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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
N-[2-(methylthio)ethyl]-2-[(3,3,3-trifluoropropyl)thio]-Adenosine 5''-(hydrogen P-1H-imidazol-1-ylphosphonate) N-[2-(methylthio)ethyl]-2-[(3,3,3-trifluoropropyl)thio]-Adenosine 5''-(hydrogen P-1H-imidazol-1-ylphosphonate) 1054332-15-8 C19H25F3N7O6PS2
N-[5-(4-Bromophenyl)-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N''-propyl-sulfamide N-[5-(4-Bromophenyl)-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N''-propyl-sulfamide 2211059-00-4 C19H21BrN6O4S
2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-5-hydroxy-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-5-hydroxy-7,8-dimethoxy- 2253977-80-7 C27H36N2O6
Benzeneacetic acid, 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, methyl ester Benzeneacetic acid, 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, methyl ester 1187954-56-8 C33H41NO4
D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-[(2R)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy- D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-[(2R)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy- 50896-99-6 C22H43N5O13
3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-3,5-pyridinedicarboxylate 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-3,5-pyridinedicarboxylate 331258-36-7 C28H25ClN2O7
3,4-Dihydro-7-(4-chlorobutoxy)-2(1H)-quinolinone 3,4-Dihydro-7-(4-chlorobutoxy)-2(1H)-quinolinone 120004-79-7 C13H16ClNO2
D(-)-AMETHOPTERIN D(-)-AMETHOPTERIN 51865-79-3 C20H22N8O5
Sugammadex sodium Impurity 46 Sugammadex sodium Impurity 46
Tenofovir Impurity 103 Tenofovir Impurity 103
Cabozantinib impurity 44 Cabozantinib impurity 44
Cabozantinib impurity 40 Cabozantinib impurity 40
Cabozantinib impurity 74 Cabozantinib impurity 74
5-hydroxy-N,1,2-trimethyl-1H-indole-3-carboxamide 5-hydroxy-N,1,2-trimethyl-1H-indole-3-carboxamide
Doxofylline Impurity 25 Doxofylline Impurity 25
Dapoxetine impurity 62 Dapoxetine impurity 62
Dapoxetine impurity 56 Dapoxetine impurity 56
Bimatoprost Impurity 11 Bimatoprost Impurity 11
Bimatoprost Impurity 9 Bimatoprost Impurity 9
Dolutegravir Impurity 18 Dolutegravir Impurity 18
PeraMpanel PeraMpanel 380918-53-6 C23H15N3O
Lenvatinib Impurity 33 Lenvatinib Impurity 33
isopropyl 2-(2-oxopyrrolidin-1-yl)acetate isopropyl 2-(2-oxopyrrolidin-1-yl)acetate 1249080-59-8 C9H15NO3
Pitavastatin Impurity 71 Pitavastatin Impurity 71
Rosuvastatin EP Impurity M Sodium Salt Rosuvastatin EP Impurity M Sodium Salt
Furosemide impurity 8 Furosemide impurity 8
Febuxostat Impurity 108 Febuxostat Impurity 108
Flucloxacillin EP Impurity J Flucloxacillin EP Impurity J
Phosphonic acid, P-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, mono[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl] ester Phosphonic acid, P-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, mono[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl] ester 1878175-77-9 C17H23N10O4P
Acetic acid, 2-[[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]amino]-2-oxo-, ethyl ester Acetic acid, 2-[[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]amino]-2-oxo-, ethyl ester 480450-85-9 C21H31N5O5S
3H-Oxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3-butanoic acid, 1b-(4-fluorophenyl)hexahydro-β,7-dihydroxy-7-(1-methylethyl)-1a-phenyl-7a-[(phenylamino)carbonyl]-, (βR,3R)- 3H-Oxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3-butanoic acid, 1b-(4-fluorophenyl)hexahydro-β,7-dihydroxy-7-(1-methylethyl)-1a-phenyl-7a-[(phenylamino)carbonyl]-, (βR,3R)- 1193817-52-5 C33H35FN2O7
Hexanoic acid, 3-formyl-, ethyl ester Hexanoic acid, 3-formyl-, ethyl ester 54374-02-6 C9H16O3
D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)- D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)- 154877-92-6 C9H16O5
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2463617-49-2 C51H56N16O4
Benzoic acid, 4-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]- Benzoic acid, 4-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]- 906673-43-6 C14H11BO5
Benzenemethanamine, α,α'-sulfonylbis(methylene)bis[3-ethoxy-4-methoxy- Benzenemethanamine, α,α'-sulfonylbis(methylene)bis[3-ethoxy-4-methoxy- 2417213-71-7 C22H32N2O6S
1H-Purine-2,6-dione, 8-(3-amino-1-piperidinyl)-7-(3-chloro-2-buten-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- 1H-Purine-2,6-dione, 8-(3-amino-1-piperidinyl)-7-(3-chloro-2-buten-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- 2138805-26-0 C25H29ClN8O2
1,3-Benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-N1,N3-bis(2,3-dihydroxypropyl)-2,4-diiodo- 1,3-Benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-N1,N3-bis(2,3-dihydroxypropyl)-2,4-diiodo- 1651211-78-7 C19H27I2N3O9
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxy-3-ethylbenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxy-3-ethylbenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
(E)-1-(4-(2-carboxyvinyl)benzyl)-1H-imidazole 3-oxide (E)-1-(4-(2-carboxyvinyl)benzyl)-1H-imidazole 3-oxide
Aprepitant impurity 2 Aprepitant impurity 2
Aprepitant impurity 4 Aprepitant impurity 4
Vonoprazan Impurity B-2 Vonoprazan Impurity B-2
2-(Cyanomethylthio)acetic acid 2-(Cyanomethylthio)acetic acid 55817-29-3 C4H5NO2S
2(1H)-Pyridinone, 1-(3-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)- 2(1H)-Pyridinone, 1-(3-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)- 2437650-75-2 C15H19N3O2
4(1H)-Pyridinone, 1-(6-methoxy-1H-benzimidazol-2-yl)-2,3,5-trimethyl- 4(1H)-Pyridinone, 1-(6-methoxy-1H-benzimidazol-2-yl)-2,3,5-trimethyl- 2512216-37-2 C16H17N3O2
Budesonide Impurity 31 Budesonide Impurity 31
Budesonide Impurity 23 Budesonide Impurity 23
Hexanoic acid, 3-(chloromethyl)-, (3R)- Hexanoic acid, 3-(chloromethyl)-, (3R)- 2101641-90-9 C7H13ClO2
Bisoprolol Impurity Bisoprolol Impurity 2226263-68-7 C18H31NO4
2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)- 2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)- 1261219-83-3 C18H17NO4
Tofacitinib Impurity Tofacitinib Impurity 2504210-41-5 C29H38N10O2
tert-butyl 2-((4R,6S)-6-((E)-2-(4-(3-fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate tert-butyl 2-((4R,6S)-6-((E)-2-(4-(3-fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate
2-Pentenoic acid, 3-amino-2-cyano-5-[(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-5-oxo-, ethyl ester, (2E)- 2-Pentenoic acid, 3-amino-2-cyano-5-[(3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-5-oxo-, ethyl ester, (2E)- 2459302-85-1 C21H27N7O3
M-ISOBUTYL IBUPROFEN M-ISOBUTYL IBUPROFEN 66622-47-7 C13H18O2
1,3-BIS(METHYLTHIO)-2-PROPANOL 1,3-BIS(METHYLTHIO)-2-PROPANOL 31805-83-1 C5H12OS2
CHLORHEXIDENE DIACETATE IMPURITY A CHLORHEXIDENE DIACETATE IMPURITY A 152504-08-0 C16H24ClN9
Fesoterodine Impurity 14 Fesoterodine Impurity 14
Dexamethasone EP impurities E Dexamethasone EP impurities E
(R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide (R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide C11H21BrN2O2
Empagliflozin Impurity 57(R,R) Empagliflozin Impurity 57(R,R)
Azacitidine Impurity 37 Azacitidine Impurity 37 206269-46-7 C8H12N4O5
Aripiprazole peroxide degradation Impurity (MW:303Da) Aripiprazole peroxide degradation Impurity (MW:303Da)
Pramipexole Impurity Reference Pramipexole Impurity Reference
2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+ 2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+
3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester 3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester 100688-45-7 C13H14O4
Acetaminophen Impurity 14 Acetaminophen Impurity 14 1991204-56-8 C16H18N2O2
Ketoconazole Impurity 7 Ketoconazole Impurity 7 172032-21-2 C11H12Cl2O3
Rosuvastatin Impurity 59 Rosuvastatin Impurity 59
5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide 5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
Losartan Impurity 12 Losartan Impurity 12 727718-93-6 C22H22ClN9
benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride 1865726-28-8 C17H19NO4S
Glycopyrrolate Impurity 12 Glycopyrrolate Impurity 12 857353-41-4 C13H14O3
(4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide (4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide 4660-26-8 C22H22N2O8
Regorafenib Impurity 38 Regorafenib Impurity 38
Cefazolin Impurity 28 Cefazolin Impurity 28
4-Isobutylacetophenone (Ibuprofen impurity) 4-Isobutylacetophenone (Ibuprofen impurity)
Acarbose Impurity IV (JP) Acarbose Impurity IV (JP) C13H21NO7
(2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans
-cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside (2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans -cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside 773899-29-9 C35H36O14
Demethylagrimonolide 6-O-glucoside Demethylagrimonolide 6-O-glucoside 1257408-55-1 C23H26O10
Vonoprazan Impurity 57 Vonoprazan Impurity 57
Tafluprost Impurity 9 Tafluprost Impurity 9 2099033-66-4 C27H41NO8
AZITHROMYCIN IMPURITY A AZITHROMYCIN IMPURITY A
Isomer 1 of Tazobactam Impurity 3 Isomer 1 of Tazobactam Impurity 3
Ceftiofur USP Impurity I Ceftiofur USP Impurity I
Aztreonam Open-Ring Impurity Aztreonam Open-Ring Impurity 102579-58-8 C13H19N5O9S2
Cephalexin Degradation Impurity A Cephalexin Degradation Impurity A
Azlocillin Impurity 8 Azlocillin Impurity 8
Pregabalin-8687(mixture of 4 isomers) Pregabalin-8687(mixture of 4 isomers)
7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one 7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one 1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one
(E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine (E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
Dolutegravir Impurity C Dolutegravir Impurity C 1802141-49-6 C22H23F2N3O5
Adefovir Dipivoxil Impurity 24 Adefovir Dipivoxil Impurity 24 116384-58-8 C14H23O7PS
Dapoxetine Impurity 68 Dapoxetine Impurity 68 119357-48-1 C19H18O
Tobramycin Impurity Tobramycin Impurity 74501-86-3 C18H35N5O8
Peramivir Impurity 24 Peramivir Impurity 24
2-CHLORO-6-AMINO-9-(2',3',5'-TRI-O-ACETYL--D-RIBOFURANOSYL)PURINE 2-CHLORO-6-AMINO-9-(2',3',5'-TRI-O-ACETYL--D-RIBOFURANOSYL)PURINE 79999-39-6 C16H18ClN5O7
Avatrombopag Impurity 38 Avatrombopag Impurity 38
(1S,1'S,2S,2'S)-2,2'-((pentane-1,5-diylbis(oxy))bis(3-oxopropane-3,1-diyl))bis(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium) (1S,1'S,2S,2'S)-2,2'-((pentane-1,5-diylbis(oxy))bis(3-oxopropane-3,1-diyl))bis(1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium) 96946-55-3 C53H72N2O12+2
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