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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
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
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
Phosphonic acid, [[2-(6-amino-9H-purin-9-yl)propoxy]methyl]- (9CI) Phosphonic acid, [[2-(6-amino-9H-purin-9-yl)propoxy]methyl]- (9CI) 107021-20-5 C9H14N5O4P
Sitagliptin EP Impurity 7 Sitagliptin EP Impurity 7
Sitagliptin EP Impurity H Sitagliptin EP Impurity H
7-Benzofurancarboxamide, 4-amino-5-chloro-2,3-dihydro-3-hydroxy-N-[1-(3-methoxypropyl)-4-piperidinyl]- 7-Benzofurancarboxamide, 4-amino-5-chloro-2,3-dihydro-3-hydroxy-N-[1-(3-methoxypropyl)-4-piperidinyl]- 2636673-48-6 C18H26ClN3O4
Beprostatin impurity 4 Beprostatin impurity 4
cis-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole cis-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole 65621-78-5 C17H16ClNO
methyl tosylcarbamate methyl tosylcarbamate 14437-03-7 C9H11NO4S
(1R,2R,4S,5S,7s,9r)-9-butyl-9-methyl-7-((2-phenylacryloyl)oxy)-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium (1R,2R,4S,5S,7s,9r)-9-butyl-9-methyl-7-((2-phenylacryloyl)oxy)-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium 786598-71-8 C21H28NO3+
(+)-2-Ethoxy-4-(N-3-Methyl-1(S)-(2-(1-Piperidinyl)Phenyl)-Butyl)Carbamoylmethyl) (+)-2-Ethoxy-4-(N-3-Methyl-1(S)-(2-(1-Piperidinyl)Phenyl)-Butyl)Carbamoylmethyl) 147770-06-7 C29H40N2O4
4-Chloro-2-(chloromethyl)-3-Methyl Pyridine Hydrochloride 4-Chloro-2-(chloromethyl)-3-Methyl Pyridine Hydrochloride 152402-97-6 C7H8Cl3N
4-(3-CYANO-2-METHYLPROPIONYL)ACETAMILIDE 4-(3-CYANO-2-METHYLPROPIONYL)ACETAMILIDE 42075-21-8
Erythromycin, 6-O-Methyl-2',4'-Bis-O-(Trimethylsilyl)-, 9-[O-(1-Methoxy-1-Methylethyl)Oxime] Erythromycin, 6-O-Methyl-2',4'-Bis-O-(Trimethylsilyl)-, 9-[O-(1-Methoxy-1-Methylethyl)Oxime] 119699-81-9 C48H94N2O14Si2
(R)-8-(3-aminopiperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-7-(3-oxobutyl)-3,7-dihydro-1H-purine-2,6-dione (R)-8-(3-aminopiperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-7-(3-oxobutyl)-3,7-dihydro-1H-purine-2,6-dione
Isavuconazole Impurity 37 Isavuconazole Impurity 37
"mixture of 2-amino-9-[[2-(hydroxymethoxy) ethoxy]methyl]-1,9-dihydro-6H-purin-6-one and 2-amino-9-[[2-(hydroxyethoxy)methoxy]methyl]-1,9- dihydro-6H-purin-6-one,"
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)
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)
N-((R)-1-(((R)-3-methyl-1-((3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)butyl)amino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxamide N-((R)-1-(((R)-3-methyl-1-((3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)butyl)amino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxamide 1375004-39-9 C29H39BN4O4
(S)-1-(2-(((1r,3R,5S,7S)-3,5-dihydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile (S)-1-(2-(((1r,3R,5S,7S)-3,5-dihydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile
Mannitol EP impurity B Mannitol EP impurity B
Mannitol EP impurity A Mannitol EP impurity A
Peramivir Amino Carboxylic Isomerism Impurity Peramivir Amino Carboxylic Isomerism Impurity
Peramivir Chlorinated Impurity Peramivir Chlorinated Impurity
Brivaracetam Impurity 999 Brivaracetam Impurity 999
Dasatinib impurity 48 Dasatinib impurity 48
Pemetrexed Impurity 120 Pemetrexed Impurity 120
Ticagrelor Impurity 101 Ticagrelor Impurity 101
4-tosyl-1,4,8,11-tetraazabicyclo[9.3.1]pentadecane 4-tosyl-1,4,8,11-tetraazabicyclo[9.3.1]pentadecane
1-(3-((2,4-dimethylphenyl)thio)phenyl)piperazine hydrochloride 1-(3-((2,4-dimethylphenyl)thio)phenyl)piperazine hydrochloride 2137793-92-9
Apixaban impurity 66S Apixaban impurity 66S
Aatrombopag Impurity 17 Aatrombopag Impurity 17 1268118-96-2 C7H4BrClN2S2
(R)-(-)-2-AMINOBUTANAMIDE HYDROCHLORIDE, 97% (R)-(-)-2-AMINOBUTANAMIDE HYDROCHLORIDE, 97% 103765-03-3 C4H11ClN2O
Flomoxef Impurity 20 Sodium Salt Flomoxef Impurity 20 Sodium Salt 2095697-77-9 C15H18F2N6O7S2
(Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylic acid (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylic acid 883903-90-0 C13H13N2NaO2
((2R,3S,4R)-3,4,5-trihydroxytetrahydrofuran-2-yl)methyl isobutyrate ((2R,3S,4R)-3,4,5-trihydroxytetrahydrofuran-2-yl)methyl isobutyrate 2591381-21-2 C9H16O6
3-Thiophenecarboxylic acid, 4-(bromomethyl)-2-[[(2,6-difluorophenyl)methyl](propoxycarbonyl)amino]-5-(4-nitrophenyl)-, ethyl ester 3-Thiophenecarboxylic acid, 4-(bromomethyl)-2-[[(2,6-difluorophenyl)methyl](propoxycarbonyl)amino]-5-(4-nitrophenyl)-, ethyl ester 2591260-07-8 C25H23BrF2N2O6S
Cyclohexanecarboxylic acid, 2-[[[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]butyl]amino]carbonyl]-, (1R,2S)-rel- Cyclohexanecarboxylic acid, 2-[[[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]butyl]amino]carbonyl]-, (1R,2S)-rel- 190582-37-7 C23H32N4O3S
Ivabradine Impurity II Ivabradine Impurity II
(1R,2R,4S,5S,7r)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate (1R,2R,4S,5S,7r)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate 792155-94-3 C18H19NO4S2
Ipragliflozin Impurity 6 Ipragliflozin Impurity 6
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
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
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
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
3,4-Dihydro-7-(4-chlorobutoxy)-2(1H)-quinolinone 3,4-Dihydro-7-(4-chlorobutoxy)-2(1H)-quinolinone 120004-79-7 C13H16ClNO2
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
D(-)-AMETHOPTERIN D(-)-AMETHOPTERIN 51865-79-3 C20H22N8O5
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