251932030193442019332250.09
单位质量响应值RSD%判断
70795.0370944.040.15数据可信
加速6月-供试品溶液-TYN28批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1607919-60791913.12611.2016.1713.1311.2016.18
2361742-3617427.8107.81
3514451-51445111.10811.11
4562555-56255512.14612.15
5522410-52241011.28011.28
6542725-54272511.71811.72
10min11212729-121272926.18424.179.6326.2124.199.63
2908524-90852419.61619.63
31135673-113567324.52124.54
41149667-114966724.82324.84
51178561-117856125.44725.47
61131101-113110124.42224.44
15min11734849-173484937.45834.267.6537.5234.327.66
21385187-138518729.90829.95
31535778-153577833.15933.22
41664982-166498235.94936.01
51568816-156881633.87333.93
61631645-163164535.22935.29
20min12075007-207500744.80241.587.1444.9341.707.14
21717110-171711037.07537.17
31895715-189571540.93141.05
42023554-202355443.69143.81
51826499-182649939.43639.55
62016571-201657143.54043.66
30min12204345-220434547.59546.734.2547.8046.914.25
22140563-214056346.21846.37
32242832-224283248.42648.61
42193038-219303847.35147.54
51989524-198952442.95643.14
62214687-221468747.81848.01
45min12196580-219658047.42747.451.7747.7147.711.76
22196019-219601947.41547.65
32249518-224951848.57048.83
42191669-219166947.32147.59
52131941-213194146.03146.29
62218820-221882047.90748.18
60min12194417-219441747.38047.710.9047.7448.050.88
22212609-221260947.77348.09
32243732-224373248.44548.79
42188017-218801747.24247.59
52203541-220354147.57747.91
62215337-221533747.83248.18
极限12176915-217691547.00247.731.2547.4448.161.22
22219123-221912347.91448.31
32238051-223805148.32248.75
42178912-217891247.04647.48
52238763-223876348.33848.75
62212350-221235047.76848.20
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.341114435111429411151291114434111469711145980.03
227.251113195111316711131810.01
单位质量响应值RSD%判断
40768.0340850.680.15数据可信
长期6月-供试品溶液-TYN28批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1271681-27168110.78211.3214.0610.7811.3214.09
2305949-30594912.14212.14
3272489-27248910.81410.81
4340553-34055313.51613.52
5298766-29876611.85711.86
6221839-2218398.8048.80
10min1623483-62348324.74424.987.9724.7625.007.98
2687048-68704827.26727.29
3621640-62164024.67124.69
4687680-68768027.29227.31
5594303-59430323.58623.61
6562150-56215022.31022.32
15min1952164-95216437.78935.654.3337.8535.714.34
2915458-91545836.33236.40
3901921-90192135.79535.85
4902618-90261835.82235.89
5882523-88252335.02535.08
6834561-83456133.12133.17
20min11171835-117183546.50742.955.6146.6343.075.60
21018953-101895340.43940.57
31077820-107782042.77542.89
41137095-113709545.12845.26
51057862-105786241.98342.10
61030115-103011540.88240.99
30min11283586-128358650.94249.154.6151.1449.344.60
21139942-113994245.24145.43
31267493-126749350.30350.49
41291098-129109851.24051.44
51239736-123973649.20149.39
61208628-120862847.96748.14
45min11288180-128818051.12451.101.6451.4151.381.62
21256677-125667749.87450.14
31271760-127176050.47250.75
41290429-129042951.21351.50
51305485-130548551.81152.08
61313653-131365352.13552.39
60min11282547-128254750.90051.271.4751.2751.631.45
21278249-127824950.73051.08
31271389-127138950.45850.82
41288807-128880751.14951.52
51318139-131813952.31352.67
61311941-131194152.06752.41
极限11278815-127881550.75251.191.3951.2151.641.36
21280808-128080850.83151.27
31270737-127073750.43250.87
41285083-128508351.00151.46
51314269-131426952.15952.60
61309813-130981351.98352.41
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.341932276193273019324111932957193321419327180.02
227.251930845192999719304210.04
单位质量响应值RSD%判断
70691.9570841.140.15数据可信
长期6月-供试品溶液-TYN28批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1467017-46701710.09810.5514.3810.1010.5414.35
2522808-52280811.30511.30
3467309-46730910.10410.10
4582940-58294012.60512.60
5512045-51204511.07211.07
6374456-3744568.0978.10
10min11076433-107643323.27523.458.0723.2923.478.07
21185235-118523525.62825.65
31071412-107141223.16723.18
41185187-118518725.62725.65
51021465-102146522.08722.11
6967153-96715320.91220.93
15min11646523-164652335.60233.564.3835.6633.614.38
21580585-158058534.17734.24
31561174-156117433.75733.81
41557366-155736633.67433.74
51525065-152506532.97633.03
61440507-144050731.14831.20
20min12028886-202888643.87040.465.7243.9840.575.71
21756500-175650037.98038.10
31865625-186562540.34040.45
41966899-196689942.53042.65
51828661-182866139.54139.65
61780895-178089538.50838.61
30min12223558-222355848.07946.324.7748.2746.504.77
21965041-196504142.49042.67
32195772-219577247.47947.66
42234953-223495348.32648.52
52143948-214394846.35846.53
62090530-209053045.20345.37
45min12231248-223124848.24648.221.6148.5148.481.60
22175847-217584747.04847.30
32205338-220533847.68547.94
42233625-223362548.29748.57
52258731-225873148.84049.09
62275307-227530749.19849.44
60min12222266-222226648.05148.361.4748.4048.701.45
22210804-221080447.80448.13
32201367-220136747.60047.94
42231348-223134848.24848.60
52279929-227992949.29849.63
62273440-227344049.15849.48
极限12216520-221652047.92748.311.3548.3648.731.33
22219912-221991248.00148.41
32200646-220064647.58448.00
42226418-222641848.14148.57
52276604-227660449.22649.64
62266456-226645649.00749.41
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