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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Paclitaxel EP Impurity M Paclitaxel EP Impurity M
Parecoxib Sodium Impurity H Parecoxib Sodium Impurity H 501093-49-8 C16H14N2O4S
Posaconazole Impurity 10 Posaconazole Impurity 10
Posaconazole Impurity 63 Posaconazole Impurity 63 208187-15-9 C20H26F2O4
(S)-4,5,6,7-Tetrahydro-N2,N6-propionyl-2,6-benzothiazolediaMine (S)-4,5,6,7-Tetrahydro-N2,N6-propionyl-2,6-benzothiazolediaMine 1373869-91-0 C11H17N3O2
SofosBuvir impurity 62 SofosBuvir impurity 62
Tamoxifen EP Impurity E Tamoxifen EP Impurity E C26H29NO
Tenofovir impurity P Tenofovir impurity P
Tirofiban Impurity 3 Tirofiban Impurity 3 1346918-32-8 C13H19NO5S
Trelagliptin Impurity 19 Trelagliptin Impurity 19
N-((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine oxide N-((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine oxide 2028267-73-2 C16H20N6O2
D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-methoxyphenyl)methyl]phenyl]-, (1S)- D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-methoxyphenyl)methyl]phenyl]-, (1S)- 333359-90-3 C20H23ClO6
Flucloxacillin Sodium Impurity E Flucloxacillin Sodium Impurity E
Amifostine Impurity 1 Amifostine Impurity 1
Clindamycin Phosphate EP Impurity H Clindamycin Phosphate EP Impurity H
2-Thia-5-azabicyclo[2.2.1]heptane-5-carboxylic acid, 3-oxo-, (4-nitrophenyl)methyl ester, (1S,4S)- 2-Thia-5-azabicyclo[2.2.1]heptane-5-carboxylic acid, 3-oxo-, (4-nitrophenyl)methyl ester, (1S,4S)- 151072-00-3 C13H12N2O5S
Brexpiprazole Impurity Brexpiprazole Impurity 2116542-21-1 C38H40N4O4S
4-(1-(2,3-dimethylphenyl)propyl)-1H-imidazole 4-(1-(2,3-dimethylphenyl)propyl)-1H-imidazole 86347-62-8 C14H18N2
Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate 202534-94-9 C15H16FNO4
Tofacitinib Impurity H Tofacitinib Impurity H
3',6'-Dehydroclindamycin 3',6'-Dehydroclindamycin 1440605-51-5 C18H31ClN2O5S
Iguratimod Impurity 5 Iguratimod Impurity 5 84594-95-6 C13H11NO4
Cefradine Impurity F Cefradine Impurity F
Mirabegron Impurity Mirabegron Impurity 1684452-83-2 C26H28N6O3S2
1-methyl-1H-indol-6-ol 1-methyl-1H-indol-6-ol 130570-60-4 C9H9NO
2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 118485-48-6 C13H13NO3S
32-Carboxycyanocobalamin 32-Carboxycyanocobalamin 121483-62-3 C63H87CoN13O15P
Alvimopan Impurity 6 Alvimopan Impurity 6
Acarbose Impurity B Acarbose Impurity B
Sofosbuvir Impurity28 Sofosbuvir Impurity28
Rivaroxaban Impurity 10 Rivaroxaban Impurity 10
Ipragliflozin Impurity 1 Ipragliflozin Impurity 1
(17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile (17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile 98149-13-4 C20H24BrNO2
316173-27-0 316173-27-0 316173-27-0 C17H28N2O5
Azilsartan Impurity Azilsartan Impurity 1821386-21-3 C22H18N4O4
Irbesartan Impurity 7 Irbesartan Impurity 7 C25H28N6O
Voriconazole Impurity 2 Voriconazole Impurity 2
Safinamide Impurity 1 Safinamide Impurity 1
Caspofungin impurit 2 Caspofungin impurit 2
Lamivudine impurity 1 Lamivudine impurity 1
Raltitrexed Impurity 1 Raltitrexed Impurity 1 1378372-01-0 C10H10N2O2
Loratadine Impurity 6 Loratadine Impurity 6 C22H23ClN2O2
Mirabegron Impurity 3 Mirabegron Impurity 3
Atomoxetine EP Impurity A Atomoxetine EP Impurity A 873310-33-9 C16H20ClNO
Famciclovir Impurity 12 Famciclovir Impurity 12 122497-20-5 C12H15N5O4
Levofloxacin Impurity 22 Levofloxacin Impurity 22 177472-29-6 C20H25F2N3O4
Methylprednisolone EP Impurity E Methylprednisolone EP Impurity E 229019-44-7 C21H28O4
Pantoprazole Impurity 1 Pantoprazole Impurity 1 812664-93-0 C16H14ClF2N3O4S
Ticagrelor Related Compound 38D-Tartrate Ticagrelor Related Compound 38D-Tartrate 2165881-71-8 C10H19NO4
1-(1-BENZOTHIOPHEN-7-YL)PIPERAZINE 1-(1-BENZOTHIOPHEN-7-YL)PIPERAZINE 105685-06-1 C12H14N2S
4-methyl-N-(2-methyl-5-nitrophenyl)-6-(pyridin-3-yl)pyrimidin-2-amine 4-methyl-N-(2-methyl-5-nitrophenyl)-6-(pyridin-3-yl)pyrimidin-2-amine C17H15N5O2
Afatinib Impurity 21 Afatinib Impurity 21 2044709-72-8 C18H16F2N4O2
trans-Carboprost trans-Carboprost 76498-29-8 C21H36O5
N-[[2-(1H-Tetrazol-5-Yl)[1,1-Biphenyl]-4-Yl]Methyl]Amine(WXC00176) N-[[2-(1H-Tetrazol-5-Yl)[1,1-Biphenyl]-4-Yl]Methyl]Amine(WXC00176) 147225-68-1 C14H13N5
Plerixafor Impurity C Plerixafor Impurity C
Vonoprazan Impuirty 8 Vonoprazan Impuirty 8
Sitagliptin IMpurity 4 Sitagliptin IMpurity 4
Brexpiprazole Impurity1 Brexpiprazole Impurity1
Acarbose Impurity E Acarbose Impurity E
Alvimopan Impurity 1 Alvimopan Impurity 1 2250243-53-7 C14H19NO
Febuxostat Impurity A Febuxostat Impurity A
Fingolimod Hexyl Impurity Fingolimod Hexyl Impurity 1201794-93-5 C17H29NO2
Palbociclib Impurity 1 Palbociclib Impurity 1
Trelagliptin Impurity 8 Trelagliptin Impurity 8
Bromhexine Impurity H Bromhexine Impurity H 63471-27-2 C14H21BrN2
Apixaban Impurity 17 Apixaban Impurity 17 1423803-24-0 C20H19N5O3
Rivaroxaban Impurity 11 Rivaroxaban Impurity 11 1411775-06-8 C14H17N3O4
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate C25H35NO3
Flomoxef Impurity 4 Flomoxef Impurity 4
Nicardipine Impurity 5 Nicardipine Impurity 5
11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 263366-81-0 C30H24Cl2N6
Sacubitril Impurity 7 Sacubitril Impurity 7 149709-44-4 C22H25NO5
Valsartan Impurity 5 Valsartan Impurity 5 1266616-11-8 C18H21N5
3-Hydroxy Agomelatine 3-Hydroxy Agomelatine 166526-99-4 C15H17NO3
Milnacipran Impurity 4 Milnacipran Impurity 4 1353644-49-1 C15H21NO2
(3S,5R)-Atorvastatin (3S,5R)-Atorvastatin 887324-52-9 C33H35FN2O5
Heptyl Deoctyl Fingolimod Hydrochloride Heptyl Deoctyl Fingolimod Hydrochloride 745767-97-9 C18H31NO2
Tenofovir Fumarate Tenofovir Fumarate 1246812-23-6 C21H34N5O9P
Prucalopride Impurity C Prucalopride Impurity C 1599434-55-5 C17H24ClN3O3
1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 2205053-60-5 C21H24FN3O4
Brexpiprazole N-Oxide Brexpiprazole N-Oxide 1191900-58-9 C25H27N3O3S
2,6-Dibenzyloxyacetophenone 2,6-Dibenzyloxyacetophenone 3886-19-9 C22H20O3
ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate 1059630-08-8 C14H17BrN2O2
diphenhydramine impurity diphenhydramine impurity C17H21NO
Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride 143016-68-6 C8H10Cl3N
1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide 1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide C18H23IN4S
2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid 1657014-33-9 C16H16N2O3S
vildagliptin Impurity O vildagliptin Impurity O 2253194-12-4 C12H18N4O2
methyl (41R,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41R,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 38990-17-9 C21H26N2O3
1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine 1450657-31-4 C12H17NO4S
Apremilast Impurity D Apremilast Impurity D
Canagliflozin Impurity 17 Canagliflozin Impurity 17 1951467-28-9 C24H23FO6S
Canagliflozin Impurity 22 Canagliflozin Impurity 22
Carfilzomib Impurity 3 Carfilzomib Impurity 3
Dolutegravir Impurity 4 Dolutegravir Impurity 4
Febuxostat Impurity 20 Febuxostat Impurity 20
Lenvatinib Impurity 1 Lenvatinib Impurity 1
methyl (41S,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41S,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 83508-82-1 C21H26N2O3
4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester 4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester 1941177-45-2 C29H37N7O3
Cabozantinib impurity 1 Cabozantinib impurity 1 748707-58-6 C17H16N2O3
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