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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
Bisoprolol Impurity 53 Bisoprolol Impurity 53
Pitavastatin Impurity 98 Pitavastatin Impurity 98
Perospirone Impurity 29 Perospirone Impurity 29
Perospirone Impurity 24 Perospirone Impurity 24
Perospirone Impurity 7 Perospirone Impurity 7 1002359-81-0
2-methyl-4-(((2E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,6,10,14- tetraen-1-yl)oxy)naphthalen-1-yl acetate 2-methyl-4-(((2E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,6,10,14- tetraen-1-yl)oxy)naphthalen-1-yl acetate
Paxlovid Impurity 17 Paxlovid Impurity 17
Related impurities of fluoxetine sodium 19 Related impurities of fluoxetine sodium 19
Fondaparinux sodium impurity 16 Fondaparinux sodium impurity 16
Fondaparinux Sodium Impurity 11 Fondaparinux Sodium Impurity 11
Oxacillin  Impurity E Oxacillin Impurity E
AZOBENZENE-3-CARBOXYLICACID AZOBENZENE-3-CARBOXYLICACID 14474-22-7 C13H10N2O2
Bosutinib Impurity 40 Bosutinib Impurity 40
Ticagrelor Impurity J&K Ticagrelor Impurity J&K
Olodaterol Impurity 24 Olodaterol Impurity 24
Miglitol Isomer ImpurityB Miglitol Isomer ImpurityB
benzhydryl (6R,7S)-7-(2-mercaptoacetamido)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate benzhydryl (6R,7S)-7-(2-mercaptoacetamido)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
43,50-Dicarboxy-cyanoco balamin 43,50-Dicarboxy-cyanoco balamin
Ibuprofen Alcohol Ibuprofen Alcohol 36039-36-8 C13H20O
4-PYRIDINECARBOXIMIDIC ACID, HYDRAZIDE 4-PYRIDINECARBOXIMIDIC ACID, HYDRAZIDE 89830-71-7 C6H8N4
2-PENTANOYLBENZOIC ACID 2-PENTANOYLBENZOIC ACID 550-37-8 C12H14O3
3-(Dimethylamino)-1-(2-thienyl)-1-propanol 3-(Dimethylamino)-1-(2-thienyl)-1-propanol 13636-02-7 C9H15NOS
Benzamide, 2,5-dichloro-N-(3-methylbutyl)- Benzamide, 2,5-dichloro-N-(3-methylbutyl)- 349086-08-4 C12H15Cl2NO
BECLOTIAMINE BECLOTIAMINE 13471-78-8 C12H16Cl2N4S
methyl 5-sulpho-o-anisate methyl 5-sulpho-o-anisate 94134-07-3 C9H10O6S
2,4-dioxo-3-azaspiro[5.5]undecane-1,5-dicarbonitrile 2,4-dioxo-3-azaspiro[5.5]undecane-1,5-dicarbonitrile 4355-15-1 C12H13N3O2
Sugammadex Impurity 12 Monomer(Org198958-2(RRT0.45)) Sugammadex Impurity 12 Monomer(Org198958-2(RRT0.45)) 2412953-11-6 C72H112O49S8
Sulfamide, N-[5-phenyl-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N'-propyl- Sulfamide, N-[5-phenyl-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N'-propyl- 2300968-85-6 C19H22N6O4S
Acetamide, 2-chloro-N-(2-chloroacetyl)-N-(2,6-dimethylphenyl)- Acetamide, 2-chloro-N-(2-chloroacetyl)-N-(2,6-dimethylphenyl)- 112843-97-7 C12H13Cl2NO2
1-[2-cyano-1-(cyanoimino)ethyl]piperidine 1-[2-cyano-1-(cyanoimino)ethyl]piperidine 56488-00-7 C9H12N4
Oseltamivir Impurity 99 Oseltamivir Impurity 99
Oseltamivir  Impurity 92 Oseltamivir Impurity 92
Oseltamivir  Impurity 76 Oseltamivir Impurity 76
Regorafenib Impurity ABCDEFGHJKL Regorafenib Impurity ABCDEFGHJKL
(S)-2-((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)-1-iminohexahydro pyrrolo[1,2-a]pyrazin-4(1H)-one hydrochloride (S)-2-((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)-1-iminohexahydro pyrrolo[1,2-a]pyrazin-4(1H)-one hydrochloride
Benzonitrile, 4-[2-[(1R,2S)-2-(2,5-difluorophenyl)-2-hydroxy-1-methyl-3-(1H-1,2,4-triazol-1-yl)propyl]-4-thiazolyl]-, rel- Benzonitrile, 4-[2-[(1R,2S)-2-(2,5-difluorophenyl)-2-hydroxy-1-methyl-3-(1H-1,2,4-triazol-1-yl)propyl]-4-thiazolyl]-, rel- 1797905-83-9 C22H17F2N5OS
3,4,5-Piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2S,3S,4R,5S)- 3,4,5-Piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2S,3S,4R,5S)- 1550201-56-3 C8H17NO5
1-(2,4-difluoro-6-hydroxyphenyl)prop-2-en-1-one 1-(2,4-difluoro-6-hydroxyphenyl)prop-2-en-1-one
1-(4-fluorophenyl)-1,3-dihydro-1-[3-(methylamino)propyl]isobenzofuran-5-carbonitrile 1-(4-fluorophenyl)-1,3-dihydro-1-[3-(methylamino)propyl]isobenzofuran-5-carbonitrile 62498-67-3 C19H19FN2O
17,21-Dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione 21-Acetate 17,21-Dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione 21-Acetate 10106-41-9 C24H30O5
Abiolone Impurity 24 Abiolone Impurity 24
Deerasirox Impurity II Deerasirox Impurity II
Brivaracetam Impurity 49 Brivaracetam Impurity 49
Paroxetine EP Impurity J HCl Paroxetine EP Impurity J HCl
Brivaracetam Impurity 99 Brivaracetam Impurity 99
Bendamustine Impurity 39 Bendamustine Impurity 39
AvatrombopagImpurity42 AvatrombopagImpurity42
(R)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid (R)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid
Hydrazinecarboxamide, 2-(6-hydroxy-1-methyl-1H-indol-5-yl)- Hydrazinecarboxamide, 2-(6-hydroxy-1-methyl-1H-indol-5-yl)- 70063-07-9 C10H12N4O2
1H-Pyrrole-3-carboxaldehyde, 1-[(5-chloro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)- 1H-Pyrrole-3-carboxaldehyde, 1-[(5-chloro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)- 2514742-82-4 C16H10ClFN2O3S
3,5-Pyridinedicarboxylic acid, 2-[(2-chloroethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester 3,5-Pyridinedicarboxylic acid, 2-[(2-chloroethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester 221446-45-3 C20H23Cl2NO5
	Crisaborole Impurity 20 Crisaborole Impurity 20
(1R,4S) Sertraline Hydrochloride (1R,4S) Sertraline Hydrochloride 79896-32-5 C17H18Cl3N
4-Desmethoxy-4-chloro Omeprazole Sulfide 4-Desmethoxy-4-chloro Omeprazole Sulfide 220757-74-4 C16H16ClN3OS
2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE 115538-83-5 C11H14ClNO3
1,1-BIS-(4-ISOBUTYLPHENYL)ETHANE 1,1-BIS-(4-ISOBUTYLPHENYL)ETHANE 102120-87-6 C22H30
Sugammadex sodium Impurity 52 Sugammadex sodium Impurity 52
Sugammadex sodium Impurity 43 Sugammadex sodium Impurity 43
Sugammadex sodium Impurity 39 Sugammadex sodium Impurity 39
Apixaban Impurity 52 Apixaban Impurity 52 1620494-31-6 C31H29N5O4
Cefazolin Impurity EP-J Cefazolin Impurity EP-J
Cabozantinib impurity 41 Cabozantinib impurity 41
Cabozantinib impurity 67 Cabozantinib impurity 67
ethyl 6-bromo-2-(bromomethyl)-5-hydroxy-1-methyl-1H-indole-3-carboxylate ethyl 6-bromo-2-(bromomethyl)-5-hydroxy-1-methyl-1H-indole-3-carboxylate 149246-36-6 C13H13Br2NO3
Dapoxetine impurity 50 Dapoxetine impurity 50
Doxofylline Impurity 18 Doxofylline Impurity 18
Dapoxetine impurity 63 Dapoxetine impurity 63
Dapoxetine impurity 57 Dapoxetine impurity 57
Bosutinib Impurity 2 (N-Desmethyl Bosutinib) Bosutinib Impurity 2 (N-Desmethyl Bosutinib) 380843-81-2 C25H27Cl2N5O3
Chloromethyl ethyl carbonate Chloromethyl ethyl carbonate 35179-98-7 C4H7ClO3
Bimatoprost Impurity 10 Bimatoprost Impurity 10
Carbetocin S-Oxide II Carbetocin S-Oxide II
Empagliflozin Impurity 82 Empagliflozin Impurity 82 2452301-16-3 C17H16ClIO2
Empagliflozin Impurity 88 Empagliflozin Impurity 88
Tofacitinib Impurity K Tofacitinib Impurity K 2328165-36-0 C16H21N5O3
Olopatadine Impurity 13 Olopatadine Impurity 13 55453-90-2 C18H16O4
Avibactam sodium Impurity CIA Avibactam sodium Impurity CIA
4-((2-amino-2-oxoethyl)amino)butanoic acid 4-((2-amino-2-oxoethyl)amino)butanoic acid 1096803-44-9 C6H12N2O3
Lenvatinib impurity LFZZ-17 Lenvatinib impurity LFZZ-17 C11H9NO4
Ornidazole Impurity 25 Ornidazole Impurity 25
Pitavastatin Impurity 72 Pitavastatin Impurity 72
Febuxostat Impurity 109 Febuxostat Impurity 109
(Z)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-methoxyquinazolin-6-yl)-4-(piperidin-1-yl)but-2-enamide (Z)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-methoxyquinazolin-6-yl)-4-(piperidin-1-yl)but-2-enamide
(1S,3R,5S,6R)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate (1S,3R,5S,6R)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate
Nicergoline EP Impurity IJ Nicergoline EP Impurity IJ
Fulvestrant impurityABCDEFGHJKL Fulvestrant impurityABCDEFGHJKL
2-((6S,8S,9S,10S,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxohexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate 2-((6S,8S,9S,10S,11S,13S,14S,17R)-11,17-dihydroxy-6,10,13-trimethyl-3-oxohexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate 114696-04-7 C24H36O6
Isavuconazole Impurity 49 Isavuconazole Impurity 49
(R)-5-(2-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-methoxyethyl)-8-hydroxyquinolin-2(1H)-one (R)-5-(2-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-methoxyethyl)-8-hydroxyquinolin-2(1H)-one
Avatrombopag Impurity 51 Avatrombopag Impurity 51
Tafluprost Impurity 18 Tafluprost Impurity 18
Rosuvastatin Impurity 161 Rosuvastatin Impurity 161
Rosuvastatin Impurity 155 Rosuvastatin Impurity 155
Rosuvastatin Impurity 146 Rosuvastatin Impurity 146
Rosuvastatin Impurity 126 Rosuvastatin Impurity 126
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-di(thiophen -2-yl)acetate 29461-90-3 C18H21NO3S2
Digoxin Impurity 2 Digoxin Impurity 2
DUTP, 100MM SOLUTION DUTP, 100MM SOLUTION 94736-09-1 C9H16N2NaO14P3
Oxacillin USP Impurity D Oxacillin USP Impurity D
Oxacillin sodium EP impurity B Oxacillin sodium EP impurity B
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