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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
Parecoxib Impurity D Parecoxib Impurity D
Parecoxib Impurity I Parecoxib Impurity I
1-Hydroxymethyl-beta-carboline glucoside 1-Hydroxymethyl-beta-carboline glucoside 1408311-12-5 C18H20N2O6
Axitinib Impurity D Axitinib Impurity D 1443118-72-6 C29H25N5OS
Lenvatinib Impurity d Lenvatinib Impurity d 417717-04-5 C20H17ClN4O4
4-bromo-3-(hydroxymethyl)phenol 4-bromo-3-(hydroxymethyl)phenol 2737-20-4 C7H7BrO2
4-(4-Bromo-3-formyl-phenoxy)-benzonitrile 4-(4-Bromo-3-formyl-phenoxy)-benzonitrile 906673-54-9 C14H8BrNO2
Atracurium Impurity E Atracurium Impurity E
Linagliptin Impurity I Linagliptin Impurity I
1H-Pyrrole-3-carbonitrile,5-(2-fluorophenyl)-1-(3-pyridinylsulfonyl)- 1H-Pyrrole-3-carbonitrile,5-(2-fluorophenyl)-1-(3-pyridinylsulfonyl)- 1807642-39-2 C16H10FN3O2S
4-amino-1-[(2RS)-2-(2,4-difluorophenyl)-2-hydroxy-3(1H-
1,2,4-triazol-1-yl)propyl]-4H-1,2,4-triazolium 4-amino-1-[(2RS)-2-(2,4-difluorophenyl)-2-hydroxy-3(1H- 1,2,4-triazol-1-yl)propyl]-4H-1,2,4-triazolium 749821-19-0 C13H14F2N7O+
Canagliflozin Defluoro Impurity Canagliflozin Defluoro Impurity
Dapagliflozin Impurity 6 Dapagliflozin Impurity 6
Imatinib Impurity 7 Imatinib Impurity 7 581076-64-4 C8H12N4
Nilotinib Impurity 1 Nilotinib Impurity 1 641571-05-3 C28H22F3N7O
Riociguat Impurtiy 1 Riociguat Impurtiy 1
Riociguat Impurtiy 6 Riociguat Impurtiy 6 1702271-98-4 C18H17FN8
Axitinib Impurity 4 Axitinib Impurity 4 1443118-73-7 C22H20N4OS
Palonosetron Impurity 7 Palonosetron Impurity 7 177932-92-2 C18H24N2O
4-(2,3-Dichlorophenyl)-2,6-diMethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 4-(2,3-Dichlorophenyl)-2,6-diMethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 138279-32-0 C15H13Cl2NO4
IMp. A (EP) as Hydrochloride: 3-[[[2-[(DiaMinoMethylene)aMino]thiazol-4-yl]- Methyl]sulphanyl]propaniMidaMide Hydrochloride IMp. A (EP) as Hydrochloride: 3-[[[2-[(DiaMinoMethylene)aMino]thiazol-4-yl]- Methyl]sulphanyl]propaniMidaMide Hydrochloride
Terbutaline IMpurity B Terbutaline IMpurity B 94120-05-5 C13H19NO3
Benzoic acid, 4-[(4-Methyl-1-piperazinyl)Methyl]-3-(trifluoroMethyl)- Benzoic acid, 4-[(4-Methyl-1-piperazinyl)Methyl]-3-(trifluoroMethyl)- 859282-11-4 C14H17F3N2O2
N-(5-Chloropyridin-2-yl)oxalaMic acid ethyl ester N-(5-Chloropyridin-2-yl)oxalaMic acid ethyl ester 349125-08-2 C9H9ClN2O3
5-chloro-2,3-diphenylpyrazine 5-chloro-2,3-diphenylpyrazine 41270-66-0 C16H11ClN2
Canagliflozin iMpurity Canagliflozin iMpurity
Vortioxetine iMpurity Vortioxetine iMpurity 853745-55-8 C10H14BrClN2
PD 312236 PD 312236 501666-24-6 C20H35NO11
(17α)-3,3-[1,2-Ethanediylbis(oxy)]-17-hydroxy-19-norpregna-5(10),9(11)-diene-21-nitrile (17α)-3,3-[1,2-Ethanediylbis(oxy)]-17-hydroxy-19-norpregna-5(10),9(11)-diene-21-nitrile 190662-30-7 C22H29NO3
(S)-4-(4-Hydrazinobenzyl)-2-oxazolidinone Hydrochloride (S)-4-(4-Hydrazinobenzyl)-2-oxazolidinone Hydrochloride 139264-57-6 C10H14ClN3O2
1-[4-(4-AMino-6,7-diMethoxy-2-quinazolinyl)-1-piperazinyl]-5-hydroxy-1-pentanone 1-[4-(4-AMino-6,7-diMethoxy-2-quinazolinyl)-1-piperazinyl]-5-hydroxy-1-pentanone 109678-71-9 C19H27N5O4
4-[2-(2-AMino-4,5,6,7-tetrahydro-4,6-dioxo-3H-pyrrolo[2,3-d]pyriMidin-5-yl)ethyl]benzoic Acid 4-[2-(2-AMino-4,5,6,7-tetrahydro-4,6-dioxo-3H-pyrrolo[2,3-d]pyriMidin-5-yl)ethyl]benzoic Acid 193265-47-3 C15H14N4O4
9-(1,3-Dioxolan-2-ylMethyl)-3,9-dihydro-1,3-diMethyl-1H-purine-2,6-dione 9-(1,3-Dioxolan-2-ylMethyl)-3,9-dihydro-1,3-diMethyl-1H-purine-2,6-dione 1174289-18-9 C11H14N4O4
DesMethyl AMisulpride DesMethyl AMisulpride 148516-54-5 C16H25N3O4S
DiMethoxy Dienogest DiMethoxy Dienogest 102193-41-9 C22H31NO3
Desfluoro Rosuvastatin Sodium Salt Desfluoro Rosuvastatin Sodium Salt 847849-66-5 C22H29N3O6S
N-Benzoyl-N-[2-(phenyl)ethyl]-N-carbamic Acid R-Quinuclidinol Ester Succinic Acid Salt N-Benzoyl-N-[2-(phenyl)ethyl]-N-carbamic Acid R-Quinuclidinol Ester Succinic Acid Salt 1798817-92-1 C27H32N2O7
Tadalafil EP IMpurity A Tadalafil EP IMpurity A
(1R,3R,4R)-3-AMino-4-hydroxy-cyclohexanecarboxylic acid ethyl ester (1R,3R,4R)-3-AMino-4-hydroxy-cyclohexanecarboxylic acid ethyl ester 1392745-70-8 C14H25NO5
(S)-3-Hydroxypiperidine (S)-3-Hydroxypiperidine 24211-55-0 C5H11NO
Aprepitant iMpurity B Aprepitant iMpurity B
Aripiprazole iMpurity 4 Aripiprazole iMpurity 4 1424857-63-5 C36H42Cl2N4O4
Aripiprazole iMpurity 4 Aripiprazole iMpurity 4 1424857-63-5 C36H42Cl2N4O4
(1R,2R,4S)-2-[(tert-butoxycarbonyl)aMino]-4-[(diMethylaMino)carbonyl]cyclohexyl Methanesulfonate (1R,2R,4S)-2-[(tert-butoxycarbonyl)aMino]-4-[(diMethylaMino)carbonyl]cyclohexyl Methanesulfonate 929693-31-2 C15H28N2O6S
Brimonidine Impurity E Brimonidine Impurity E 168329-48-4 C9H8BrN5
Dapagliflozin Impurity G Dapagliflozin Impurity G
Dapoxetine Impurity B Dapoxetine Impurity B
Esomeprazole EP Impurity Esomeprazole EP Impurity
Fesoterodine Diol Dimer Fesoterodine Diol Dimer 1428856-45-4 C44H60N2O3
Gimeracil Impurity Gimeracil Impurity 17902-24-8 C8H9ClN2O3
Pramipexole Impurity H Pramipexole Impurity H
Quercetin 3-rutinoside 7-glucoside Quercetin 3-rutinoside 7-glucoside 30311-61-6 C33H40O21
Rivaroxaban Impurity H Rivaroxaban Impurity H 1807455-76-0 C25H24Cl2N4O6S2
Vonoprazan impurity A Vonoprazan impurity A
3-Cyano-4-isobutoxybenzoic acid 3-Cyano-4-isobutoxybenzoic acid 528607-60-5 C12H13NO3
Desethyl Sildenafil Desethyl Sildenafil 139755-91-2 C20H26N6O4S
N-Desisopropyl-N-forMyl Bisoprolol N-Desisopropyl-N-forMyl Bisoprolol 1346602-59-2 C16H25NO5
N-DesMethyl Olopatadine N-DesMethyl Olopatadine 113835-92-0 C20H21NO3
10-Keto DextroMethorphan 10-Keto DextroMethorphan 57969-05-8 C18H23NO2
5-Chloro-N1-Methylbenzene-1,2-diaMine 5-Chloro-N1-Methylbenzene-1,2-diaMine 84859-27-8 C7H9ClN2
(1'S,3'S,4'S)-Entecavir IsoMer (1'S,3'S,4'S)-Entecavir IsoMer 1367369-80-9 C12H15N5O3
Iso Ganciclovir Iso Ganciclovir 86357-09-7 C9H13N5O4
(1S,3R)-1-Benzo[1,3]dioxol-5-yl-2-(2-chloro-acetyl)-2,3,4,9-tetrahydro-1H-b-carboline-3-carboxylic Acid Methyl Ester (1S,3R)-1-Benzo[1,3]dioxol-5-yl-2-(2-chloro-acetyl)-2,3,4,9-tetrahydro-1H-b-carboline-3-carboxylic Acid Methyl Ester 629652-40-0 C22H19ClN2O5
Moxifloxacin Methyl Ester Moxifloxacin Methyl Ester 721970-35-0 C22H26FN3O4
Atomoxetine Related Compound C (10 mg) (N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride) Atomoxetine Related Compound C (10 mg) (N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride) 873310-31-7 C17H22ClNO
Dofetilide Related Compound A (25 mg) (N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl]methanesulfonamide) Dofetilide Related Compound A (25 mg) (N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl]methanesulfonamide) 176447-94-2 C18H25N3O5S2
5-Methyl-2-(1H-1,2,3-triazol-1-yl)benzoic acid 5-Methyl-2-(1H-1,2,3-triazol-1-yl)benzoic acid 1149352-55-5 C10H9N3O2
9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 1256584-80-1 C21H17IN2O
9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 1256584-80-1 C21H17IN2O
2-(MethylcarbaMoyl)benzoic acid 2-(MethylcarbaMoyl)benzoic acid 6843-36-3 C9H9NO3
1-(4-(2-Methoxyethyl)phenoxy)-3-(oxiran-2-ylMethoxy)propan-2-ol 1-(4-(2-Methoxyethyl)phenoxy)-3-(oxiran-2-ylMethoxy)propan-2-ol 1416440-64-6 C15H22O5
(3S,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine (3S,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine 1354621-59-2 C14H22N2
1H-BenziMidazole-7-carboxylic acid, 1-[[2'-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]Methyl] -2-ethoxy-, ethyl ester 1H-BenziMidazole-7-carboxylic acid, 1-[[2'-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]Methyl] -2-ethoxy-, ethyl ester 1403474-70-3 C27H24N4O5
6-acetyl-2-aMino-8-cyclopentyl-5-Methylpyrido[2,3-d]pyriMidin-7(8H)-one 6-acetyl-2-aMino-8-cyclopentyl-5-Methylpyrido[2,3-d]pyriMidin-7(8H)-one 571189-64-5 C15H18N4O2
Apixaban-13C-D3 Apixaban-13C-D3 1261393-15-0 C2413CH22D3N5O4
IMp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]-CarbaMate IMp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]-CarbaMate
IMp. C (EP): Methyl-2-[4-[2-[(4-Chlorobenzoyl)aMino]ethyl]phenoxy]-2-Methylpropanoate IMp. C (EP): Methyl-2-[4-[2-[(4-Chlorobenzoyl)aMino]ethyl]phenoxy]-2-Methylpropanoate
5-PyriMidinecarboxylic acid, 4-(4-fluorophenyl)-1,2-dihydro-6-(1-Methylethyl)-2-oxo-, Methyl ester 5-PyriMidinecarboxylic acid, 4-(4-fluorophenyl)-1,2-dihydro-6-(1-Methylethyl)-2-oxo-, Methyl ester 488798-37-4 C15H15FN2O3
Nebivolol O-Beta-D-Glucuronide Nebivolol O-Beta-D-Glucuronide 1698091-61-0
Nicergoline IMp. C (EP) Nicergoline IMp. C (EP)
Perindopril IMpurity E Perindopril IMpurity E
Pitavastatin 3-Oxo SodiuM Pitavastatin 3-Oxo SodiuM 2245811-12-3 C25H22FNO4
PraMipexole IMp.BI-II828BS PraMipexole IMp.BI-II828BS C20H32N6S2
Propofol IMpurity F Propofol IMpurity F
Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt) Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt) 1422619-13-3 C22H26FN3O6S
Sertraline IMpurity (SRTRC-3) Sertraline IMpurity (SRTRC-3) C17H17Cl2N
Avanafil IMpurity 8 (R-Avanafil) Avanafil IMpurity 8 (R-Avanafil)
EzetiMibe ring-opening dehydrate iMpurity EzetiMibe ring-opening dehydrate iMpurity 1292292-63-7 C24H21F2NO3
Fondaparinux sodiuM iMpurity 1 Fondaparinux sodiuM iMpurity 1 348625-84-3 C13H21NO19S3
Pitavastatin IMpurity 4 (PP-4) Pitavastatin IMpurity 4 (PP-4) 1422058-54-5 C25H22FNO3
Pregabalin IMpurity Pregabalin IMpurity 159029-27-3 C7H18N2
Valdecoxib 3'-SulfonaMide IMpurity Valdecoxib 3'-SulfonaMide IMpurity 1373038-56-2 C16H14N2O3S
(3R,4R)-4-(2,5-Difluorophenyl)-3-Methyl-4-(1H-1,2,4-triazol-1-ylMethyl)-2-oxetanone (3R,4R)-4-(2,5-Difluorophenyl)-3-Methyl-4-(1H-1,2,4-triazol-1-ylMethyl)-2-oxetanone 483340-20-1 C13H11F2N3O2
6,7-DiMethoxy-2-(4-(tetrahydrofuran-2-carbonyl)piperazin-1-yl)quinazolin-4(1H)-one 6,7-DiMethoxy-2-(4-(tetrahydrofuran-2-carbonyl)piperazin-1-yl)quinazolin-4(1H)-one 1177261-73-2 C19H24N4O5
2-Hydroxy Atorvastatin Calcium Salt 2-Hydroxy Atorvastatin Calcium Salt 265989-46-6 C33H37CaFN2O6
13-oxo-1,4,7,10-Tetraazabicyclo[8.2.1]tridecane-4,7-diacetic Acid 13-oxo-1,4,7,10-Tetraazabicyclo[8.2.1]tridecane-4,7-diacetic Acid 229312-33-8 C13H22N4O5
rac-Clopidogrel Carboxylic Acid Hydrochloride rac-Clopidogrel Carboxylic Acid Hydrochloride 1015247-88-7 C15H15Cl2NO2S
Milnacipran IMpurity Milnacipran IMpurity 810696-16-3 C11H11NO
Terbutaline IMpurity 8 Terbutaline IMpurity 8 28924-20-1 C26H30BrNO3
Etoricoxib IMpurity Etoricoxib IMpurity 1350206-14-2 C18H16N2O2S
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