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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
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
krypton-82 krypton-82 14191-81-2 Kr
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
3-amino-5-[(methylthio)methyl]oxazolidin-2-one 3-amino-5-[(methylthio)methyl]oxazolidin-2-one 25517-72-0 C5H10N2O2S
(3aS-cis)-1,3-dibenzyltetrahydro-1H-thieno[3,4-d]imidazole-2,4-dione (3aS-cis)-1,3-dibenzyltetrahydro-1H-thieno[3,4-d]imidazole-2,4-dione 28092-52-6 C19H18N2O2S
L-Cefadroxil Impurity F(EP) L-Cefadroxil Impurity F(EP)
Oseltamivir  Impurity 94 Oseltamivir Impurity 94
Oseltamivir  Impurity 82 Oseltamivir Impurity 82
Oseltamivir  Impurity 74 Oseltamivir Impurity 74
Uridine, 5'-(2-methylpropanoate) (9CI) Uridine, 5'-(2-methylpropanoate) (9CI) 886538-48-3 C13H18N2O7
AZITHROMYCIN IMPURITY A AZITHROMYCIN IMPURITY A
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
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
Dapagliflozin Impurity 47 Dapagliflozin Impurity 47
Crisaborole Impurity 17 Crisaborole Impurity 17
Crisaborole Impurity 19 Crisaborole Impurity 19
1,5-Pentanedione, 1-(2-fluorophenyl)-5-[(4S)-2-oxo-4-phenyl-3-oxazolidinyl]- 1,5-Pentanedione, 1-(2-fluorophenyl)-5-[(4S)-2-oxo-4-phenyl-3-oxazolidinyl]- 2514695-40-8 C20H18FNO4
4-ethoxy-3-(4-pyridyl)-3-buten-2-one 4-ethoxy-3-(4-pyridyl)-3-buten-2-one 88349-61-5 C11H13NO2
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,"
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
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
Bimatoprost Impurity 11 Bimatoprost Impurity 11
Bimatoprost Impurity 9 Bimatoprost Impurity 9
Dolutegravir Impurity 18 Dolutegravir Impurity 18
3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile 3-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile 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
Linagliptin Dimer impurity (N-C-C-C Dimer)Q: What is 
Linagliptin Dimer impurity (N-C-C-C Dimer) Q: What is the CAS Number of 
Linagliptin Dimer impurity (N-C-C-C Dimer) Linagliptin Dimer impurity (N-C-C-C Dimer)Q: What is Linagliptin Dimer impurity (N-C-C-C Dimer) Q: What is the CAS Number of Linagliptin Dimer impurity (N-C-C-C Dimer) 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
Glycine, N-(2-aminobenzoyl)-, ethyl ester Glycine, N-(2-aminobenzoyl)-, ethyl ester 5973-34-2 C11H14N2O3
6-Chloro-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzoxanine-8-carboxylic acid 6-Chloro-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzoxanine-8-carboxylic acid 123040-79-9 C10H8ClNO4
3-Amino-3-azabicyclo[3.3.0]octane 3-Amino-3-azabicyclo[3.3.0]octane 54528-00-6 C7H14N2
(S)-Methyl 2-aminobutanoate (S)-Methyl 2-aminobutanoate 15399-22-1 C5H11NO2
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