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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
Febuxostat Impurity 42 Febuxostat Impurity 42
Pregabalin Impurity 11 Pregabalin Impurity 11 2375259-86-0 C8H16ClNO2
Ticagrelor Impurity 44 Ticagrelor Impurity 44
Exemestane Impurity 2 Exemestane Impurity 2
Empagliflozin Impurity 4 Empagliflozin Impurity 4
Moxifloxacin Impurity 14 Moxifloxacin Impurity 14
2-Benzothiazolamine 2-Benzothiazolamine
Cefodizime Impurity E Cefodizime Impurity E
Penicillin Impurity C Penicillin Impurity C
Cefminox Sodium impurity C Cefminox Sodium impurity C
Cefotiam Impurity C Cefotiam Impurity C
Dequalinium EP Impurity B Dequalinium EP Impurity B 747387-02-6 C30H40N4+2
Peramivir Impurity F Peramivir Impurity F
1-{[4-BENZYL-2-(3,4-DIMETHOXYPHENYL)-4H-CHROMEN-3-YL]METHYL}PIPERIDINIUM CHLORIDE 1-{[4-BENZYL-2-(3,4-DIMETHOXYPHENYL)-4H-CHROMEN-3-YL]METHYL}PIPERIDINIUM CHLORIDE C30H34ClNO3
4-Hydroxyisophthalonitrile 4-Hydroxyisophthalonitrile 34133-58-9 C8H4N2O
Empagliflozin Impurity 81 Empagliflozin Impurity 81
Iohexol Impurity M Iohexol Impurity M
Relugolix Impurity 18 Relugolix Impurity 18
1,2-Benzenediol, 4-(1-hydroxyethyl)- 1,2-Benzenediol, 4-(1-hydroxyethyl)- 37491-94-4 C8H10O3
Acetamide, 2-(diethylamino)-N-(3,4-dimethylphenyl)- Acetamide, 2-(diethylamino)-N-(3,4-dimethylphenyl)- 3213-16-9 C14H22N2O
(trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'- biphenyl]-4-yl)piperidine (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'- biphenyl]-4-yl)piperidine 1217975-87-5 C25H24FNO3
AMOXICILLIN TRIHYDRATE IMP. E (EP): (2RS,4S)-2-[[[(2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL]AMINO]METHYL]-5,5-DIMETHYLTHIAZOLIDINE-4-CARBOXYLIC ACID (PENILLOIC ACIDS OF AMOXICILLIN) AMOXICILLIN TRIHYDRATE IMP. E (EP): (2RS,4S)-2-[[[(2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL]AMINO]METHYL]-5,5-DIMETHYLTHIAZOLIDINE-4-CARBOXYLIC ACID (PENILLOIC ACIDS OF AMOXICILLIN)
4-CHLORO-7-(2-CHLORO-ETHOXY)-6-(2-METHOXY-ETHOXY)-QUINAZOLINE 4-CHLORO-7-(2-CHLORO-ETHOXY)-6-(2-METHOXY-ETHOXY)-QUINAZOLINE 183322-20-5 C13H14Cl2N2O3
METHYL 2-(O-NITROBENZYLIDENE)-ACETOACETATE METHYL 2-(O-NITROBENZYLIDENE)-ACETOACETATE 39562-27-1 C12H11NO5
Sugammadex sodium Impurity 48 Sugammadex sodium Impurity 48
Sugammadex sodium Impurity 47 Sugammadex sodium Impurity 47
Tenofovir Impurity 95 Tenofovir Impurity 95 1884329-63-8 C8H10BrN5
Tenofovir Impurity 117 Tenofovir Impurity 117 1643116-22-6 C8H11N5O
Tafluprost Impurity E Tafluprost Impurity E
Cabozantinib impurity 36 Cabozantinib impurity 36
Apigenin 7-O-(2'',6''-di-O-E-p-coumaroyl)glucoside Apigenin 7-O-(2'',6''-di-O-E-p-coumaroyl)glucoside 1448779-19-8 C39H32O14
Dapoxetine impurity 69 Dapoxetine impurity 69
4-FLUORO-2-METHYLBENZAMIDE 4-FLUORO-2-METHYLBENZAMIDE 886501-45-7 C8H8FNO
Rabeprazole Impurity 15 Rabeprazole Impurity 15
4-((2-amino-2-oxoethyl)(hydroxy)amino)butanoic acid 4-((2-amino-2-oxoethyl)(hydroxy)amino)butanoic acid 2454698-45-2 C6H12N2O4
Lenvatinib Impurity LFZZ-8 Lenvatinib Impurity LFZZ-8 C44H40Cl2N8O8
Pemetrexed disodium Impurity 19 Pemetrexed disodium Impurity 19
Brivaracetam Impurity 32 Brivaracetam Impurity 32
Apixaban Impurity 56 Apixaban Impurity 56 2444918-46-9 C15H19N3O2
1-((2R,3R)-3-(4-(aminomethyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride 1-((2R,3R)-3-(4-(aminomethyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride
Ticagrelor Impurity 107 Ticagrelor Impurity 107
2-Thiazolamine, 5-bromo-4-(5-bromo-4-chloro-2-thienyl)- 2-Thiazolamine, 5-bromo-4-(5-bromo-4-chloro-2-thienyl)- 2401867-89-6 C7H3Br2ClN2S2
Carbamic acid, N-[1,1'-biphenyl]-2-yl-, 1-[2-[[4-(hydroxymethyl)benzoyl]methylamino]ethyl]-4-piperidinyl ester Carbamic acid, N-[1,1'-biphenyl]-2-yl-, 1-[2-[[4-(hydroxymethyl)benzoyl]methylamino]ethyl]-4-piperidinyl ester 1682660-39-4 C29H33N3O4
sodium 3-(4-((1H-imidazol-1-yl)methyl)phenyl)-3-hydroxypropanoate sodium 3-(4-((1H-imidazol-1-yl)methyl)phenyl)-3-hydroxypropanoate
(4S,6R)-((4R,6S)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)methyl 6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylate (4S,6R)-((4R,6S)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)methyl 6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylate
tert-butyl 2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-2-methyl-4- oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methyl propanoate tert-butyl 2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-2-methyl-4- oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methyl propanoate
Atomoxetine Impurity 15 Atomoxetine Impurity 15 881995-45-5 C19H23NO2
Pitavastatin Impurity 13 (Pitavastatin 2,4,6-Triene Impurity) Pitavastatin Impurity 13 (Pitavastatin 2,4,6-Triene Impurity) 2086271-67-0 C25H20FNO2
(2S,5R)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2- carboxylic acid sodium (2S,5R)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2- carboxylic acid sodium
impurity 39 impurity 39
(2R,3R,4R,5S)-6-((2,4-dibromo-6-((cyclohexyl(methyl)amino)methyl)phenyl)amino)hexane-1,2,3,4,5-pentaol (2R,3R,4R,5S)-6-((2,4-dibromo-6-((cyclohexyl(methyl)amino)methyl)phenyl)amino)hexane-1,2,3,4,5-pentaol
Bosutinib Impurity 32 Bosutinib Impurity 32
6,6'-Methylenebis[1,2,3,9-tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one 6,6'-Methylenebis[1,2,3,9-tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one 1365727-09-8 C29H26N2O2
Ampicillin Dimer Disodium Salt Ampicillin Dimer Disodium Salt 94730-51-5 C32H39N6NaO8S2
Anastrozole EP Impurity I Anastrozole EP Impurity I 120511-91-3 C15H17ClN2
Anastrozole EP Impurity I Anastrozole EP Impurity I 120511-91-3 C15H17ClN2
(2R,5S)-5-(3,4-Dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid  (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester (2R,5S)-5-(3,4-Dihydro-2,4-dioxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester 389128-28-3 C18H26N2O5S
Everolimus impurity F Everolimus impurity F
Ceftriaxone Sodium impurity 4 Ceftriaxone Sodium impurity 4
Sugammadex sodium Hepta-Iodine Impurity Sugammadex sodium Hepta-Iodine Impurity
Abitrone project impurity Abitrone project impurity
105981-34-8 105981-34-8 105981-34-8 C15H22N4S
1364671-52-2 1364671-52-2 1364671-52-2 C19H19ClN6O3S
1627504-43-1 1627504-43-1 1627504-43-1 C14H14ClN7
Pramipexole Impurity Q Pramipexole Impurity Q
Aprepitant Impurity 42 Aprepitant Impurity 42 172678-47-6 C20H18F7NO2
Efinaconazole Related Impurity 13 Efinaconazole Related Impurity 13 2055912-03-1 C24H32FN5O
DexMedetoMidine IMpurity 17 DexMedetoMidine IMpurity 17
Sofosbuvir IMpurity 21 Sofosbuvir IMpurity 21 2138483-01-7 C17H17FN2O6
Moxifloxacin Impurity 1 Moxifloxacin Impurity 1
Moxifloxacin Impurity 22 Moxifloxacin Impurity 22
Linagliptin Impurity F Linagliptin Impurity F
Trelagliptin Impurity 4 Trelagliptin Impurity 4
Fudosteine Impurity 1 Fudosteine Impurity 1
Sugammadex Impurity 17 Sugammadex Impurity 17 2414905-36-3 C82H120NaO48PS7
Apixaban Impurity 28 Apixaban Impurity 28 2208275-54-9
Fluvastatin EP Impurity E Fluvastatin EP Impurity E C24H26FNO4
Oseltamivir Impurity 24 Oseltamivir Impurity 24
(3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate) (3S,3'S,4R,4'R)-diphenyl 3,3'-(oxybis(methylene))bis(4-(4- fluorophenyl)piperidine-1-carboxylate) C38H38F2N2O5
Nettopitan impurity Nettopitan impurity
Afatinib Impurity 74 Afatinib Impurity 74 1259015-90-1 C7H13NO2
Carboprost Impurity 1 Carboprost Impurity 1
Beraprost Impurity 1 Beraprost Impurity 1
Benzenebutanoic acid, β-amino-2,5-difluoro-, (βR)- Benzenebutanoic acid, β-amino-2,5-difluoro-, (βR)- 936630-56-7 C10H11F2NO2
Cyclopropanecarboxylic acid, 1-[[(2-fluorophenyl)amino]carbonyl]- Cyclopropanecarboxylic acid, 1-[[(2-fluorophenyl)amino]carbonyl]- 918642-61-2 C11H10FNO3
Isavuconazole Impurity 34 Isavuconazole Impurity 34
PREDNICARBATE IMPURITY F PREDNICARBATE IMPURITY F
2-Propanol, 1,1'-[methylenebis(4,1-phenyleneoxy)]bis[3-[(1-methylethyl)amino]- 2-Propanol, 1,1'-[methylenebis(4,1-phenyleneoxy)]bis[3-[(1-methylethyl)amino]- 1225195-70-9 C25H38N2O4
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2031272-32-7 C47H40N4O4
(4R,5S,6S)-3-[[(3S,5S)-1-[(4-Aminophenyl)methyl]-5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-Azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid Sodium Salt (4R,5S,6S)-3-[[(3S,5S)-1-[(4-Aminophenyl)methyl]-5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-Azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid Sodium Salt 866186-66-5 C29H33N4NaO7S
(R)-cis-5ξ-Methyl Atracurium Dibesylate (R)-cis-5ξ-Methyl Atracurium Dibesylate 1193104-82-3 C60H79N2O15S+
2-(((Z)-(1-(2-Aminothiazol-4-yl)-2-(((2R,3R)-2-methyl-4-oxo-1-sulfoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic Acid 2-(((Z)-(1-(2-Aminothiazol-4-yl)-2-(((2R,3R)-2-methyl-4-oxo-1-sulfoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic Acid C13H17N5O8S2
7-[4-[2-[[[4-(3-Carboxy-6-fluoro-1-methyl-4-oxo-1H,4H-[1,3]thiazeto[3,2-a]quinolin-7-yl)-1-piperazinyl]carbonyl]oxy]-3-oxobutyl]-1-piperazinyl]-6-fluoro-1-methyl-4-oxo-1H,4H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic acid 7-[4-[2-[[[4-(3-Carboxy-6-fluoro-1-methyl-4-oxo-1H,4H-[1,3]thiazeto[3,2-a]quinolin-7-yl)-1-piperazinyl]carbonyl]oxy]-3-oxobutyl]-1-piperazinyl]-6-fluoro-1-methyl-4-oxo-1H,4H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic acid 156834-58-1 C37H36F2N6O9S2
(6R,7S)-7-ACCA (6R,7S)-7-ACCA 108260-07-7 C7H7ClN2O3S
Enrofloxacin Impurity 1 Enrofloxacin Impurity 1 1128234-60-5 C19H22ClN3O3
Peramivir Impurity 20 Peramivir Impurity 20
Ambroxol Impurity 33 Ambroxol Impurity 33 199472-91-8 C13H20N2O
Bilastine Impurity 12 Bilastine Impurity 12 1638785-18-8 C30H42N4O3
Tadalafil Impurity 66 Tadalafil Impurity 66 1598416-07-9 C21H18N2O5
Peramivir Impurity 36 Peramivir Impurity 36
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