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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
Voriconzolegenotoxicimpurity Voriconzolegenotoxicimpurity
N4,N7-bis(3-chloro-4-fluorophenyl)-8-nitroquinazoline-4,7-diamine N4,N7-bis(3-chloro-4-fluorophenyl)-8-nitroquinazoline-4,7-diamine
1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl- 1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl- 956344-27-7 C14H19N3O3
Iohexol ImpuritiesD Iohexol ImpuritiesD
ethyl (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylate ethyl (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylate
2-Demethoxy-2-chloro Urapidil HCl 2-Demethoxy-2-chloro Urapidil HCl
Isavuconazole Impurity 43 Isavuconazole Impurity 43
Elagolix Impurity 41 Elagolix Impurity 41
Benzeneacetic acid, α-hydroxy-, (1R,5R)-3,3,5-trimethylcyclohexyl ester, (αR)-rel- Benzeneacetic acid, α-hydroxy-, (1R,5R)-3,3,5-trimethylcyclohexyl ester, (αR)-rel- 79356-86-8 C17H24O3
Ethyl (2E)-3-[4-(Dibromomethyl)phenyl]prop-2-enoate Ethyl (2E)-3-[4-(Dibromomethyl)phenyl]prop-2-enoate
8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)-1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)-1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
	Bumetanide Impurity 18 Bumetanide Impurity 18
Cefradine Impurity J Cefradine Impurity J
N-Desmethyl Clarithromycin N-Desmethyl Clarithromycin 101666-68-6 C37H67NO13
Oseltamivir Impurity 126 Oseltamivir Impurity 126
2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1) 2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1) 936490-85-6 C20H25ClN2O5
4-hydroxypyrrolidin-2-one 4-hydroxypyrrolidin-2-one 96820-00-7 C4H7NO2
glycopyrronium bromide glycopyrronium bromide 475468-09-8 C19H28NO3.Br
monocalcium mono((3R,5S,E)-7-(4-(3-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate) monocalcium mono((3R,5S,E)-7-(4-(3-fluorophenyl)-6-isopropyl-2- (N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6- enoate)
Rocuronium Bromide Impurity 19 、21、22 Rocuronium Bromide Impurity 19 、21、22
Flucloxacillin impurity D Flucloxacillin impurity D
Ritonavir EP Impurity STU Ritonavir EP Impurity STU
Letermovir Impurity 1 Letermovir Impurity 1
Roxadustat Impurity 16 Roxadustat Impurity 16
Perospirone Impurity 19 Perospirone Impurity 19
Dolutegravir Impurity 14(Sodium Salt) Dolutegravir Impurity 14(Sodium Salt)
Fondaparinux sodium impurity 5 Fondaparinux sodium impurity 5
Fondaparinux sodium impurity 20 Fondaparinux sodium impurity 20
Piperacillin  Impurity R Piperacillin Impurity R
Lasmiditan Impurity 6 Lasmiditan Impurity 6
1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride 1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride
Lasmiditan Impurity 8 Lasmiditan Impurity 8
1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate 1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate 2760465-02-7 C17H22N4O2S
Ethacridine Impurity 10 Ethacridine Impurity 10 20304-71-6 C21H16N2O4
(S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide (S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide 135729-78-1 C18H24N2O
2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
Olodaterol Impurity 31 Olodaterol Impurity 31
(S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide (S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide 192726-05-9 C27H38N4O3
2-Hydrazinoadenosine 2-Hydrazinoadenosine 15763-11-8 C10H15N7O4
Desacetylvinblastine hydrazide Desacetylvinblastine hydrazide 55383-37-4 C43H56N6O7
Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)imino]-3,4,5,6,7,8-hexahydro-8-hydroxy-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]- Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)imino]-3,4,5,6,7,8-hexahydro-8-hydroxy-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]- 1383430-03-2 C26H23FIN5O5
protosappanin A protosappanin A 102036-28-2 C15H12O5
delta(3)-cefotiam delta(3)-cefotiam 142182-63-6 C18H23N9O4S3
anemonin anemonin 508-44-1 C10H8O4
alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol 62580-79-4 C7H10ClN3O4
7-(deoxyadenosin-N(6)-yl)aristolactam I 7-(deoxyadenosin-N(6)-yl)aristolactam I 127191-86-0 C27H22N6O7
(3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-yl acetate (3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-yl acetate 2875066-46-7 C16H17F5O4
BENAZEPRILAT BENAZEPRILAT 86541-78-8 C22H24N2O5
9-Methylene-9H-fluorene 9-Methylene-9H-fluorene 4425-82-5 C14H10
2-PIPERIDIN-4-YL-1H-BENZOIMIDAZOLE 2-PIPERIDIN-4-YL-1H-BENZOIMIDAZOLE 38385-95-4 C12H15N3
4-CHLORO-3,5-DIMETHYL 2-CHLORMETHYL PYRIDINE.HCL 4-CHLORO-3,5-DIMETHYL 2-CHLORMETHYL PYRIDINE.HCL 142885-96-9 C8H9Cl2N
9-DIHYDROESTRADIOL 9-DIHYDROESTRADIOL 791-69-5 C18H22O2
(2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity) (2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity) 130676-66-3 C29H55NO6
2-(2-Fluoro-4-iodo-aniline)-4-hydroxy-1, 5-dimethyl-6-oxo-1,6-dihydro-pyridine-3-carboxylic acid cyclopropylamide 2-(2-Fluoro-4-iodo-aniline)-4-hydroxy-1, 5-dimethyl-6-oxo-1,6-dihydro-pyridine-3-carboxylic acid cyclopropylamide 3018911-27-5 C17H17FIN3O3
Sugammadex sodium Impurity 48 Sugammadex sodium Impurity 48
Sugammadex sodium Impurity 47 Sugammadex sodium Impurity 47
Tenofovir Impurity 95 Tenofovir Impurity 95 1884329-63-8 C8H10BrN5
Tenofovir Impurity 117 Tenofovir Impurity 117 1643116-22-6 C8H11N5O
Tafluprost Impurity E Tafluprost Impurity E
Cabozantinib impurity 36 Cabozantinib impurity 36
Apigenin 7-O-(2'',6''-di-O-E-p-coumaroyl)glucoside Apigenin 7-O-(2'',6''-di-O-E-p-coumaroyl)glucoside 1448779-19-8 C39H32O14
Dapoxetine impurity 69 Dapoxetine impurity 69
4-FLUORO-2-METHYLBENZAMIDE 4-FLUORO-2-METHYLBENZAMIDE 886501-45-7 C8H8FNO
1-{[4-BENZYL-2-(3,4-DIMETHOXYPHENYL)-4H-CHROMEN-3-YL]METHYL}PIPERIDINIUM CHLORIDE 1-{[4-BENZYL-2-(3,4-DIMETHOXYPHENYL)-4H-CHROMEN-3-YL]METHYL}PIPERIDINIUM CHLORIDE C30H34ClNO3
4-Hydroxyisophthalonitrile 4-Hydroxyisophthalonitrile 34133-58-9 C8H4N2O
Empagliflozin Impurity 81 Empagliflozin Impurity 81
Iohexol Impurity M Iohexol Impurity M
Relugolix Impurity 18 Relugolix Impurity 18
Rabeprazole Impurity 15 Rabeprazole Impurity 15
4-((2-amino-2-oxoethyl)(hydroxy)amino)butanoic acid 4-((2-amino-2-oxoethyl)(hydroxy)amino)butanoic acid 2454698-45-2 C6H12N2O4
Lenvatinib Impurity LFZZ-8 Lenvatinib Impurity LFZZ-8 C44H40Cl2N8O8
Pemetrexed disodium Impurity 19 Pemetrexed disodium Impurity 19
Brivaracetam Impurity 32 Brivaracetam Impurity 32
Apixaban Impurity 56 Apixaban Impurity 56 2444918-46-9 C15H19N3O2
1-((2R,3R)-3-(4-(aminomethyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride 1-((2R,3R)-3-(4-(aminomethyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride
Ticagrelor Impurity 107 Ticagrelor Impurity 107
2-Thiazolamine, 5-bromo-4-(5-bromo-4-chloro-2-thienyl)- 2-Thiazolamine, 5-bromo-4-(5-bromo-4-chloro-2-thienyl)- 2401867-89-6 C7H3Br2ClN2S2
Carbamic acid, N-[1,1'-biphenyl]-2-yl-, 1-[2-[[4-(hydroxymethyl)benzoyl]methylamino]ethyl]-4-piperidinyl ester Carbamic acid, N-[1,1'-biphenyl]-2-yl-, 1-[2-[[4-(hydroxymethyl)benzoyl]methylamino]ethyl]-4-piperidinyl ester 1682660-39-4 C29H33N3O4
sodium 3-(4-((1H-imidazol-1-yl)methyl)phenyl)-3-hydroxypropanoate sodium 3-(4-((1H-imidazol-1-yl)methyl)phenyl)-3-hydroxypropanoate
(4S,6R)-((4R,6S)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)methyl 6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylate (4S,6R)-((4R,6S)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)methyl 6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylate
tert-butyl 2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-2-methyl-4- oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methyl propanoate tert-butyl 2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-2-methyl-4- oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methyl propanoate
Atomoxetine Impurity 15 Atomoxetine Impurity 15 881995-45-5 C19H23NO2
Pitavastatin Impurity 13 (Pitavastatin 2,4,6-Triene Impurity) Pitavastatin Impurity 13 (Pitavastatin 2,4,6-Triene Impurity) 2086271-67-0 C25H20FNO2
(2S,5R)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2- carboxylic acid sodium (2S,5R)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2- carboxylic acid sodium
impurity 39 impurity 39
(2R,3R,4R,5S)-6-((2,4-dibromo-6-((cyclohexyl(methyl)amino)methyl)phenyl)amino)hexane-1,2,3,4,5-pentaol (2R,3R,4R,5S)-6-((2,4-dibromo-6-((cyclohexyl(methyl)amino)methyl)phenyl)amino)hexane-1,2,3,4,5-pentaol
Androsta-4,8(14)-dien-3-one, 17-hydroxy-, (17β)- (9CI) Androsta-4,8(14)-dien-3-one, 17-hydroxy-, (17β)- (9CI) 133177-83-0 C19H26O2
Bosutinib Impurity 32 Bosutinib Impurity 32
6,6'-Methylenebis[1,2,3,9-tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one 6,6'-Methylenebis[1,2,3,9-tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one 1365727-09-8 C29H26N2O2
Ampicillin Dimer Disodium Salt Ampicillin Dimer Disodium Salt 94730-51-5 C32H39N6NaO8S2
4-Thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 6-(1-hydroxyethyl)-7-oxo-3-(tetrahydro-2-furanyl)-, [5R-[3(S*),5α,6α(R*)]]- (9CI) 4-Thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 6-(1-hydroxyethyl)-7-oxo-3-(tetrahydro-2-furanyl)-, [5R-[3(S*),5α,6α(R*)]]- (9CI) 106560-13-8 C12H15NO5S
1-Naphthalenecarboxylic acid, 8-[[(3S)-1-azabicyclo[2.2.2]oct-3-ylamino]methyl]-5,6,7,8-tetrahydro-, (8S)- 1-Naphthalenecarboxylic acid, 8-[[(3S)-1-azabicyclo[2.2.2]oct-3-ylamino]methyl]-5,6,7,8-tetrahydro-, (8S)- 2407763-21-5 C19H26N2O2
Peramivir Impurity 58 Peramivir Impurity 58
4'-hydroxyflurbiprofen 4'-hydroxyflurbiprofen 52807-12-2 C15H13FO3
D-biotin-d-sulfoxide D-biotin-d-sulfoxide 10406-89-0 C10H16N2O4S
3,4-dihydroxyphenylpyruvic acid 3,4-dihydroxyphenylpyruvic acid 4228-66-4 C9H8O5
Imimidistine impurity E Imimidistine impurity E
(1R,2S)-2-[[(2,4-Dimethyl-5-pyrimidinyl)oxy]methyl]-2-(3-fluorophenyl)-N-2-pyridinylcyclopropanecarboxamide (1R,2S)-2-[[(2,4-Dimethyl-5-pyrimidinyl)oxy]methyl]-2-(3-fluorophenyl)-N-2-pyridinylcyclopropanecarboxamide 1369763-94-9 C22H21FN4O2
Nemonoxacin Impurity 5 Nemonoxacin Impurity 5 2770004-79-8 C24H29N3O8
4-hydroxypenicillin V 4-hydroxypenicillin V 20880-67-5 C16H18N2O6S
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