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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
Avatrombopag Impurity 58 Avatrombopag Impurity 58
4-Methoxyglucobrassicin 4-Methoxyglucobrassicin 83327-21-3 C17H22N2O10S2
4-nitro-1H-Imidazole-2-carboxaldehyde 4-nitro-1H-Imidazole-2-carboxaldehyde 33543-81-6 C4H3N3O3
1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1133-49-9 C10H13ClO3
Bumetanide Impurity 19 Bumetanide Impurity 19
Rocuronium Bromide Impurity 26 、27 Rocuronium Bromide Impurity 26 、27
Roxadustat Impurity 20 Roxadustat Impurity 20
Ruxolitinib Impurity Ruxolitinib Impurity
	Sitagliptin Impurity 82 Sitagliptin Impurity 82
(1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate (1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate
Perospirone Impurity 21 Perospirone Impurity 21
Perospirone Impurity 11 Perospirone Impurity 11
Dolutegravir Impurity 21 Dolutegravir Impurity 21
Related impurities of fluoxetine sodium 6 Related impurities of fluoxetine sodium 6
Fondaparinux sodium impurity 7 Fondaparinux sodium impurity 7
Fondaparinux sodium impurity 3 Fondaparinux sodium impurity 3
Oxacillin sodium  Impurity B Oxacillin sodium Impurity B
Revefenacin Impurity 21 Revefenacin Impurity 21
3-Chloro-4-morpholino-1,2,5-thiadiazole 3-Chloro-4-morpholino-1,2,5-thiadiazole 30165-96-9 C6H8ClN3OS
2,6-DIMETHYL-4-(3-NITRO-PHENYL)-PYRIDINE-3,5-DICARBOXYLIC ACID DIMETHYL ESTER 2,6-DIMETHYL-4-(3-NITRO-PHENYL)-PYRIDINE-3,5-DICARBOXYLIC ACID DIMETHYL ESTER 76258-20-3 C17H16N2O6
3-(2-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 3-(2-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 191155-81-4 C10H11F3O
monocalcium mono((3R,5S,E)-7-(4-(2-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate) monocalcium mono((3R,5S,E)-7-(4-(2-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate)
Benzenepropanoic acid, 4-(2-oxiranylmethoxy)- Benzenepropanoic acid, 4-(2-oxiranylmethoxy)- 2167848-51-1 C12H14O4
(S)-(+)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine (S)-(+)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine 132335-46-7 C19H21NOS
OEM Honey OEM Honey
D-Tryptophan, N-(trifluoroacetyl)- (9CI) D-Tryptophan, N-(trifluoroacetyl)- (9CI) 22220-03-7 C13H11F3N2O3
2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-N-(5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-1H-indazol-3-yl)benzamide 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-N-(5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)-1H-indazol-3-yl)benzamide
1H-benzo[d][1,2,3]triazol-1-yl 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoate 1H-benzo[d][1,2,3]triazol-1-yl 2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoate
1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 193902-78-2 C14H20N4O4
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate
Relugolix Impurity 25 Relugolix Impurity 25
Lumateperone Impurity 5 Lumateperone Impurity 5
Sugammadex Sodium Impurity ORG139131-1 Sugammadex Sodium Impurity ORG139131-1
2-[4-(Azidomethyl)phenyl]benzoic acid 2-[4-(Azidomethyl)phenyl]benzoic acid
2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 88150-46-3 C20H23ClN4O5
((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt ((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt
Brivaracetam Impurity 56 Brivaracetam Impurity 56
Oxytocin Impurity 3 Oxytocin Impurity 3
Rosuvastatin Impurity 158 Rosuvastatin Impurity 158
Rosuvastatin Impurity 139 Rosuvastatin Impurity 139
Rosuvastatin Impurity 124 Rosuvastatin Impurity 124
Hesperidin methylchalcone Hesperidin methylchalcone 24292-52-2 C29H36O15
Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide 70381-75-8 C12H14BrCl2N3O2
4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro- 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro- 79617-95-1 C17H17Cl2N
Avatrombopag Impurity 77 Avatrombopag Impurity 77
methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate
N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity A(USP) Ertapenem Impurity A(USP)
D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel- D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel- 2740644-40-8 C14H22N2O6
2-hydroxy-3-oxobutyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate 2-hydroxy-3-oxobutyl 2-ethoxy-1-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2731089-65-7 C27H34N2O6
2-(2-ethoxy-3-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one 2-(2-ethoxy-3-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one
Bumetanide Photodegradable Impurity 15 Bumetanide Photodegradable Impurity 15
Bisoprolol Impurity 48 Bisoprolol Impurity 48
1-Ethyl-3(3-dimethylamino)urea 1-Ethyl-3(3-dimethylamino)urea 32897-26-0 C8H19N3O
Brivaracetam Impurity 29 Brivaracetam Impurity 29
L-erythro-Hexuronic acid, 3,5-dideoxy-, 1,1-dimethylethyl ester L-erythro-Hexuronic acid, 3,5-dideoxy-, 1,1-dimethylethyl ester 1501982-84-8 C10H18O5
(Gly8-OH)-Carbetocin (Impurity B) (Gly8-OH)-Carbetocin (Impurity B)
D-Asn4-Carbetocin (Impurity F) D-Asn4-Carbetocin (Impurity F)
Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester 543699-60-1 C24H18N2O3
1,2-bis(2-methoxyphenoxy)ethane 1,2-bis(2-methoxyphenoxy)ethane 553-45-7 C16H18O4
Dispiro[11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11,2'-oxirane-3',4''-piperidine]-1''-carboxylic acid, 8-chloro-5,6-dihydro-, ethyl ester, 1-oxide Dispiro[11H-benzo[5,6]cyclohepta[1,2-b]pyridine-11,2'-oxirane-3',4''-piperidine]-1''-carboxylic acid, 8-chloro-5,6-dihydro-, ethyl ester, 1-oxide 1432057-93-6 C22H23ClN2O4
Oseltamivir Impurity 109 Oseltamivir Impurity 109
Oseltamivir  Impurity 81 Oseltamivir Impurity 81
Oseltamivir  Impurity 71 Oseltamivir Impurity 71
1-hydrazino-3-(methylthio)propan-2-ol 1-hydrazino-3-(methylthio)propan-2-ol 14359-97-8 C4H12N2OS
Benzenemethanol, 4-(3-chloro-2-hydroxypropoxy)- Benzenemethanol, 4-(3-chloro-2-hydroxypropoxy)- 293302-44-0 C10H13ClO3
N,N-bis((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)pyridine-3-sulfonamide N,N-bis((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)pyridine-3-sulfonamide 2514957-29-8 C27H22F2N4O2S
2,4(1H,3H)-Pyrimidinedione, 1-β-L-ribofuranosyl-, 4-oxime (9CI) 2,4(1H,3H)-Pyrimidinedione, 1-β-L-ribofuranosyl-, 4-oxime (9CI) 402725-23-9 C9H13N3O6
1H-Indole-2-sulfonic acid, 6-hydroxy-1-methyl- 1H-Indole-2-sulfonic acid, 6-hydroxy-1-methyl- 2271443-87-7 C9H9NO4S
methyl 4-hydroxy-2-oxopyrrolidine-1-acetate methyl 4-hydroxy-2-oxopyrrolidine-1-acetate 85614-52-4 C7H11NO4
5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 74509-79-8 C9H19NO2
Sitagliptin EP Impurity 5 Sitagliptin EP Impurity 5
Simvastatin Impurity 6 Simvastatin Impurity 6
colocynthin colocynthin 1398-78-3 C38H54O13
Anastrozole Impurity 14 Anastrozole Impurity 14
Pemetrexed Impurity 42 Pemetrexed Impurity 42
2-(6-Aminopurin-9-yl)ethanol 2-(6-Aminopurin-9-yl)ethanol 707-99-3 C7H9N5O
9-Azabicyclo[3.3.1]Nonane-9-Acetic Acid, 3-(Ethoxycarbonyl)-7-Oxo-, Ethyl Ester 9-Azabicyclo[3.3.1]Nonane-9-Acetic Acid, 3-(Ethoxycarbonyl)-7-Oxo-, Ethyl Ester 115956-03-1 C15H23NO5
Cefathiamidine Impurity F Cefathiamidine Impurity F
1-(Bromophenylmethyl)-4-chlorobenzene 1-(Bromophenylmethyl)-4-chlorobenzene 948-54-9 C13H10BrCl
Flomoxef oxidation impurities Flomoxef oxidation impurities
Toltrazuril Impurity 1 Toltrazuril Impurity 1
((2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-4,4-difluoro-3-hydroxytetrahydrofuran-2-yl)methyl benzoate ((2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-4,4-difluoro-3-hydroxytetrahydrofuran-2-yl)methyl benzoate
Aprepitant Impurity 53 Aprepitant Impurity 53
Cetrorelix Impurity 21 Cetrorelix Impurity 21
Brivaracetam Impurity 43 Brivaracetam Impurity 43
Canagliflozin Impurity 25 Complete Set Canagliflozin Impurity 25 Complete Set
Peramivir Intermediate Impurity 37 Peramivir Intermediate Impurity 37
Peramivir Diastereomer Impurity 1 Peramivir Diastereomer Impurity 1
Vinpocetine impurity 18 drops Vinpocetine impurity 18 drops
Canagliflozin Impurities 999 Canagliflozin Impurities 999
1,4,8,11-tetraazacyclotetradecane sodium chelation 1,4,8,11-tetraazacyclotetradecane sodium chelation
Apixaban Impurity D(BMS-719288)+ Apixaban Impurity D(BMS-719288)+
4-Methoxy-2,3,5-trimethylpyride-N-oxide 4-Methoxy-2,3,5-trimethylpyride-N-oxide 86604-80-0 C9H13NO2
((R)-3-Methyl-1-((R)-3-phenyl-2-(pyrazine-2-carboxaMido)propanaMido)butyl)boronic acid ((R)-3-Methyl-1-((R)-3-phenyl-2-(pyrazine-2-carboxaMido)propanaMido)butyl)boronic acid 1132709-15-9 C19H25BN4O4
(S)-N-(1-AMino-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide (S)-N-(1-AMino-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide 289472-80-6 C14H14N4O2
(3aS,4R,6S,6aR)-6-AMinotetrahydro-2,2-diMethyl-4H-cyclopenta-1,3-dioxol-4-ol (3aS,4R,6S,6aR)-6-AMinotetrahydro-2,2-diMethyl-4H-cyclopenta-1,3-dioxol-4-ol 592533-90-9 C8H15NO3
(4R,6S)-tert-Butyl-6-cyanoMethyl-2,2-diMethyl-1,3-dioxane-4-acetate (4R,6S)-tert-Butyl-6-cyanoMethyl-2,2-diMethyl-1,3-dioxane-4-acetate 196085-84-4 C14H23NO4
(1R,2R,3S,5R)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1R,2R,3S,5R)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 2096989-55-6 C23H28F2N6O4S
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