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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
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)
(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
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one 3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one 153139-56-1 C16H20N2O
Roxithromycin Impurity K Roxithromycin Impurity K
Bepotastine N-Oxide Impurity Bepotastine N-Oxide Impurity
Nintedanib Impurity 25 Nintedanib Impurity 25
Tripterygium glycosides Tripterygium glycosides
Digoxin Impurity 1 Digoxin Impurity 1
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
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
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
Fondaparinux sodium impurity 12 Fondaparinux sodium impurity 12
Piperacillin impurity L Piperacillin impurity L
Piperacillin  Impurity X Piperacillin Impurity X
ETHYLTRITYLETHER ETHYLTRITYLETHER 968-39-8 C21H20O
Bosutinib Impurity 41 Bosutinib Impurity 41
(S)-3-Dimethylamino-3-phenylpropanol (S)-3-Dimethylamino-3-phenylpropanol 82769-75-3 C11H17NO
ethyl 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5- carboxylate 2230270-05-8 C18H20N2O3S
Cefminox Sodium Impurity 6 Cefminox Sodium Impurity 6
Flurbiprofen Impurity 7 Flurbiprofen Impurity 7
Imidafenacin Impurity 8 Imidafenacin Impurity 8 503598-05-8 C20H21N3O3
Pregabalin Impurity E Pregabalin Impurity E 1239692-16-0 C11H24ClNO2
Rosuvastatin Impurity 86 Rosuvastatin Impurity 86
Cefathiamidine Impurity 8 Cefathiamidine Impurity 8
Urapidil impurity 7 Urapidil impurity 7 108997-11-1 C24H34N4O2
methyl 3-[[4-chloro-2-(phenylamino)phenyl]methylamino]-3-oxopropanoate. methyl 3-[[4-chloro-2-(phenylamino)phenyl]methylamino]-3-oxopropanoate. 2089061-92-5 C17H17ClN2O3
Pregabalin Impurity 15 Pregabalin Impurity 15
Pregabalin Impurity 32 Pregabalin Impurity 32
4-Hydroxyphthalic Acid 4-Hydroxyphthalic Acid 501666-22-4 C14H25NO6
(RS)-3-tert-butyl 4-ethyl thiazolidine-3,4-dicarboxylate (RS)-3-tert-butyl 4-ethyl thiazolidine-3,4-dicarboxylate C11H19NO4S
Linagliptin Impurity 53 Linagliptin Impurity 53
Nintedanib Impurity 52 Nintedanib Impurity 52 2410284-89-6 C22H30N6O2
Olaparib Impurity 21 Olaparib Impurity 21
Oseltamivir Impurity 43 Oseltamivir Impurity 43
Osimertinib Impurity 3 Osimertinib Impurity 3
Rosuvastatin Impurity 48 Rosuvastatin Impurity 48
Sildenafil Impurity 37 Sildenafil Impurity 37 C22H30N6O4S
Sitagliptin Impurity 80 Sitagliptin Impurity 80
Teneligliptin Impurity 2 Teneligliptin Impurity 2
Ticagrelor Impurity 104 Ticagrelor Impurity 104
Ticagrelor Impurity 95 Ticagrelor Impurity 95
Tofacitinib Impurity 120 Tofacitinib Impurity 120
Vildagliptin Impurity 46 Vildagliptin Impurity 46
Carbocistein Impurity C Carbocistein Impurity C
(2S,4R)-N-((2S,3S,4S)-1-(((2S,3R)-5-amino-1 (2S,4R)-N-((2S,3S,4S)-1-(((2S,3R)-5-amino-1
Erythromycin Impurity 4 Erythromycin Impurity 4
Itraconazole iMpurity 5 Itraconazole iMpurity 5
Trelagliptin Impurity 15 Trelagliptin Impurity 15
Sofosbuvir Impurity 57 Sofosbuvir Impurity 57
Celecoxib Impurity 6 Celecoxib Impurity 6 C17H14F3N3O2S
Emtricitabine Impurity 6 Emtricitabine Impurity 6
Erlotinib Impurity 26 Erlotinib Impurity 26
Fosaprepitant Impurity 5 Fosaprepitant Impurity 5
Dapoxetine Impurity 5 Dapoxetine Impurity 5 1181810-25-2 C19H16O
Regorafenib Impurity 10 Regorafenib Impurity 10
Bosutinib Impurity 7 Bosutinib Impurity 7
Ticagrelor Impurity 12 Ticagrelor Impurity 12
Ticagrelor Impurity 63 Ticagrelor Impurity 63 2227766-79-0 C9H9ClFN
Canagliflozin Impurity 5 Canagliflozin Impurity 5
Canagliflozin Impurity 15 Canagliflozin Impurity 15
N-(2-HYDROXYETHYL)ISONICOTINAMIDE, 99 N-(2-HYDROXYETHYL)ISONICOTINAMIDE, 99 6265-74-3 C8H10N2O2
BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER) BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER) 103129-58-4 C26H32N2O5
CLOPIDOGREL  RELATED  COMPOUND  C  (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE,  HYDROGEN SUL- FATE) CLOPIDOGREL RELATED COMPOUND C (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE, HYDROGEN SUL- FATE) 120202-71-3 C16H18ClNO6S2
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