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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
4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one 4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one C8H11FN3O4S-
Anastrozole Impurity 3 Anastrozole Impurity 3
Cephalexin Impurity 4 Cephalexin Impurity 4 C16H17N3O4S
Rivaroxaban Impurity 42 Rivaroxaban Impurity 42
(R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid (R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid 1422514-05-3 C22H26FN3O6S
Atorvastatin 2-Fluoro t-Butyl Ester Atorvastatin 2-Fluoro t-Butyl Ester 1099474-28-8 C40H47FN2O5
Cabozantinib Impurity C Cabozantinib Impurity C
(3R,4R)-N,4-dimethyl-piperidin-3-amine (3R,4R)-N,4-dimethyl-piperidin-3-amine 1354469-76-3 C7H16N2
4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine 4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine 952518-97-7 C9H7N5
5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 881676-90-0 C16H12N2O3S
3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)- 3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)- 100332-12-5 C13H18FNO
r-Cytidine r-Cytidine 13913-16-1 C9H13N3O5
Pyridine, 4-chloro-2-(chloromethyl)-3-methyl- Pyridine, 4-chloro-2-(chloromethyl)-3-methyl- 168167-48-4 C7H7Cl2N
Bezafibrate Impurity D Bezafibrate Impurity D 41859-58-9 C21H24ClNO4
Cloxacillin Sodium EP Impurity B (Mixture of Diastereomers) Cloxacillin Sodium EP Impurity B (Mixture of Diastereomers) 1642559-64-5 C18H20ClN3O4S
Ezetimibe Related Impurity 37 Ezetimibe Related Impurity 37 204589-68-4 C24H19F2NO2
S, R-Isovalganciclovir Impurity S, R-Isovalganciclovir Impurity 1356932-18-7 C14H22N6O5
Sofosbuvir Impurity 8 Sofosbuvir Impurity 8 944476-44-2 C24H22N2O8
(S)-4-(TERT-BUTOXY)-2-ISOPROPYL-4-OXOBUTANOIC ACID (S)-4-(TERT-BUTOXY)-2-ISOPROPYL-4-OXOBUTANOIC ACID 134807-43-5 C11H20O4
Acarbose D-Fructose IMpurity Acarbose D-Fructose IMpurity 1013621-79-8 C25H43NO18
2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-aMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-, 1-ethyl 9-(1-Methylethyl) ester, 5-oxide 2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-aMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-, 1-ethyl 9-(1-Methylethyl) ester, 5-oxide 1422284-16-9 C18H28N5O10P
(R)-α-[2-(1-naphthalenyloxy)ethyl]-benzeneMethanol (R)-α-[2-(1-naphthalenyloxy)ethyl]-benzeneMethanol 156453-53-1 C19H18O2
Sofosbuvir Impurity Sofosbuvir Impurity 1233335-82-4 C16H25FN3O9P
Ethyl 3,4-O-isopropylideneshikiMate Ethyl 3,4-O-isopropylideneshikiMate 136994-78-0 C12H18O5
4-Vinyl-piperidine-4-carboxylic acid ethyl ester 4-Vinyl-piperidine-4-carboxylic acid ethyl ester 1509910-91-1 C10H17NO2
(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid 1039307-95-3 C18H21NO2
EMpagliflozin  iMpurity 16 EMpagliflozin iMpurity 16
((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester ((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester 149709-58-0 C20H23NO3
1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol 1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol 86347-12-8 C13H16N2O
(R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one (R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one 1612153-32-8 C20H20FNO4
(S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one (S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one 528565-93-7 C20H20FNO4
Posaconazole iMpurity 3 Posaconazole iMpurity 3
135270-13-2 135270-13-2 135270-13-2 C12H11F2N3O
1-((2'-cyanobiphenyl-4-yl)methyl)-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid 1-((2'-cyanobiphenyl-4-yl)methyl)-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid 1098100-87-8 C26H23N3O2
Fimasartan Impurity Fimasartan Impurity
2-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methyl)(methyl)amino)succinic acid 2-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methyl)(methyl)amino)succinic acid C21H20FN3O6S
()-Olivil 4″-O-glucoside ()-Olivil 4″-O-glucoside 76880-93-8 C26H34O12
2-(DIETHYLAMINO)-N-(2,4-DIMETHYLPHENYL)ACETAMIDE 2-(DIETHYLAMINO)-N-(2,4-DIMETHYLPHENYL)ACETAMIDE 17289-53-1 C14H22N2O
(3RS)-3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one (3RS)-3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one C16H20N2O
Isatin indicator solution Isatin indicator solution C8H5NO2
Oxaliplatin impurity Oxaliplatin impurity
NiMesulide EP IMpurity NiMesulide EP IMpurity 38880-53-4 C7H8N2O5S
Alogliptin Impurity D Alogliptin Impurity D 1926163-25-8 C61H86N16O13
Moxifloxacin Impurities Moxifloxacin Impurities
Parecoxib Impurity K Parecoxib Impurity K 198471-69-1 C17H16N2O3S
Linagliptin Impurity K Linagliptin Impurity K 1638744-06-5 C25H29BrN8O2
(R)-2-((6-(3-((3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile (R)-2-((6-(3-((3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile 1917324-13-0 C31H28F2N8O4
L-Phenylalanine, N-[(5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl]-3-(methylsulfonyl)-, phenylmethyl ester, hydrochloride (1:1) L-Phenylalanine, N-[(5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl]-3-(methylsulfonyl)-, phenylmethyl ester, hydrochloride (1:1) 1194550-65-6 C27H27Cl3N2O5S
Alogliptin Related Compound 23 Alogliptin Related Compound 23 1618644-29-3 C20H13ClN4O2
Etoricoxib Impurity 14 Etoricoxib Impurity 14
Riociguat Impurtiy 3 Riociguat Impurtiy 3
Trelagliptin Impurity 2 Trelagliptin Impurity 2
Chlorhexidine Impurity B Chlorhexidine Impurity B 1308292-89-8 C16H26ClN9O
Dapoxetine Impurity D Dapoxetine Impurity D
Fludarabine Phosphate iMpurity B Fludarabine Phosphate iMpurity B 149297-79-0 C5H5N5O
nifedipine iMpurity C nifedipine iMpurity C 111304-31-5 C12H11NO5
RofluMilast related substance RofluMilast related substance 475271-62-6 C16H14Cl2N2O3
Ritonavir EP Impurity I Ritonavir EP Impurity I 165315-26-4 C36H46N6O5S2
(6R-trans)-7-[(2,2-diMethyl-1-oxopropyl)aMino]-3-Methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2- (6R-trans)-7-[(2,2-diMethyl-1-oxopropyl)aMino]-3-Methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2- 146794-70-9 C13H18N2O4S
3-[3-[[[(7S)-3,4-DiMethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]Methyl]MethylaMino]propyl]-1,3-dihydro-7,8-diMethoxy-H-3-benzazepin-2-one 3-[3-[[[(7S)-3,4-DiMethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]Methyl]MethylaMino]propyl]-1,3-dihydro-7,8-diMethoxy-H-3-benzazepin-2-one 1086026-31-4 C27H34N2O5
7-[(3R)-3-[(N-Acetyl)AMino]-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoroMethyl)-1,2,4-triazolo[4,3-a]pyrazine 7-[(3R)-3-[(N-Acetyl)AMino]-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoroMethyl)-1,2,4-triazolo[4,3-a]pyrazine 1379666-94-0 C18H17F6N5O2
2-[[Methyl[(3S)-3-(1-naphthalenyloxy)-3-(2-thienyl)propyl]aMino]carbonyl]benzoic Acid 2-[[Methyl[(3S)-3-(1-naphthalenyloxy)-3-(2-thienyl)propyl]aMino]carbonyl]benzoic Acid 199191-67-8 C26H23NO4S
Labetalol IMpurity B Labetalol IMpurity B 802620-01-5 C20H25NO4
Ritonavir EP Impurity C Ritonavir EP Impurity C 1010808-43-1 C25H29N3O4S
AcetaMide, N,N-bis[2-(7-Methoxy-1-naphthalenyl)ethyl]- AcetaMide, N,N-bis[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1385018-58-5 C28H29NO3
(S)-quinuclidin-3-aMine (S)-quinuclidin-3-aMine 120570-05-0 C7H14N2
(1R,3aR,7aR)-7a-Methyl-1-((R)-6-Methylheptan-2-yl)hexahydro-1H-inden-4(2H)-one (1R,3aR,7aR)-7a-Methyl-1-((R)-6-Methylheptan-2-yl)hexahydro-1H-inden-4(2H)-one 66251-18-1 C18H32O
Eltrombopag Impurity 5 Eltrombopag Impurity 5
Exemestane Impurity 1 Exemestane Impurity 1 159354-61-7 C20H24O3
Iguratimod Impurity 9 Iguratimod Impurity 9 1179354-65-4 C18H16N2O6S
Lidocaine Impurity Lidocaine Impurity 35891-84-0 C11H16N2O.ClH
Pramipexole Impurity J Pramipexole Impurity J
Rosuvastatin EP Impurity B (Sodium Salt) Rosuvastatin EP Impurity B (Sodium Salt)
Solifenacin Related Compound 14 Solifenacin Related Compound 14 605696-10-4 C25H30N2O2
4-amino-1-((2R,3R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one 4-amino-1-((2R,3R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one 160552-54-5 C8H11N3O4S
1-(4-Hydroxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide 1-(4-Hydroxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide 503612-76-8 C24H23N5O4
8-[(1R)-1-Hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]amino]ethyl]-6-(phenylmethoxy)-2H-1,4-benzoxazin-3(4H)-one 8-[(1R)-1-Hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]amino]ethyl]-6-(phenylmethoxy)-2H-1,4-benzoxazin-3(4H)-one 869478-13-7 C28H32N2O5
1-(2-(methylamino)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 1-(2-(methylamino)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 743460-48-2 C21H27N3O2
Cefuroxime Sodium impurity D Cefuroxime Sodium impurity D C16H16N4NaO8S
Silodosin impurity A Silodosin impurity A
cefditoren △-3 isomer cefditoren △-3 isomer
Ixazomib Impurity 1 Ixazomib Impurity 1 1201903-02-7 C24H33BCl2N2O4
Ofloxacin/Levofloxacin Impurity E Ofloxacin/Levofloxacin Impurity E
(3S)-9,10-difluoro-3-methyl-7-oxo-2,3,6,7-tetrahydro-5H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid (3S)-9,10-difluoro-3-methyl-7-oxo-2,3,6,7-tetrahydro-5H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid 1026952-91-9 C13H11F2NO4
((4-Methoxyphenoxy)methylene)dibenzene ((4-Methoxyphenoxy)methylene)dibenzene 85686-16-4 C20H18O2
Tofacitinib Impurity L Tofacitinib Impurity L
1-chloro-3-(dimethoxymethyl)benzene 1-chloro-3-(dimethoxymethyl)benzene 3395-80-0 C9H11ClO2
N-(3-bromo-4-oxocyclohexyl)acetamide N-(3-bromo-4-oxocyclohexyl)acetamide 687639-03-8 C8H12BrNO2
methyl (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate methyl (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate C44H51N9O4
Alvimopan Impurity 5 Alvimopan Impurity 5
Palbociclib-d8 Palbociclib-d8 1628752-83-9 C24H21D8N7O2
Ivabradine Impurity 15 Ivabradine Impurity 15 1132667-04-9 C12H17NO2
Sofosbuvir Impurity27 Sofosbuvir Impurity27
Isavuconazole Impurity 12 Isavuconazole Impurity 12
Tacrolimus Impurity 3 Tacrolimus Impurity 3 161861-10-5 C45H71NO13
Aprepitant EP Impurity C Aprepitant EP Impurity C 2208275-99-2 C29H25F7N4O3
Bisoprolol EP Impurity J Bisoprolol EP Impurity J 1797024-50-0 C15H24O5
Ceftriaxone Impurity Ceftriaxone Impurity 79221-95-7 C18H18N8O8S3
Betaxolol EP Impurity E Betaxolol EP Impurity E 1329613-85-5 C18H31NO3
Tulobuterol Impurity Tulobuterol Impurity 34356-83-7 C8H5Br2ClO
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