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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
Cabozantinib impurity L Cabozantinib impurity L
Gadobutrol Impurity 2 Gadobutrol Impurity 2 2447549-29-1
Pemetrexed disodium EP Impurity C Pemetrexed disodium EP Impurity C
Crisaborole Impurity 6 Crisaborole Impurity 6
Olprinone Impurity E Olprinone Impurity E
Nicorandil Impurity D Nicorandil Impurity D
Propyphenazone EP impurity C Propyphenazone EP impurity C 2731375-50-9 C17H24N2O
Vardenafil Impurity 15 Vardenafil Impurity 15 448184-54-1 C19H23N5O6S
Etoricoxib N'-Oxide Etoricoxib N'-Oxide 325855-71-8 C18H15ClN2O3S
Oseltamivir Oseltamivir 651324-07-1 C26H44N2O4
Flucloxacillin Impurity 2 Flucloxacillin Impurity 2
Cefminox Impurity 4 Cefminox Impurity 4
Adefovir Impurity 4 Adefovir Impurity 4
Febuxostat Impurity 69 Febuxostat Impurity 69
Furosemide Impurity 16 Furosemide Impurity 16 133989-65-8 C12H12N2O6S
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 2803375-40-6 C30H32O5S2
Oseltamivir Impurity 31 Oseltamivir Impurity 31
Riociguat IMpurtiy C Riociguat IMpurtiy C
Aclidinium Bromide Impurity 1 Aclidinium Bromide Impurity 1
Ampicillin Impurity 7 Ampicillin Impurity 7
Meropenem impurity diastereomer 1 Meropenem impurity diastereomer 1 96035-27-7 C15H19N3O5S
methyl 4-hydroxy-6-phenoxyisoquinoline-3-carboxylate methyl 4-hydroxy-6-phenoxyisoquinoline-3-carboxylate 1509958-11-5 C17H13NO4
Palbociclib-012 Palbociclib-012 2206135-30-8 C41H55N11O5
(3S,4S)-3-(β-D-Glucopyranosyloxy)dihydro-3,4-bis[(4-hydroxy-3-methoxyphenyl)methyl]-2(3H)-furanone (3S,4S)-3-(β-D-Glucopyranosyloxy)dihydro-3,4-bis[(4-hydroxy-3-methoxyphenyl)methyl]-2(3H)-furanone 858127-38-5 C26H32O12
Tigecycline Impurity E Tigecycline Impurity E
Cefminox Impurity B Cefminox Impurity B
isopropyl 4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl) benzenesulfonate isopropyl 4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl) benzenesulfonate C20H19F3N2O3S
1-Ethyl-2-[[(2-methoxy-5-sulphamoyl 1-Ethyl-2-[[(2-methoxy-5-sulphamoyl
2-(4-Bromo-3-formylphenoxy)-benzonitrile 2-(4-Bromo-3-formylphenoxy)-benzonitrile 1160182-46-6 C14H8BrNO2
Carbetocin S-Oxide I Carbetocin S-Oxide I
Dolutegravir Impurity 15 Dolutegravir Impurity 15
1-(4-NITRO-PHENYL)-1H-PYRIDIN-2-ONE 1-(4-NITRO-PHENYL)-1H-PYRIDIN-2-ONE 53427-97-7 C11H8N2O3
5'-(2-cyanophenyl)-6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridine] 1-oxide 5'-(2-cyanophenyl)-6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridine] 1-oxide 380919-67-5 C23H15N3O2
Empagliflozin Impurity 86 Empagliflozin Impurity 86
Olopatadine Impurity 11 HBr Olopatadine Impurity 11 HBr 4174-84-9 C21H24Br2NP
Iohexol Impurity P Iohexol Impurity P
Avibactam sodium Impurity CEA Avibactam sodium Impurity CEA
Sulbactam Impurity 2 Sulbactam Impurity 2 111790-24-0 C8H13NO6S
Vortioxetine Impurity 8 HCl Vortioxetine Impurity 8 HCl 2137722-14-4 C18H23ClN2S
Relugolix Impurity 1 Relugolix Impurity 1 3009131-53-4
Oseltamivir Diastereomer III HCl Oseltamivir Diastereomer III HCl 2413185-95-0 C16H28N2O4
Rocuronium bromide impurity (3,16,17-triol) Rocuronium bromide impurity (3,16,17-triol) C23H39NO4
4-(4-amino-3-chlorophenoxy)-7-methoxyquinoline-6-carboxylic acid 4-(4-amino-3-chlorophenoxy)-7-methoxyquinoline-6-carboxylic acid C17H13ClN2O4
Ornidazole Impurity 26 Ornidazole Impurity 26
Pitavastatin Impurity 73 Pitavastatin Impurity 73
Furosemide Impurity 24 Furosemide Impurity 24
Brivaracetam Impurity 34 Brivaracetam Impurity 34
1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-(((3-(hydroxymethyl)pyridin-2-yl)(methyl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride 1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-(((3-(hydroxymethyl)pyridin-2-yl)(methyl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride
Amoxicillin Impurity ABCDEFGHIJKLM Amoxicillin Impurity ABCDEFGHIJKLM
Amoxicillin Impurity ABCDEFGHIJKLM Amoxicillin Impurity ABCDEFGHIJKLM
β-D-Glucopyranoside, [[(3R,3aS,6S,6aR)-tetrahydro-3a-hydroxy-1H,3H-furo[3,4-c]furan-3,6-diyl]bis(2-methoxy-4,1-phenylene)]bis β-D-Glucopyranoside, [[(3R,3aS,6S,6aR)-tetrahydro-3a-hydroxy-1H,3H-furo[3,4-c]furan-3,6-diyl]bis(2-methoxy-4,1-phenylene)]bis 112747-99-6 C32H42O17
1H-1,2,4-Triazole-1-propanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)- 1H-1,2,4-Triazole-1-propanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)- 1222655-38-0 C14H14F2N6O
3-Pyrrolidinepropanoic acid, α-[[(1,1-dimethylethoxy)carbonyl]amino]-2-oxo-, (αS,3S)- 3-Pyrrolidinepropanoic acid, α-[[(1,1-dimethylethoxy)carbonyl]amino]-2-oxo-, (αS,3S)- 741267-75-4 C12H20N2O5
Topiroxostat Impurity 44 Topiroxostat Impurity 44 1824131-48-7 C7H6N4O
Fexofenadine Impurity 12 Fexofenadine Impurity 12 1010812-98-2 C32H37NO4
2,2'-(oxybis((2-chloro-5-iodophenyl)methylene))diphenol 2,2'-(oxybis((2-chloro-5-iodophenyl)methylene))diphenol C26H18Cl2I2O3
Gliclazide Impurity 6 Gliclazide Impurity 6 1207714-41-7 C8H10N2O3S
Phenol, 4,4'-(4-pyridinylmethylene)bis- Phenol, 4,4'-(4-pyridinylmethylene)bis- 109810-81-3 C18H15NO2
Ropivacaine Impurity 50 Ropivacaine Impurity 50
Glycine, N-[(4,7-dihydroxy-1-methyl-3-isoquinolinyl)carbonyl]- Glycine, N-[(4,7-dihydroxy-1-methyl-3-isoquinolinyl)carbonyl]- 2173338-12-8 C13H12N2O5
5-Thiazolecarboxylic acid, 2-[3,5-diformyl-4-(2-methylpropoxy)phenyl]-4-methyl-, ethyl ester 5-Thiazolecarboxylic acid, 2-[3,5-diformyl-4-(2-methylpropoxy)phenyl]-4-methyl-, ethyl ester 2375033-26-2 C19H21NO5S
Furosemide Impurity 6 Furosemide Impurity 6 74793-12-7 C12H10ClNO3
Lumateperone Impurity 3 Lumateperone Impurity 3 313544-76-2 C17H21N3O3
Butanoic acid, L-2-aminobutanoyl-L-2-amino-, methyl ester (9CI) Butanoic acid, L-2-aminobutanoyl-L-2-amino-, methyl ester (9CI) 772292-30-5 C9H18N2O3
Hexanoic acid, 3-(hydroxymethyl)-, (3R)- Hexanoic acid, 3-(hydroxymethyl)-, (3R)- 2096999-79-8 C7H14O3
2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-1-(ethoxysulfonyl)-2-methyl-4-oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid 2-(((Z)-(1-(2-aminothiazol-4-yl)-2-(((2S,3S)-1-(ethoxysulfonyl)-2-methyl-4-oxoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid
3-Thiophenecarboxylic acid, 4-formyl-2,5-dihydro-2-(4-hydroxybutylidene)-5-methyl-, (2Z)- 3-Thiophenecarboxylic acid, 4-formyl-2,5-dihydro-2-(4-hydroxybutylidene)-5-methyl-, (2Z)- 1025974-23-5 C11H14O4S
1H-Pyrrole-3-methanamine, 1-[(1,4-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 1H-Pyrrole-3-methanamine, 1-[(1,4-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 2416241-98-8 C17H18FN3O2S
impurity 44 impurity 44
3-((2-acetamido-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy)propane- 1,2-diyl diacetate 3-((2-acetamido-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy)propane- 1,2-diyl diacetate 96429-68-4
L-erythro-Pentonic acid, 2-deoxy-2-fluoro-2-methyl-, γ-lactone, 3,5-dibenzoate, (2S)- L-erythro-Pentonic acid, 2-deoxy-2-fluoro-2-methyl-, γ-lactone, 3,5-dibenzoate, (2S)- 1946820-91-2 C20H17FO6
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