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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 51 Apixaban Impurity 51 1620494-29-2 C33H32N4O5
4-(5-methyl-2-phenyloxazol-4-yl)benzenesulfonamide 4-(5-methyl-2-phenyloxazol-4-yl)benzenesulfonamide 2242749-01-3 C16H14N2O3S
Cefazolin Impurity EP-I Cefazolin Impurity EP-I
Cabozantinib impurity 42 Cabozantinib impurity 42
Cabozantinib impurity 55 Cabozantinib impurity 55
Canagliflozin Impurity 68 Canagliflozin Impurity 68
Dapoxetine impurity 51 Dapoxetine impurity 51
Doxofylline Impurity 20 Doxofylline Impurity 20
Dapoxetine impurity 64 Dapoxetine impurity 64
Dapoxetine impurity 58 Dapoxetine impurity 58
4-(DICHLOROMETHYL)BENZONITRILE 4-(DICHLOROMETHYL)BENZONITRILE 74231-65-5 C8H5Cl2N
3-(4-FLUORO-PHENYL)-1-ISOPROPYL-1H-INDOLE-2-CARBALDEHYDE 3-(4-FLUORO-PHENYL)-1-ISOPROPYL-1H-INDOLE-2-CARBALDEHYDE 101125-34-2 C18H16FNO
3,4-DIMETHOXY-2-HYDROXYBENZALDEHYDE 3,4-DIMETHOXY-2-HYDROXYBENZALDEHYDE 19283-70-6 C9H10O4
Brivaracetam Impurity 55 Brivaracetam Impurity 55
alpha-(4-chlorophenyl)-alpha-[2-(dimethylamino)ethyl]pyridine-2-acetonitrile alpha-(4-chlorophenyl)-alpha-[2-(dimethylamino)ethyl]pyridine-2-acetonitrile 65676-21-3 C17H18ClN3
Baloxavir Impurity ABCDEFGHJKL Baloxavir Impurity ABCDEFGHJKL
1H-Pyrrole-3-methanamine, 5-(2-fluorophenyl)-N-[[5-(2-fluorophenyl)-1H-pyrrol-3-yl]methyl]- 1H-Pyrrole-3-methanamine, 5-(2-fluorophenyl)-N-[[5-(2-fluorophenyl)-1H-pyrrol-3-yl]methyl]- 2514724-36-6 C22H19F2N3
scopoline scopoline 487-27-4 C8H13NO2
4-PYRIDIN-4-YL-BUTYRIC ACID 4-PYRIDIN-4-YL-BUTYRIC ACID 102878-73-9 C9H11NO2
N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide 1474-02-8 C21H26N2O
Oseltamivir Impurity 106 Oseltamivir Impurity 106
Oseltamivir  Impurity 85 Oseltamivir Impurity 85
Oseltamivir  Impurity 83 Oseltamivir Impurity 83
Oseltamivir  Impurity 75 Oseltamivir Impurity 75
[1,1'-bicyclohexyl]-1-carboxylic acid [1,1'-bicyclohexyl]-1-carboxylic acid 60263-54-9 C13H22O2
3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-6-(dimethylamino)- 3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-6-(dimethylamino)- 2626934-45-8 C25H30Cl2N6OS2
Dapagliflozin Impurity 49 Dapagliflozin Impurity 49
11-[3-(dimethylamino)propyl]-6,11-dihydrodibenz[b,e]oxepin-11-ol 11-[3-(dimethylamino)propyl]-6,11-dihydrodibenz[b,e]oxepin-11-ol 4504-88-5 C19H23NO2
Avatrombopag Impurity ABCDEFGHJKL Avatrombopag Impurity ABCDEFGHJKL
1-(2-chloroethyl)-3-(dicyclopropylmethyl)urea 1-(2-chloroethyl)-3-(dicyclopropylmethyl)urea 54187-03-0 C10H17ClN2O
1,3-Dioxane-4-acetic acid, 6-[2-[3-[[[2-[(4R,6R)-6-[2-(1,1-dimethylethoxy)-2-oxoethyl]-2,2-dimethyl-1,3-dioxan-4-yl]ethyl]amino]carbonyl]-5-(4-fluorophenyl)-2-(1-methylethyl)-4-phenyl-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, 1,1-dimethylethyl ester, (4R,6R)- 1,3-Dioxane-4-acetic acid, 6-[2-[3-[[[2-[(4R,6R)-6-[2-(1,1-dimethylethoxy)-2-oxoethyl]-2,2-dimethyl-1,3-dioxan-4-yl]ethyl]amino]carbonyl]-5-(4-fluorophenyl)-2-(1-methylethyl)-4-phenyl-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, 1,1-dimethylethyl ester, (4R,6R)- 1229658-18-7 C48H67FN2O9
1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, 1,1-dimethylethyl ester, (βS,δR)- 1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, 1,1-dimethylethyl ester, (βS,δR)- 2588261-38-3 C37H43FN2O5
3-hydroxy-2,4-dimethoxybenzaldehyde 3-hydroxy-2,4-dimethoxybenzaldehyde 32246-34-7 C9H10O4
butyl 3-aminosulphonyl-5-butylamino-4-phenoxybenzoate butyl 3-aminosulphonyl-5-butylamino-4-phenoxybenzoate 32643-00-8 C21H28N2O5S
11beta,16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione 11beta,16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione 1171-81-9 C21H30O6
trans-2-amino-N-(4-hydroxycyclohexyl)benzamide trans-2-amino-N-(4-hydroxycyclohexyl)benzamide 15942-11-7 C13H18N2O2
4-O-(Carboxymethyl)rifamycin 4-O-(Carboxymethyl)rifamycin 13929-35-6 C39H49NO14
ethyl 3,5-bis(benzyloxy)benzoate ethyl 3,5-bis(benzyloxy)benzoate 50841-46-8 C23H22O4
Oxytocin oxide impurity reference substance Oxytocin oxide impurity reference substance
Troxipide Impurity 7 Troxipide Impurity 7
Avatrombopag Impurity 44 Avatrombopag Impurity 44
Bendamustine Impurity 37A Bendamustine Impurity 37A
Bimatoprost Impurity 23 Bimatoprost Impurity 23
Oxacillin Impurity IMPA Oxacillin Impurity IMPA
Rebamipide Impurity X(Rebamipide Impurity 7) Rebamipide Impurity X(Rebamipide Impurity 7)
(1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
Acetic acid, 2-[(4-oxo-2-phenyl-4H-1-benzopyran-7-yl)oxy]-, methyl ester Acetic acid, 2-[(4-oxo-2-phenyl-4H-1-benzopyran-7-yl)oxy]-, methyl ester 27654-54-2 C18H14O5
sodium 1-(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)ethane-1-sulfonate sodium 1-(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)ethane-1-sulfonate
Pyrimidine, 4,6-dichloro-5-nitroso-2-(propylthio)- Pyrimidine, 4,6-dichloro-5-nitroso-2-(propylthio)- 2512210-19-2 C7H7Cl2N3OS
5-Pyrimidinamine, 4,6-dichloro-N-hydroxy-2-(propylthio)- 5-Pyrimidinamine, 4,6-dichloro-N-hydroxy-2-(propylthio)- 2517939-84-1 C7H9Cl2N3OS
(R)-4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)benzenediazonium   tetrafluoroborate (R)-4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)benzenediazonium tetrafluoroborate 1630761-21-5 C11H11N4O+
8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 1-oxide 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 1-oxide
N-acetyl-β-D-glucosidase N-acetyl-β-D-glucosidase
2-(4-carboxypiperidin-1-yl)-3-chloro-5-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)pyridine 1-oxide 2-(4-carboxypiperidin-1-yl)-3-chloro-5-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)pyridine 1-oxide
Brivaracetam Impurity 50 Brivaracetam Impurity 50
6-Hydroxymoxifloxacin Impurities 6-Hydroxymoxifloxacin Impurities
(S)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid (S)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid
1,3-bis(5-bromo-2-methoxyphenyl)adamantane 1,3-bis(5-bromo-2-methoxyphenyl)adamantane 932033-56-2 C24H26Br2O2
(S)-dimethyl 2-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioate (S)-dimethyl 2-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioate 67676-60-2 C22H27ClN8O5
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-[[[5-(hydroxymethyl)-2-furanyl]methylene]amino]-, ethyl ester, (3S,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-[[[5-(hydroxymethyl)-2-furanyl]methylene]amino]-, ethyl ester, (3S,4R,5S)- 2413185-90-5 C22H32N2O6
2-Pyrazinecarboxylic acid, 6-methyl-, 4-oxide 2-Pyrazinecarboxylic acid, 6-methyl-, 4-oxide 51037-31-1 C6H6N2O3
tert-butyl (3R,5R)-7-(1-((3R,5R)-7-(tert-butoxy)-3,5-dihydroxy-7-oxoheptyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoate tert-butyl (3R,5R)-7-(1-((3R,5R)-7-(tert-butoxy)-3,5-dihydroxy-7-oxoheptyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoate
Furoxine GSK Open Ring Impurity Furoxine GSK Open Ring Impurity
4-Piperidinecarboxylic acid, 1-[3-chloro-5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-4-oxido-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-2-pyridinyl]- 4-Piperidinecarboxylic acid, 1-[3-chloro-5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-4-oxido-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-2-pyridinyl]- 2681355-40-6 C29H34Cl2N6O4S2
Isavuconazole Impurity 48 Isavuconazole Impurity 48
5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-hydroxyquinolin-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-hydroxyquinolin-2(1H)-one)
(4-hydroxy-1-(hydroxymethyl)-7-phenoxyisoquinoline-3-carbonyl)glycine (4-hydroxy-1-(hydroxymethyl)-7-phenoxyisoquinoline-3-carbonyl)glycine
(S)-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-5-nitroisoindoline-1,3-dione (S)-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-5-nitroisoindoline-1,3-dione C20H20N2O8S
2-(4-(2-(4-(1-(2-methoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid 2-(4-(2-(4-(1-(2-methoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid C27H35N3O3
Tafluprost Impurity 19 Tafluprost Impurity 19
Rosuvastatin Impurity 162 Rosuvastatin Impurity 162
Rosuvastatin Impurity 151 Rosuvastatin Impurity 151
Rosuvastatin Impurity 148 Rosuvastatin Impurity 148
FUROSEMIDE ACYL-B-D-GLUCURONIDE FUROSEMIDE ACYL-B-D-GLUCURONIDE 72967-59-0 C18H19ClN2O11S
Digoxin Impurity 1 Digoxin Impurity 1
CetearylGlucosideCetearyl Glucoside CetearylGlucosideCetearyl Glucoside 246159-33-1
Bisoprolol Impurity 40 Bisoprolol Impurity 40
2H-Naphtho[1,2-b]pyran-6-ol, 2,5-dimethyl-2-[(3E,7E)-4,8,12-trimethyl-3,7,11-tridecatrienyl]- (9CI) 2H-Naphtho[1,2-b]pyran-6-ol, 2,5-dimethyl-2-[(3E,7E)-4,8,12-trimethyl-3,7,11-tridecatrienyl]- (9CI) 65941-19-7 C31H40O2
Amifostine Impurity 15 Amifostine Impurity 15 10297-31-1 C7H17Br3N2
Doxylamine Impurity G Doxylamine Impurity G
2,4-Pyrimidinediol, 6-chloro- (9CI) 2,4-Pyrimidinediol, 6-chloro- (9CI) 107577-09-3 C4H3ClN2O2
2,4-Pyrimidinediol, 6-chloro- (9CI) 2,4-Pyrimidinediol, 6-chloro- (9CI) 107577-09-3 C4H3ClN2O2
[1,1'-Biphenyl]-3,3'-dicarboxamide, 6,6'-diamino-5-chloro-N3,N3'-bis[2-(diethylamino)ethyl]-2,4'-dimethoxy- [1,1'-Biphenyl]-3,3'-dicarboxamide, 6,6'-diamino-5-chloro-N3,N3'-bis[2-(diethylamino)ethyl]-2,4'-dimethoxy- 1242047-99-9 C28H43ClN6O4
Phenoxymethylpenicillin Potassium Impurity 8 Phenoxymethylpenicillin Potassium Impurity 8
Bumetanide Impurity 23 Bumetanide Impurity 23
Rocuronium Bromide Impurity 34、35、36 Rocuronium Bromide Impurity 34、35、36
Vinpocetine impurity C Vinpocetine impurity C 70155-05-4 C23H28N2O3
Cloxacillin Impurity X Cloxacillin Impurity X
Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl- 2649802-40-2 C21H15F4N5OS2
1-(4-((2-(4-hydroxypiperidin-1-yl)ethyl)(methyl)carbamoyl)benzyl)piperidine-4-carboxamide 1-(4-((2-(4-hydroxypiperidin-1-yl)ethyl)(methyl)carbamoyl)benzyl)piperidine-4-carboxamide
Azilsartan Impurity 107 Azilsartan Impurity 107
Perospirone Impurity 25 Perospirone Impurity 25
Paxlovid Impurity 16 Paxlovid Impurity 16
3-(2-(cyclopent-1-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide 3-(2-(cyclopent-1-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
	Fondaparinux sodium impurity 17 Fondaparinux sodium impurity 17
Valdecoxib N-Oxide Valdecoxib N-Oxide
Olodaterol Impurity 23 Olodaterol Impurity 23
	Miglitol Isomer impurities C Miglitol Isomer impurities C
8-(2,3-dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium bromide 8-(2,3-dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium bromide 2043655-58-7 C14H19Cl3N2
Alpha-D-Methylglucoside Alpha-D-Methylglucoside
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