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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 115 Oseltamivir Impurity 115
Avatrombopag Impurity 70 Avatrombopag Impurity 70
3,4-dihydroxybutanoic acid 3,4-dihydroxybutanoic acid 1518-61-2 C4H8O4
Isocyclosporin A Isocyclosporin A 59865-16-6 C62H111N11O12
GINKGOLIC ACIDS GINKGOLIC ACIDS
R-DULOXETINE HYDROCHLORIDE R-DULOXETINE HYDROCHLORIDE 910138-96-4 C18H20ClNOS
Perospirone Impurity 26 Perospirone Impurity 26
Paxlovid Impurity 15 Paxlovid Impurity 15
3-(2-(cyclopent-2-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide 3-(2-(cyclopent-2-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
Canagliflozin Impurity 84 Canagliflozin Impurity 84
Fondaparinux sodium impurity 18 Fondaparinux sodium impurity 18
Fondaparinux sodium impurity 13 Fondaparinux sodium impurity 13
Siponimod Impurity 10 Siponimod Impurity 10
Lasmiditan Impurity 1 Lasmiditan Impurity 1
Aciclovir Impurity 7 Aciclovir Impurity 7
(5R,6R)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one (5R,6R)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one
Peramivir dehydrated deacetylated impurity Peramivir dehydrated deacetylated impurity
Oseltamivir Impurity 120 Oseltamivir Impurity 120
2-Piperazine-4-amino-6,7-dimethoxyquinazoline 2-Piperazine-4-amino-6,7-dimethoxyquinazoline 60547-97-9 C14H19N5O2
N-ACETYL-4-BENZOQUINONE IMINE N-ACETYL-4-BENZOQUINONE IMINE 50700-49-7 C8H7NO2
DIGOXIGENIN-TETRA-DIGITOXOSIDE DIGOXIGENIN-TETRA-DIGITOXOSIDE 31539-05-6 C47H74O17
Afatinib impurity 82 Afatinib impurity 82
Afatinib impurity 82 Afatinib impurity 82
Sugammadex sodium Impurity 51 Sugammadex sodium Impurity 51
Sugammadex sodium Impurity 42 Sugammadex sodium Impurity 42
Org49095 Org49095 2412952-95-3 C71H111NaO48S8
Clopidogrel Impurity 55 Clopidogrel Impurity 55
Cabozantinib impurity 43 Cabozantinib impurity 43
Cabozantinib impurity 75 Cabozantinib impurity 75
PHORBOL PHORBOL 17673-25-5 C20H28O6
TRANS-4-AMINOCROTONIC ACID TRANS-4-AMINOCROTONIC ACID 38090-53-8 C4H7NO2
Avatrombopag Impurity 23 Avatrombopag Impurity 23
Avatrombopag Impurity 34 Avatrombopag Impurity 34
Cisatracurium besylate impurity11 Cisatracurium besylate impurity11
(3R,5S,E)-tert-butyl 7-(4-(2-fluorophenyl)-6-isopropyl-2-(N-methyl methylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate (3R,5S,E)-tert-butyl 7-(4-(2-fluorophenyl)-6-isopropyl-2-(N-methyl methylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate
Acetamide, N-?[4-?[5-?(acetylamino)?-?2-?hydroxyphenoxy]?phenyl]?- Acetamide, N-?[4-?[5-?(acetylamino)?-?2-?hydroxyphenoxy]?phenyl]?- 2575516-61-7 C16H16N2O4
Cilastatin Impurity H Cilastatin Impurity H
(trans, trans)-3,3'-(1,4,7,10-tetraazacyclododecane-1,7-diyl)bis(butane-1,2,4-triol) (trans, trans)-3,3'-(1,4,7,10-tetraazacyclododecane-1,7-diyl)bis(butane-1,2,4-triol)
Olodaterol Impurity 22 Olodaterol Impurity 22
Olodaterol Impurity 25 Olodaterol Impurity 25
Cationic panthenol Cationic panthenol
Deiodo Trametinib Deiodo Trametinib 871700-65-1 C26H24FN5O4
32,43,50-Tricarboxy-cyanoco balamin 32,43,50-Tricarboxy-cyanoco balamin
Butanoic acid, 2-[3-[[2-benzoxazolyl[3-(4-hydroxyphenoxy)propyl]amino]methyl]phenoxy]- Butanoic acid, 2-[3-[[2-benzoxazolyl[3-(4-hydroxyphenoxy)propyl]amino]methyl]phenoxy]- 848260-34-4 C27H28N2O6
(S)-Azelastine (S)-Azelastine 143228-85-7 C22H24ClN3O
	Relugolix Impurity 92 Relugolix Impurity 92
N-Desethyl Vardenafil N-Desethyl Vardenafil 448184-46-1 C21H28N6O4S
O-Desmethyl Gefitinib O-Desmethyl Gefitinib 847949-49-9 C21H22ClFN4O3
Pyrazole N-Demethyl Sildenafil Pyrazole N-Demethyl Sildenafil 139755-95-6 C21H28N6O4S
S-(-)-Tolterodine S-(-)-Tolterodine 124937-53-7 C22H31NO
Zolmitriptan N-Oxide Zolmitriptan N-Oxide 251451-30-6 C16H21N3O3
3-(hydroxymethyl)-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one 3-(hydroxymethyl)-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde 2519517-78-1 C20H22ClNO2
7-CHLORO-1,3DIHYDRO-5-FLUOROPHENYL-2-NITRO-METHYLENE-2H-1,4-BENZODIAZEPINE-4-OXIDE 7-CHLORO-1,3DIHYDRO-5-FLUOROPHENYL-2-NITRO-METHYLENE-2H-1,4-BENZODIAZEPINE-4-OXIDE 60656-76-0 C16H11ClFN3O3
Cabozantinib impurity 73 Cabozantinib impurity 73
Canagliflozin Impurity 69 Canagliflozin Impurity 69
Dapoxetine impurity 65 Dapoxetine impurity 65
Dapoxetine impurity 59 Dapoxetine impurity 59
2-bromo-3-(1,3,2-dioxaborinan-2-yl)benzonitrile 2-bromo-3-(1,3,2-dioxaborinan-2-yl)benzonitrile 380919-34-6 C23H17N3O2
Empagliflozin Impurity 83 Empagliflozin Impurity 83
Ambroxol Imp.O Ambroxol Imp.O 1807328-39-7 C13H12Br2N2O
Olopatadine Impurity 10 HBr Olopatadine Impurity 10 HBr 4174-83-8 C22H26Br2NP
Octreotide  (Dimer, Parallel) Octreotide (Dimer, Parallel) 1926163-80-5 C98H132N20O20S4
Iohexol Impurity Q Iohexol Impurity Q
Avibactam sodium Impurity CIS Avibactam sodium Impurity CIS
Diphenidol Impurity 2 Diphenidol Impurity 2 63645-18-1 C16H17ClO
(2,5-dibromophenyl)(4-ethoxyphenyl)methanone (2,5-dibromophenyl)(4-ethoxyphenyl)methanone 1713015-63-4 C15H12Br2O2
Flucloxacillin Impurity 1 Flucloxacillin Impurity 1
Rocuronium Bromide Impurity 39 Rocuronium Bromide Impurity 39
Ticagrelor Intermediate 1 D-Tartrate Ticagrelor Intermediate 1 D-Tartrate 2376278-72-5 C14H25NO10
2-(3,5-dicyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid 2-(3,5-dicyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid 2428631-65-4 C17H15N3O3S
Roxadustat impurity ZZ5 Roxadustat impurity ZZ5 C17H12ClNO4
Lenvatinib impurity LFZZ-7 Lenvatinib impurity LFZZ-7 C11H9ClN2O2
Rosuvastatin Impurity 119 Rosuvastatin Impurity 119
Rosuvastatin Impurity 105 Rosuvastatin Impurity 105
(2R,3R,4R,5S,6R)-2-(acetoxymethyl)-6-(4-chloro-3-(4-(((S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate (2R,3R,4R,5S,6R)-2-(acetoxymethyl)-6-(4-chloro-3-(4-(((S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate 1620758-27-1 C31H35ClO11
Febuxostat Impurity 99 Febuxostat Impurity 99
Furosemide Impurity 20 Furosemide Impurity 20
1-((2S,3S)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium 1-((2S,3S)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium
(3R,4R,5S)-ethyl 4,5-diacetamido-3-(pentan-3-yloxy)cyclohex-1- enecarboxylate (3R,4R,5S)-ethyl 4,5-diacetamido-3-(pentan-3-yloxy)cyclohex-1- enecarboxylate 1191921-01-3 C18H30N2O5
Ticagrelor Impurity 109 Ticagrelor Impurity 109
Ticagrelor Impurity 134 Ticagrelor Impurity 134
2-Propenamide, 2-cyano-3-(3,4-dihydroxyphenyl)-N,N-diethyl-, (2E)- 2-Propenamide, 2-cyano-3-(3,4-dihydroxyphenyl)-N,N-diethyl-, (2E)- 1217439-96-7 C14H16N2O3
Benzonitrile, 4,4'-[[2,2'-bis(hydroxymethyl)[1,1'-biphenyl]-4,4'-diyl]bis(oxy)]bis- Benzonitrile, 4,4'-[[2,2'-bis(hydroxymethyl)[1,1'-biphenyl]-4,4'-diyl]bis(oxy)]bis- 2254541-79-0 C28H20N2O4
Benzoic acid, 3-(butylamino)-5-[(butylamino)sulfonyl]-4-phenoxy- Benzoic acid, 3-(butylamino)-5-[(butylamino)sulfonyl]-4-phenoxy- 28469-01-4 C21H28N2O5S
Thailanstatin A Thailanstatin A 1426953-21-0 C28H41NO9
Acetamide, N-[9-[[2-(acetyloxy)-1-(hydroxymethyl)ethoxy]methyl]-6,9-dihydro-6-oxo-1H-purin-2-yl]- Acetamide, N-[9-[[2-(acetyloxy)-1-(hydroxymethyl)ethoxy]methyl]-6,9-dihydro-6-oxo-1H-purin-2-yl]- 298197-26-9 C13 H17 N5 O6
Topiroxostat Impurity 46 Topiroxostat Impurity 46
Topiroxostat Impurity 43 Topiroxostat Impurity 43
N-(2-(1-hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-methyl formamide N-(2-(1-hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-methyl formamide 1643948-40-6 C17H25NO3
Regorafenib Impurity 40 Regorafenib Impurity 40
3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo-, ethyl ester 3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo-, ethyl ester 2489671-14-7 C17H18FNO5
Bisoprolol Impurity 17 Bisoprolol Impurity 17 109791-19-7 C15H23NO5
Furosemide Impurity 5 Furosemide Impurity 5 518336-22-6 C12H10ClNO3
Lumateperone Impurity 2 Lumateperone Impurity 2 313544-32-0 C16H19N3O3
Pramipexole Impurity 55 Pramipexole Impurity 55 959012-83-0 C8H11NO2
2-Pyridinecarboxamide, 4,4′-[carbonylbis[imino(3-fluoro-4,1-phenylene)oxy]]bis[N-methyl- 2-Pyridinecarboxamide, 4,4′-[carbonylbis[imino(3-fluoro-4,1-phenylene)oxy]]bis[N-methyl- 2438857-80-6 C27H22F2N6O5
Nicergoline Impurity 01 Nicergoline Impurity 01
impurity 38 impurity 38
Aprepitant impurity 1 Aprepitant impurity 1
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