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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
cefditoren E-isomer(C=C) cefditoren E-isomer(C=C)
Mixture of Lamivudine Impurity Ⅳ and Impurity Ⅴ Mixture of Lamivudine Impurity Ⅳ and Impurity Ⅴ
2-Ethoxybenzimidohydrazide 2-Ethoxybenzimidohydrazide 889943-46-8 C9H13N3O
O-Desethyl Azilsartan O-Desethyl Azilsartan 1442400-68-1 C23H16N4O5
17- Phenyl Trinor Prostaglandin F2α Methyl Amide 17- Phenyl Trinor Prostaglandin F2α Methyl Amide 155206-01-2 C24H35NO4
Disalicylimide Disalicylimide 1972-71-0 C14H11NO4
Atomoxetine impurity D Atomoxetine impurity D 1643684-02-9 C17H21NO
but-3-en-2-one compound with imidazo[1,2-a]pyridine (1:1) but-3-en-2-one compound with imidazo[1,2-a]pyridine (1:1) 106730-70-5 C13H15N3O
(R)-2-(Boc-aMino)-2-phenylethyl 4-Methylbenzenesulfonate (R)-2-(Boc-aMino)-2-phenylethyl 4-Methylbenzenesulfonate 126610-77-3 C20H25NO5S
(2R,3R,4R,5S)-5-(4-chloro-3-(4-((S)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-2-(2-hydroxyethyl)tetrahydrofuran-2,3,4-triol (2R,3R,4R,5S)-5-(4-chloro-3-(4-((S)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-2-(2-hydroxyethyl)tetrahydrofuran-2,3,4-triol C23H27ClO7
Pyrido[2,3-d]pyriMidin-7(8H)-one, 8-cyclopentyl-5-Methyl-2-[[5-(1-piperazinyl)-2-pyridinyl]aMino]-, hydrochloride (1:) Pyrido[2,3-d]pyriMidin-7(8H)-one, 8-cyclopentyl-5-Methyl-2-[[5-(1-piperazinyl)-2-pyridinyl]aMino]-, hydrochloride (1:) 571189-66-7 C22H28ClN7O
Olaparib iMpurity Olaparib iMpurity 2905342-00-7 C24H25FN4O4
(2S,3R,4R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-5-((S)-1,2-dihydroxyethyl)tetrahydrofuran-3,4-diol (2S,3R,4R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-5-((S)-1,2-dihydroxyethyl)tetrahydrofuran-3,4-diol C21H25ClO6
(R)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl) butanoate .(R)-2-hydroxy-2-phenylacetate (R)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl) butanoate .(R)-2-hydroxy-2-phenylacetate 1253055-94-5 C19H20F3NO5
Olaparib iMpurity A Olaparib iMpurity A
(1S,2S,3R,5S)-3-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol C14H20ClN5O4S
Posaconazole iMpurity 5 Posaconazole iMpurity 5
APST-ZA APST-ZA 635705-72-5 C20H22N2O6S
DESETHYLENE CIPROFLOXACIN DESETHYLENE CIPROFLOXACIN 103222-12-4 C15H16FN3O3
2-aminobutanenitrile 2-aminobutanenitrile 40651-89-6 C4H8N2
Lenacapavir impurity Lenacapavir impurity 3060953-29-6 C39H32ClF10N7O5S2
	N-nitroso-desmethyl-Clemastine N-nitroso-desmethyl-Clemastine
Finerenone Impurity 123 Finerenone Impurity 123
3,5-androstadien-17-one 3,5-androstadien-17-one 1912-63-6 C19H26O
3-phenylpyrazin-2-ol 3-phenylpyrazin-2-ol 73200-73-4 C10H8N2O
1-(Isopropylamino)-3-(4-methylphenoxy)propane-2-ol 1-(Isopropylamino)-3-(4-methylphenoxy)propane-2-ol 5790-46-5 C13H21NO2
5H-Dibenz[b,f]azepine-10,11-dione 5H-Dibenz[b,f]azepine-10,11-dione 19579-83-0 C14H9NO2
Ethanesulfonic acid ethyl ester Ethanesulfonic acid ethyl ester 1912-30-7 C4H10O3S
DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 110119-84-1 C24H30ClNO3
(2S,5R)-3α-Chloromethyl-3-methyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2β-carboxylic acid benzhydryl ester (2S,5R)-3α-Chloromethyl-3-methyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2β-carboxylic acid benzhydryl ester 85573-73-5 C21H20ClNO3S
2-Propylidenepropanedinitrile 2-Propylidenepropanedinitrile 52833-34-8 C6H6N2
4,4'-Dihydroxyazoxybenzene 4,4'-Dihydroxyazoxybenzene 15596-57-3 C12H10N2O3
5-[[(2-Aminoethyl)thio]methyl]-N,N-dimethyl-2-furfurylamine 5-[[(2-Aminoethyl)thio]methyl]-N,N-dimethyl-2-furfurylamine 66356-53-4 C10H18N2OS
(3AS,7AS)-HEXAHYDRO-1H-ISOINDOLE-1,3(2H)-DIONE (3AS,7AS)-HEXAHYDRO-1H-ISOINDOLE-1,3(2H)-DIONE 117307-09-2 C8H11NO2
8-Methoxyquinolin-2(1H)-one 8-Methoxyquinolin-2(1H)-one 22614-69-3 C10H9NO2
7-Bromo Epinastine 7-Bromo Epinastine 1217052-16-8 C16H14BrN3
1,3-Bis[4-(2-methoxyethyl)phenoxy]- 1,3-Bis[4-(2-methoxyethyl)phenoxy]- 230975-30-1 C21H28O5
5-Deshydroxymethyl-5-chloro Losartan  (Losartan Impurity K) 5-Deshydroxymethyl-5-chloro Losartan (Losartan Impurity K) 1159977-26-0 C21H20Cl2N6
Desfluoro Fluvoxamine Desfluoro Fluvoxamine 1217214-94-2 C15H22F2N2O2
Deuterated methane mixture Deuterated methane mixture
Electronic special standard gas Electronic special standard gas
Low concentration active component standard gas Low concentration active component standard gas
Nilotinib N-Oxide Nilotinib N-Oxide 1246817-85-5 C28H22F3N7O2
Bis[(2-guanidino-4-thiazolyl)methyl]disulfide Bis[(2-guanidino-4-thiazolyl)methyl]disulfide 129083-44-9 C10H14N8S4
Topiroxostat Impurity 5 Topiroxostat Impurity 5 1199273-82-9 C14H7N7
N-Ethoxycarbonyl Ciprofloxacin N-Ethoxycarbonyl Ciprofloxacin 93594-29-7 C20H22FN3O5
Norepinephrine Tartrate Impurity G Norepinephrine Tartrate Impurity G 13062-58-3 C22H21NO3
Vortioxetine Impurity 1 Vortioxetine Impurity 1 1293489-71-0 C17H20N2S
4-bromo-2-nitropyridine 4-bromo-2-nitropyridine 909712-10-3 C5H3BrN2O2
Acemetacin Impurity F Acemetacin Impurity F
1,3-Bis(1H-1,2,4-triazol-1-yl)-2-propanone 1,3-Bis(1H-1,2,4-triazol-1-yl)-2-propanone 98414-56-3 C7H8N6O
2-[[(3aR,4S,6R,6aS)-6-(7-azanyl-5-propylsulfanyl-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,2-dimethyl-4,5,6,6a-tetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl]oxy]ethanol 2-[[(3aR,4S,6R,6aS)-6-(7-azanyl-5-propylsulfanyl-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,2-dimethyl-4,5,6,6a-tetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl]oxy]ethanol 1354945-69-9 C17H26N6O4S
Vonoprazan Impurity E Vonoprazan Impurity E
2-(2-aminobut-3-enyl)propanedioic acid 2-(2-aminobut-3-enyl)propanedioic acid 1378466-25-1 C7H11NO4
2-[2-(2-METHOXY-PHENOXY)-ETHYL]-ISOINDOLE-1,3-DIONE 2-[2-(2-METHOXY-PHENOXY)-ETHYL]-ISOINDOLE-1,3-DIONE 26646-63-9 C17H15NO4
N-(4-methoxy-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)-5-((6-(2- methyl-2H-indazol-5-yl)pyrimidin-4-yl)amino)phenyl)acrylamide N-(4-methoxy-2-(4-(3-methoxyazetidin-1-yl)piperidin-1-yl)-5-((6-(2- methyl-2H-indazol-5-yl)pyrimidin-4-yl)amino)phenyl)acrylamide
Amifostine Thiol Dihydrochloride Amifostine Thiol Dihydrochloride 14653-77-1 C5H14N2S
Butyl Itraconazole Butyl Itraconazole 89848-51-1 C35H38Cl2N8O4
Betamethasone 9,11-Epoxide Propionate Betamethasone 9,11-Epoxide Propionate 205105-83-5 C25H32O6
N-[(1R,3r,5S)-9-azabicyclo[3.3.1]non-3-yl]-1-Methyl-1H-indazole-3-carboxaMide hydrochloride N-[(1R,3r,5S)-9-azabicyclo[3.3.1]non-3-yl]-1-Methyl-1H-indazole-3-carboxaMide hydrochloride 141136-01-8 C17H22N4O.ClH
BIRG 616 BS BIRG 616 BS 287980-84-1 C12H10N4O
3-AMino-4-(2-chlorophenyl)-6-nitro-2(1H)-quinolinone 3-AMino-4-(2-chlorophenyl)-6-nitro-2(1H)-quinolinone 55198-89-5 C15H10ClN3O3
3-Dehydroxy-3-oxo-4,5-dihydro OxazepaM 3-Dehydroxy-3-oxo-4,5-dihydro OxazepaM 19554-95-1 C15H11ClN2O2
8-DeMethyl Ivabradine 8-DeMethyl Ivabradine 304464-97-9 C26H34N2O5
CitalopraM DiMethylaMinobutanone CitalopraM DiMethylaMinobutanone 1329745-98-3 C25H33FN2O2
DesMethyl Erlotinib Carboxylate Acid DesMethyl Erlotinib Carboxylate Acid 882172-60-3 C21H19N3O5
(E/Z)-FK-506 26,28-Allylic Ester RearrangeMent IMpurity (E/Z)-FK-506 26,28-Allylic Ester RearrangeMent IMpurity 131944-48-4 C44H69NO12
[[4-[(3-Methylphenyl)aMino]-3-pyridinyl]sulfonyl]carbaMic Acid Ethyl Ester [[4-[(3-Methylphenyl)aMino]-3-pyridinyl]sulfonyl]carbaMic Acid Ethyl Ester 72810-57-2 C15H17N3O4S
12-Hydroxy Irinotecan 12-Hydroxy Irinotecan 185336-12-3 C33H38N4O7
Losartan IsoMer  IMpurity, PotassiuM Salt Losartan IsoMer IMpurity, PotassiuM Salt 860644-28-6 C22H22ClKN6O
PidotiMod Diketopiperazine-6-propanoic Acid PidotiMod Diketopiperazine-6-propanoic Acid 161771-75-1 C9H12N2O4S
RofluMilast N-Oxide RofluMilast N-Oxide 292135-78-5 C17H14Cl2F2N2O4
AzithroMycin IMpurity J AzithroMycin IMpurity J
EsMolol Acid SodiuM Salt EsMolol Acid SodiuM Salt 83356-60-9 C15H22NNaO4
Thyroxine Ethyl Ester Thyroxine Ethyl Ester 76353-71-4 C17H15I4NO4
(4-Chlorophenyl)[4-(1-Methylethoxy)phenyl]Methanone (Fenofibrate IMpurity) (4-Chlorophenyl)[4-(1-Methylethoxy)phenyl]Methanone (Fenofibrate IMpurity) 154356-96-4 C16H15ClO2
5-Acetyl Rhein 5-Acetyl Rhein 875535-35-6 C17H10O7
7'-Methyl-2'-propyl-1H,3'H-2,5'-bibenzo[d]iMidazole 7'-Methyl-2'-propyl-1H,3'H-2,5'-bibenzo[d]iMidazole 884330-09-0 C18H18N4
5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethanol 5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethanol 112935-93-0 C14H20N2O5
Deoxy Fesoterodine Deoxy Fesoterodine 895137-81-2 C26H37NO2
Bisacodyl Related Compound C (20 mg) (4-[(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) Bisacodyl Related Compound C (20 mg) (4-[(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) 72901-16-7 C20H17NO3
(6R,7R)-7-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 5-oxide (6R,7R)-7-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 5-oxide 934986-48-8 C14H13N5O6S2
(2S)-1-[(2S)-2-Methyl-3-Methylsulfinylpropanoyl]pyrrolidine-2-carboxylic acid (2S)-1-[(2S)-2-Methyl-3-Methylsulfinylpropanoyl]pyrrolidine-2-carboxylic acid 78636-31-4 C14H22N2O6S2
3-Methyl- N-[4-trifluo- roMethyl) phenyl]-4- isoxazole carboxaMide 3-Methyl- N-[4-trifluo- roMethyl) phenyl]-4- isoxazole carboxaMide
2-[[[4-(2,2,2-Trifluoroethoxy)-3-Methyl-1-oxopyridin-2-yl]Methyl]sulfanyl]-1H-benziMidazole 2-[[[4-(2,2,2-Trifluoroethoxy)-3-Methyl-1-oxopyridin-2-yl]Methyl]sulfanyl]-1H-benziMidazole 163119-30-0 C16H14F3N3O2S
(11β,16β)-9-BroMo-11-hydroxy-16-Methyl-17,21-bis(1-oxopropoxy)pregna-1,4-diene-3,20-dione (11β,16β)-9-BroMo-11-hydroxy-16-Methyl-17,21-bis(1-oxopropoxy)pregna-1,4-diene-3,20-dione 52092-14-5 C28H37BrO7
ClotriMazole IMpurity A ClotriMazole IMpurity A 23593-71-7 C22H17ClN2
9-Nitrominocycline 9-Nitrominocycline 149934-16-7 C23H26N4O9
N-(3,5-DiMethyladaMantan-1-yl)forMaMide N-(3,5-DiMethyladaMantan-1-yl)forMaMide 351329-88-9 C13H21NO
N-(Methylsulfonyl)-4'-nitro-2'-phenoxyMethanesulfonanilide N-(Methylsulfonyl)-4'-nitro-2'-phenoxyMethanesulfonanilide 51765-72-1 C14H14N2O7S2
Olanzapine ThioacetoxyMethylidene IMpurity

Discontinued Olanzapine ThioacetoxyMethylidene IMpurity Discontinued 1320360-87-9 C17H20N4O2S
1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1385018-57-4 C26H27NO2
1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1385018-57-4 C26H27NO2
24R-Calcipotriol 24R-Calcipotriol 112827-99-3 C27H40O3
Methotrexate IMpurity C Methotrexate IMpurity C
Paroxetine EP IMpurity G Paroxetine EP IMpurity G 69675-10-1 C12H14FN
Itraconazole impurity C Itraconazole impurity C
1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 143158-55-8 C15H13F2NO4
3-((3S,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanenitrile 3-((3S,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanenitrile 1092578-48-7 C16H20N6O
4-aMino-5-chloro-2,3-dihydro-N-4-piperidinyl-7-BenzofurancarboxaMide 4-aMino-5-chloro-2,3-dihydro-N-4-piperidinyl-7-BenzofurancarboxaMide 137211-64-4 C14H18ClN3O2
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