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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
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
6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-
7,9-dihydro-8H-purin-8-one 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dihydro-8H-purin-8-one 1361569-10-9 C18H13FN8O
Apremilast impurity 32 Apremilast impurity 32
Baricitinib Impurity 5 Baricitinib Impurity 5
Bendamustine Impurity 28 Bendamustine Impurity 28
Bortezomib Impurity 20 Bortezomib Impurity 20
Canagliflozin Impurity 27 Canagliflozin Impurity 27 2265214-89-7 C18H14BrFS
Edoxaban Impurity 23 (1S,2S,4R) Edoxaban Impurity 23 (1S,2S,4R)
Edoxaban Impurity 38 Edoxaban Impurity 38 2081883-53-4 C14H27N3O3
Ezetimibe Impurity 33 Ezetimibe Impurity 33 1829558-53-3 C13H10FNO
Imatinib Impurity 14 Imatinib Impurity 14
Levofloxacin Impurity 20 Levofloxacin Impurity 20 C18H20FN3O4
Pantoprazole Impurity 12 Pantoprazole Impurity 12
Solifenacin Related Compound 7 Solifenacin Related Compound 7
Vonoprazan Impurity 12 Vonoprazan Impurity 12
Apixaban Impurity 22 Apixaban Impurity 22
Avibactam Impurity A Avibactam Impurity A
Avibactam Impurity F Avibactam Impurity F
Brexpiprazole Impurity K Brexpiprazole Impurity K
Cefaclor Impurity 3 Cefaclor Impurity 3
Milrinone Impurity 7 Milrinone Impurity 7 2250242-59-0 C14H13N3O
Silodosin Impurity 1 Silodosin Impurity 1
Sulpiride Impurity 1 Sulpiride Impurity 1
Tenofovir Impurity 54 Tenofovir Impurity 54
Trelagliptin Impurity Y Trelagliptin Impurity Y 1938080-42-2 C13H10FN3O3
Trelagliptin Impurity Y Trelagliptin Impurity Y 1938080-42-2 C13H10FN3O3
Cefathiamidine Impurity 10 Cefathiamidine Impurity 10
Nebivolol Impurity 3 Nebivolol Impurity 3 1029684-20-5 C18H20FNO2
Pemetrexed Pemetrexed 155405-79-1 C12H13BrO3
(1s,4s)-4-((2-amino-3-bromobenzyl)amino)cyclohexan-1-ol hydrochloride (1s,4s)-4-((2-amino-3-bromobenzyl)amino)cyclohexan-1-ol hydrochloride C13H20BrClN2O
Edaravone Impurity 19 Edaravone Impurity 19
Linagliptin Impurity 48 Linagliptin Impurity 48
(3R,5S,E)-methyl 3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethyl sulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate (3R,5S,E)-methyl 3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethyl sulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate C23H31N3O6S
(R)-3,5-dibromo-N-((1-ethylpyrrolidin-2-yl)methyl)-2,6-dimethoxybenzamide (R)-3,5-dibromo-N-((1-ethylpyrrolidin-2-yl)methyl)-2,6-dimethoxybenzamide C16H22Br2N2O3
Mesna Impurity 1 (2-Ethoxy-Ethanesulfonic Acid) Mesna Impurity 1 (2-Ethoxy-Ethanesulfonic Acid) 90663-51-7 C4H10O4S
Vonoprazan Impurity Z-7 Vonoprazan Impurity Z-7
Caspofungin Impurity QA Caspofungin Impurity QA
Cabozantinib impurity 27 Cabozantinib impurity 27
Cabozantinib impurity 32 Cabozantinib impurity 32
Rivaroxaban Degradation Impurity B Rivaroxaban Degradation Impurity B
Dapoxetine impurity 26 Dapoxetine impurity 26
Pregabalin Impurity 12 Pregabalin Impurity 12 1013624-61-7 C7H11NO3
Pralatrexate Impurity 6 Pralatrexate Impurity 6
Pitavastatin Impurity 37 Pitavastatin Impurity 37
Dapoxetine impurity 30 Dapoxetine impurity 30
(2S,4S)-5-(Biphenyl-4-yl)-4-[(3-carboxypropionyl)amino]-2-methylpentanoic acid ethyl ester,calcium salt(2:1) (2S,4S)-5-(Biphenyl-4-yl)-4-[(3-carboxypropionyl)amino]-2-methylpentanoic acid ethyl ester,calcium salt(2:1)
1-(7,8-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1-(7,8-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1822601-94-4 C12H15N
5-(hydroxymethyl)-3-[(5-nitro-2-furyl)methylideneamino]oxazolidin-2-one 5-(hydroxymethyl)-3-[(5-nitro-2-furyl)methylideneamino]oxazolidin-2-one 41359-15-3 C9H9N3O6
L-GLUCONO-1,5-LACTONE L-GLUCONO-1,5-LACTONE 52153-09-0 C6H10O6
C-Desmethyl Atenolol C-Desmethyl Atenolol 1797116-92-7 C13H20N2O3
Arthromerin B Arthromerin B 31049-08-8 C21H22O11
Losartan Impurity 7 Losartan Impurity 7 358685-13-9 C33H24Br2N4
Fenofibric Acid 1-Carboxyl-1-methylethyl Ester Fenofibric Acid 1-Carboxyl-1-methylethyl Ester 1797121-54-0 C21H21ClO6
2-Chloro-4'-fluorobenzophenone 2-Chloro-4'-fluorobenzophenone 1806-23-1 C13H8ClFO
1-(((2R,4R)-4-((Benzyloxy)methyl)-2-(2,4-difluorophenyl)tetrahydrofuran-2-yl)methyl)-1H-1,2,4-triazole 1-(((2R,4R)-4-((Benzyloxy)methyl)-2-(2,4-difluorophenyl)tetrahydrofuran-2-yl)methyl)-1H-1,2,4-triazole 165115-83-3 C21H21F2N3O2
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aR,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aR,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid 855661-71-1 C21H24FN3O4
4-[(4-aminohex-5-enoyl)amino]hex-5-enoic acid (mixture of the 4 stereoisomers) 4-[(4-aminohex-5-enoyl)amino]hex-5-enoic acid (mixture of the 4 stereoisomers) 748817-01-8
Iopamidol Impurity K Iopamidol Impurity K 1788899-70-6 C17H23I2N3O8
N-(2-(diethylamino)ethyl)-2-hydroxyquinoline-4-carboxamide N-(2-(diethylamino)ethyl)-2-hydroxyquinoline-4-carboxamide 87864-08-2 C16H21N3O2
5-(2-Fluorophenyl)-1-(3-pyridinylsulfonyl)-1H-pyrrole-3-carboxylic acid 5-(2-Fluorophenyl)-1-(3-pyridinylsulfonyl)-1H-pyrrole-3-carboxylic acid 1883595-37-6 C16H11FN2O4S
Ritonavir EP Impurity B Ritonavir EP Impurity B 765875-58-9 C28H36N4O4S
2-[4-(2,3-DIHYDROXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(2,3-DIHYDROXYPROPOXY)PHENYL]ACETAMIDE 61698-76-8 C11H15NO4
3-OXO-3-(2,4,5-TRIFLUORO-3-METHOXY-PHENYL)-PROPIONIC ACID ETHYL ESTER 3-OXO-3-(2,4,5-TRIFLUORO-3-METHOXY-PHENYL)-PROPIONIC ACID ETHYL ESTER 112811-68-4 C12H11F3O4
2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-N5,N5- dimethylpyrimidine-4,5,6-triamine 2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-N5,N5- dimethylpyrimidine-4,5,6-triamine 1169770-52-8 C19H19FN8
Lenvatinib Impurity 34 Lenvatinib Impurity 34
Sitafloxacin Impurity 18 Sitafloxacin Impurity 18
Canagliflozin Impurity 47 Canagliflozin Impurity 47
Olprinone Impurity C Olprinone Impurity C
Atracurium Impurity 29 Atracurium Impurity 29
Posaconazole Impurity 71 Posaconazole Impurity 71
Canagliflozin Impurity 53 Canagliflozin Impurity 53
Atracurium Impurity 32 Atracurium Impurity 32
Tofacitinib Impurity 104 Tofacitinib Impurity 104
Rotigotine Impurity 1 Rotigotine Impurity 1
Afatinib impurity 49 Afatinib impurity 49
Afatinib impurity 49 Afatinib impurity 49
Cabozantinib impurity L Cabozantinib impurity L
Gadobutrol Impurity 2 Gadobutrol Impurity 2
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
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