盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000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%
19.763962952397939839721733970782397990839730430.18
29.793999876400488640023810.09
单位质量响应值RSD%判断
407074.08408823.390.31数据可信
长期6月-供试品溶液-2025081721批-盐酸二甲双胍-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%
5min1177028-1770284.3394.416.504.344.416.47
2176670-1766704.3314.33
3193394-1933944.7414.74
4173462-1734624.2524.25
5164210-1642104.0254.03
6193784-1937844.7504.75
10min1360242-3602428.8319.153.918.859.173.91
2397738-3977389.7509.77
3377816-3778169.2619.29
4361173-3611738.8538.87
5363773-3637738.9178.94
6379101-3791019.2939.32
15min1510432-51043212.51212.352.8512.5812.422.84
2477712-47771211.71011.78
3516010-51601012.64912.72
4499651-49965112.24812.31
5504088-50408812.35712.42
6515473-51547312.63612.71
20min1640617-64061715.70315.492.0815.8315.622.05
2607802-60780214.89915.03
3629468-62946815.43015.56
4645172-64517215.81515.94
5636440-63644015.60115.73
6632475-63247515.50415.64
30min1849612-84961220.82720.881.2321.0321.091.21
2833548-83354820.43320.64
3853043-85304320.91121.12
4862190-86219021.13521.34
5861488-86148821.11821.32
6851479-85147920.87221.08
45min11116105-111610527.35927.200.6327.6727.510.63
21099365-109936526.94927.25
31106019-110601927.11227.43
41118304-111830427.41327.72
51107571-110757127.15027.46
61109927-110992727.20827.52
60min11353633-135363333.18232.770.7833.6333.220.76
21340641-134064132.86333.30
31333903-133390332.69833.15
41323454-132345432.44232.89
51338691-133869132.81533.26
61330081-133008132.60433.06
120min12044108-204410850.10749.401.4150.7250.011.39
21970246-197024648.29748.90
31996750-199675048.94649.56
42027741-202774149.70650.32
52040020-204002050.00750.62
62011557-201155749.30949.92
180min12527966-252796661.96861.580.9262.8362.440.91
22499126-249912661.26162.11
32504094-250409461.38362.24
42497910-249791061.23162.09
52551548-255154862.54663.41
62492033-249203361.08761.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12899467-289946771.07570.750.5172.2571.920.51
22884963-288496370.71971.87
32894400-289440070.95072.12
42860776-286077670.12671.29
52898118-289811871.04272.21
62880637-288063770.61371.78
360min13433567-343356784.16783.860.6085.7085.380.59
23413567-341356783.67785.18
33441703-344170384.36685.89
43391524-339152483.13684.65
53406938-340693883.51485.04
63439215-343921584.30585.82
480min13754537-375453792.03592.600.7493.9994.540.73
23742794-374279491.74793.67
33815924-381592493.54095.48
43791745-379174592.94794.88
53764871-376487192.28894.23
63794898-379489893.02494.97
600min13932894-393289496.40796.340.6798.8298.740.67
23887244-388724495.28897.67
33952985-395298596.90099.31
43911228-391122895.87698.27
53942924-394292496.65399.06
63953422-395342296.91099.32
720min13986948-398694897.73298.411.03100.62101.301.01
23951642-395164296.86799.73
34045679-404567999.172102.07
44023052-402305298.617101.49
54013616-401361698.386101.28
64067228-406722899.700102.59
极限13970752-397075297.33597.931.02100.72101.311.00
23963005-396300597.145100.49
34062936-406293699.595102.99
43987549-398754997.747101.12
53961572-396157297.110100.49
64024311-402431198.648102.04
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数6250
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%
112.383252332643325973256832657325980.17
212.503278332818328000.08
单位质量响应值RSD%判断
2633.122624.000.25数据可信
长期6月-供试品溶液-2025081721批-达格列净-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%
5min137390-3739091.49291.442.6491.4991.442.64
235508-3550886.88786.89
338169-3816993.39993.40
437627-3762792.07292.07
537324-3732491.33191.33
638200-3820093.47493.47
10min138485-3848594.17294.342.1994.6394.792.19
236940-3694090.39190.83
339109-3910995.69996.17
438660-3866094.60095.06
538830-3883095.01695.47
639287-3928796.13496.60
15min138406-3840693.97993.602.6794.9194.532.67
236367-3636788.98989.88
339074-3907495.61396.56
437883-3788392.69993.63
538806-3880694.95795.89
638964-3896495.34496.29
20min138648-3864894.57194.391.8895.9795.791.88
237159-3715990.92792.26
338813-3881394.97496.40
439192-3919295.90297.30
538664-3866494.61096.02
638966-3896695.34996.77
30min138171-3817193.40494.130.9995.2795.991.01
237834-3783492.57994.36
338778-3877894.88996.79
438651-3865194.57896.45
538637-3863794.54496.42
638727-3872794.76496.67
45min138099-3809993.22794.241.2795.5796.571.28
237880-3788092.69194.94
338979-3897995.38197.75
438661-3866194.60396.95
538342-3834293.82296.17
639105-3910595.68998.06
60min138455-3845594.09894.381.0696.9097.191.04
238594-3859494.43997.15
339051-3905195.55798.41
437917-3791792.78295.60
538451-3845194.08996.91
638943-3894395.29398.15
120min138569-3856994.37794.191.6197.6597.481.61
237265-3726591.18794.37
338727-3872794.76498.09
438645-3864594.56397.85
538783-3878394.90198.19
638976-3897695.37398.70
180min138093-3809393.21394.031.2296.9697.781.23
237724-3772492.31095.95
338849-3884995.06398.86
438318-3831893.76397.52
538909-3890995.20998.98
638675-3867594.63798.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138100-3810093.23093.761.2297.4497.991.22
237879-3787992.68996.79
338913-3891395.21999.50
437858-3785892.63896.87
538307-3830793.73697.98
638850-3885095.06599.35
360min138043-3804393.09093.391.3097.7798.081.30
237666-3766692.16896.73
338781-3878194.89699.65
437958-3795892.88297.57
537769-3776992.42097.13
638783-3878394.90199.66
480min137908-3790892.76093.731.3097.9098.891.30
237637-3763792.09797.12
338805-3880594.955100.18
438702-3870294.70399.86
538068-3806893.15198.32
638703-3870394.70599.94
600min137625-3762592.06792.281.3497.6897.901.34
236946-3694690.40695.89
338178-3817893.42199.12
437446-3744691.62997.26
537739-3773992.34697.99
638329-3832993.79099.49
720min137148-3714890.90091.981.7196.9798.071.69
236682-3668289.76095.70
338178-3817893.42199.59
437762-3776292.40398.49
537389-3738991.49097.59
638381-3838193.917100.09
极限136988-3698890.50991.261.6597.0397.811.62
236629-3662989.63096.02
338088-3808893.20099.84
437412-3741291.54698.10
536736-3673689.89296.45
637910-3791092.76599.41
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000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%
19.763964537396985239595273954564396019039617340.15
29.794045755400046140231080.80
单位质量响应值RSD%判断
405915.37410940.550.88数据可信
长期6月-供试品溶液-2025081721批-盐酸二甲双胍-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%
5min1192385-1923854.7115.0510.664.715.0510.62
2182207-1822074.4614.46
3228792-2287925.6025.60
4232574-2325745.6955.69
5214579-2145795.2545.25
6186983-1869834.5784.58
10min1370859-3708599.0819.081.639.109.111.62
2366294-3662948.9698.99
3376049-3760499.2089.24
4361897-3618978.8618.89
5373118-3731189.1369.16
6377797-3777979.2509.27
15min1524220-52422012.83612.922.0212.9012.992.03
2518014-51801412.68412.75
3526136-52613612.88212.96
4521964-52196412.78012.85
5548332-54833213.42613.50
6528155-52815512.93213.00
20min1646664-64666415.83415.851.3715.9715.991.36
2648911-64891115.88916.02
3661909-66190916.20716.35
4649849-64984915.91216.05
5636146-63614615.57615.72
6640975-64097515.69415.83
30min1844222-84422220.67121.513.1020.8821.723.08
2858403-85840321.01821.23
3908896-90889622.25422.47
4866180-86618021.20821.42
5882657-88265721.61221.83
6910471-91047122.29322.51
45min11092149-109214926.74127.291.2627.0627.621.25
21115125-111512527.30427.62
31106123-110612327.08327.41
41129488-112948827.65627.98
51117850-111785027.37127.70
61127281-112728127.60227.93
60min11287383-128738331.52232.561.7131.9733.011.70
21342363-134236332.86833.32
31332184-133218432.61933.08
41323031-132303132.39432.86
51349479-134947933.04233.50
61343314-134331432.89133.35
120min11958479-195847947.95349.042.2048.5649.662.19
22023614-202361449.54850.16
32081163-208116350.95751.59
41981017-198101748.50549.13
51995790-199579048.86749.49
61977592-197759248.42149.05
180min12485704-248570460.86361.571.3361.7162.431.32
22552274-255227462.49363.36
32529546-252954661.93662.82
42542643-254264362.25763.12
52466853-246685360.40161.27
62509804-250980461.45362.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12843792-284379269.63070.501.1770.7871.671.17
22917920-291792071.44572.62
32885662-288566270.65671.85
42915703-291570371.39172.57
52840908-284090869.56070.73
62870912-287091270.29471.47
360min13358308-335830882.22883.101.0983.7384.621.08
23426070-342607083.88785.42
33434201-343420184.08785.63
43416514-341651483.65485.19
53347657-334765781.96883.49
63380277-338027782.76684.29
480min13730793-373079391.34990.920.9293.2692.870.90
23767740-376774092.25394.21
33710665-371066590.85692.82
43701421-370142190.62992.58
53704472-370447290.70492.64
63665507-366550789.75091.69
600min13855842-385584294.41095.191.1196.7897.591.09
23935037-393503796.35098.76
33868700-386870094.72597.15
43936949-393694996.39698.80
53831944-383194493.82596.21
63897363-389736395.42797.82
720min13917017-391701795.90896.301.1098.7599.181.07
24008259-400825998.142101.04
33896305-389630595.40198.30
43945628-394562896.60999.50
53891450-389145095.28298.14
63939898-393989896.46999.34
极限13867281-386728194.69194.311.1398.0197.661.09
23883499-388349995.08898.47
33840695-384069594.04097.41
43785714-378571492.69396.06
53825540-382554093.66997.00
63906815-390681595.65999.01
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数6250
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%
112.383247732565325683244232505325110.17
212.503290932864328860.10
单位质量响应值RSD%判断
2626.092630.880.13数据可信
长期6月-供试品溶液-2025081721批-达格列净-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%
5min138030-3803093.06191.261.6293.0691.261.62
237648-3764892.12692.13
337469-3746991.68891.69
436365-3636588.98788.99
537451-3745191.64491.64
636813-3681390.08390.08
10min138390-3839093.94293.281.3694.4193.741.36
238379-3837993.91594.38
337938-3793892.83693.29
437638-3763892.10292.55
538863-3886395.09995.56
637503-3750391.77192.22
15min138505-3850594.22393.631.2395.1694.551.24
238526-3852694.27595.20
338351-3835193.84694.77
437861-3786192.64793.55
538791-3879194.92395.86
637536-3753691.85292.76
20min138506-3850694.22693.811.0795.6395.201.04
238485-3848594.17495.58
337892-3789292.72394.12
438984-3898495.39596.76
538176-3817693.41894.83
637971-3797192.91794.29
30min138547-3854794.32693.771.0296.2095.631.01
238241-3824193.57795.45
338550-3855094.33396.19
437588-3758891.97993.82
538340-3834093.81995.69
638656-3865694.59396.43
45min138283-3828393.68093.150.9296.0395.480.91
238036-3803693.07695.42
337548-3754891.88194.21
437847-3784792.61394.92
538555-3855594.34696.69
638129-3812993.30395.61
60min137250-3725091.15292.311.1893.9795.101.15
238053-3805393.11795.92
337797-3779792.49195.28
437110-3711090.81093.58
538187-3818793.44596.26
637944-3794492.85095.62
120min137900-3790092.74392.882.3396.0296.132.27
238537-3853794.30297.57
339260-3926096.07199.32
436800-3680090.05193.27
537998-3799892.98396.27
637235-3723591.11594.35
180min138386-3838693.93293.511.2097.6797.231.18
239005-3900595.44799.19
338286-3828693.68797.42
437748-3774892.37196.04
537909-3790992.76596.51
637938-3793892.83696.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138035-3803593.07392.790.9797.2896.980.95
238526-3852694.27598.49
338062-3806293.13997.34
437753-3775392.38396.52
537610-3761092.03396.25
637536-3753691.85296.01
360min137960-3796092.89093.202.4997.5697.852.37
237939-3793992.83897.53
338191-3819193.45598.12
437233-3723391.11195.71
537338-3733891.36896.04
639864-3986497.549102.16
480min137888-3788892.71391.421.6697.8596.541.60
237866-3786692.66097.82
337618-3761892.05397.18
436553-3655389.44794.50
537638-3763892.10297.23
636603-3660389.56994.67
600min137383-3738391.47890.481.8297.0896.061.74
237553-3755391.89497.51
337118-3711890.82996.42
437021-3702190.59296.09
537119-3711990.83296.42
635665-3566587.27492.83
720min136965-3696590.45589.791.0996.5195.821.06
237303-3730391.28297.36
336466-3646689.23495.28
436161-3616188.48794.44
536671-3667189.73595.78
636597-3659789.55495.54
极限136323-3632388.88487.121.9195.3993.591.82
235921-3592187.90094.43
335721-3572187.41193.90
434415-3441584.21590.61
535252-3525286.26392.76
635970-3597088.02094.46
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000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%
19.764040212404937840352074043305405025640436720.16
29.794028531403801940332750.17
单位质量响应值RSD%判断
414310.66411979.060.40数据可信
长期6月-供试品溶液-WK2170批-盐酸二甲双胍-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%
5min1115918-1159182.8063.1814.452.813.1814.47
2153111-1531113.7063.71
3132937-1329373.2183.22
4131349-1313493.1793.18
5150004-1500043.6313.63
6104216-1042162.5232.52
10min1263780-2637806.3857.158.186.407.178.18
2298245-2982457.2197.24
3283492-2834926.8626.88
4298783-2987837.2327.25
5337174-3371748.1618.18
6291414-2914147.0547.07
15min1394481-3944819.54810.224.869.5910.274.88
2409975-4099759.9239.98
3418248-41824810.12410.17
4442057-44205710.70010.75
5449772-44977210.88710.95
6418899-41889910.13910.19
20min1517410-51741012.52413.033.6312.6213.133.63
2514562-51456212.45512.56
3541392-54139213.10413.21
4556675-55667513.47413.58
5561910-56191013.60113.71
6537933-53793313.02113.12
30min1709229-70922917.16718.012.7317.3218.182.74
2754969-75496918.27418.44
3760252-76025218.40218.57
4735493-73549317.80217.98
5763587-76358718.48218.66
6740567-74056717.92518.09
45min1946482-94648222.90923.852.4323.1524.112.43
2970353-97035323.48723.75
3994983-99498324.08324.34
4985432-98543223.85224.11
51011589-101158924.48524.76
61003424-100342424.28824.54
60min11167552-116755228.26029.172.1028.6229.542.10
21183966-118396628.65829.03
31236128-123612829.92030.30
41215940-121594029.43229.81
51220369-122036929.53929.93
61206468-120646829.20229.58
120min11823830-182383044.14545.101.8044.6445.621.80
21835734-183573444.43444.95
31861117-186111745.04845.58
41896562-189656245.90646.43
51853575-185357544.86545.41
61909063-190906346.20846.73
180min12310357-231035755.92257.282.0856.6458.032.07
22320988-232098856.17956.92
32439408-243940859.04559.80
42352087-235208756.93257.69
52374462-237446257.47358.24
62401399-240139958.12558.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12668981-266898164.60266.241.7165.6067.271.71
22702498-270249865.41366.44
32778888-277888867.26268.31
42721016-272101665.86266.90
52761243-276124366.83567.89
62786636-278663667.45068.49
360min13226160-322616078.08879.811.8779.4181.171.86
23253667-325366778.75480.10
33301501-330150179.91281.30
43320453-332045380.37181.74
53278380-327838079.35280.74
63402683-340268382.36183.74
480min13609555-360955587.36888.681.9089.0890.441.89
23611364-361136487.41289.15
33672794-367279488.89990.68
43680749-368074989.09290.87
53617360-361736087.55789.34
63790227-379022791.74293.53
600min13797600-379760091.92092.952.7494.0795.162.71
23708403-370840389.76191.94
33883800-388380094.00796.24
43818164-381816492.41894.64
53811010-381101092.24594.47
64021003-402100397.32799.58
720min13908851-390885194.61395.761.7997.2298.441.77
23913440-391344094.72497.35
33975633-397563396.22998.93
43877045-387704593.84396.52
53995136-399513696.70199.39
64068497-406849798.477101.21
极限13912633-391263394.70495.361.9997.7998.511.95
23971728-397172896.13599.24
33993421-399342196.66099.84
43824595-382459592.57395.72
53893433-389343394.24097.41
64042011-404201197.836101.07
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数6250
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%
112.383324333068332013303832984331070.34
212.503313333159331460.06
单位质量响应值RSD%判断
2674.232651.680.60数据可信
长期6月-供试品溶液-WK2170批-达格列净-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%
5min124726-2472659.72365.639.7659.7265.639.76
225236-2523660.95560.96
324870-2487060.07160.07
430342-3034273.28873.29
530322-3032273.24073.24
627524-2752466.48266.48
10min136129-3612987.26688.934.9587.5689.264.95
236060-3606087.09987.40
334893-3489384.28184.58
435738-3573886.32286.69
538442-3844292.85393.22
639654-3965495.78096.11
15min136813-3681388.91891.414.6889.6592.184.68
237965-3796591.70192.44
335546-3554685.85886.58
437176-3717689.79590.59
538959-3895994.10294.93
640607-4060798.08298.89
20min137434-3743490.41891.754.0791.6092.984.07
237573-3757390.75491.95
336306-3630687.69488.84
436915-3691589.16590.41
539333-3933395.00596.31
640361-4036197.48898.79
30min137962-3796291.69492.454.0493.3394.144.03
238859-3885993.86095.51
336679-3667988.59590.18
436482-3648288.11989.81
539165-3916594.59996.38
640496-4049697.81499.60
45min137764-3776491.21592.444.3293.3194.604.31
238910-3891093.98396.11
336526-3652688.22590.26
436527-3652788.22790.36
539167-3916794.60496.85
640741-4074198.406100.68
60min137913-3791391.57592.553.1794.1295.173.19
239064-3906494.35596.95
336810-3681088.91191.38
437205-3720589.86592.44
538942-3894294.06196.78
639976-3997696.55899.33
120min138232-3823292.34692.263.6595.3595.343.64
238834-3883493.80096.86
336112-3611287.22590.14
437621-3762190.87093.89
538051-3805191.90995.10
640336-4033697.428100.68
180min137975-3797591.72592.213.3095.1995.753.30
238651-3865193.35896.89
336932-3693289.20692.56
436844-3684488.99392.47
538417-3841792.79396.44
640239-4023997.193100.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137330-3733090.16791.123.5794.0995.123.57
238282-3828292.46696.47
336238-3623887.52991.33
436420-3642087.96991.89
538276-3827692.45296.57
639808-3980896.152100.38
360min137225-3722589.91390.544.2294.2994.994.19
237955-3795591.67796.14
335309-3530985.28589.52
436561-3656188.31092.67
537830-3783091.37595.95
640029-4002996.686101.39
480min137163-3716389.76490.474.0594.5995.374.02
238184-3818492.23097.15
335861-3586186.61991.28
436124-3612487.25492.06
537376-3737690.27895.31
640018-4001896.660101.85
600min136728-3672888.71389.124.6693.9994.484.60
236593-3659388.38793.77
335467-3546785.66790.76
435308-3530885.28390.52
537224-3722489.91195.40
640052-4005296.742102.42
720min136599-3659988.40189.274.1294.1295.074.09
237459-3745990.47996.30
335521-3552185.79891.32
435189-3518984.99690.66
537670-3767090.98896.92
639304-3930494.935101.09
极限136586-3658688.37088.694.3894.5394.944.31
237665-3766590.97697.25
335527-3552785.81291.77
434601-3460183.57589.67
536733-3673388.72595.12
639188-3918894.655101.29
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000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%
19.764050832403926540435374054691405870640494060.20
29.794056141407982840679840.42
单位质量响应值RSD%判断
414898.16415524.410.11数据可信
长期6月-供试品溶液-WK2170批-盐酸二甲双胍-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%
5min1165295-1652953.9813.3015.123.983.3015.09
2121817-1218172.9342.93
3152997-1529973.6853.68
4143063-1430633.4463.45
5109032-1090322.6262.63
6130470-1304703.1423.14
10min1269466-2694666.4906.644.136.516.664.13
2286678-2866786.9046.92
3276900-2769006.6696.69
4291460-2914607.0207.04
5267636-2676366.4466.46
6262591-2625916.3246.34
15min1404671-4046719.7469.882.409.809.932.41
2420829-42082910.13510.18
3419629-41962910.10610.16
4415284-41528410.00210.05
5396460-3964609.5489.59
6404273-4042739.7379.78
20min1528971-52897112.74012.772.4012.8412.862.39
2546192-54619213.15513.25
3527641-52764112.70812.81
4543782-54378213.09713.20
5516644-51664412.44312.54
6516937-51693712.45012.55
30min1720731-72073117.35817.522.6017.5217.682.60
2726820-72682017.50517.67
3741976-74197617.87018.04
4754627-75462718.17518.34
5700487-70048716.87117.03
6719544-71954417.33017.49
45min1977471-97747123.54223.480.8723.7923.730.88
2983846-98384623.69523.95
3972801-97280123.42923.68
4983968-98396823.69823.96
5965415-96541523.25123.49
6965392-96539223.25123.50
60min11191182-119118228.68928.911.3629.0629.281.35
21202930-120293028.97229.34
31188173-118817328.61628.99
41219470-121947029.37029.75
51180847-118084728.44028.80
61218961-121896129.35829.72
120min11875027-187502745.15845.411.8345.6745.931.83
21879187-187918745.25945.78
31857582-185758244.73845.25
41948237-194823746.92247.45
51855633-185563344.69145.19
61898089-189808945.71446.22
180min12368769-236876957.05056.601.4757.7957.341.47
22378562-237856257.28658.03
32304848-230484855.51056.25
42387397-238739757.49858.26
52314053-231405355.73256.45
62346588-234658856.51657.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12781088-278108866.98066.441.6868.0067.471.67
22794523-279452367.30468.33
32724240-272424065.61166.63
42821201-282120167.94668.99
52707978-270797865.21966.22
62724217-272421765.61066.63
360min13313460-331346079.80279.981.9581.1681.341.94
23409962-340996282.12683.49
33279972-327997278.99580.34
43392022-339202281.69483.08
53261563-326156378.55279.88
63268807-326880778.72680.07
480min13667635-366763588.33288.201.1190.0989.961.08
23700419-370041989.12190.90
33668260-366826088.34790.09
43623071-362307187.25989.05
53707489-370748989.29291.01
63607260-360726086.87888.62
600min13824030-382403092.09893.140.9694.3095.340.92
23850395-385039592.73394.96
33899532-389953293.91796.10
43854230-385423092.82695.06
53851920-385192092.77094.94
63924039-392403994.50796.68
720min13977972-397797295.80696.132.2398.4798.802.19
24012196-401219696.63099.32
33966965-396696595.54198.19
44154526-4154526100.058102.75
53940616-394061694.90697.54
63896861-389686193.85396.50
极限13924021-392402194.50794.700.7297.6597.840.69
23959651-395965195.36598.53
33972231-397223195.66898.80
43898199-389819993.88597.08
53922290-392229094.46597.57
63915032-391503294.29097.41
盐酸二甲双胍达格列净片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数6250
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%
112.383370133386331513340133243333760.63
212.503338933555334720.36
单位质量响应值RSD%判断
2695.962677.760.48数据可信
长期6月-供试品溶液-WK2170批-达格列净-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%
5min126159-2615962.62263.008.0662.6263.008.06
227959-2795966.93166.93
324220-2422057.98057.98
429004-2900469.43369.43
527014-2701464.66964.67
623549-2354956.37456.37
10min135443-3544384.84786.553.1385.1686.863.14
236857-3685788.23288.57
334644-3464482.93483.22
437899-3789990.72691.07
535964-3596486.09486.42
636116-3611686.45886.74
15min136966-3696688.49389.492.2989.2390.242.29
237657-3765790.14790.92
336341-3634186.99787.70
438164-3816491.36192.16
536688-3668887.82788.58
638491-3849192.14492.86
20min137658-3765890.14990.212.5791.3391.402.57
237636-3763690.09791.32
335955-3595586.07387.21
438695-3869592.63293.89
537659-3765990.15291.34
638496-3849692.15693.33
30min137853-3785390.61691.482.1692.2593.132.16
237975-3797590.90892.59
337651-3765190.13391.70
439752-3975295.16296.88
537557-3755789.90891.55
638504-3850492.17593.81
45min138193-3819391.43091.321.6293.5193.421.63
237995-3799590.95693.09
337073-3707388.74990.77
438615-3861592.44094.64
538138-3813891.29993.39
638860-3886093.02795.12
60min137925-3792590.78991.552.7993.3394.112.76
238079-3807991.15793.74
336673-3667387.79190.26
439260-3926093.98496.64
537895-3789590.71793.27
639627-3962794.86397.42
120min138139-3813991.30192.613.1194.3095.633.08
238300-3830091.68694.73
337270-3727089.22192.12
440456-4045696.84899.98
538128-3812891.27594.28
639826-3982695.33998.38
180min138741-3874192.74291.642.9596.1995.122.92
239134-3913493.68397.18
336226-3622686.72190.07
438843-3884392.98696.60
537707-3770790.26793.73
639029-3902993.43196.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138211-3821191.47391.552.3695.3995.492.36
237941-3794190.82794.80
337368-3736889.45593.24
439842-3984295.37899.46
537509-3750989.79393.70
638578-3857892.35296.33
360min137592-3759289.99190.642.7294.3695.032.70
238301-3830191.68996.11
336359-3635987.04091.27
439102-3910293.60698.16
537130-3713088.88593.25
638685-3868592.60897.05
480min137393-3739389.51589.811.0894.3494.661.12
237591-3759189.98994.87
336847-3684788.20892.87
437588-3758889.98295.00
537583-3758389.97094.77
638093-3809391.19196.10
600min136497-3649787.37089.242.5192.6494.542.45
236579-3657987.56692.90
336679-3667987.80692.91
437883-3788390.68896.16
537164-3716488.96794.22
638868-3886893.04698.41
720min137125-3712588.87489.422.3894.5895.162.36
237241-3724189.15194.92
336344-3634487.00492.55
438998-3899893.35799.28
536984-3698488.53694.24
637418-3741889.57595.40
极限136418-3641887.18187.920.9893.3394.110.98
236482-3648287.33493.55
336633-3663387.69693.68
436765-3676588.01294.40
536647-3664787.72993.87
637412-3741289.56195.83
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2026-04-10 14:07:36 完成)
生成报告数据部分(等待生成报告)
Current page cost:1.83 s