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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
ACETAMINOPURINE ACETAMINOPURINE 6034-68-0 C7H7N5O
N-(2,4-dimethylphenyl)piperidine-2-carboxamide N-(2,4-dimethylphenyl)piperidine-2-carboxamide 99552-32-6 C14H20N2O
HERBACETIN-3,8-DIGLUCOPYRANOSIDE HERBACETIN-3,8-DIGLUCOPYRANOSIDE 99224-12-1 C27H30O17
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
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
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
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
(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
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
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
4-PYRIDINECARBOXIMIDIC ACID, HYDRAZIDE 4-PYRIDINECARBOXIMIDIC ACID, HYDRAZIDE 89830-71-7 C6H8N4
2-PENTANOYLBENZOIC ACID 2-PENTANOYLBENZOIC ACID 550-37-8 C12H14O3
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
Brivaracetam Impurity 37 Brivaracetam Impurity 37
Ticagrelor Impurity 133 Ticagrelor Impurity 133
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
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 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
4-[(1,3-Dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]-benzamide 4-[(1,3-Dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]-benzamide 1187188-59-5 C14H12BNO4
2-Propenoic acid, 3-[4-(hydroxymethyl)phenyl]- 2-Propenoic acid, 3-[4-(hydroxymethyl)phenyl]- 219915-41-0 C10H10O3
L-Alanine, 3-[(R)-(carboxymethyl)sulfinyl]- L-Alanine, 3-[(R)-(carboxymethyl)sulfinyl]- 61475-35-2 C5H9NO5S
Phenol, 2-(2-phenyldiazenyl)- Phenol, 2-(2-phenyldiazenyl)- 2362-57-4 C12H10N2O
3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo- 3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo- 2410658-30-7 C15H14FNO5
Hexanoic acid, 3-(hydroxymethyl)- Hexanoic acid, 3-(hydroxymethyl)- 81381-87-5 C7H14O3
1-Pyrrolidinecarboxylic acid, 3,3'-dithiobis[5-[(dimethylamino)carbonyl]-, 1,1'-bis[(4-nitrophenyl)methyl] ester, (3S,3'S,5S,5'S)- 1-Pyrrolidinecarboxylic acid, 3,3'-dithiobis[5-[(dimethylamino)carbonyl]-, 1,1'-bis[(4-nitrophenyl)methyl] ester, (3S,3'S,5S,5'S)- 936226-36-7 C30H36N6O10S2
D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-, (1S)- D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-, (1S)- 946525-39-9 C22H27ClO6
Topiroxostat Impurity 42 Topiroxostat Impurity 42
Crisaborole intermediate Crisaborole intermediate 1187188-60-8 C14H13BO4
Regorafenib Impurity MHY Regorafenib Impurity MHY
2-Thiazolamine, 5-(4-cyclohexyl-1-piperazinyl)-4-(4,5-dichloro-2-thienyl)- 2-Thiazolamine, 5-(4-cyclohexyl-1-piperazinyl)-4-(4,5-dichloro-2-thienyl)- 570407-63-5 C17H22Cl2N4S2
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2417213-74-0 C42H42N4O12S
Lumateperone Impurity 6 Lumateperone Impurity 6 313368-82-0 C23H26FN3O
1H-?Indole-?5,?6-?diol, 1-?[3-?(4-?hydroxyphenyl)?-?1-?methylpropyl]?- 1H-?Indole-?5,?6-?diol, 1-?[3-?(4-?hydroxyphenyl)?-?1-?methylpropyl]?- 2514709-72-7 C18H19NO3
6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoic acid) 6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoic acid)
4-Pyrimidineethanol, 6-bromo-α-(2,4-difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)- 4-Pyrimidineethanol, 6-bromo-α-(2,4-difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)- 1307315-04-3 C16H13BrF3N5O
Cycloocta[b]pyridine, 2-(4-ethyl-1,4-dioxido-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro- Cycloocta[b]pyridine, 2-(4-ethyl-1,4-dioxido-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro- 2247538-61-8 C23H30FN3O2
Apremilast Impurity 84 Apremilast Impurity 84 2096492-43-0 C22H24N2O8S
Vonoprazan Impurity B-3 Vonoprazan Impurity B-3
3-Azetidineacetamide, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]- 3-Azetidineacetamide, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]- 2271228-51-2 C16H19N7O3S
Budesonide Impurity 26 Budesonide Impurity 26
Peramivir Impurity 48 Peramivir Impurity 48
Tolvaptan dehydroxylated impurity Tolvaptan dehydroxylated impurity
3-Quinolinemethanol, 2-cyclopropyl-4-phenyl- 3-Quinolinemethanol, 2-cyclopropyl-4-phenyl- 2153433-73-7 C19H17NO
Avatrombopag Impurity 37 Avatrombopag Impurity 37
Piperacillin ImpurityABCDEFGHI Piperacillin ImpurityABCDEFGHI
5,6-DIMETHOXY-2-PYRIDIN-4-YLMETHYL-INDAN-1-ONE 5,6-DIMETHOXY-2-PYRIDIN-4-YLMETHYL-INDAN-1-ONE 4803-57-0 C17H17NO3
3-(Dimethylamino)-1-(2-thienyl)-1-propanol 3-(Dimethylamino)-1-(2-thienyl)-1-propanol 13636-02-7 C9H15NOS
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
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
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