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
Cefonicid Impurity 1 Cefonicid Impurity 1
1589503-93-4 1589503-93-4 1589503-93-4 C27H24F2N6O3S
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
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
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
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
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
Cefathiamidine Impurity 10 Cefathiamidine Impurity 10
Nebivolol Impurity 3 Nebivolol Impurity 3 1029684-20-5 C18H20FNO2
Pemetrexed Pemetrexed 155405-79-1 C12H13BrO3
4-Hydroxyphthalic Acid 4-Hydroxyphthalic Acid 501666-22-4 C14H25NO6
(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
Lenvatinib Impurity 34 Lenvatinib Impurity 34
Sitafloxacin Impurity 18 Sitafloxacin Impurity 18
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