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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
Levofloxacin Impurity 23 Levofloxacin Impurity 23 2206825-95-6 C19H21ClFN3O4
Nitrendipine impurity 1 Nitrendipine impurity 1 1242511-98-3 C18H18N2O5
methyl 7-bromo-4-hydroxyisoquinoline-3-carboxylate methyl 7-bromo-4-hydroxyisoquinoline-3-carboxylate 1572439-66-7 C11H8BrNO3
Dapoxetine impurity Dapoxetine impurity 2242008-36-0 C28H26O3
Pregabalin Impurity 11 Pregabalin Impurity 11 177432-20-1 C7H11NO3
Pregabalin Impurity 6 Pregabalin Impurity 6 2102350-92-3 C9H15NO3
Sunitinib Impurity 2 Sunitinib Impurity 2
(2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl)tetrahydro-2H-pyran-3,4,5-triol (2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl)tetrahydro-2H-pyran-3,4,5-triol 2452300-89-7 C21H26O6
(R)-Zanubrutinib (R)-Zanubrutinib 1691249-44-1 C27H29N5O3
LUMAT-005 LUMAT-005 313369-16-3 C16H19N3O3
Fimasartan Impurity F Fimasartan Impurity F
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
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
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
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
1-METHYL-2-PHENOXYETHYLAMINE 1-METHYL-2-PHENOXYETHYLAMINE 35205-54-0 C9H13NO
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
Brexpiprazole Impurity 76 Brexpiprazole Impurity 76 433303-94-7 C12H14N2S
Phenacetin Impurity 3 Phenacetin Impurity 3 24176-84-9 C14H13ClN2O2
2-(isopropylamino)-3-(4-(2-methoxyethyl)phenoxy)propan-1-ol 2-(isopropylamino)-3-(4-(2-methoxyethyl)phenoxy)propan-1-ol 109632-11-3 C15H25NO3
Pabuxilibu impurities Pabuxilibu impurities
ERYTHROMYCIN IMPURITY G ERYTHROMYCIN IMPURITY G
Amylmetacresol EP impurity E Amylmetacresol EP impurity E
(2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide (2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide 2232201-72-6 C11H18N2O3
methyl 1-hydroxy-2-oxoindoline-6-carboxylate methyl 1-hydroxy-2-oxoindoline-6-carboxylate 1895918-24-7 C10H9NO4
Dapagliflozin Impurity (MW: 437Da) Dapagliflozin Impurity (MW: 437Da)
Cetirizine Impurity BHA Cetirizine Impurity BHA
Macitentandesbromopyrimidine Impurity Macitentandesbromopyrimidine Impurity
Cilastatin EP Impurity H Cilastatin EP Impurity H
Febuxostat Impurity 130 Febuxostat Impurity 130 1643131-93-4 C20H25NO5S
(2-Chlorophenyl)diphenylmethanol (2-Chlorophenyl)diphenylmethanol
Nilotinib Impurity 27 Nilotinib Impurity 27 1807606-80-9 C28H22F3N7O2
Juncusol 2-O-glucoside Juncusol 2-O-glucoside 175094-14-1 C24H28O7
Homovanillyl alcohol 4-O-glucoside Homovanillyl alcohol 4-O-glucoside 104380-15-6 C15H22O8
(6R,9R)-3-Oxo-α-ionol glucoside (6R,9R)-3-Oxo-α-ionol glucoside 77699-19-5 C19H30O7
Myricetin 3,7,3'-trimethyl ether 5'-O-glucoside Myricetin 3,7,3'-trimethyl ether 5'-O-glucoside 2170444-56-9 C24H26O13
Vonoprazan Impurity 53 Vonoprazan Impurity 53
Vonoprazan Impurity 61 Vonoprazan Impurity 61
Emtricitabine Ring-opening Impurity Emtricitabine Ring-opening Impurity
Tafluprost Impurity 1 (Tafluprost (1S,2S,3S,5R)-Isomer) Tafluprost Impurity 1 (Tafluprost (1S,2S,3S,5R)-Isomer)
Escitalopram Butyryl Impurity Escitalopram Butyryl Impurity 1803244-58-7 C25H33FN2O2
Osimertinib Impurity N Osimertinib Impurity N 1932710-29-6 C31H35N7O3
Oseltamivir isomer impurity Oseltamivir isomer impurity
Ethyl 4-bromo-3-hydroxybutyrate Ethyl 4-bromo-3-hydroxybutyrate 32224-01-4 C6H11BrO3
SULPIRIDE IMPURITY B SULPIRIDE IMPURITY B
(2R,4S)-Isopropyl 5-([1,1''-biphenyl]-4-yl)-4-(4-isopropoxy-4-oxobutanamido)-2-methylpentanoate (2R,4S)-Isopropyl 5-([1,1''-biphenyl]-4-yl)-4-(4-isopropoxy-4-oxobutanamido)-2-methylpentanoate 2216755-67-6 C28H37NO5
1,2-Dihydro Diethyl Loteprednol Carbonate 1,2-Dihydro Diethyl Loteprednol Carbonate 82048-81-5 C26H36O9
Nilotinib 3-Imidazolyl N-oxide Nilotinib 3-Imidazolyl N-oxide 2139382-75-3 C28H22F3N7O2
α,α''-[(Methylimino)di-2,1-ethanediyl]bis-benzenemethanol α,α''-[(Methylimino)di-2,1-ethanediyl]bis-benzenemethanol 857786-66-4 C19H25NO2
sodium 5-methoxy-2-sulfinatobenzo[d]imidazol-1-id sodium 5-methoxy-2-sulfinatobenzo[d]imidazol-1-id
2-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propanoic acid 2-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propanoic acid
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