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 25 Cabozantinib impurity 25
Afatinib impurity 43 Afatinib impurity 43
Vildagliptin Impurity 39 Vildagliptin Impurity 39
Tazobactam Impurity D Tazobactam Impurity D
Palonosetron Impurity 22 Palonosetron Impurity 22 1217547-14-2 C19H24N2O2
Pitavastatin Impurity 35 Pitavastatin Impurity 35
Pralatrexate Impurity 15 Pralatrexate Impurity 15
Pitavastatin Impurity 52 Pitavastatin Impurity 52
Pitavastatin Impurity 60 Pitavastatin Impurity 60 1661064-71-6 C25H22FNO3
Lenvatinib Impurity 43 Lenvatinib Impurity 43
Voriconazole Impurity 10 Voriconazole Impurity 10
Prednicarbate Impurity D Prednicarbate Impurity D
Olprinone Impurity A Olprinone Impurity A 141354-29-2 C12H10N4O
Everolimus EP Impurity E Everolimus EP Impurity E 1237826-25-3 C52H79NO14
Edaravone Impurity P4 Edaravone Impurity P4
Afatinib impurity 47 Afatinib impurity 47
Canagliflozin Impurity 50 Canagliflozin Impurity 50
Canagliflozin Impurity 66 Canagliflozin Impurity 66
Acyclovir Impurity 12 Acyclovir Impurity 12
4-(4-Hydroxy-3-hydroxymethyl-phenoxy)-benzonitrile 4-(4-Hydroxy-3-hydroxymethyl-phenoxy)-benzonitrile C14H11NO3
Cabozantinib impurity P Cabozantinib impurity P
Rotigotine Impurity 7 Rotigotine Impurity 7
Nicorandil Impurity B Nicorandil Impurity B
Cilastatin Impurity 8 Cilastatin Impurity 8
Tamsulosin impurity E Tamsulosin impurity E C20H28N2O5S
Flucloxacillin Impurity H Flucloxacillin Impurity H
Cefminox Impurity 2 Cefminox Impurity 2
Afatinib Impurity 56 Afatinib Impurity 56
Aprepitant Impurity 34 Aprepitant Impurity 34
Baricitinib Impurity 6 Baricitinib Impurity 6 2166596-69-4 C12H19N3O2Si
Bosutinib Impurity 14 Bosutinib Impurity 14
Brivaracetam Impurity 16 Brivaracetam Impurity 16
Etoricoxib Impurity 41 Etoricoxib Impurity 41 855307-80-1 C18H13ClN2O2S
Fluvoxamine Impurity 10 Fluvoxamine Impurity 10
Nintedanib Impurity 50 Nintedanib Impurity 50 2410284-90-9 C56H52N8O8
Olopatadine Impurity 8 Olopatadine Impurity 8
Oseltamivir Impurity 36 Oseltamivir Impurity 36
Palbociclib Impurity 61 Palbociclib Impurity 61 2222404-53-5 C14H20N4O4
Palbociclib Impurity 41 Palbociclib Impurity 41
Saxagliptin Impurity 8 Saxagliptin Impurity 8
Tenofovir Impurity 63 Tenofovir Impurity 63
Ticagrelor Impurity 99 Ticagrelor Impurity 99
Ticagrelor Impurity 114 Ticagrelor Impurity 114
Ticagrelor Impurity 98 Ticagrelor Impurity 98
Tofacitinib Impurity 118 Tofacitinib Impurity 118
Trelagliptin Impurity 23 Trelagliptin Impurity 23
Vildagliptin Impurity 33 Vildagliptin Impurity 33
Vildagliptin Impurity 44 Vildagliptin Impurity 44
Voriconazole Impurity 16 Voriconazole Impurity 16 1157981-64-0 C10H7F2N3O
Itraconazole iMpurity 3 Itraconazole iMpurity 3
1-(3,5-bis(benzyloxy)phenyl)-2,2-dibromoethan-1-one 1-(3,5-bis(benzyloxy)phenyl)-2,2-dibromoethan-1-one C22H18Br2O3
Axitinib Impurity 8 Axitinib Impurity 8
Agomelatine Impurity 11 Agomelatine Impurity 11
Saxagliptin Impurity 7 Saxagliptin Impurity 7
Bis{2-[benzyl(methyl)amino]ethyl} 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride Bis{2-[benzyl(methyl)amino]ethyl} 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride 71784-27-5 C35H41ClN4O6
3-amino-6-chloro-2-methyl-4-phenylquinazolin-4-ol 3-amino-6-chloro-2-methyl-4-phenylquinazolin-4-ol 27537-87-7 C15H14ClN3O
Riluzole 5-Trifluoromethoxy Isomer Riluzole 5-Trifluoromethoxy Isomer 752969-85-0 C8H5F3N2OS
Pazufloxacin Impurity 7 Pazufloxacin Impurity 7 171567-48-9 C15H15FN2O3
Empagliflozin Impurity 42 Empagliflozin Impurity 42
2-amino-2-(4-nonylphenethyl)propane-1,3-diol 2-amino-2-(4-nonylphenethyl)propane-1,3-diol 746594-44-5 C20H35NO2
Zopiclone Impurity 17 Zopiclone Impurity 17
Pregabalin Impurity D Pregabalin Impurity D 53439-96-6 C11H14O3
Cephalosporin Impurity 3 HCl Cephalosporin Impurity 3 HCl 2429-86-9 C14H17N3O6S
((2R,3S,4R,5R,6S)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl) methyl)-4-methylphenyl)-3,4,5-trihydroxytetrahydro- 2H-pyran-2-yl)methyl acetate ((2R,3S,4R,5R,6S)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl) methyl)-4-methylphenyl)-3,4,5-trihydroxytetrahydro- 2H-pyran-2-yl)methyl acetate 2146135-87-5 C26H27FO6S
Atracurium Impurity 5 Atracurium Impurity 5
Cefazolin Impurity 1 Cefazolin Impurity 1
Tofacitinib Impurity 77 Tofacitinib Impurity 77 1640971-51-2 C16H20N6O2
Tofacitinib Impurity 84 Tofacitinib Impurity 84
Cetirizine impurity B 2HCl Cetirizine impurity B 2HCl 1000690-91-4 C19H22Cl2N2O2
7-Despropyl 7-Methyl Vardenafil 7-Despropyl 7-Methyl Vardenafil 2169247-39-4 C21H28N6O4S
Apixaban Impurity 32 Apixaban Impurity 32
Apremilast Impurity 20 Apremilast Impurity 20
Bendamustine Impurity 36 Bendamustine Impurity 36
Bosutinib Impurity 7 Bosutinib Impurity 7 219786-51-3 C10H12BrNO4
Cefazolin Impurity 13 Cefazolin Impurity 13
Cefoxitin Impurity 4 Cefoxitin Impurity 4
Cilnidipine Impurity 3 Cilnidipine Impurity 3 123853-41-8 C24H22N2O6
Erlotinib Impurity 50 Erlotinib Impurity 50
Pitavastatin Impurity 26 Pitavastatin Impurity 26
Plerixafor Impurity 2 Plerixafor Impurity 2
Pregabalin Impurity 48 Pregabalin Impurity 48 1239856-83-7 C11H23NO2
Rivaroxaban Impurity 76 Rivaroxaban Impurity 76
Rocuronium bromide Impurity 36 Rocuronium bromide Impurity 36
Cinacalcet Impurity 23 Cinacalcet Impurity 23
Erlotinib Impurity 24 Erlotinib Impurity 24
Ticagrelor Impurity 47 Ticagrelor Impurity 47
Edaravone Impurity 10 Edaravone Impurity 10
Empagliflozin Impurity 10 Empagliflozin Impurity 10
Canagliflozin Impurity 10 Canagliflozin Impurity 10
Rivaroxaban Impurity 35 Rivaroxaban Impurity 35
Febuxostat Impurity 67 Febuxostat Impurity 67
Hydroxytyrosol 4-O-glucoside Hydroxytyrosol 4-O-glucoside 54695-80-6 C14H20O8
Riociguat IMpurtiy A Riociguat IMpurtiy A
Peramivir Impurity C Peramivir Impurity C
Lincomycin sulfoxide Impurity 6 Lincomycin sulfoxide Impurity 6
Metronidazole IMpurity 5 Metronidazole IMpurity 5
Sulpiride Impurity 5 Sulpiride Impurity 5
methyl 3-(4-(3-(ethylamino)-2-hydroxypropoxy)phenyl)propanoate  hydrochloride methyl 3-(4-(3-(ethylamino)-2-hydroxypropoxy)phenyl)propanoate hydrochloride C15H24ClNO4
Tacrolimus Impurity F Tacrolimus Impurity F
Cefminox Impurity E Cefminox Impurity E
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