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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
14,15-Dehydro Budesonide 14,15-Dehydro Budesonide 131918-64-4 C25H32O6
2-(BenzylMethylaMino)-3',4'-dihydroxyacetophenone 2-(BenzylMethylaMino)-3',4'-dihydroxyacetophenone 36467-25-1 C16H17NO3
2'-O-(5'-Deoxy-β-D-ribofuranosyl) Capecitabine 2'-O-(5'-Deoxy-β-D-ribofuranosyl) Capecitabine 1262133-66-3 C20H30FN3O9
4-Defluoro-4-hydroxy Gefitinib 4-Defluoro-4-hydroxy Gefitinib 847949-50-2 C22H25ClN4O4
2-[2-(2-AMINO-9H-PURIN-9-YL)ETHYL]-1,3-PROPANEDIOL 2-[2-(2-AMINO-9H-PURIN-9-YL)ETHYL]-1,3-PROPANEDIOL 104227-86-3 C10H15N5O2
1,4,8,11-Tetrakis[(4-methylphenyl)sulfonyl]-1,4,8,11-tetraazacyclotetradecane 1,4,8,11-Tetrakis[(4-methylphenyl)sulfonyl]-1,4,8,11-tetraazacyclotetradecane 71089-74-2 C38H48N4O8S4
1-Propanol,3-[(1,1-dimethylethyl)amino]-2-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]-oxy]- 1-Propanol,3-[(1,1-dimethylethyl)amino]-2-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]-oxy]- 59697-06-2 C13H24N4O3S
Anagrelide impurity 4 Anagrelide impurity 4 1092352-99-2 C10H6Cl3N3O
Anagrelide impurity 4 Anagrelide impurity 4 1092352-99-2 C10H6Cl3N3O
rac Cetirizine N-Oxide > 70% by HPLC
(Mixture of Diastereomers) rac Cetirizine N-Oxide > 70% by HPLC (Mixture of Diastereomers) 1076199-80-8 C21H25ClN2O4
6-Hydroxy Nicorandil 6-Hydroxy Nicorandil 113743-17-2 C8H9N3O5
trans-Itraconazole trans-Itraconazole 252964-65-1 C35H38Cl2N8O4
N-(2-Pyridyl)oxamic Acid N-(2-Pyridyl)oxamic Acid 13120-39-3 C7H6N2O3
(trans)-4-Propyl-1-methyl-L-proline (trans)-4-Propyl-1-methyl-L-proline 13380-36-4 C9H17NO2
N-Nordextromethorphan
N-Nordextromethorphan 1531-23-3 C17H23NO
(S,S,R,R)-Orlistat (S,S,R,R)-Orlistat 111466-62-7 C29H53NO5
17β-Carboxy-17-desoxy Dexamethasone 17β-Carboxy-17-desoxy Dexamethasone 75262-69-0 C21H27FO4
1-(dimethoxymethyl)-3-methoxybenzene 1-(dimethoxymethyl)-3-methoxybenzene 59276-28-7 C10H14O3
Peramivir dehydrated deacetylated impurity Peramivir dehydrated deacetylated impurity
Oseltamivir Impurity 120 Oseltamivir Impurity 120
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)
4-[5-({2-[(4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H benzimidazol-2-yl]butanoic acid 4-[5-({2-[(4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazol-2-yl}butanoyl)oxy]ethyl}(2-chloroethyl)amino)-1-methyl-1H benzimidazol-2-yl]butanoic acid 1926162-37-9 C32H42Cl4N6O4
Isavuconazole Impurity 39 Isavuconazole Impurity 39 207224-73-5 C21H18F2N4OS
Anastrozole Impurity 41 Anastrozole Impurity 41
Anastrozole Impurity 41 Anastrozole Impurity 41
Isavuconazole Impurityi45 Isavuconazole Impurityi45
Gatifloxacinacid Gatifloxacinacid 121577-32-0 C19H22FN3O4.ClH
Bisoprolol Impurity 41 Bisoprolol Impurity 41
1,4-Naphthalenedione, 2-(3-hydroxy-3,7,11,15-tetramethyl-1,6,10,14-hexadecatetraenyl)-3-methyl-, (,E,E)- (9CI) 1,4-Naphthalenedione, 2-(3-hydroxy-3,7,11,15-tetramethyl-1,6,10,14-hexadecatetraenyl)-3-methyl-, (,E,E)- (9CI) 65061-22-5 C31H40O3
Piperacilin Piperacilin
	Varenicline Impurity D Varenicline Impurity D 1002359-81-0
2-Propanone, 1-(2-hydroxypropoxy)- (9CI) 2-Propanone, 1-(2-hydroxypropoxy)- (9CI) 90817-38-2 C6H12O3
Nirmatrelvir Impurity 4 Nirmatrelvir Impurity 4
Nifedipine Impurity L Nifedipine Impurity L
2-Pyrrolidinone, 3,4-dihydroxy-5-(hydroxymethyl)-, (3R,4R,5R)- (9CI) 2-Pyrrolidinone, 3,4-dihydroxy-5-(hydroxymethyl)-, (3R,4R,5R)- (9CI) 155102-96-8 C5H9NO4
Bumetanide Impurity 24 Bumetanide Impurity 24
Rocuronium Bromide Impurity 37、38、39 Rocuronium Bromide Impurity 37、38、39
Ritonavir EP Impurity HIJ Ritonavir EP Impurity HIJ
Crisaborole Impurity 42 Crisaborole Impurity 42
2,3-DICHLOROPYRIDINE-5-CARBONYL CHLORIDE 2,3-DICHLOROPYRIDINE-5-CARBONYL CHLORIDE 54127-29-6 C6H2Cl3NO
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
Lasmiditan Impurity 1 Lasmiditan Impurity 1
(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
Olodaterol Impurity 22 Olodaterol Impurity 22
Olodaterol Impurity 25 Olodaterol Impurity 25
Cationic panthenol Cationic panthenol
Benazepril impurity A Benazepril impurity A C24H28N2O5
3S,4R-4-[phenyl-1-methylpiperidinyl] methanol 3S,4R-4-[phenyl-1-methylpiperidinyl] methanol 176022-03-0 C13H19NO
Tazobactam Impurity DBT Tazobactam Impurity DBT
diginatin diginatin 52589-12-5 C41H64O15
Thiophene, 2-(2-fluorophenyl)-5-[(5-iodo-2-methylphenyl)methyl]- Thiophene, 2-(2-fluorophenyl)-5-[(5-iodo-2-methylphenyl)methyl]- 2436275-33-9 C18H14FIS
3-Chloro Avanafil 3-Chloro Avanafil
Revefenacin Impurity 2 Revefenacin Impurity 2 1158699-78-5 C14H17NO4
(R)-2-(4-Methoxyphenyl)-1-methylethanamine (R)-2-(4-Methoxyphenyl)-1-methylethanamine 58993-79-6 C10H15NO
N-[5-[(1RS)-2-[benzyl[(1RS)-2-(4-methoxyphenyl)- 1-methylethyl]amino]-1-hydroxyethyl]-2- hydroxyphenyl]formamide N-[5-[(1RS)-2-[benzyl[(1RS)-2-(4-methoxyphenyl)- 1-methylethyl]amino]-1-hydroxyethyl]-2- hydroxyphenyl]formamide 2514947-17-0 C26H30N2O4
Azelastine Impurity K Azelastine Impurity K
(4R,6R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1- (4R,6R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1-
Carbazochrome Sodium Sulfonate Impurity 1 Carbazochrome Sodium Sulfonate Impurity 1
Rosuvastatin Impurity 147 Rosuvastatin Impurity 147
Febuxostat Impurity 15 Complete Set Febuxostat Impurity 15 Complete Set
Cetrorelix Impurity 10 Cetrorelix Impurity 10
Cetrorelix Impurity 3 (9-D-Pro) Cetrorelix Impurity 3 (9-D-Pro)
Peramivir Intermediate Impurity 42 Peramivir Intermediate Impurity 42
Nintedanib impurity A drops Nintedanib impurity A drops
Tofacitinib impurity N drops Tofacitinib impurity N drops
Carboprost impurity 999 Carboprost impurity 999
Bumetanide impurity C drops Bumetanide impurity C drops
Apixaban Impurity 79 Apixaban Impurity 79
Troxipide Impurity 6 Troxipide Impurity 6
Piperacillin Impurity K Piperacillin Impurity K
2-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzoic acid 2-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzoic acid
3-Thiophenecarboxylic acid, 4-methyl-5-(4-nitrophenyl)-2-[(propoxycarbonyl)amino]-, ethyl ester 3-Thiophenecarboxylic acid, 4-methyl-5-(4-nitrophenyl)-2-[(propoxycarbonyl)amino]-, ethyl ester 2591260-03-4 C18H20N2O6S
Pemetrexed disodium Impurity 32 Pemetrexed disodium Impurity 32
Androsta-1,4-diene-17-carboxylic acid, 11,16,17-trihydroxy-3-oxo-, (11β,16α,17α)- Androsta-1,4-diene-17-carboxylic acid, 11,16,17-trihydroxy-3-oxo-, (11β,16α,17α)- 1185143-75-2 C20H26O6
(3R,5R)-7-(1-((3R,5R)-6-carboxy-3,5-dihydroxyhexyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoic acid (3R,5R)-7-(1-((3R,5R)-6-carboxy-3,5-dihydroxyhexyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoic acid
Tazobactam Impurity LTE Tazobactam Impurity LTE
Isavuconazole Impurity 47 Isavuconazole Impurity 47
5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-(benzyloxy)quinolin-2(1H)-one) 5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-(benzyloxy)quinolin-2(1H)-one) 753498-27-0 C49H49N3O6
2-((6S,8S,9S,10R,11S,13S,14S,17S)-11-hydroxy-6,10,13-trimethyl-3-oxo- 6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxoacetic acid 2-((6S,8S,9S,10R,11S,13S,14S,17S)-11-hydroxy-6,10,13-trimethyl-3-oxo- 6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxoacetic acid
	Eltrombopag Impurity 37 Eltrombopag Impurity 37 350024-70-3 C14H18N2O
(S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-((2-hydroxyethyl)sulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide (S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-((2-hydroxyethyl)sulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide C23H26N2O8S
2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropan-1-ol 2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropan-1-ol C28H39N3O2
Tafluprost Impurity 20 Tafluprost Impurity 20
Rosuvastatin Impurity 149 Rosuvastatin Impurity 149
2-CHLOROMETHYL-5-TRIFLUOROMETHYL-[1,3,4]OXADIAZOLE 2-CHLOROMETHYL-5-TRIFLUOROMETHYL-[1,3,4]OXADIAZOLE 723286-98-4 C4H2ClF3N2O
Rifampicin Quinone Oxide Rifampicin Quinone Oxide
1-(2-(4-(((2-(4-(([1,1'-biphenyl]-2-ylcarbamoyl)oxy)piperidin-1-yl)ethyl)(methyl)amino)methyl)-N-methylbenzamido)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 1-(2-(4-(((2-(4-(([1,1'-biphenyl]-2-ylcarbamoyl)oxy)piperidin-1-yl)ethyl)(methyl)amino)methyl)-N-methylbenzamido)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate
1-Phenyl-3,4-dihydroisoquinoline 1-Phenyl-3,4-dihydroisoquinoline 52250-50-7 C15H13N
Pyrazinecarboxamide, 3,6-difluoro- (9CI) Pyrazinecarboxamide, 3,6-difluoro- (9CI) 356783-29-4 C5H3F2N3O
Benzamide, 3-hydrazino- (9CI) Benzamide, 3-hydrazino- (9CI) 473927-51-4 C7H9N3O
N-Deshydroxyethyl Dasatinib N-Deshydroxyethyl Dasatinib 910297-51-7 C20H22ClN7OS
N-Desethyl Sunitinib N-Desethyl Sunitinib 356068-97-8 C20H23FN4O2
6-(4-{2-[5-(tert-Butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 6-(4-{2-[5-(tert-Butyl-dimethyl-silanyloxy)-2-methylene-cyclohexylidene]-ethylidene}-7a-methyl-octahydro-inden-1-yl)-2-methyl-heptan-2-ol 140710-90-3 C33H58O2Si
2-chloro-N-(4-ethoxyphenyl)-4-nitrobenzamide 2-chloro-N-(4-ethoxyphenyl)-4-nitrobenzamide 328258-90-8 C15H13ClN2O4
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