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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
Oseltamivir Impurity 113 Oseltamivir Impurity 113
Avatrombopag Impurity 65 Avatrombopag Impurity 65
Apremilast Impurity 46 Apremilast Impurity 46
N-[[7-(Aminosulfonyl)-6-chloro-2,3-dihydro-1,1-dioxo-4H-1,2,4-benzothiadiazin-4-yl]methyl]-6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-Dioxode N-[[7-(Aminosulfonyl)-6-chloro-2,3-dihydro-1,1-dioxo-4H-1,2,4-benzothiadiazin-4-yl]methyl]-6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-Dioxode 402824-96-8 C15H16Cl2N6O8S4
N-Desmethyl Tamoxifen Hydrochloride N-Desmethyl Tamoxifen Hydrochloride 15917-65-4 C25H27NO.ClH
(3S,5S)-Atorvastatin sodium salt (3S,5S)-Atorvastatin sodium salt 501121-34-2 C33H35FN2O5
2,6-Di(tert-butyl)-4-hydroxy-4-methyl-2,5-cyclohexadien-1-one 2,6-Di(tert-butyl)-4-hydroxy-4-methyl-2,5-cyclohexadien-1-one 10396-80-2 C15H24O2
Pentavitin Pentavitin 100843-69-4
1H-Thieno[3,4-d]imidazole-4-valeric acid, hexahydro-2-oxo-, stereoisomer (8CI) 1H-Thieno[3,4-d]imidazole-4-valeric acid, hexahydro-2-oxo-, stereoisomer (8CI) 21788-37-4 C10H16N2O3S
pazufloxacin pazufloxacin 166665-94-7 C16H15FN2O4
MK 485 MK 485 28875-92-5 C10H14N2O4
2-Naphthalenamine, N-(diphenylmethylene)-6-fluoro-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-5-[2-[tris(1-methylethyl)silyl]ethynyl]- 2-Naphthalenamine, N-(diphenylmethylene)-6-fluoro-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-5-[2-[tris(1-methylethyl)silyl]ethynyl]- 2816821-08-4 C40H47BFNO2Si
1,3-Dioxane-4-aceticacid,6-(cyanomethyl)-2,2-dimethyl-,(4R,6R)-(9CI) 1,3-Dioxane-4-aceticacid,6-(cyanomethyl)-2,2-dimethyl-,(4R,6R)-(9CI) 807312-27-2 C10H15NO4
Esmolol Impurity 46 Esmolol Impurity 46
bromobenzarone bromobenzarone 94729-09-6 C17H13BrO3
Oprinone Impurity 3 Oprinone Impurity 3
Methanone, [5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl][(2S)-2-methyl-2-(7-methyl-1H-benzimidazol-2-yl)-1-pyrrolidinyl]- Methanone, [5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl][(2S)-2-methyl-2-(7-methyl-1H-benzimidazol-2-yl)-1-pyrrolidinyl]- 1505484-96-7 C23H24N6O2
digoxigenin-bis(digitoxoside) digoxigenin-bis(digitoxoside) 5297-05-2 C35H54O11
Meropenem Impurity MAP-B Meropenem Impurity MAP-B
(S,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-hydroxybut-2-enamide (S,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-hydroxybut-2-enamide
5-Methoxy-2-Hydroxy Benzimidazole 5-Methoxy-2-Hydroxy Benzimidazole 208-75-3 C13H9N
SODIUM CAMPTOTHECIN SODIUM CAMPTOTHECIN 25387-67-1 C20H17N2NaO5
(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)-L-cysteine (5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)-L-cysteine 2238849-52-8 C13H15N3O3S
Doxylamine Impurity E Doxylamine Impurity E
Phenoxymethylpenicillin Potassium EP Impurity F Phenoxymethylpenicillin Potassium EP Impurity F 2714805-53-3 C15H20N2O4S
17 alpha-cyanomethyl-19-nortestosterone 17 alpha-cyanomethyl-19-nortestosterone 67473-36-3 C20H27NO2
desmethylazelastine desmethylazelastine 47491-38-3 C21H22ClN3O
8-hydroxyclomipramine 8-hydroxyclomipramine 83385-97-1 C19H23ClN2O
Ro 15-3505 Ro 15-3505 78756-33-9 C15H14ClN3O3
L 683519 L 683519 132172-14-6 C43H67NO12
benzylpenicilloic acid benzylpenicilloic acid 13057-98-2 C16H20N2O5S
erythralosamine erythralosamine 546-57-6 C29H49NO8
N-Nitroso Racecadotril N-Nitroso Racecadotril
Sulbactam-d5 Sulbactam-d5 1322880-00-1 C8H6D5NO5S
6-methylprednisone 6-methylprednisone 91523-05-6 C22H28O5
HYDROXYMETHYL CELECOXIB HYDROXYMETHYL CELECOXIB 170571-00-3 C17H14F3N3O3S
2-(2-cyanophenyl)benzonitrile 2-(2-cyanophenyl)benzonitrile 4341-02-0 C14H8N2
ETHYL (1R,5R,6R)-5-(1-ETHYLPROPOXY)-7-AZABICYCLO[4.1.0]HEPT-3-ENE-3-CARBOXYLATE ETHYL (1R,5R,6R)-5-(1-ETHYLPROPOXY)-7-AZABICYCLO[4.1.0]HEPT-3-ENE-3-CARBOXYLATE 204255-02-7 C14H23NO3
Lemborexant impurity 13 Lemborexant impurity 13
(1,1-DIOXIDO-3-OXO-1,2-BENZISOTHIAZOL-2(3H)-YL)ACETIC ACID (1,1-DIOXIDO-3-OXO-1,2-BENZISOTHIAZOL-2(3H)-YL)ACETIC ACID 52188-11-1 C9H7NO5S
N-(3-AMINOPROPYL)DIETHANOLAMINE N-(3-AMINOPROPYL)DIETHANOLAMINE 4985-85-7 C7H18N2O2
(3S.4S.5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-yl acetate (3S.4S.5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-yl acetate 3041980-36-0 C14H15F5O3
2-Methylpropaneboronic acid (1S,2S,3R,5S)-(+)-2,3-pinanediol ester 2-Methylpropaneboronic acid (1S,2S,3R,5S)-(+)-2,3-pinanediol ester 84110-34-9 C14H25BO2
Mirtazapine N-Oxide Mirtazapine N-Oxide 155172-12-6 C17H19N3O
3-Oxo Citalopram 3-Oxo Citalopram 372941-54-3 C20H19FN2O2
Quetiapine N-Oxide Quetiapine N-Oxide 1076199-40-0 C21H25N3O3S
Celebrex Carboxylic Acid Methyl Ester Celebrex Carboxylic Acid Methyl Ester 1189893-75-1 C18H14F3N3O4S
(S)-BoroLeu-(-)-Pinanediol-hydrochloride (S)-BoroLeu-(-)-Pinanediol-hydrochloride 945606-99-5 C15H29BClNO2
N-(2,4-dimethylphenyl)piperidine-2-carboxamide N-(2,4-dimethylphenyl)piperidine-2-carboxamide 99552-32-6 C14H20N2O
pyrrolidinyl)-, (2β,3α,5α,16β,17β)- pyrrolidinyl)-, (2β,3α,5α,16β,17β)- 144209-33-6 C27H46N2O2
(4S,6S)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester (4S,6S)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester 472967-95-6 C40H47FN2O5
6a-Methylprednisone 21-Acetate 6a-Methylprednisone 21-Acetate 115321-98-7 C24H30O6
Aztreonam Amide Aztreonam Amide 1219444-93-5 C13H20N6O8S2
N'-[(2Z)-Piperazin-2-ylidene]trifluoroacetohydrazide N'-[(2Z)-Piperazin-2-ylidene]trifluoroacetohydrazide 763105-70-0 C6H9F3N4O
2-chloro-N-(2,4-dimethylphenyl)acetamide 2-chloro-N-(2,4-dimethylphenyl)acetamide 39106-10-0 C10H12ClNO
sodium [2S-(2alpha,5alpha,6beta)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate sodium [2S-(2alpha,5alpha,6beta)]-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 73335-78-1 C8H9BrNNaO3S
8-chloro-3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione 8-chloro-3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione 4921-49-7 C8H9ClN4O2
2-amino-1-(3,4-dihydroxyphenyl)ethan-1-one 2-amino-1-(3,4-dihydroxyphenyl)ethan-1-one 499-61-6 C8H9NO3
Benzoic acid, 5-(aminosulfonyl)-2-[[[4-methoxy-3-(methoxycarbonyl)phenyl]sulfonyl]oxy]-, methyl ester Benzoic acid, 5-(aminosulfonyl)-2-[[[4-methoxy-3-(methoxycarbonyl)phenyl]sulfonyl]oxy]-, methyl ester 2267259-70-9 C17H17NO10S2
2(1H)-Quinolinone, 7-(4-chlorobutoxy)-1-(4-chlorobutyl)-3,4-dihydro- 2(1H)-Quinolinone, 7-(4-chlorobutoxy)-1-(4-chlorobutyl)-3,4-dihydro- 2295935-56-5 C17H23Cl2NO2
7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9,10-difluoro-2,3-dihydro-2-methyl-7-oxo-, (S)- (9CI) 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9,10-difluoro-2,3-dihydro-2-methyl-7-oxo-, (S)- (9CI) 129798-65-8 C13H9F2NO4
Sitagliptin EP Impurity 1 Sitagliptin EP Impurity 1
4,6-Methano-1,3,2-benzodioxaborole-2-methanamine, hexahydro-3a,8,8-trimethyl-α-(2-methylpropyl)-, (αS,3aR,4R,6R,7aS)-, 2,2,2-trifluoroacetate (1:1) 4,6-Methano-1,3,2-benzodioxaborole-2-methanamine, hexahydro-3a,8,8-trimethyl-α-(2-methylpropyl)-, (αS,3aR,4R,6R,7aS)-, 2,2,2-trifluoroacetate (1:1) 2363753-29-9 C17H29BF3NO4
Beprostatin impurity 3 Beprostatin impurity 3
endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate 22235-81-0 C19H27NO3
8,11-Dioxa-3,5-diazadodecanoic acid, 12-(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)-10-(hydroxymethyl)-2,6-bis(1-methylethyl)-7-oxo-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, (2S,6S)- 8,11-Dioxa-3,5-diazadodecanoic acid, 12-(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)-10-(hydroxymethyl)-2,6-bis(1-methylethyl)-7-oxo-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, (2S,6S)- 1654737-35-5 C29H44N12O10
(1R,3r,5S,8R)-8-butyl-3-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-8-methyl-8-azabicyclo[3.2.1]octan-8-ium (1R,3r,5S,8R)-8-butyl-3-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-8-methyl-8-azabicyclo[3.2.1]octan-8-ium 99571-66-1 C21H32NO3+
1,3-dihydro-1-oxoisobenzofuran-5-carboxamide 1,3-dihydro-1-oxoisobenzofuran-5-carboxamide 85118-25-8 C9H7NO3
(R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-2-((4-methylquinazolin-2-yl)methoxy)-3,7-dihydro-6H-purin-6-one (R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-2-((4-methylquinazolin-2-yl)methoxy)-3,7-dihydro-6H-purin-6-one 2446799-72-8 C25H28N8O2
CETEARYL GLUCOSIDE CETEARYL GLUCOSIDE
Troxipide Impurity 8 Troxipide Impurity 8
Peramivir Impurity 12/11 Peramivir Impurity 12/11
(1S,2R,3R,4R)-3-((S)-1-acetamido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentane-1-carboxylic acid (1S,2R,3R,4R)-3-((S)-1-acetamido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentane-1-carboxylic acid
Ceftazidime Impurity IMPA Ceftazidime Impurity IMPA
Pitavastatin Impurity 82 Pitavastatin Impurity 82
Terbutaline EP Impurity B Complete Set Terbutaline EP Impurity B Complete Set
Peramivir Intermediate impurity 2 Peramivir Intermediate impurity 2
Cetrorelix Impurity 8 (+L-Pro) Cetrorelix Impurity 8 (+L-Pro)
Peramivir Intermediate Impurity 44 Peramivir Intermediate Impurity 44
Peramivir Hydroxy Isomeric Impurity Peramivir Hydroxy Isomeric Impurity
Nintedanib impurity F drops Nintedanib impurity F drops
Favipiravir Impurities 1-19 Favipiravir Impurities 1-19
Ticagrelor Impurity 138X Ticagrelor Impurity 138X
Apremilast Impurity 999 Apremilast Impurity 999
Pranoprofen Impurity C Pranoprofen Impurity C
isopropyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate isopropyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate
N-(3-chloro-4-fluorophenyl)-7-fluoro-6,8-dinitroquinazolin-4-amine N-(3-chloro-4-fluorophenyl)-7-fluoro-6,8-dinitroquinazolin-4-amine
(S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-5,12-dihydroxy-7-methoxy-6,11-dioxo-3,4,6,11-tetrahydrotetracene-2-carboxylic acid (S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-5,12-dihydroxy-7-methoxy-6,11-dioxo-3,4,6,11-tetrahydrotetracene-2-carboxylic acid
3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)- 3-Azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1R)-1-cyano-2-[(3S)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2S)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1R,2S,5S)- 2755812-41-8 C23H32F3N5O4
Carbonic acid, (12aR)-12-[(11S)-7,8-difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-3,4,6,8,12,12a-hexahydro-6,8-dioxo-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl methyl ester Carbonic acid, (12aR)-12-[(11S)-7,8-difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-3,4,6,8,12,12a-hexahydro-6,8-dioxo-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl methyl ester 1985606-48-1 C26H21F2N3O6S
3-(4-cyanophenoxy)benzyl acetate 3-(4-cyanophenoxy)benzyl acetate 2990481-66-6 C16H13NO3
5-chloro-N-(4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)-6-(4-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)piperidin-1-yl)nicotinamide 5-chloro-N-(4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)-6-(4-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)piperidin-1-yl)nicotinamide 2948773-23-5
Methylprednisolone EP Impurity D1 Methylprednisolone EP Impurity D1
Nirmatrelvir Impurity 13 Nirmatrelvir Impurity 13
γ-Cyclodextrin, 6A,6B,6C,6D,6E,6F,6G-heptabromo-6A,6B,6C,6D,6E,6F,6G-heptadeoxy- γ-Cyclodextrin, 6A,6B,6C,6D,6E,6F,6G-heptabromo-6A,6B,6C,6D,6E,6F,6G-heptadeoxy- 2458187-21-6 C48H73Br7O33
2-Pyridinecarboxamide, 4-hydroxy-N-methyl- (9CI) 2-Pyridinecarboxamide, 4-hydroxy-N-methyl- (9CI) 611226-36-9 C7H8N2O2
2-Pyridinemethanol, 4-hydroxy-3,5-dimethyl- (9CI) 2-Pyridinemethanol, 4-hydroxy-3,5-dimethyl- (9CI) 727375-13-5 C8H11NO2
Bumetanide Impurity 22 Bumetanide Impurity 22
Rocuronium Bromide Impurity 32 、33 Rocuronium Bromide Impurity 32 、33
Flucloxacillin Sodium Impurity X Flucloxacillin Sodium Impurity X
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