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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
Mirabegron Impurity 21 Mirabegron Impurity 21
Apixaban Impurity 18 Apixaban Impurity 18 473927-65-0 C20H17IN4O3
Clopidogrel Impurity 12 Clopidogrel Impurity 12 C15H14ClNO2S
Oseltamivir Impurity 25 Oseltamivir Impurity 25
Ritonavir EP Impurity P Ritonavir EP Impurity P
Tacrolimus Impurity 4 Tacrolimus Impurity 4 686773-61-5 C44H69NO12
(2R,4S)-isopropyl5-([1,1'-biphenyl]-4-yl)-4-(2,5-dioxopyrrolidin-1- yl)-2-methylpentanoate (2R,4S)-isopropyl5-([1,1'-biphenyl]-4-yl)-4-(2,5-dioxopyrrolidin-1- yl)-2-methylpentanoate C25H29NO4
methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate hydrochloride methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate hydrochloride C16H24ClNO5
Aprepitant iMpurity 37 Aprepitant iMpurity 37
Vitamin E Impurity 3 Vitamin E Impurity 3 1560705-69-2 C29H50O2
(trans)-phenyl3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)piperidine-1-carboxylate (trans)-phenyl3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)piperidine-1-carboxylate C32H28FNO5
arformoterol tartrate impurity arformoterol tartrate impurity
arformoterol tartrate impurity arformoterol tartrate impurity
Cefraprazole impurity Cefraprazole impurity
Afatinib Impurity QAQ Afatinib Impurity QAQ
Afatinib Impurity QAQ Afatinib Impurity QAQ
Afatinib Impurity SHO Afatinib Impurity SHO 2223677-65-2 C38H30Cl2F2N8O6
Afatinib Impurity SHO Afatinib Impurity SHO 2223677-65-2 C38H30Cl2F2N8O6
Cetirizine impurity 14 Cetirizine impurity 14 C21H25ClN2O3
Vitamin B1 Impurity 1 Vitamin B1 Impurity 1 C12H17ClN4OS
Diquafosol Impurity UP2U Diquafosol Impurity UP2U 221169-12-6 C18H25N4NaO17P2
Pemetrexed disodium  Impurity Pemetrexed disodium Impurity 17405-00-4 C7H5ClN2O2
Vonoprazan Impurity Z-1 Vonoprazan Impurity Z-1
IPC-Mixed Tenofovir Trimer IPC-Mixed Tenofovir Trimer
Olanzapine impurity M Olanzapine impurity M C17H20N4S
Afatinib impurity 41 Afatinib impurity 41 69169-63-7 C5H9NO2
Vildagliptin Impurity 38 Vildagliptin Impurity 38 956508-24-0 C10H16N2O3
Tazobactam Impurity C Tazobactam Impurity C
Palonosetron Impurity TM1-YA Palonosetron Impurity TM1-YA
Pitavastatin Impurity 33 Pitavastatin Impurity 33
Pralatrexate Impurity 14 Pralatrexate Impurity 14
Pitavastatin Impurity 51 Pitavastatin Impurity 51
Pitavastatin Impurity 59 Pitavastatin Impurity 59
Lenvatinib Impurity 42 Lenvatinib Impurity 42
Tazobactam Impurity 8 Tazobactam Impurity 8
Prednicarbate Impurity B Prednicarbate Impurity B
Doxofylline Impurity 13 Doxofylline Impurity 13
Afatinib impurity 46 Afatinib impurity 46
Afatinib impurity 46 Afatinib impurity 46
Canagliflozin Impurity 60 Canagliflozin Impurity 60
Canagliflozin Impurity 65 Canagliflozin Impurity 65
Rosuvastatin Impurity 75 Rosuvastatin Impurity 75
Androstan-17-one,3-[[(4-methylphenyl)sulfonyl]oxy]-,(3,5)- Androstan-17-one,3-[[(4-methylphenyl)sulfonyl]oxy]-,(3,5)- 10429-07-9 C26H36O4S
Cabozantinib Impurity 48 Cabozantinib Impurity 48 202916-99-2 C17H15NO3
Landiolol impurity R Landiolol impurity R
6-Oxo-Palonosetron 6-Oxo-Palonosetron 848074-10-2 C19H22N2O2
Teneligliptin Impurity 8 Teneligliptin Impurity 8
(trans)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)-1-methylpiperidin-3-yl) methanol (trans)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)-1-methylpiperidin-3-yl) methanol
2,4(1H,3H)-Pyrimidinedione, 3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-6-methyl- 2,4(1H,3H)-Pyrimidinedione, 3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-6-methyl- 2354391-45-8 C13H10F4N2O2
Cyclopropane, nitroso- Cyclopropane, nitroso- 28017-92-7 C3H5NO
Hyoscine Butylbromide EP Impurity D Hyoscine Butylbromide EP Impurity D
Carbetocin Impurity 1 Carbetocin Impurity 1
Carboprost Trometamol Impurity A Carboprost Trometamol Impurity A
Procaine Impurity 2 Procaine Impurity 2 C13H20N2O2
Acyclovir Impurity 11 Acyclovir Impurity 11
Selexipag Impurity 6 Selexipag Impurity 6
Cabozantinib impurity N Cabozantinib impurity N
Barcitinib impurity-09 Barcitinib impurity-09 1187594-16-6 C14H13N7
Rotigotine Impurity 6 Rotigotine Impurity 6
Olprinone Impurity 7 Olprinone Impurity 7 2236020-10-1 C9H10N2
Cilastatin Impurity 2 Cilastatin Impurity 2
Cilastatin Impurity 7 Cilastatin Impurity 7
Dabrafenib Impurity 1 Dabrafenib Impurity 1 1907654-22-1 C24H21F3N4O3S2
Eliglustat Impurity 2(Eliglustat SR-Isomer) Eliglustat Impurity 2(Eliglustat SR-Isomer) 1092472-66-6 C23H36N2O4
Tamsulosin impurity C Tamsulosin impurity C C20H28N2O5S
Umeclidinium Bromide Impurity 9 DiHCl Umeclidinium Bromide Impurity 9 DiHCl 494778-36-8 C18H32N2O4
Flucloxacillin Impurity 4 Flucloxacillin Impurity 4
Ipratropium bromide Impurity 4 Ipratropium bromide Impurity 4 C20H29Br2NO3
Cefminox Impurity 6 Cefminox Impurity 6
Afatinib Impurity 55 Afatinib Impurity 55
Apremilast Impurity 30 Apremilast Impurity 30 1609546-91-9
Aprepitant Impurity 33 Aprepitant Impurity 33 502537-39-5 C20H20F7NO3
Brivaracetam Impurity 9 Brivaracetam Impurity 9
Esomeprazole Impurity 43 Esomeprazole Impurity 43 2826359-93-5
Etoricoxib Impurity 40 Etoricoxib Impurity 40
Lenvatinib Impurity 31 Lenvatinib Impurity 31
Oseltamivir Impurity 35 Oseltamivir Impurity 35 757965-01-8 C14H22O4
Palbociclib Impurity 39 Palbociclib Impurity 39
Posaconazole Impurity 75 Posaconazole Impurity 75
Rabeprazole Impurity 22 Rabeprazole Impurity 22
Sunitinib Impurity 12 Sunitinib Impurity 12
Ticagrelor Impurity 113 Ticagrelor Impurity 113
Ticagrelor Impurity 97 Ticagrelor Impurity 97
Tofacitinib Impurity 117 Tofacitinib Impurity 117
Trelagliptin Impurity 22 Trelagliptin Impurity 22
Trelagliptin Impurity 29 Trelagliptin Impurity 29
Vildagliptin Impurity 43 Vildagliptin Impurity 43
Dexchlorpheniramine impurity F Dexchlorpheniramine impurity F
Irbesartan IMpurity F Irbesartan IMpurity F C25H28N6O
Itraconazole iMpurity 2 Itraconazole iMpurity 2
Palbociclib Impurity 6 Palbociclib Impurity 6 1874141-57-7 C33H45N7O4
Azacitidine Impurity 1 Azacitidine Impurity 1
Saxagliptin Impurity 5 Saxagliptin Impurity 5
Cinacalcet Impurity 18 Cinacalcet Impurity 18
Erlotinib Impurity 23 Erlotinib Impurity 23 2021249-11-4 C23H18F6N6O
Erlotinib Impurity 36 Erlotinib Impurity 36
Fasudil Impurity 17 Fasudil Impurity 17
Febuxostat Impurity 50 Febuxostat Impurity 50
Varenicline Impurity 8 Varenicline Impurity 8
Ticagrelor Impurity 53 Ticagrelor Impurity 53 2750247-77-7 C17H27ClN4O4S
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