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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
Empagliflozin Impurity 58 Empagliflozin Impurity 58
Exemestane Impurity 6 Exemestane Impurity 6 14895-71-7
Gadobutrol Impurity 10 Gadobutrol Impurity 10
Linagliptin Impurity 55 Linagliptin Impurity 55
Oseltamivir Impurity 52 Oseltamivir Impurity 52
Palbociclib Impurity 65 Palbociclib Impurity 65
Pimecrolimus Impurity 1 Pimecrolimus Impurity 1
Rosuvastatin Impurity 99 Rosuvastatin Impurity 99
Terbutaline Impurity 18 Terbutaline Impurity 18
Ticagrelor Impurity 123 Ticagrelor Impurity 123
Tofacitinib Impurity 112 Tofacitinib Impurity 112 2179757-75-4 C12H19N3O2
Trelagliptin Impurity 42 Trelagliptin Impurity 42
Carbocistein Impurity E Carbocistein Impurity E
Moxifloxacin Impurity 37 Moxifloxacin Impurity 37 1803729-19-2 C7H3ClF2O2
Nimodipine  Impurity 12 Nimodipine Impurity 12 39562-18-0 C19H22N2O6
Rosuvastatin Impurity 53 Rosuvastatin Impurity 53
Sulbactam  Impurity 8 Sulbactam Impurity 8 75527-88-7 C8H10BrNO5S
Tenofovir Impurity 64 Tenofovir Impurity 64 1878175-76-8 C13H23N5O8P2
Ticagrelor Impurity 65 Ticagrelor Impurity 65
Ticagrelor Impurity 72 Ticagrelor Impurity 72 1402150-11-1 C24H28F2N6O5S
Topiroxostat Impurity 18 Topiroxostat Impurity 18
Isorhamnetin 3,7-O-diglucoside Isorhamnetin 3,7-O-diglucoside 6758-51-6 C28H32O17
Afatinib Impurity 26 Afatinib Impurity 26
Amifostine Impurity 5 Amifostine Impurity 5 712255-27-1 C5H9BrN2
Amikacin EP Impurity E Amikacin EP Impurity E
Aztreonam Impurity 5 Aztreonam Impurity 5 2195336-17-3 C4H10N2O5S
Canagliflozin Impurity 35 Canagliflozin Impurity 35
Cefazolin Impurity 7 (Cefazolin Trimethylsilyl Ester) Cefazolin Impurity 7 (Cefazolin Trimethylsilyl Ester) 1072000-00-0 C17H22N8O4S3Si
Dapagliflozin Impurity 25 Dapagliflozin Impurity 25
Doripenem Impurity 1 Doripenem Impurity 1
Erlotinib Impurity 54 Erlotinib Impurity 54
Erlotinib Impurity 59 Erlotinib Impurity 59
Etoposide Impurity 5 Etoposide Impurity 5
Olaparib Impurity 26 Olaparib Impurity 26
Oseltamivir Impurity 14 Oseltamivir Impurity 14 2081110-44-1 C16H28N2O4
Rocuronium bromide Impurity 35 Rocuronium bromide Impurity 35
Adefovir Impurity 5 Adefovir Impurity 5
Apremilast Impurity QJ Apremilast Impurity QJ
Apremilast Impurity TTN Apremilast Impurity TTN
AZD9291 Osimertinib Impurity 1 AZD9291 Osimertinib Impurity 1
Dextrorotation lansoprazole Impurity I Dextrorotation lansoprazole Impurity I
Ivabradine Impurity 31 Ivabradine Impurity 31
lansoprazole Impurity 28 lansoprazole Impurity 28
Lincomycin sulfoxide Impurity 1 Lincomycin sulfoxide Impurity 1
Olanzapine impurity Q Olanzapine impurity Q C17H20N4S
Palbociclib Impurity 32 Palbociclib Impurity 32
Ropivacaine Impurity 32 Ropivacaine Impurity 32
Ropivacaine Impurity 41 Ropivacaine Impurity 41
Sugammadex sodium dimer Sugammadex sodium dimer
Sugammadex sodium Org49095 Impurity Sugammadex sodium Org49095 Impurity
Topiroxostat Impurity Ⅲ-2 Topiroxostat Impurity Ⅲ-2
Parecoxib Impurity 12 Parecoxib Impurity 12 2229657-81-0 C19H18N2O4S
Afatinib impurity 29 Afatinib impurity 29 1957132-02-3 C22H23ClFN5O2
Avibactam Impurity 44 Avibactam Impurity 44 2064219-22-1 C23H46N4O6S
Bortezomib Impurity W Bortezomib Impurity W
Butyphthalide impurity 43 Butyphthalide impurity 43 952412-99-6 C11H14O3
Cabozantinib impurity 23 Cabozantinib impurity 23 406-00-8 C6H6FNO
Celecoxib Impurity 17 Celecoxib Impurity 17 2247197-65-3 C17H14F3N3O4S
Dapoxetine impurity 21 Dapoxetine impurity 21
Febuxostat Impurity 74 Febuxostat Impurity 74
Febuxostat Impurity 79 Febuxostat Impurity 79
Febuxostat Impurity 94 Febuxostat Impurity 94
Fosaprepitant Impurity ELS Fosaprepitant Impurity ELS
Lenvatinib Impurity 14 Lenvatinib Impurity 14 417719-45-0 C19H17ClN4O4
Lenvatinib Impurity 23 Lenvatinib Impurity 23
Olsalazine Impurity F Olsalazine Impurity F
Regorafenib Impurity 19 Regorafenib Impurity 19
Regorafenib Impurity 26 Regorafenib Impurity 26
Sitafloxacin Impurity ZZ-B-01 Sitafloxacin Impurity ZZ-B-01
Tofacitinib Impurity 3 Tofacitinib Impurity 3 1206825-36-6 C13H19N5
Tofacitinib Impurity 89 Tofacitinib Impurity 89
Nintedanib Impurity L Nintedanib Impurity L 2095596-44-2 C31H33N5O4
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10,11,13- pentahydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6- azacyclopentadecan-15-one (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10,11,13- pentahydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6- azacyclopentadecan-15-one 117693-42-2 C22H43NO7
Rizatriptan EP Impurity A Rizatriptan EP Impurity A 887001-08-3 C28H35N7
Dapoxetine iMpurity Dapoxetine iMpurity 38262-42-9 C11H10O3S
Eltrombopag Impurity 7 Eltrombopag Impurity 7
Saxagliptin Impurity 9 Saxagliptin Impurity 9
(1r,4r)-4-((2-aminobenzyl)amino)cyclohexanol (1r,4r)-4-((2-aminobenzyl)amino)cyclohexanol 15992-77-5 C15H22N2O5
Moxifloxacin degrade Impurity Moxifloxacin degrade Impurity
Edaravone Impurity 17 Edaravone Impurity 17
Capecitabine impurity 7 Capecitabine impurity 7
Linagliptin Impurity 46 Linagliptin Impurity 46
((3R,5S,E)-3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethylsulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate)calcium(II) ((3R,5S,E)-3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethylsulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate)calcium(II) C44H56CaN6O12S2
Levofloxacin Impurity 24 Levofloxacin Impurity 24 C18H20FN3O4
(trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide (trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide 1932275-13-2 C10H9F2NO
(3R,5S,Z)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid calcium(II) (3R,5S,Z)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid calcium(II) 1445208-17-2 C22H28FN3O6S
Tafluprost Impurity 7 Tafluprost Impurity 7 733036-94-7 C25H35FO5
Tropisetron Impurity 1 Tropisetron Impurity 1
Fosaprepitant Impurity DBJ Fosaprepitant Impurity DBJ
Cabozantinib impurity 29 Cabozantinib impurity 29
Cabozantinib impurity 34 Cabozantinib impurity 34
Carfilzomib Impurity YGH Carfilzomib Impurity YGH
Ondansetron Impurity 3 Ondansetron Impurity 3
Irsogladine Impurity GDT Irsogladine Impurity GDT
Carvedilol Impurity NH Carvedilol Impurity NH
Pregabalin Impurity 8 Pregabalin Impurity 8 44996-52-3 C7H11NO3
Pregabalin Impurity 14 Pregabalin Impurity 14 1610546-44-5 C7H11NO3
Cefditoren Impurity 1 Cefditoren Impurity 1
Cefadroxil Impurity C Cefadroxil Impurity C 79962-91-7 C16H17N3O5S
Pralatrexate Impurity 8 Pralatrexate Impurity 8 112408-16-9 C8H15NO4
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