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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
Posaconazole iMpurity 4 Posaconazole iMpurity 4 2125944-53-6 C30H35N5O3
Everolimus Ring-Opening Impurity Everolimus Ring-Opening Impurity 1708118-13-1 C53H83NO14
Topiroxostat Impurity 6 Topiroxostat Impurity 6 2044704-63-2 C7H8N4O2
Dienogest Impurity I Dienogest Impurity I 65928-65-6 C20H27NO2
Febuxostat Impurity 8 Febuxostat Impurity 8 144060-62-8 C16H17NO4S
Lornoxicam Impurity 9 Lornoxicam Impurity 9 70374-36-6 C6H6ClNO4S2
Ticagrelor Related Compound 3 Ticagrelor Related Compound 3 88756-83-6 C8H15NO3
135270-10-9 135270-10-9 135270-10-9 C12H11F2N3O
Tadalafil EP Impurity Tadalafil EP Impurity 479545-76-1 C21H16N2O5
Vonoprazan Impurity C Vonoprazan Impurity C
(5RS)-5-Ethyl-2,6-diimino-5-phenyl-1,2,5,6-tetrahydropyrimidin-4(3H)-one (5RS)-5-Ethyl-2,6-diimino-5-phenyl-1,2,5,6-tetrahydropyrimidin-4(3H)-one 69125-70-8 C12H14N4O
4-(benzyloxy)-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid 4-(benzyloxy)-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid 942195-83-7 C16H14N2O3
Tofacitinib Impurity G Tofacitinib Impurity G
Ceftaroline Fosamil Impurity 6 Ceftaroline Fosamil Impurity 6 953037-71-3 C22H20N8O5S4
Zolmitriptan Related Compound F Zolmitriptan Related Compound F 1350928-05-0 C38H53N7O4
4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butan-1-ol 4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butan-1-ol 913614-15-0 C16H22N2OS
3-((methoxycarbonyl)methyl)-5-methylhexanoic acid 3-((methoxycarbonyl)methyl)-5-methylhexanoic acid 181289-11-2 C10H18O4
Cyanocobalamin Impurity F Cyanocobalamin Impurity F 23208-66-4 C63H85CoN13O15P
Acarbose Impurity D Acarbose Impurity D
Acarbose Impurity D Acarbose Impurity D
Acarbose Impurity C Acarbose Impurity C
Acarbose Impurity C Acarbose Impurity C
Nintedanib Impurity G (Intedanib Impurity G) Nintedanib Impurity G (Intedanib Impurity G)
Canagliflozin alpha-Isomer Impurity Canagliflozin alpha-Isomer Impurity
Dapagliflozin Impurity 4 Dapagliflozin Impurity 4
Isavuconazole Impurity 9 Isavuconazole Impurity 9
Apremilast Impurity E Apremilast Impurity E
Bisoprolol EP Impurity N Bisoprolol EP Impurity N 1346601-75-9 C17H29NO4
Rosuvastatin EP Impurity J Rosuvastatin EP Impurity J
Bosutinib Impurity Bosutinib Impurity 380843-12-9 C19H15Cl2N3O3
4-(4-Chloro-pyrimidin-2-ylamino)-benzamide 4-(4-Chloro-pyrimidin-2-ylamino)-benzamide 1629023-90-0 C18H12N6
Methyl 4-(4-fluorophenyl)-6-isopropyl-2-oxo-1,2,3,4-tetrahydropyrimidine-5-carboxylate Methyl 4-(4-fluorophenyl)-6-isopropyl-2-oxo-1,2,3,4-tetrahydropyrimidine-5-carboxylate 488798-36-3 C15H17FN2O3
Nateglinide Methyl Ester Nateglinide Methyl Ester 105746-47-2 C20H29NO3
(1S,2S,3R,5S)-3-(5-Amino-6-chloro-2-(propylthio)pyrimidin-4-ylamino)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(5-Amino-6-chloro-2-(propylthio)pyrimidin-4-ylamino)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 1402150-32-6 C14H23ClN4O4S
Lamivudine impurity 6 Lamivudine impurity 6 147126-64-5 C14H24O4S
Palbociclib Impurity G Palbociclib Impurity G
Trifluridine Impurity 1 Trifluridine Impurity 1
Tigecycline Impurity 1 Tigecycline Impurity 1 1138343-10-8 C29H38N5O10+
Cephalexin Impurity 3 Cephalexin Impurity 3 C16H17N3O4S
Vonoprazan Impurity 2 Vonoprazan Impurity 2
Sildenafil Impurity F Sildenafil Impurity F 263897-18-3 C21H28N6O4S
Cetirizine impurity 5 Cetirizine impurity 5 C21H25ClN2O3
Valsartan impurity 35 Valsartan impurity 35 1283097-98-2 C24H29N5O3
Valsartan Impurity 16 Valsartan Impurity 16 2680532-87-8 C7H16N2O
Istradefylline Impurity 1 Istradefylline Impurity 1
Everolimus impurity 4 Everolimus impurity 4
Ambrisentan Impurity 3 Ambrisentan Impurity 3 178306-49-5 C16H16O4
Avanafil Impurity 9 Avanafil Impurity 9
Erlotinib Imp.15 Erlotinib Imp.15
Erlotinib Imp.5 Erlotinib Imp.5
Ticagrelor Imp.Q Ticagrelor Imp.Q
Avibactam Impurity 15 Avibactam Impurity 15 1416134-60-5 C15H20N2O3
(1R,3R)-Solifenacin Succinate 2 (1R,3R)-Solifenacin Succinate 2 740780-79-4 C23H26N2O2
Daptomycin Impurity 3 Daptomycin Impurity 3
Duluvir impurity 1 Duluvir impurity 1
Lincomycin sulfoxide Impurity D Lincomycin sulfoxide Impurity D
Lornoxicam Impurity 4 Lornoxicam Impurity 4
Netupitant Impurity 3 Netupitant Impurity 3
nicergoline impurity B nicergoline impurity B
Tacrolimus Impurity B Tacrolimus Impurity B
Oxytetracycline Impurity Oxytetracycline Impurity
1H-Benz[de]isoquinolin-1-one,2,4,5,6-tetrahydro-2-[(3S)-1-oxido-1-azabicyclo[2.2.2]oct-3-yl]- 1H-Benz[de]isoquinolin-1-one,2,4,5,6-tetrahydro-2-[(3S)-1-oxido-1-azabicyclo[2.2.2]oct-3-yl]- 1021456-82-5 C19H22N2O2
Erlotinib Impurity 20 Erlotinib Impurity 20 236750-62-2 C13H20N2O5
Afatinib Impurity 17 Afatinib Impurity 17 1870880-09-3 C20H18Cl2FN5O
6-amino-1,5-dimethylpyrimidine-2,4(1H,3H)-dione 6-amino-1,5-dimethylpyrimidine-2,4(1H,3H)-dione 63959-47-7 C6H9N3O2
Ciclosporin impurity Ciclosporin impurity
Atomoxetine impurity Atomoxetine impurity 42064-62-0 C18H24ClNO
Conivaptan impurity Conivaptan impurity 1129433-63-1 C32H26N4O2
Terazosin impurity Terazosin impurity 1260939-66-9 C19H27N5O4
ent-Ivabradine Hydrochloride ent-Ivabradine Hydrochloride 167072-91-5 C27H36N2O5
SofosBuvir Impurity 2 SofosBuvir Impurity 2
isopropyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate isopropyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate 1346238-10-5 C19H22N2O3S
1,3-diphenylpropan-1-ol 1,3-diphenylpropan-1-ol 14097-24-6 C15H16O
Canagliflozin Impurity 21 Canagliflozin Impurity 21
Canagliflozin Impurity 7 Canagliflozin Impurity 7
Dolutegravir Glucoside Dolutegravir Glucoside
Fasudil Impurity 5 Fasudil Impurity 5 2044702-91-0 C10H9NO3S
Ibrutinib Impurity 10 Ibrutinib Impurity 10
Lesinurad Impurity 4 Lesinurad Impurity 4 1533519-97-9 C17H14BrN3O2S
1-(5-(2-fluorophenyl)-1H-pyrrol-3-yl)-N-methylmethanamine 1-(5-(2-fluorophenyl)-1H-pyrrol-3-yl)-N-methylmethanamine 1610043-62-3 C12H13FN2
FeBuxostat Impurity 26 FeBuxostat Impurity 26 1886961-39-2 C14H12N2O3S
Rivaroxaban degradation impurity 2 Rivaroxaban degradation impurity 2
(S)-methyl 2-(((S)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate (S)-methyl 2-(((S)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate 1911578-88-5 C16H13F5NO5P
(R)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium (R)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium C19H28NO3+
5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidine-2,4(1H,3H)-dione 5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidine-2,4(1H,3H)-dione C8H9FN2O4S
Amlodipine Impurity 13 Amlodipine Impurity 13 C26H31ClN2O8S
Apixaban Impurity 13 Apixaban Impurity 13
Aripiprazole-Impurity 17 Aripiprazole-Impurity 17 1424857-89-5 C16H17Cl4N3
Aripiprazole-Impurity 17 Aripiprazole-Impurity 17 1424857-89-5 C16H17Cl4N3
Cefathiamidine Impurity 3 Cefathiamidine Impurity 3 1417570-09-2 C17H26N4O4S2
Rivaroxaban Impurity 34 Rivaroxaban Impurity 34
Rivaroxaban Impurity 43 Rivaroxaban Impurity 43 2197189-38-9 C19H18ClN3O6S
(S)-thiazolidine-4-carboxylic acid (D) (S)-thiazolidine-4-carboxylic acid (D) C4H7NO2S
Clindamycin 2,4-Diphosphate Clindamycin 2,4-Diphosphate 1309048-48-3 C18H35ClN2O11P2S
1-(5,6,7,8-tetrahydronaphthalen-1-yl)ethan-1-amine hydrochloride 1-(5,6,7,8-tetrahydronaphthalen-1-yl)ethan-1-amine hydrochloride 154377-56-7 C12H17N
Abiraterone Impurity 4 Abiraterone Impurity 4 2118-32-3 C23H34O2
Brexpiprazole Impurity 20 Brexpiprazole Impurity 20 1420987-85-4 C20H20N2S2
Cabozantinib Impurity D Cabozantinib Impurity D
4,9-diisobutyl-1,6-diazecane-2,7-dione 4,9-diisobutyl-1,6-diazecane-2,7-dione 1990538-03-8 C16H30N2O2
ethyl 7-chloro-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate ethyl 7-chloro-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate 75073-15-3 C12H9ClFNO3
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