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
Ticagrelor Impurity 122 Ticagrelor Impurity 122
Tofacitinib Impurity 111 Tofacitinib Impurity 111 2374700-37-3 C27H31N5O2S
Trelagliptin Impurity 41 Trelagliptin Impurity 41
Carbocistein Impurity D Carbocistein Impurity D
Ranitidine impurity F Ranitidine impurity F C13H22N4O3S
Beclometasone Impurity B Beclometasone Impurity B
(3R)-Nmethyl-3-(3-methylphenoxy)-3-phenylpropan-1-amine (3R)-Nmethyl-3-(3-methylphenoxy)-3-phenylpropan-1-amine 1643684-05-2 C17H22ClNO
Caspofungin Impurity 6 Caspofungin Impurity 6
Erythromycin Impurity 3 Erythromycin Impurity 3 1357466-70-6 C38H69N3O13S
Itraconazole iMpurity 6 Itraconazole iMpurity 6
Ribavirin API  Impurity O Ribavirin API Impurity O 799-87-1 C13H11N2O8P
Aprepitant Impurity 14 Aprepitant Impurity 14
Trelagliptin Impurity 16 Trelagliptin Impurity 16
Decitabine Impurity 7 Decitabine Impurity 7
Fosaprepitant Impurity 6 Fosaprepitant Impurity 6
Dapoxetine Impurity 6 Dapoxetine Impurity 6
Regorafenib Impurity 13 Regorafenib Impurity 13
Topiroxostat Impurity 4 Topiroxostat Impurity 4
7-Hydroxy Alosetron 7-Hydroxy Alosetron 863485-44-3 C17H18N4O2
Dolutegravir 2-Desfluoro Impurity Dolutegravir 2-Desfluoro Impurity 1863916-88-4 C20H20FN3O5
Moxifloxacin Impurity 46 Moxifloxacin Impurity 46 1932499-97-2 C8H16N2
Posaconazole Impurity 43 Posaconazole Impurity 43 1428118-40-4 C13H20N2O2
Empagliflozin Impurity 32 Empagliflozin Impurity 32 1620758-25-9 C24H29ClO8
Sugammadex Impurity 16 Sugammadex Impurity 16 2412952-97-5 C69H108BrNaO46S7
1,1'-(1,4,8,11-tetraazacyclotetradecane-1,11-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride 1,1'-(1,4,8,11-tetraazacyclotetradecane-1,11-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride C14H24Cl2F6N4O2
9-fluoro-6,7-dihydro-5-methyl-1-oxo-8-(4-oxo-1,2,3,4-tetrahydro-1-pyridyl)-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid 9-fluoro-6,7-dihydro-5-methyl-1-oxo-8-(4-oxo-1,2,3,4-tetrahydro-1-pyridyl)-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid 130539-72-9 C19H17FN2O4
Clopidogrel Clopidogrel 444728-15-8 C15H15ClN2OS
(3R,5S)-5-((S)-8-fluoro-4-isopropyl-2-(N-methylmethyl sulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5- dihydroxypentanoate calcium(II) (3R,5S)-5-((S)-8-fluoro-4-isopropyl-2-(N-methylmethyl sulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5- dihydroxypentanoate calcium(II) 854898-50-3 C44H54CaF2N6O12S2
Arbidol Impurity I Arbidol Impurity I 153633-10-4 C22H24Br2N2O3S
Palonosetron Impurity 9 Palonosetron Impurity 9 2216755-75-6 C18H24N2O
Zopiclone Impurity 12 Zopiclone Impurity 12
Selexipag impurity Selexipag impurity
2-(3-formyl-4-isobutoxyphenyl)-N,N,4-trimethylthiazole- 5-carboxamide 2-(3-formyl-4-isobutoxyphenyl)-N,N,4-trimethylthiazole- 5-carboxamide 1380049-42-2 C18H22N2O3S
Benidipine Impurity V Benidipine Impurity V
Cefazolin USP Impurity L-△2 Cefazolin USP Impurity L-△2
Fluconazole Impurity M Fluconazole Impurity M C13H12F2N6O
Nicorandil Impurity 14 Nicorandil Impurity 14
Ticagrelor Impurity 64 Ticagrelor Impurity 64
Ticagrelor Impurity 71 Ticagrelor Impurity 71
Tolterodine EP Impurity G Tolterodine EP Impurity G 1554029-91-2 C22H32NO2+
Topiroxostat Impurity 23 Topiroxostat Impurity 23 2044706-78-5 C20H12N10
Bosutinib Impurity 8 Bosutinib Impurity 8
Ticagrelor Impurity 13 Ticagrelor Impurity 13
Ticagrelor Impurity 66 Ticagrelor Impurity 66
Canagliflozin Impurity 8 Canagliflozin Impurity 8
Canagliflozin Impurity 16 Canagliflozin Impurity 16
Oseltamivir Impurity 12 Oseltamivir Impurity 12
Oseltamivir Impurity 32 Oseltamivir Impurity 32
Riociguat IMpurtiy E Riociguat IMpurtiy E
Meropenem impurity diastereomer 2 Meropenem impurity diastereomer 2 96035-15-3 C15H19N3O5S
Clindamycin Impurity A Clindamycin Impurity A
Tigecycline Impurity F Tigecycline Impurity F
Fasudil iMpurity A Fasudil iMpurity A
Cefminox Impurity C Cefminox Impurity C
Varenicline Impurity 1 Varenicline Impurity 1
Amlodipine Impurity 27 Disodium Salt Amlodipine Impurity 27 Disodium Salt 120289-11-4 C19H20ClNO7
Erlotinib Impurity 47 HCl Erlotinib Impurity 47 HCl
Saxagliptin Impurity 34 Saxagliptin Impurity 34 2173146-31-9 C17H25NO5
Afatinib Impurity 25 Afatinib Impurity 25
Bendamustine Impurity 34 Bendamustine Impurity 34
Canagliflozin Impurity 29 Canagliflozin Impurity 29
Cefazolin Impurity 6 Cefazolin Impurity 6 66636-33-7 C14H20N4O3S3Si
Ciprofloxacin Impurity 5 Ciprofloxacin Impurity 5 C17H18FN3O3
Erlotinib Impurity 53 Erlotinib Impurity 53 749181-30-4 C21H25N3O4
Etoposide Impurity 4 Etoposide Impurity 4 101648-60-6 C35H32Cl6O16
Olaparib Impurity 25 Olaparib Impurity 25 1423030-11-8 C16H9FO4
Olaparib Impurity 32 Olaparib Impurity 32
Oseltamivir Impurity 23 Oseltamivir Impurity 23 2241125-39-1 C9H16N2O3
Rosuvastatin Impurity 85 Rosuvastatin Impurity 85
Amoxicillin Impurity T Amoxicillin Impurity T C16H19N3O5S
Apremilast Impurity OH Apremilast Impurity OH
Atracurium Impurity T Atracurium Impurity T
Dextrorotation lansoprazole Impurity H Dextrorotation lansoprazole Impurity H
Dextrorotation lansoprazole Impurity M Dextrorotation lansoprazole Impurity M
lansoprazole Impurity 26 lansoprazole Impurity 26
Lincomycin sulfone Impurity 2 Lincomycin sulfone Impurity 2
Palbociclib Impurity 31 Palbociclib Impurity 31 2955712-44-2
Parecoxib Impurity T Parecoxib Impurity T 198471-83-9 C19H18N2O5S
Ropivacaine Impurity 31 Ropivacaine Impurity 31
Ropivacaine Impurity 40 Ropivacaine Impurity 40
Sugammadex sodium Decomposition process Impurity 3 Sugammadex sodium Decomposition process Impurity 3
Sugammadex sodium Org48301 Impurity Sugammadex sodium Org48301 Impurity
Topiroxostat Impurity Ⅱ-3 Topiroxostat Impurity Ⅱ-3
Ivabradine related compound 9 Ivabradine related compound 9 85175-49-1 C12H13NO4
Afatinib impurity 28 Afatinib impurity 28
blonanserin impurity O blonanserin impurity O
Butyphthalide impurity 42 Butyphthalide impurity 42 952412-79-2 C10H12O3
Butyphthalide impurity 48 Butyphthalide impurity 48
Dapoxetine impurity 20 Dapoxetine impurity 20
Empagliflozin Impurity POE Empagliflozin Impurity POE
Febuxostat Impurity 73 Febuxostat Impurity 73
Febuxostat Impurity 78 Febuxostat Impurity 78
Ibrutinib Impurity 21 Ibrutinib Impurity 21 1642571-08-1 C27H30N6O3
Lenvatinib Impurity 22 Lenvatinib Impurity 22
Moxifloxacin Impurity 47 Moxifloxacin Impurity 47
Parecoxib sodium Impurity 35 Parecoxib sodium Impurity 35
Tofacitinib Impurity 20 Tofacitinib Impurity 20 1092578-44-3 C27H31N5O2S
Tofacitinib Impurity 88 Tofacitinib Impurity 88
Vildagliptin Impurity ZA9 Vildagliptin Impurity ZA9
Nintedanib Impurity K Nintedanib Impurity K
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