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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-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
Olaparib Impurity A Olaparib Impurity A
Dapoxetine Impurity 2 Dapoxetine Impurity 2
Voriconazole Impurity 5 Voriconazole Impurity 5
tetrahydrofuran-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate tetrahydrofuran-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate 1404453-75-3 C17H22O4
Lamivudine impurity 5 Lamivudine impurity 5
Clopidogrel Impurity 2 Clopidogrel Impurity 2 C15H14ClNO2S
Mirabegron Impurity 6 Mirabegron Impurity 6 2762802-64-0 C10H11ClN4O3S2
Pitavastatin Impurity 3 Pitavastatin Impurity 3
Solifenacin EP Impurity D Solifenacin EP Impurity D
Cephalexin Impurity 2 Cephalexin Impurity 2 C16H17N3O4S
Cefuroxime Impurity 3 Cefuroxime Impurity 3 C16H16N4O8S
Vonoprazan Impurity 11 Vonoprazan Impurity 11
Atracurium Impurity A Atracurium Impurity A 2724465-40-9 C28H39NO7
Erlotinib Imp.14 Erlotinib Imp.14
Sorafenib related compound 12 Sorafenib related compound 12 284461-74-1 C20H14ClF3N4O3
Apremilast Impurity 10 Apremilast Impurity 10 1809170-71-5 C22H26N2O8S
(1R,3S)-Solifenacin Succinate (1R,3S)-Solifenacin Succinate 774517-20-3 C23H26N2O2
Dacpomycin Impurity 2 Dacpomycin Impurity 2
Nicorandil Impurity 3 Nicorandil Impurity 3
Tacrolimus Impurity A Tacrolimus Impurity A
1H-Benz[de]isoquinolin-1-one,2-(3S)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-,(3aR)- 1H-Benz[de]isoquinolin-1-one,2-(3S)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-,(3aR)- 135729-73-6 C19H24N2O
Afatinib Impurity 16 Afatinib Impurity 16
Empagliflozin (R)-Isomer Empagliflozin (R)-Isomer 864070-43-9 C23H27ClO7
Mirabegron Impurity 19 Mirabegron Impurity 19
(Z)-Mutagenic Impurity of Tenofovir Disoproxil (Z)-Mutagenic Impurity of Tenofovir Disoproxil 1464851-21-5 C8H9N5
Moxifloxacin impurity (20) Moxifloxacin impurity (20)
(R)-2-(2-(tert-butoxy)-2-oxoethyl)pentanoic acid (R)-2-(2-(tert-butoxy)-2-oxoethyl)pentanoic acid 112106-16-8 C11H20O4
Bazedoxifene impurity Bazedoxifene impurity
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
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
Tamsulosin impurity Tamsulosin impurity 1429436-97-4 C20H28N2O5S
Clarithromycin (9Z)-Oxime Clarithromycin (9Z)-Oxime 127253-05-8 C38H70N2O13
N-Desmethyl Clarithromycin (9E)-Oxime N-Desmethyl Clarithromycin (9E)-Oxime 127182-43-8 C37H68N2O13
Ticagrelor Impurity 24 Ticagrelor Impurity 24 1482484-92-3 C7H11N3O2S
Moxifloxacin Impurity Moxifloxacin Impurity 1797982-51-4 C16H16FNO5
sofosBuvir impurity 1 sofosBuvir impurity 1
2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-carboxylic acid 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-carboxylic acid 144060-52-6 C15H14N2O3S
Cyclosporin Impurity 19 Cyclosporin Impurity 19 107335-26-2 C62H111N11O13
Alogliptin Related Compound 26 Alogliptin Related Compound 26 865759-10-0 C25H24N6O2
R-Tirofiban R-Tirofiban 158808-86-7 C22H36N2O5S
Canagliflozin Impurity 20 Canagliflozin Impurity 20
Canagliflozin Impurity 6 Canagliflozin Impurity 6
Carfilzomib Impurity 6 Carfilzomib Impurity 6
Daclatasvir Impurity 5 (SRSS-Isomer) Daclatasvir Impurity 5 (SRSS-Isomer) 1009117-28-5 C40H50N8O6
Dolutegravir Impurity 7 Dolutegravir Impurity 7 2244161-71-3 C20H21N3O5
Istradefylline Impurity F Istradefylline Impurity F
Linagliptin Impurity 22 Linagliptin Impurity 22
Nintedanib impurity G Nintedanib impurity G 894783-61-0 C30H31N5O4
3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine) 3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine) 1010818-93-5 C27H34N2O2
Febuxostat impurity 36 Febuxostat impurity 36 1805770-40-4 C12H12N2O
N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide 2031255-27-1 C28H26N6O3
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
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