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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
Crisaborole Impurity ABCDEFGHJKL Crisaborole Impurity ABCDEFGHJKL
3-Azetidinecarboxylic acid, 1-[(4-acetyl-2-ethylphenyl)methyl]- 3-Azetidinecarboxylic acid, 1-[(4-acetyl-2-ethylphenyl)methyl]- 2474774-17-7 C15H19NO3
1-chloro-3-(chlorophenylmethyl)benzene 1-chloro-3-(chlorophenylmethyl)benzene 13391-39-4 C13H10Cl2
2,3'-Bipyridine, 5-chloro-3-[4-(methylsulfonyl)phenyl]-, hydrochloride (1:1) 2,3'-Bipyridine, 5-chloro-3-[4-(methylsulfonyl)phenyl]-, hydrochloride (1:1) 202409-39-0 C17H14Cl2N2O2S
2-Pyridinecarbonitrile, 5-isocyanato-3-(trifluoromethyl)- 2-Pyridinecarbonitrile, 5-isocyanato-3-(trifluoromethyl)- 1950587-21-9 C8H2F3N3O
1,1'-((methylenebis(4-methoxy-3,1-phenylene))bis(2-(dimethylamino)ethane-1,1-diyl))dicyclohexanol 1,1'-((methylenebis(4-methoxy-3,1-phenylene))bis(2-(dimethylamino)ethane-1,1-diyl))dicyclohexanol
Apalutamide Desfluoro Impurity Apalutamide Desfluoro Impurity 1332389-57-7 C21H16F3N5O2S
2-amino-4-(2-(benzyl(1-(4-methoxyphenyl)propan-2-yl)amino)-1-hydroxyethyl)phenol 2-amino-4-(2-(benzyl(1-(4-methoxyphenyl)propan-2-yl)amino)-1-hydroxyethyl)phenol
Peramivir Deacetyl Impurity Peramivir Deacetyl Impurity
Empagliflozin Impurity 116 Empagliflozin Impurity 116
(3R,5aS)-5,8-dioxooctahydro-5H-pyrrolo[1,2-a]thiazolo[3,2-d]pyrazine-3-carboxylic acid (3R,5aS)-5,8-dioxooctahydro-5H-pyrrolo[1,2-a]thiazolo[3,2-d]pyrazine-3-carboxylic acid
Phospholipid Impurity 1(DPPE-MPEG5000 Impurity 1) Phospholipid Impurity 1(DPPE-MPEG5000 Impurity 1)
Carbazochrome Sodium Sulfonate Impurity 4 Carbazochrome Sodium Sulfonate Impurity 4
Empagliflozin Furanose Impurity Empagliflozin Furanose Impurity
Rosuvastatin Impurity 144 Rosuvastatin Impurity 144
Cetrorelix Impurity 11 Cetrorelix Impurity 11
Cetrorelix Impurity 4 (8-D-Arg) Cetrorelix Impurity 4 (8-D-Arg)
Cetrorelix Impurity 1 (+L-Arg) Cetrorelix Impurity 1 (+L-Arg)
Amlodipine Impurity 23 (E-Isomer) Amlodipine Impurity 23 (E-Isomer) C26H31ClN2O8S
Axitinib Impurity 12 Axitinib Impurity 12
Axitinib Impurity 17 Axitinib Impurity 17
Erlotinib Impurity 37 Erlotinib Impurity 37
Gefitinib impurity M Gefitinib impurity M
Linagliptin Impurity CD10088 Linagliptin Impurity CD10088
Tacrolimus Ring-opening Impurity Tacrolimus Ring-opening Impurity 1393890-33-9 C44H69NO12
Tadalafil Impurity 35 Tadalafil Impurity 35 749864-17-3 C20H18N2O4
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE C21H28Cl2N2O2
Epinastine Impurity 1 HCl Epinastine Impurity 1 HCl 141342-71-4 C15H15N3O2
Flurbiprofen Impurity 5 Flurbiprofen Impurity 5 124635-84-3 C18H19FO4
Azacitidine Impurity 31 Azacitidine Impurity 31 65024-85-3 C11H16O8
Diazepam Impurity 3 Diazepam Impurity 3 176796-46-6 C17H17ClN2O2
Pitavastatin Impurity 19 Sodium Salt Pitavastatin Impurity 19 Sodium Salt 1980814-87-6 C25H24FNO5
Peramivir Intermediate Impurity 36 Peramivir Intermediate Impurity 36
Peramivir Intermediate Impurity 41 Peramivir Intermediate Impurity 41
Peramivir Impurity 999 Peramivir Impurity 999
Palonosetron impurity 20XH Palonosetron impurity 20XH
Apixaban Impurity 89 Apixaban Impurity 89
Levofloxacin benzopazine impurity Levofloxacin benzopazine impurity
Bumetanide Impurity 14 Bumetanide Impurity 14 1431501-10-8 C21H27NO3
Trans,rel-(1R,4R)-4-{[(2-Aminophenyl)methyl]amino}cyclohexan-1-ol Hydrochloride Trans,rel-(1R,4R)-4-{[(2-Aminophenyl)methyl]amino}cyclohexan-1-ol Hydrochloride
Sugammadex Sodium Impurity 08 Sugammadex Sodium Impurity 08
2-bromo-3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile 2-bromo-3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile
Org199425-1(RRT0.59) Org199425-1(RRT0.59) 2412953-12-7 C72H112O49S8
4a(2H)-Isoquinolinol, octahydro-4-(4-methoxyphenyl)-2-methyl- 4a(2H)-Isoquinolinol, octahydro-4-(4-methoxyphenyl)-2-methyl- 2568340-30-5 C17H25NO2
3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 2468737-92-8 C25H27Cl2N5O3
Uridine, 4-oxime, 5'-(2-methylpropanoate), (4E)- Uridine, 4-oxime, 5'-(2-methylpropanoate), (4E)- 2492423-30-8 C13H19N3O7
Empagliflozin Furanose Impurity Empagliflozin Furanose Impurity
Tazobactam Impurity XTE Tazobactam Impurity XTE
Isavuconazole Impurity 46 Isavuconazole Impurity 46
5-(1-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-2-hydroxyethyl)-8-hydroxyquinolin-2(1H)-one 5-(1-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-2-hydroxyethyl)-8-hydroxyquinolin-2(1H)-one 2226428-25-5 C24H28N2O3
3-Pyrrolidinepropanoic acid, α-[[(1,1-dimethylethoxy)carbonyl]amino]-2-oxo-, methyl ester, (αR,3R)-rel- 3-Pyrrolidinepropanoic acid, α-[[(1,1-dimethylethoxy)carbonyl]amino]-2-oxo-, methyl ester, (αR,3R)-rel- 2740235-22-5 C13H22N2O5
2-(4-ethylpiperazin-1-yl)-4-(2-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine 2-(4-ethylpiperazin-1-yl)-4-(2-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine C23H30FN3
1-Naphthalenamine, 4-(2,3-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1R,4S)-rel- 1-Naphthalenamine, 4-(2,3-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1R,4S)-rel- 2184053-08-3 C17H17Cl2N
Rosuvastatin Impurity 152 Rosuvastatin Impurity 152
N-(4-(4-fluorophenyl)-5-((E)-2-((2R,4R)-4-hydroxy-6- oxotetrahydro-2H-pyran-2-yl)vinyl)-6-isopropylpyrimidin- 2-yl)-N-methylmethanesulfonamide N-(4-(4-fluorophenyl)-5-((E)-2-((2R,4R)-4-hydroxy-6- oxotetrahydro-2H-pyran-2-yl)vinyl)-6-isopropylpyrimidin- 2-yl)-N-methylmethanesulfonamide C22H26FN3O5S
Fulvestrant EP Impurity E Fulvestrant EP Impurity E 2170200-14-1 C32H45F5O3S
Bumetanide iMpurity F Bumetanide iMpurity F
IODIXANOL  RELATED COMPOUND D  (50 MG)  (5-[ACETYL(2-HYDROXY-3-METHYLPROPYL)AMINO]-N,N'-BIS(2,3-DIHYDROXYPROPYL)2,4,6-TRIIODO-1,3-BENZE-NEDICARBOXAMIDE) IODIXANOL RELATED COMPOUND D (50 MG) (5-[ACETYL(2-HYDROXY-3-METHYLPROPYL)AMINO]-N,N'-BIS(2,3-DIHYDROXYPROPYL)2,4,6-TRIIODO-1,3-BENZE-NEDICARBOXAMIDE) 89797-00-2 C20H28I3N3O9
NIMODIPINE   RELATED  COMPOUND  B  (50 MG) (BIS(2-METHOXYETHYL) 2,6-DIMETHYL-4-(3-NITROPHE-NYL)-1,4-DIHYDROPYRIDINE-3,5-DICARBOXYLATE) (AS) NIMODIPINE RELATED COMPOUND B (50 MG) (BIS(2-METHOXYETHYL) 2,6-DIMETHYL-4-(3-NITROPHE-NYL)-1,4-DIHYDROPYRIDINE-3,5-DICARBOXYLATE) (AS) 70172-96-2 C21H26N2O8
N-Depiperidin-3-amine Linagliptin Dimer N-Depiperidin-3-amine Linagliptin Dimer 2253964-98-4 C45H44N14O4
(1R,5R,6S)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-2-ene-3-carboxylic Acid Ethyl Ester (1R,5R,6S)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-2-ene-3-carboxylic Acid Ethyl Ester 1476028-68-8 C9H12O4
(8S,11S,Z)-5-(2-Aminothiazol-4-yl)-11-(3-guanidinopropyl)-2,2-dimethyl-6,9-dioxo-8-((S)-1-(sulfoamino)ethyl)-3-oxa-4,7,10-triazadodec-4-ene-1,12-dioic Acid (8S,11S,Z)-5-(2-Aminothiazol-4-yl)-11-(3-guanidinopropyl)-2,2-dimethyl-6,9-dioxo-8-((S)-1-(sulfoamino)ethyl)-3-oxa-4,7,10-triazadodec-4-ene-1,12-dioic Acid C19H31N9O10S2
Brepperazole impurity Brepperazole impurity
Mupirocin iMpurity 4 Mupirocin iMpurity 4 C26H44O9
Tenofovirdisoproxil Impurity C Tenofovirdisoproxil Impurity C 1878175-82-6 C11H17N5O2
Cytarabine Impurity 13 Cytarabine Impurity 13 82855-62-7 C17H19N5O8
2052297-80-8 2052297-80-8 2052297-80-8 C12H21NO3
Pramipexole Impurity L Pramipexole Impurity L
1020151-61-4 1020151-61-4 1020151-61-4 C14H23ClO3S
Nicergoline Impurity M Nicergoline Impurity M
Apixaban Impurity 48 Apixaban Impurity 48
ethyl 2-(4-(tert-butoxy)-3-cyanophenyl)-4-methylthiazole-5- carboxylate ethyl 2-(4-(tert-butoxy)-3-cyanophenyl)-4-methylthiazole-5- carboxylate C18H20N2O3S
(trans)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro- [1,1'-biphenyl]-4-yl)piperidine-1-carboxylate (trans)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro- [1,1'-biphenyl]-4-yl)piperidine-1-carboxylate C32H28FNO5
Moxifloxacin Impurity 9 Moxifloxacin Impurity 9
Ticagrelor Impurity 10 Ticagrelor Impurity 10
Tofacitinib Impurity O Tofacitinib Impurity O
Celecoxib Impurity 5 Celecoxib Impurity 5 C17H14F3N3O2S
Prasugrel Impurity 10 Prasugrel Impurity 10
Amlodipine N-Lactoside Amlodipine N-Lactoside 749864-27-5 C32H45ClN2O15
Sugammadex Impurity 19 Sugammadex Impurity 19 2379877-89-9
Apixaban Impurity 29 Apixaban Impurity 29
Alogliptin Impurity 22 Alogliptin Impurity 22
Ritonavir Impurity Ritonavir Impurity 1414933-89-3 C23H32N2O3
Riociguat Impurity 7 Riociguat Impurity 7
Tacrolimus Impurity 5 Tacrolimus Impurity 5 161861-18-3 C44H67NO12
monocalciummono(4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5- methoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoate) monocalciummono(4-(((2S,4R)-1-([1,1'-biphenyl]-4-yl)-5- methoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoate) C23H26CaNO5
Aprepitant iMpurity 38 Aprepitant iMpurity 38
Aprepitant iMpurity 41 Aprepitant iMpurity 41
(E)-3'-(2-(1-(3,4-dimethylphenyl) (E)-3'-(2-(1-(3,4-dimethylphenyl)
Tenofovir Tenofovir 34956-22-4 C14H23O6PS
Afatinib Impurity YHQ Afatinib Impurity YHQ
Sorafenib impurity 24/N-Methyl-4-[4-[[2-[(methylamino)carbonyl]-4-pyridinyl]amino]phenoxy]-2-pyridinecarboxamide Sorafenib impurity 24/N-Methyl-4-[4-[[2-[(methylamino)carbonyl]-4-pyridinyl]amino]phenoxy]-2-pyridinecarboxamide 2004659-83-8 C20H19N5O3
Cabozantinib Impurity 49 Cabozantinib Impurity 49 190728-26-8 C17H14N2O5
Landiolol impurity S Landiolol impurity S
Mupirocin Calcium EP Impurity G Mupirocin Calcium EP Impurity G C26H44CaO9
Atorvastatin Impurity 40 Atorvastatin Impurity 40 1116118-82-1 C50H64FN3O8
Hyoscine Butylbromide EP Impurity F Hyoscine Butylbromide EP Impurity F
Tocopherol EP Impurity D Tocopherol EP Impurity D
Org246653-1(RRT0.35) Org246653-1(RRT0.35)
1H-Isoindole-1,3(2H)-dione, 2-[(2S)-2,3-dihydroxypropyl]- 1H-Isoindole-1,3(2H)-dione, 2-[(2S)-2,3-dihydroxypropyl]- 119835-88-0 C11H11NO4
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