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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
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
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
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
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
Pramipexole 828 Impurity Pramipexole 828 Impurity
E-Ceftazidime Oxide Impurity E-Ceftazidime Oxide Impurity
Cefuroxime Impurity D Δ3-Isomer Cefuroxime Impurity D Δ3-Isomer
Ampicillin Open-Ring Formylation Impurity Ampicillin Open-Ring Formylation Impurity
Faropenem Degradation Impurity A Faropenem Degradation Impurity A
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
Eribulin Impurity 2 Eribulin Impurity 2
(2S)-dimethyl 2-(4-(4-oxobutan-2-yl)benzamido)pentanedioate (2S)-dimethyl 2-(4-(4-oxobutan-2-yl)benzamido)pentanedioate
(E)-1-(2,4-difluorostyryl)-1H-1,2,4-triazole (E)-1-(2,4-difluorostyryl)-1H-1,2,4-triazole
Peramivir Impurity 22 Peramivir Impurity 22
Olaparib Impurity 58 Olaparib Impurity 58 848136-41-4 C22H21FN4O3
Fluconazole Impurity 4 Fluconazole Impurity 4 168479-96-7 C10H7F2N3O
Roxatidine Impurity 7 Roxatidine Impurity 7 876497-65-3 C7H6N2O2
Sparfloxacin Impurity Sparfloxacin Impurity 126457-99-6 C19H21F2N3O3
Peramivir Impurity 39 Peramivir Impurity 39
Imatinib impurity 39 Imatinib impurity 39
7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE 7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE 203395-59-9 C13H14BrNO2
DESMETHYL ATOMOXETINE HYDROCHLORIDE DESMETHYL ATOMOXETINE HYDROCHLORIDE 881995-46-6 C16H19NO.ClH
2-HYDROXY-5-BENZYLOXYACETOPHENONE 2-HYDROXY-5-BENZYLOXYACETOPHENONE 30992-63-3 C15H14O3
2-[(4-METHOXY-3-METHYL-2-PYRIDINYL)-METHYLTHIO]-BENZIMIDAZOLE 2-[(4-METHOXY-3-METHYL-2-PYRIDINYL)-METHYLTHIO]-BENZIMIDAZOLE 102804-82-0 C15H15N3OS
2-[(4-METHYLPIPERAZIN-1-YL)METHYL]BENZONITRILE 2-[(4-METHYLPIPERAZIN-1-YL)METHYL]BENZONITRILE 864069-00-1 C13H17N3
Afatinib impurity 84 Afatinib impurity 84
Sugammadex sodium Impurity 40 Sugammadex sodium Impurity 40
Sugammadex sodium Impurity 44 Sugammadex sodium Impurity 44
Sugammadex sodium Impurity 49 Sugammadex sodium Impurity 49
Cefazolin Impurity EP-E Cefazolin Impurity EP-E
Canagliflozin Impurity 70 Canagliflozin Impurity 70
Dapoxetine impurity 66 Dapoxetine impurity 66
EP Impurity Catalog EP Impurity Catalog
2-[(5-CARBOXY-4-METHOXY-3-METHYLPYRID-2-YL)-METHYLSULFO]-5-METHOXYBENZIMIDAZOLE 2-[(5-CARBOXY-4-METHOXY-3-METHYLPYRID-2-YL)-METHYLSULFO]-5-METHOXYBENZIMIDAZOLE 120003-72-7 C17H17N3O5S
Gadobutrol Impurity 3 Gadobutrol Impurity 3
Empagliflozin Impurity 84 Empagliflozin Impurity 84
Octreotide  (Dimer, Antiparallel) Octreotide (Dimer, Antiparallel) 1926163-78-1 C98H132N20O20S4
Iohexol Impurity O Iohexol Impurity O
Avibactam sodium Impurity CES Avibactam sodium Impurity CES
(2,5-dichlorophenyl)(4-ethoxyphenyl)methanone (2,5-dichlorophenyl)(4-ethoxyphenyl)methanone 1097076-93-1 C15H12Cl2O2
Lenvatinib impurity LFZZ-10 Lenvatinib impurity LFZZ-10 C11H8Cl2N2O2
(2S,5S)-(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl 5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate (2S,5S)-(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl 5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
Febuxostat Impurity 98 Febuxostat Impurity 98
(2-(methyl((vinyloxy)carbonyl)amino)pyridin-3-yl)methyl 2-(methylamino)acetate hydrochloride (2-(methyl((vinyloxy)carbonyl)amino)pyridin-3-yl)methyl 2-(methylamino)acetate hydrochloride
1-(4-bromo-3,5-dimethoxyphenyl)ethanone 1-(4-bromo-3,5-dimethoxyphenyl)ethanone 1333472-28-8 C10H11BrO3
Ticagrelor Impurity 117 Ticagrelor Impurity 117
Ticagrelor Impurity 136 Ticagrelor Impurity 136
Phenol, 2-(diphenylmethyl)-5-methyl- Phenol, 2-(diphenylmethyl)-5-methyl- 411239-19-5 C20H18O
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-(formylamino)-, ethyl ester, (3R,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-(formylamino)-, ethyl ester, (3R,4R,5S)- 2148317-96-6 C17H28N2O5
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-(5-chloro-2-ethoxyphenyl)-5-methyl-7-propyl- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-(5-chloro-2-ethoxyphenyl)-5-methyl-7-propyl- 2245167-80-8 C17H19ClN4O2
Posaconazole impurity 18 Posaconazole impurity 18 1819334-66-1 C44H49F2N8O4+
(4S,6R)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylic acid (4S,6R)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylic acid 2095786-11-9 C13H22O6
Crisaborole intermediate Crisaborole intermediate 2354382-27-5 C14H8BCl2NO3
Ropivacaine Impurity 48 Ropivacaine Impurity 48
2(1H)-Pyridinone, 1,1'-[(1E)-1,2-diazenediyldi-4,1-phenylene]bis[5,6-dihydro-3-(4-morpholinyl)- 2(1H)-Pyridinone, 1,1'-[(1E)-1,2-diazenediyldi-4,1-phenylene]bis[5,6-dihydro-3-(4-morpholinyl)- 1998079-15-4 C30H34N6O4
2,4-Heptadienoic acid, 7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-, (2Z,4E)- 2,4-Heptadienoic acid, 7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-, (2Z,4E)- 1148131-09-2 C33H31FN2O3
2(3H)-Furanone, dihydro-4-(1-methylethyl)-, (4S)- 2(3H)-Furanone, dihydro-4-(1-methylethyl)-, (4S)- 53657-15-1 C7H12O2
IRAS vials are low alkaline and meet the pharmacopoeia standards of various countries IRAS vials are low alkaline and meet the pharmacopoeia standards of various countries
Crisaborole Impurity 9 HCl Crisaborole Impurity 9 HCl 1187187-01-4 C14H15BClNO3
2H-Indol-2-one, 3-[[3,5-dimethyl-4-(1-pyrrolidinylcarbonyl)-1H-pyrrol-2-yl]methylene]-5-fluoro-1,3-dihydro- 2H-Indol-2-one, 3-[[3,5-dimethyl-4-(1-pyrrolidinylcarbonyl)-1H-pyrrol-2-yl]methylene]-5-fluoro-1,3-dihydro- 2135339-43-2 C20H20FN3O2
Nicergoline Impurity 02 Nicergoline Impurity 02
Bromhexine ImpurityABCDEFGHJKL Bromhexine ImpurityABCDEFGHJKL
1-Butanone, 1-(4-fluorophenyl)-4-[(6bR,10aR)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]- 1-Butanone, 1-(4-fluorophenyl)-4-[(6bR,10aR)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]- 1576240-16-8 C24H28FN3O
impurity 37 impurity 37
Aprepitant impurity 3 Aprepitant impurity 3
sodium (6R,7S)-7-(2-(1H-tetrazol-1-yl)acetamido)-3-(((5-methyl- 1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium (6R,7S)-7-(2-(1H-tetrazol-1-yl)acetamido)-3-(((5-methyl- 1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
2(1H)-Pyridinone, 1-(4-aminophenyl)-3-chloro-5,6-dihydro- 2(1H)-Pyridinone, 1-(4-aminophenyl)-3-chloro-5,6-dihydro- 1801881-15-1 C11H11ClN2O
1,4,7,10-Tetraazacyclododecane-1,4-diacetic acid 1,4,7,10-Tetraazacyclododecane-1,4-diacetic acid 229312-34-9 C12H24N4O4
Pentanoic acid, 3-(bromomethyl)-4-methyl-, ethyl ester, (3S)- Pentanoic acid, 3-(bromomethyl)-4-methyl-, ethyl ester, (3S)- 2432911-38-9 C9H17BrO2
2-Pyrrolidinone, 3-ethylidene-, (Z)- (8CI) 2-Pyrrolidinone, 3-ethylidene-, (Z)- (8CI) 930-93-8 C6H9NO
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[5-[(4-ethyl-1-piperazinyl)sulfonyl]-2-hydroxyphenyl]-5-methyl-7-propyl- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[5-[(4-ethyl-1-piperazinyl)sulfonyl]-2-hydroxyphenyl]-5-methyl-7-propyl- 2411340-39-9 C21H28N6O4S
3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-[7-(hydroxymethyl)-7H-pyrrolo[2,3-d]pyrimidin-4-yl]-1H-pyrazol-1-yl]- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-[7-(hydroxymethyl)-7H-pyrrolo[2,3-d]pyrimidin-4-yl]-1H-pyrazol-1-yl]- 1187595-89-6 C17H19N7O3S
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